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The efficacy and safety of dilevalol in patients with chronic stable angina pectoris
S P Glasser1, N Bittar, V Kinhal
1Division of Cardiology, University of South Florida College of Medicine, Tampa 33612.
Insights
Dilevalol effectively reduced angina symptoms and silent ischemia in patients with chronic stable angina pectoris. This large clinical trial demonstrated significant improvements with both once-daily and twice-daily dosing, with no major side effects observed.
Area of Science:
- Cardiology
- Clinical Pharmacology
- Pharmacology
Background:
- Chronic stable angina pectoris remains a significant cardiovascular condition.
- Antianginal and anti-ischemic therapies are crucial for managing patient outcomes.
- Dilevalol, the R,R-isomer of labetalol, has potential therapeutic applications.
Purpose of the Study:
- To evaluate the antianginal and acute ischemic effectiveness of dilevalol.
- To assess the safety profile of dilevalol in patients with chronic stable angina.
- To compare fixed-dose regimens of dilevalol administered twice-daily (bid) and once-daily (qd).
Main Methods:
- A multicenter, double-blind, fixed-dose, parallel-group, placebo-controlled clinical trial.
- Patients with chronic stable angina and positive exercise tests were randomized.
- Dosing regimens included placebo, 100 mg, 200 mg, and 400 mg of dilevalol bid or qd for 4 weeks, with exercise testing at peak and trough intervals.
Main Results:
- Significant reductions in anginal frequency and nitroglycerin consumption were observed with both qd and bid dilevalol regimens.
- Exercise duration to angina onset increased, and exercise-induced ST segment depression decreased in a dose-response manner.
- Ambulatory monitoring indicated a reduction in silent ischemia episodes; no significant drug-related side effects were reported.
Conclusions:
- Dilevalol demonstrates significant antianginal and anti-ischemic efficacy in patients with chronic stable angina pectoris.
- Both once-daily and twice-daily fixed-dose regimens were equally effective.
- Dilevalol is safe and well-tolerated for the treatment of chronic stable angina.
Abstract:
This is the first reported large clinical trial of the antianginal and acute ischemic effectiveness and safety of dilevalol (the R, R-isomer of labetalol) in patients with chronic stable angina pectoris. This was a multicenter double blind fixed-dose parallel group placebo controlled trial. Patients with chronic stable angina and positive and reproducible exercise tests (+/- 20%) were included. If randomized, patients entered one of four fixed dose groups (twice a day placebo, 100 mgm, 200 mgm and 400 mgm bid for 2 weeks). Exercise testing was performed at 2 hours (peak) and 12 hours (trough) postdosing. This was followed by a 2-week once-a-day dosing regimen in which patients received the same total daily dose as the prior 2 weeks, with the full dose in the morning and a matched placebo in the evening. Exercise testing was performed at 2 hours (peak) and 24 hours (trough) postdosing. Anginal frequency and NTG consumption were significantly reduced, and equally so, by qd and bid regimens. The time of exercise to the onset of angina increased and the proportion of patients terminating exercise because of moderate angina decreased in a dose response fashion for both peak and trough tests and for both qd and bid regimens. There was also a dose related decrease in exercise induced ST segment depression and an increase in time to 1 mm ST depression. In 15 patients, 24-hour ambulatory monitoring also revealed a decrease in episodes of silent ischemia. No significant side effects related to the study drug occurred.(ABSTRACT TRUNCATED AT 250 WORDS)