Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris

Sponsor

Gachon University Gil Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02547597

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There are few data regarding anti-anginal effects between beta-blockers with and without vasodilating property. Beta-blocker without vasodilating property is generally known to have unfavorable effects on glucose and lipid metabolism. Therefore, the investigators compared carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina pectoris.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Pectoris	Drug: Carvedilol Drug: Atenolol	Phase 4

Detailed Description

Previous studies have demonstrated that beta-blockers are effective in reducing not only ischemia but also cardiovascular mortality following myocardial infarction. And, recent guidelines have suggested the potential for use of beta-blockers as first-line agents in chronic stable angina. However, beta-blockers are a diverse class with different mechanisms of action and physiological effects. Various pharmacologic properties that characterize beta-blockers include cardioselectivity, intrinsic sympathomimetic activity, and concomitant vasodilating alpha-adrenoceptor blockade, which might exhibit differential anti-anginal efficacies. In addition, traditional beta-blockers, particularly nonvasodilating beta-blockers, have been reported to have negative metabolic effects, including hyperglycemia, insulin resistance, and dyslipidemia. These unfavorable effects of beta-blockers should be considered in patients with stable angina pectoris, because the pathophysiology of coronary artery disease is associated with abnormalities in glucose and lipid metabolism. Carvedilol, a newer vasodilating beta-blocker, has been shown to differ from traditional beta-blockers in terms of metabolic effects in patients with hypertension and diabetes. However, few data regarding comparative anti-anginal and metabolic effects between beta-blockers with and without vasodilating property have been reported, particularly in patients with angina pectoris. In this study, we simultaneously compared anti-anginal and metabolic effects of carvedilol and atenolol in patients with stable angina pectoris.

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carvedilol Carvedilol 25 mg twice a day	Drug: Carvedilol
Active Comparator: Atenolol Atenolol 50 mg twice a day	Drug: Atenolol

Arm

Intervention/Treatment

Experimental: Carvedilol

Carvedilol 25 mg twice a day

Drug: Carvedilol

Active Comparator: Atenolol

Atenolol 50 mg twice a day

Drug: Atenolol

Outcome Measures

Primary Outcome Measures

Time to 1-mm ST-segment depression [After 25 weeks of treatment]
Time to 1-mm ST-segment depression at exercise treadmill test
Time to onset of angina [After 25 weeks of treatment]
Time to onset of angina at exercise treadmill test

Secondary Outcome Measures

Blood pressure at resting and peak exercise [After 25 weeks of treatment]
Blood pressure at resting and peak exercise during exercise treadmill test
Heart rate at resting and peak exercise [After 25 weeks of treatment]
Heart rate at resting and peak exercise during exercise treadmill test
Lipid profiles [After 25 weeks of treatment]
Lipid profiles: total cholesterol, triglyceride, high-density lipoprotein-cholesterol, and low-density lipoprotein-cholesterol
Glucose metabolism [After 25 weeks of treatment]
Fasting glucose, insulin, HbA1c, Quantitative Insulin-Sensitivity Check Index (QUICKI)
Seattle Angina Questionnaire (SAQ) scores [After 25 weeks of treatment]
Treatment-emergent adverse events [After 25 weeks of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Stable angina pectoris who had a positive exercise treadmill test according to the American College of Cardiology Foundation and the American Heart Association guidelines