Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00730132
• Collaborator: (none)
• Enrollment: 712
• Duration (Months): 19

Study Details

Study Description

Brief Summary

This study is being performed to evaluate what variants of lipid-lowering therapy are used in Russian clinical practice in coronary heart disease (CHD) patients with hypercholesterolemia in whom the initial statin therapy did not achieve low density lipoprotein-cholesterol (LDL-C) goals. Additionally, the efficacy and safety of all variants of modified lipid-lowering therapy are to be evaluated.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease; Hypercholesterolemia	Drug: Ezetimibe; Drug: Statin

Detailed Description

Given the observational nature of this study and that the assessment of a specific hypothesis is not foreseen, statistical assumption is not planned and the sample size calculation was not performed.

Taking into consideration the available data on the established safety profile of the therapy with statins and combination of ezetimibe with statins it has been suggested that a sample size of 750 patients will be sufficient to identify adverse events profile.

The treatment effects will be characterized by descriptive and frequency parameters.

Study Design

• Study Type: Observational
• Actual Enrollment: 712 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Study of Approaches to Lipid-lowering Therapy in Russian Patients With Coronary Heart Disease (<<Treat to Goal>>)
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
New Statin Group 1 - Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) whose lipid-lowering therapy was modified by transition to a new statin treatment	Drug: Statin; Statin titration for the Statin Dose Titration group, and new statin treatment and dosage for the New Statin group, determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients
Statin Dose Titration Group 2 - Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) whose lipid-lowering therapy was modified by increasing the dose of ongoing statin treatment	Drug: Statin; Statin titration for the Statin Dose Titration group, and new statin treatment and dosage for the New Statin group, determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients
Ezetimibe added to existing statin Group 3 - Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin treatment	Drug: Ezetimibe; Dosage determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients; Other Names: SCH 58235 Ezetrol

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin. [During the study]

   Statins included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration . 2. shift to a (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) different statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).

2. Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation [Visit 2 (Month 2, end of observation)]

   Statins included in this outcome measure included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration. 2. shift to a different (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).

3. Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation [Visit 2 (Month 2, end of observation)]

4. Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups [Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)]

5. Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups [Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and Female, from 18 to 75 years old;

• Established diagnosis of CHD;

• Previous (at least, within 1 month before inclusion in the present study) treatment with statin;

• Levels of plasma TC and LDL-C above the recommended target values

(TC> 4.5 mmol\L; LDL-C> 2.5 mmol/L);

• The written informed consent signed prior to the start of participation in the study.

Exclusion Criteria:

• Contraindications for statin and ezetimibe (Ezetrol) administration in accordance with local Russian Federation medical instructions.

• Patients refused to participate in the study and/or did not sign informed consent form.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00730132
• Other Study ID Numbers: P05464
• First Posted: Aug 8, 2008
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia; Ezetimibe

Study Results

Participant Flow

Arm/Group Title	Enrolled Patients
Arm/Group Description	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
Period Title: Overall Study
STARTED	712
COMPLETED	557
NOT COMPLETED	155

Baseline Characteristics

Arm/Group Title	Enrolled Patients
Arm/Group Description	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
Overall Participants	712
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.57 (9.367)
Sex/Gender, Customized (participants) [Number]
Female	324 45.5%
Male	386 54.2%
Not Reported	2 0.3%
Region of Enrollment (participants) [Number]
Russian Federation	712 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin.
Description	Statins included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration . 2. shift to a (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) different statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).
Time Frame	During the study

Outcome Measure Data

Analysis Population Description

The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol violations were recorded. One subject each from ezetimibe added to existing statin and new statin group were excluded (missing data)

Arm/Group Title	All Participants Analyzed
Arm/Group Description	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C. A participant was included in the study in case the lipid lowering therapy was modified in one of the following options: 1- statin dose (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) titration, 2- administration of a new statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin), 3- administration of ezetimibe in addition to current statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) therapy.
Measure Participants	557
Statin dose titration	32.1
New statin administered	42.4
Ezetimibe added on to existing statin	25.5

2. Primary Outcome

Title	Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation
Description	Statins included in this outcome measure included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration. 2. shift to a different (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).
Time Frame	Visit 2 (Month 2, end of observation)

Outcome Measure Data

Analysis Population Description

The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.

Arm/Group Title	Ezetimibe Added to Existing Statin	Statin Dose Titration	New Statin
Arm/Group Description	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
Measure Participants	141	179	235
Number [Percentage of patients]	50.4	33.5	37.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Participants Analyzed, Statin Dose Titration, New Statin
	Comments	Significance of the differences in the number of patients per group who achieved goal TC levels on Visit 2.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Pearson Chi-Square
	Comments

3. Primary Outcome

Title	Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation
Time Frame	Visit 2 (Month 2, end of observation)

Outcome Measure Data

Analysis Population Description

The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded.

Arm/Group Title	Ezetimibe Added to Existing Statin	Statin Dose Titration	New Statin
Arm/Group Description	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
Measure Participants	142	179	235
Number [Percentage of patients]	42.3	26.3	33.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Participants Analyzed, Statin Dose Titration, New Statin
	Comments	Significance of paired changes in the number of patients who achieved LDL-C target levels on Visit 2, for each treatment group comparison
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Chi square, continuity corrected. Asymptotic significance.
	Method	McNemar
	Comments

4. Primary Outcome

Title	Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups
Time Frame	Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)

Outcome Measure Data

Analysis Population Description

The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.

Arm/Group Title	Ezetimibe Added to Existing Statin	Statin Dose Titration	New Statin
Arm/Group Description	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
Measure Participants	141	179	235
Mean (Standard Deviation) [mmol/L]	25.76 (12.306)	20.01 (15.662)	22.82 (14.035)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Participants Analyzed
	Comments	Descriptive statistics of relative (%) change in TC levels from Baseline at Visit 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.7570
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 12.30606
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Statin Dose Titration
	Comments	Descriptive statistics of relative (%) change in TC from baseline at Visit 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.00
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 15.662
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	New Statin
	Comments	Descriptive statistics of relative (%) change in TC from baseline at Visit 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	22.8181
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 14.03545
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Statin Dose Titration, New Statin
	Comments	Statin Dose Titration compared to New Statin
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.143
	Comments
	Method	Games-Howell
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.80928
	Confidence Interval	(2-Sided) 95%; -6.3070 to .6884
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.48621
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	All Participants Analyzed, Statin Dose Titration
	Comments	Statin Dose Titration compared to Ezetimbe
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	Games-Howell
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.74811
	Confidence Interval	(2-Sided) 95%; -9.4298 to -2.0664
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.56351
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	All Participants Analyzed, New Statin
	Comments	New Statin compared to Ezetimibe
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.086
	Comments
	Method	Games-Howell
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.93883
	Confidence Interval	(2-Sided) 95%; -6.1948 to .3171
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.38286
	Estimation Comments

5. Primary Outcome

Title	Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups
Time Frame	Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)

Outcome Measure Data

Analysis Population Description

The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.

Arm/Group Title	Ezetimibe Added to Existing Statin	Statin Dose Titration	New Statin
Arm/Group Description	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
Measure Participants	142	179	235
Mean (Standard Deviation) [mmol/L]	32.06 (15.590)	26.81 (19.852)	28.24 (20.787)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Statin Dose Titration
	Comments	Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	26.8174
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 19.85205
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	New Statin
	Comments	Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	28.2488
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 20.78727
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	All Participants Analyzed
	Comments	Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	32.0665
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 15.59010
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Statin Dose Titration, New Statin
	Comments	Statin Dose Titration compared to New Statin
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.756
	Comments
	Method	Games-Howell
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.43138
	Confidence Interval	(2-Sided) 95%; -6.1604 to 3.2977
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.01009
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	All Participants Analyzed, Statin Dose Titration
	Comments	Statin Dose Titration compared to Ezetimibe
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.023
	Comments
	Method	Games-Howell
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.24911
	Confidence Interval	(2-Sided) 95%; -9.9072 to -.5910
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.97821
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	All Participants Analyzed, New Statin
	Comments	New Statin compared to Ezetimibe
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.107
	Comments
	Method	Games-Howell
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.81773
	Confidence Interval	(2-Sided) 95%; -8.2523 to .6169
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.88425
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	Adverse Events (AEs) and Serious Adverse Events (SAEs) are represented for all treatment subjects (n=712) not by treatment group because in this observational study the three treatment group populations cannot be clearly identified for a substantial number of subjects.
Arm/Group Title	Enrolled Patients
Arm/Group Description	Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
All Cause Mortality
	Enrolled Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Enrolled Patients
	Affected / at Risk (%)	# Events
Total	3/712 (0.4%)
Cardiac disorders
Cardiac asthma	1/712 (0.1%)	1
Cardiac failure congestive	1/712 (0.1%)	1
Coronary artery disease	1/712 (0.1%)	1
Gastrointestinal disorders
Gastric hemorrhage	1/712 (0.1%)	1
Nervous system disorders
Hypotonia	1/712 (0.1%)	1
Surgical and medical procedures
Vascular graft	1/712 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Enrolled Patients
	Affected / at Risk (%)	# Events
Total	0/712 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

A disclosure agreement restricts the rights on publications within 5 years after the document is signed off. The Clinical Trial Agreement restricts the rights on publication within 5 years after the trial completion.