Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01260324
• Collaborator: (none)
• Enrollment: 21,283
• Duration (Months): 19

Study Details

Study Description

Brief Summary

The objectives of this study were to: (1) evaluate the natural history of non-arteritic anterior ischemic optic neuropathy (NAION); (2) estimate the population incidence of NAION; and (3) identify potential risk factors for NAION.

Condition or Disease	Intervention/Treatment	Phase
Anterior Ischemic Optic Neuropathy; Ischemic Optic Neuropathy	Other: No intervention given in this observational study; Other: No intervention given in this observational study

Detailed Description

The study population consisted of members of the Ingenix Normative Health Informatics (NHI) Database during 01/01/2003 through 12/31/2007, who were 18 years of age or older with at least 183 days of continuous enrollment in the database and without any doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry.

From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283).

From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)

Study Design

• Study Type: Observational
• Actual Enrollment: 21283 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: The Detection and Epidemiology of NAION in a Commercially Insured Population in the United States.
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
NAION cases From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.	Other: No intervention given in this observational study; No intervention given in this observational study
Controls From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)	Other: No intervention given in this observational study; No intervention given in this observational study

Outcome Measures

Primary Outcome Measures

1. Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age [01-January-2003 up to 31-December-2007]

   Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.

2. Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex [01-January-2003 up to 31-December-2007]

   Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.

3. Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year [01-January-2003 up to 31-December-2007]

   Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.

4. Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region [01-January-2003 up to 31-December-2007]

   Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.

5. Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors [01-January-2003 up to 31-December-2007]

   Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.

6. Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses [01-January-2003 up to 31-December-2007]

   Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).

7. Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use [01-January-2003 up to 31-December-2007]

   Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.

8. Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) [01-January-2003 up to 31-December-2007]

9. Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [01-January-2003 up to 31-December-2007]

   Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.

10. Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [01-January-2003 up to 31-December-2007]

    Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Member of the Ingenix Normative Health Informatics (NHI) Database during 01/01/2003 through 12/31/2007

• 18 years of age or older

• Had at least 183 days of continuous enrollment in the database

• No doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry

Exclusion Criteria:

• Less than 18 years of age

• Less than 183 days of continuous enrollment in the database

• At least one doctor visit associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01260324
• Other Study ID Numbers: A1481282
• First Posted: Dec 15, 2010
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Phosphodiesterase type 5 inhibitors; non-arteritic anterior ischemic optic neuropathy; descriptive epidemiology study
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Ischemia

Study Results

Participant Flow

Arm/Group Title	NAION Cases	Controls
Arm/Group Description	Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.	From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
Period Title: Overall Study
STARTED	1283	20000
COMPLETED	1283	20000
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	NAION Cases	Controls	Total
Arm/Group Description	Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.	From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)	Total of all reporting groups
Overall Participants	1283	20000	21283
Age, Customized (participants) [Number]
18 to 34 years	43 3.4%	5954 29.8%	5997 28.2%
35 to 44 years	59 4.6%	4937 24.7%	4996 23.5%
45 to 54 years	208 16.2%	4655 23.3%	4863 22.8%
55 to 64 years	481 37.5%	3041 15.2%	3522 16.5%
65 to 74 years	247 19.3%	902 4.5%	1149 5.4%
≥75 years	245 19.1%	511 2.6%	756 3.6%
Sex: Female, Male (Count of Participants)
Female	595 46.4%	10669 53.3%	11264 52.9%
Male	688 53.6%	9331 46.7%	10019 47.1%
Number of participants with NAION diagnosis per calendar year (participants) [Number]
Year 2003	285 22.2%	3953 19.8%	4238 19.9%
Year 2004	236 18.4%	3990 20%	4226 19.9%
Year 2005	284 22.1%	4137 20.7%	4421 20.8%
Year 2006	231 18%	4081 20.4%	4312 20.3%
Year 2007	247 19.3%	3839 19.2%	4086 19.2%
Number of participants with NAION diagnosis per region of United States (participants) [Number]
Northeast	100 7.8%	2456 12.3%	2556 12%
Midwest	362 28.2%	5345 26.7%	5707 26.8%
South	656 51.1%	9158 45.8%	9814 46.1%
West	165 12.9%	3041 15.2%	3206 15.1%

Outcome Measures

1. Primary Outcome

Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Combined NAION cases and Controls populations; (n)=number of participants for NAION cases and Controls, respectively, per estimated person-years [(NAION cases n, Controls n) / person-years].

Arm/Group Title	Combined NAION Cases and Controls
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).
Measure Participants	21283
Age 18 to 34 (n=43, 5,954) / 8,042,997	0.01
Age 35 to 44 (n=59, 4,937) / 6,669,176	0.01
Age 45 to 54 (n=208, 4,655) / 6,288,235	0.03
Age 55 to 64 (n=481, 3,041) / 4,107,953	0.12
Age 65 to 74 (n=247, 902) / 1,218,472	0.20
Age ≥75 (n=245, 511) / 690,287	0.35

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Age 18 to 34
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; 0.01 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Age 35 to 44
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; 0.01 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Age 45 to 54
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; 0.03 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Age 55 to 64
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; 0.07 to 0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Age 65 to 74
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; 0.11 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Age ≥75
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; 0.15 to 0.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Age 18 to 34
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; 0.06 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Age 35 to 44
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; 0.08 to 0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Age 45 to 54
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 95%; 0.30 to 0.45
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Age 65 to 74
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.83
	Confidence Interval	(2-Sided) 95%; 2.68 to 5.47
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Age ≥75
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.73
	Confidence Interval	(2-Sided) 95%; 4.00 to 8.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

2. Primary Outcome

Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex
Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].

Arm/Group Title	Combined NAION Cases and Controls
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).
Measure Participants	21283
Female (n=595, 10,669) / 14,412,283	0.04
Male (n=688, 9,331) / 12,604,837	0.05

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Female
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Male
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.05 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Male
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.83
	Confidence Interval	(2-Sided) 95%; 1.50 to 2.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

3. Primary Outcome

Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year
Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].

Arm/Group Title	Combined NAION Cases and Controls
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).
Measure Participants	21283
Year 2003 (n=285, 3953) / 5,339,934	0.05
Year 2004 (n=236, 3,990) / 5,389,915	0.04
Year 2005 (n=284, 4,137) / 5,588,491	0.05
Year 2006 (n=231, 4,081) / 5,512,843	0.04
Year 2007 (n=247, 3,839) / 5,185,936	0.05

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Year 2003
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Year 2004
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Year 2005
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Year 2006
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Year 2007
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Year 2004
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.61 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Year 2005
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Year 2006
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.68 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Year 2007
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

4. Primary Outcome

Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region
Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].

Arm/Group Title	Combined NAION Cases and Controls
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).
Measure Participants	21283
Northeast (n=100, 2,456) / 3,317,702	0.03
Midwest (n=362, 5,345) / 7,220,325	0.05
South (n=656, 9,158) / 12,371,139	0.05
West (n=165, 3,041) / 4,107,953	0.04

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Northeast
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Midwest
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate South
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.05 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate West
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Northeast
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 95%; 0.31 to 0.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Midwest
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; 0.56 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio West
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.57 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

5. Primary Outcome

Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Description	Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Combined population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years]. Only the covariates selected by the step wise regression procedure were summarized.

Arm/Group Title	Combined NAION Cases and Controls
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).
Measure Participants	21283
Diabetes (n=349, 1,131) / 1,527,818	0.23
Smoking (n=48, 232) / 313,399	0.15
Obesity (n=25, 273) / 368,784	0.07
Nitrates (n=71, 171) / 230,996	0.31
Anti-platelet agents (n=127, 182) / 245,856	0.52
Diuretics (n=134, 296) / 399,853	0.34
Recent PDE-5 inhibitors use (n=17, 202) / 272,873	0.06

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Diabetes
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; 0.08 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Smoking
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; 0.08 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Obesity
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; 0.03 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Nitrates
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; 0.06 to 0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Anti-platelet agents
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95%; 0.12 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Diuretics
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; 0.09 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Recent PDE-5 inhibitors use
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; 0.01 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Diabetes
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.82
	Confidence Interval	(2-Sided) 95%; 1.47 to 2.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Smoking
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.34
	Confidence Interval	(2-Sided) 95%; 0.63 to 2.85
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Obesity
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 95%; 0.23 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Nitrates
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; 0.42 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Anti-platelet agents
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.12
	Confidence Interval	(2-Sided) 95%; 1.53 to 2.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Diuretics
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.24
	Confidence Interval	(2-Sided) 95%; 1.46 to 3.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Recent PDE-5 inhibitors use
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 95%; 0.31 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

6. Primary Outcome

Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].

Arm/Group Title	Combined NAION Cases and Controls
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).
Measure Participants	21283
Other retinal disorders (n=337, 240) / 324,205	1.04
Glaucoma (n=161, 353) / 476,852	0.34
Cataract (n=245, 405) / 547,097	0.45
Visual disturbances (n=291, 130) / 175,611	1.66
Blindness and low vision (n=103, 11) / 14,859	6.93
Other disorders of eye (n=143, 201) / 271,522	0.53
Occlusion / Stenosis (n=98, 75) / 101,314	0.97
Acute sinusitis (n=92, 1,123) / 1,517,011	0.06
Other dermatoses (n=114, 536) / 724,059	0.16
Bone and cartilage (n=114, 504) / 680,831	0.17
Head and neck (n=181, 771) / 1,041,510	0.17
Ill defined / Unknown causes (n=71, 183) / 247,207	0.29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Other retinal disorders
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95%; 0.28 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Glaucoma
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; 0.11 to 0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Cataract
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 95%; 0.08 to 0.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Visual disturbances
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Blindness and low vision
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	2.00
	Confidence Interval	(2-Sided) 95%; 1.60 to 2.46
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Other disorders of eye
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95%; 0.16 to 0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Occlusion and stenosis of precerebral arteries
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; 0.18 to 0.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Acute sinusitis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; 0.05 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Other dermatoses
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; 0.05 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Other disorders of bone and cartilage
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; 0.06 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Symptoms involving head and neck
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; 0.10 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Other ill defined and unknown causes of morbidity and mortality
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; 0.10 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Other retinal disorders
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.65
	Confidence Interval	(2-Sided) 95%; 4.72 to 9.38
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Glaucoma
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.60
	Confidence Interval	(2-Sided) 95%; 1.77 to 3.81
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Cataract
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.68
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Visual disturbances
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	14.20
	Confidence Interval	(2-Sided) 95%; 10.40 to 19.30
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Blindness and low vision
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	15.10
	Confidence Interval	(2-Sided) 95%; 6.60 to 34.50
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Other disorders of eye
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.02
	Confidence Interval	(2-Sided) 95%; 1.44 to 2.82
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Occlusion and stenosis of precerebral arteries
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; 0.64 to 2.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Acute sinusitis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.29
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.74
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Other dermatoses
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.34
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.77
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Other disorders of bone and cartilage
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.77
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Symptoms involving head and neck
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.37
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Odds ratio Ill defined and unknown causes of morbidity and mortality
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.64
	Confidence Interval	(2-Sided) 95%; 1.08 to 2.49
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

7. Primary Outcome

Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use
Description	Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Combined NAION cases and Controls populations. N=number of participants according to frequency of PDE-5 inhibitor use for males 40 years or older; (n)=number of participants for NAION cases and Controls, respectively, per variable of frequency of use and estimated person-years [(n=NAION cases, Controls) / person-years].

Arm/Group Title	Combined NAION Cases and Controls
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).
Measure Participants	6219
Recent use (n=17, 187) / 254,239	0.05
Any use (n=32, 322) / 437,780	0.06
Chronic use (n=16, 162) / 220,249	0.06
Non-chronic use (n=16, 160) / 217,530	0.07
Never use (n=631, 5,234) / 7,115,962	0.09

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Recent use
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.03 to 0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Any use (includes chronic and non-chronic use)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Chronic use
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.03 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Non-chronic use
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; 0.03 to 0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Combined NAION Cases and Controls
	Comments	Incidence rate Never use
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate per 1000 person-years
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; 0.08 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

8. Primary Outcome

Title	Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Participants from the NAION cases population adjudicated by medical record review.

Arm/Group Title	NAION Cases
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
Measure Participants	74
Acute	35 2.7%
Intermittent	3 0.2%
Chronic	1 0.1%
Unknown	35 2.7%

9. Primary Outcome

Title	Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Description	Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with resolution of visual symptoms (each set of variables); (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].

Arm/Group Title	NAION Cases
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
Measure Participants	57
Age 18 to 64 years (n=18) / 25.53	1.00
Age ≥65 years (n=9) / 29.94	0.56
Female (n=14) / 31.69	1.00
Male (n=13) / 23.77	1.22

10. Primary Outcome

Title	Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Description	Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
Time Frame	01-January-2003 up to 31-December-2007

Outcome Measure Data

Analysis Population Description

Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with recurrence of visual symptoms; (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].

Arm/Group Title	NAION Cases
Arm/Group Description	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
Measure Participants	74
Age 18 to 64 years (n=2) / 66.63	1.00
Age ≥65 years (n=1) / 57.39	0.62
Female (n=1) / 66.05	1.00
Male (n=2) / 57.97	2.03

Adverse Events

Time Frame	1-January-2003 up to 31-December-2007
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	NAION Cases		Controls
Arm/Group Description	Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.		From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
All Cause Mortality
	NAION Cases		Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	NAION Cases		Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1283 (0%)		0/20000 (0%)
Other (Not Including Serious) Adverse Events
	NAION Cases		Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1283 (0%)		0/20000 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.