Clinical trial NCT02547597: Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris
Official title: Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Angina Pectoris
Keywords: Beta-blockers
Anti-anginal effect
Lipid metabolism
Glucose metabolism
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 99
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to 1-mm ST-segment depression
timeFrame: After 25 weeks of treatment
measure: Time to onset of angina
timeFrame: After 25 weeks of treatment
Secondary outcomes:
measure: Blood pressure at resting and peak exercise
timeFrame: After 25 weeks of treatment
measure: Heart rate at resting and peak exercise
timeFrame: After 25 weeks of treatment
measure: Lipid profiles
timeFrame: After 25 weeks of treatment
measure: Glucose metabolism
timeFrame: After 25 weeks of treatment
measure: Seattle Angina Questionnaire (SAQ) scores
timeFrame: After 25 weeks of treatment
measure: Treatment-emergent adverse events
timeFrame: After 25 weeks of treatment
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
References:
citation: Oh PC, Kang WC, Moon J, Park YM, Kim S, Kim MG, Lee K, Ahn T, Shin EK. Anti-Anginal and Metabolic Effects of Carvedilol and Atenolol in Patients with Stable Angina Pectoris: A Prospective, Randomized, Parallel, Open-Label Study. Am J Cardiovasc Drugs. 2016 Jun;16(3):221-8. doi: 10.1007/s40256-016-0168-1.