Open AccessEfficacy of a Once‐Daily Formulation of Carvedilol for the Treatment of Hypertension
Author(s) -
Weber Michael A.,
Bakris George L.,
C Elizabeth A.,
Iyengar Malini,
Fleck Richard,
Sica Domenic A.
Publication year - 2006
Publication title -
the journal of clinical hypertension
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 67
eISSN - 1751-7176
pISSN - 1524-6175
DOI - 10.1111/j.1524-6175.2006.05696.x
Subject(s) - carvedilol , medicine , placebo , blood pressure , ambulatory blood pressure , ambulatory , adverse effect , diastole , anesthesia , cardiology , heart failure , alternative medicine , pathology
β‐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 β‐/α 1 ‐blocker, carvedilol controlled‐release (CR), in hypertensive patients off treatment or while still taking up to 2 (non‐β‐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 ≤.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 ≤.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.