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.

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