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Published on: July 9, 2020
Controlled-release carvedilol in the treatment of essential hypertension
Michael A Weber1, Domenic A Sica, Elizabeth A Tarka
1Department of Medicine, State University of New York Downstate College of Medicine, New York, New York 10170, USA. michaelwebermd@cs.com
Insights
This study shows that once-daily, controlled-release carvedilol effectively lowers blood pressure over 24 hours in patients with hypertension. The new formulation demonstrated significant reductions in both systolic and diastolic blood pressure compared to placebo.
Area of Science:
- Pharmacology
- Cardiovascular Medicine
- Clinical Trials
Background:
- Carvedilol is an established adrenergic blocker for hypertension.
- A novel once-daily, controlled-release (CR) formulation of carvedilol has been developed.
- Previous studies indicated the efficacy of this new formulation.
Purpose of the Study:
- To evaluate the efficacy and safety of a once-daily, controlled-release (CR) carvedilol formulation in treating essential hypertension.
- To compare the antihypertensive effects of three different doses of carvedilol CR against a placebo.
- To assess the 24-hour blood pressure control, including trough and peak effects, heart rate, and pulse pressure.
Main Methods:
- A double-blind, randomized, multicenter, placebo-controlled, parallel-group study involving 338 patients with essential hypertension.
- Patients received carvedilol CR (20, 40, or 80 mg) or placebo once daily for 6 weeks.
- Ambulatory blood pressure monitoring (ABPM) was used to assess 24-hour mean blood pressure, as well as trough and peak blood pressure levels.
Main Results:
- Once-daily carvedilol CR significantly reduced both diastolic blood pressure (DBP) and systolic blood pressure (SBP) compared to placebo across all measured parameters (trough, peak, and 24-hour mean).
- Placebo-corrected trough-to-peak ratios for DBP exceeded 0.6 for all carvedilol CR doses, indicating sustained 24-hour control.
- Carvedilol CR also led to significant reductions in heart rate and pulse pressure compared to placebo.
Conclusions:
- Once-daily, controlled-release carvedilol is a highly effective antihypertensive medication.
- The formulation provides continuous 24-hour blood pressure control with a clear dose-related peak effect.
- Carvedilol CR offers a valuable treatment option for patients with essential hypertension.
Abstract:
Carvedilol is a beta1-, beta2-, and alpha1-adrenergic blocker that is approved for the treatment of hypertension. A new once-daily, controlled-release (CR) formulation of carvedilol has been shown to be effective in a double-blind, randomized, multicenter, placebo-controlled, parallel-group study. In this article, we summarize the primary results of, and present additional analyses from, that trial. A total of 338 patients with essential hypertension (sitting diastolic blood pressure [DBP] >/=90 and =109 mm Hg) were randomized to receive carvedilol CR 20, 40, or 80 mg or placebo for 6 weeks. The primary objective was to compare the effects of the 3 carvedilol CR doses with placebo on 24-hour mean blood pressure using ambulatory blood pressure monitoring (ABPM). Mean DBP and systolic BP (SBP) at the drug trough (20-24 hour) blood levels for carvedilol CR and comparison of DBP and SBP at the drug peak (3-7 hour) blood levels for each dose of carvedilol CR and placebo were investigated. The effects of carvedilol CR on heart rate and pulse pressure were also examined. Once-daily administration of carvedilol CR, alone or in combination with other agents, produced clinically and statistically significant reductions compared with placebo for both DBP and SBP after 6 weeks of treatment for the following parameters: trough blood pressure by office cuff or ABPM measurements, peak blood pressure by ABPM, and 24-hour mean blood pressure by ABPM. Placebo-corrected trough-to-peak ratios for DBP were >0.6 for each carvedilol CR dose. Heart rate and pulse pressure were each significantly reduced compared with placebo for each carvedilol CR dose. We conclude that carvedilol CR is a very effective antihypertensive agent with clear dose-related peak blood pressure reduction and continuous 24-hour control.
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