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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stable Angina Pectoris

Intervention / Treatment
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* Drug: Carvedilol
* Drug: Atenolol


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Acute coronary syndrome Coronary revascularization within the past 3 months Asthma or chronic obstructive lung disease Bradycardia (heart rate < 55 beat/min) History of severe adverse reaction to beta-blockers Symptomatic arrhythmia requiring anti-arrhythmia therapy Heart failure Severe renal or hepatic failure

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carvedilol<br>Carvedilol 25 mg twice a day | Drug: Carvedilol<br> <br> |
| Active Comparator: Atenolol<br>Atenolol 50 mg twice a day | Drug: Atenolol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to 1-mm ST-segment depression | Time to 1-mm ST-segment depression at exercise treadmill test | After 25 weeks of treatment | 
| Time to onset of angina | Time to onset of angina at exercise treadmill test | After 25 weeks of treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta-blockers, Anti-anginal effect, Lipid metabolism, Glucose metabolism