Efficacy of a once-daily formulation of carvedilol for the treatment of hypertension

J Clin Hypertens (Greenwich). 2006 Dec;8(12):840-9. doi: 10.1111/j.1524-6175.2006.05696.x.


Beta-blockers with pharmacologic effects that differ from conventional agents might add to antihypertensive treatment options. This study evaluated a new once-daily formulation of the beta-/alpha1-blocker, carvedilol controlled-release (CR), in hypertensive patients off treatment or while still taking up to 2 (non-beta-blocker) agents. After a 4-week run-in phase, patients were randomized either to placebo (n=76) or carvedilol CR 20 mg (n=82), 40 mg (n=76), or 80 mg (n=86) once daily. After 6 weeks of treatment, ambulatory blood pressure monitoring was repeated to measure the primary end point of changes in mean 24-hour diastolic blood pressure. During treatment, 24-hour diastolic blood pressure fell in the placebo and carvedilol CR 20-mg, 40-mg, and 80-mg groups by (mean +/- SE) 0.4+/-0.9, 4.4+/-0.9, 7.9+/-0.9, and 9.6+/-0.9 mm Hg, respectively (P< or =.001, trend test for all carvedilol CR doses with placebo). Corresponding 24-hour systolic blood pressure changes were 0.6+/-1.4, 6.8+/-1.3, 10.1+/-1.4, and 12.5+/-1.3 mm Hg, respectively (P< or =.001, trend test). Diastolic blood pressure trough-to-peak ratios (placebo-corrected) based on ambulatory blood pressure monitoring (trough = mean of 20- to 24-hour post-dose readings; peak = mean of 3- to 7-hour post-dose readings) for 20-mg, 40-mg, and 80-mg doses were 0.73, 0.64, and 0.65, respectively. Adverse events, including clinical chemistry values, were similar in the drug-treated and placebo groups. Carvedilol CR has a clinically meaningful defined dose-dependent antihypertensive effect that persists throughout a 24-hour period.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / therapeutic use*
  • Blood Pressure
  • Canada
  • Carbazoles / administration & dosage
  • Carbazoles / therapeutic use*
  • Carvedilol
  • Delayed-Action Preparations
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Hypertension / drug therapy*
  • Hypertension / physiopathology
  • Male
  • Middle Aged
  • Propanolamines / administration & dosage
  • Propanolamines / therapeutic use*
  • Treatment Outcome
  • United States


  • Antihypertensive Agents
  • Carbazoles
  • Delayed-Action Preparations
  • Propanolamines
  • Carvedilol