Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01332487
• Collaborator: (none)
• Enrollment: 4,068

Study Details

Study Description

Brief Summary

This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: 5ARI + AB

Study Design

• Study Type: Observational
• Actual Enrollment: 4068 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Early initiation of 5ARI therapy Patients starting 5ARI therapy within 30 days of initiating AB therapy	Drug: 5ARI + AB; 5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
Delayed initiation of 5ARI therapy Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy	Drug: 5ARI + AB; 5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experienced Progression of Disease [Up to 5 months]

   The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.

Secondary Outcome Measures

1. Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male

• aged 50 years or older

• diagnostic claim for BPH

• prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).

• continuously eligible for 6 months prior to and 12 months after index prescription date

Exclusion Criteria:

• prostate or bladder cancer during the study period

• any prostate-related surgical procedure within 5 months of the index prescription date

• prescription claim for finasteride 1 mg for male pattern baldness during the study period

• 5ARI therapy prior to initiation of AB therapy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01332487
• Other Study ID Numbers: 114461
• First Posted: Apr 11, 2011
• Last Update Posted: Jun 19, 2017
• Last Verified: May 1, 2017

• Keywords provided by GlaxoSmithKline: 5-alpha-reductase inhibitor; prostate surgery; alpha-blocker; enlarged prostate; acute urinary retention; Benign prostatic hyperplasia
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

Participant Flow

Pre-assignment Detail	Participants were neither recruited nor enrolled in this retrospective observational study. Data from medical records or insurance claims databases were anonymized.

Arm/Group Title	Early Treatment	Delayed Treatment
Arm/Group Description	Participants who started 5-alpha-reductase inhibitor (5ARI) therapy within 30 days of initiating alpha-blocker (AB) treatment	Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
Period Title: Overall Study
STARTED	5554	3063
COMPLETED	5554	3063
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Early Treatment	Delayed Treatment	Total
Arm/Group Description	Participants who started 5ARI therapy within 30 days of initiating AB treatment	Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment	Total of all reporting groups
Overall Participants	5554	3063	8617
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.7 (10.2)	67.8 (10.1)	68.4 (10.2)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	5554 100%	3063 100%	8617 100%
Mean Charlson Comorbidity Index Scores (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	1.03 (1.63)	0.86 (1.41)	0.97 (1.56)
Mean Benign Prostatic Hyperplasia (BPH) Disease Stage Scores (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	0.90 (1.11)	0.79 (0.98)	0.86 (1.07)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced Progression of Disease
Description	The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.
Time Frame	Up to 5 months

Outcome Measure Data

Analysis Population Description

Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP)

Arm/Group Title	Early Treatment	Delayed Treatment
Arm/Group Description	Participants who started 5ARI therapy within 30 days of initiating AB treatment	Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
Measure Participants	5554	3063
Acute Urinary Retention	589 10.6%	393 12.8%
Surgery	280 5%	212 6.9%
Emergency Surgery	86 1.5%	52 1.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Early Treatment, Delayed Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	Acute Urinary Retention
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Early Treatment, Delayed Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.000
	Comments	Surgery
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Early Treatment, Delayed Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.597
	Comments	Emergency Surgery
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP). Only those participants who were treated with surgery within 182 days of the first prescription of 5ARI were analyzed.

Arm/Group Title	Early Treatment	Delayed Treatment
Arm/Group Description	Participants who started 5ARI therapy within 30 days of initiating AB treatment	Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
Measure Participants	106	68
On the same day	37 0.7%	27 0.9%
Within 1 week	54 1%	35 1.1%
Within 1 month	85 1.5%	51 1.7%
Within 2 months	102 1.8%	60 2%
Within 3 months	105 1.9%	64 2.1%
Within 4 months	105 1.9%	66 2.2%
Within 5 months	105 1.9%	68 2.2%
Within 6 months (182 days)	106 1.9%	68 2.2%

Adverse Events

Adverse Event Reporting Description	This was a survey of participants, and adverse event/serious adverse event information was not captured in the study.
Arm/Group Title	Early Treatment		Delayed Treatment
Arm/Group Description	Participants who started 5ARI therapy within 30 days of initiating AB treatment		Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
All Cause Mortality
	Early Treatment		Delayed Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Early Treatment		Delayed Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Early Treatment		Delayed Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.