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COMPARE: Two preparations of carvedilol comparable in patients with HF
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Two preparations of carvedilol given to patients with heart failure were found nearly bioequivalent.
Researchers for the Study to Compare the Effects of Coreg CR and Coreg IR on HF in Subjects with Stable Chronic HF (COMPARE) trial evaluated changes in left ventricular end systolic volume index when taking carvedilol controlled-release (Coreg CR, GlaxoSmithKline) compared with carvedilol instant-release (Coreg IR, GlaxoSmithKline).
“The formulation of carvedilol demonstrating efficacy in the randomized clinical trials was an immediate-release preparation requiring twice-daily administration,” said Barry H. Greenberg, MD, professor of medicine at the University of California, San Diego, School of Medicine and a member of the Cardiology Today Editorial Board. “A new controlled-release preparation of carvedilol has been approved by the FDA for treating hypertension, post-MI, LV dysfunction and HF, but it was based on pharmacodynamic and pharmacokinetic assessment of equivalents. Whether the instant-release or controlled-release preparations have comparable long-term effects in an HF population has not been studied.”
The researchers enrolled 253 patients with stable chronic HF into active comparator groups to receive daily either a carvedilol instant-release (n=128) or carvedilol controlled-release (n=125) preparation. According to Greenberg, the primary endpoint of LV end systolic volume was met, and the carvedilol controlled-release preparation demonstrated noninferiority to the carvedilol instant-release preparation.
“These findings demonstrate comparable efficacy between the controlled-release and instant-release preparations, and this supports the use of carvedilol controlled-release and instant release in patient with systolic HF,” Greenberg said.
Results also suggested that the two preparations were comparable in several secondary endpoints and in biomarkers.
For more information:
- Greenberg B. Results of a multicenter, randomized, double-blind, double-dummy parallel group study to compare effects of Coreg CR and Coreg IR on LV and systolic volume index in subjects with chronic heart failure. LBCT I.
One of the things we should not lose sight of are the impressive overall findings, in that both carvedilol instant-release and controlled-release produced impressive improvements in LV ejection fraction from baseline, with an 8% absolute increase in LVEF with both formulations. Both carvedilol CR preparations produced impressive improvements in other measures of LV structure and function, including diastolic function, as well as impressive reductions in brain natriuretic peptide levels from baseline at approximately 36%.
– Gregg C. Fonarow, MD
Professor of medicine and director of the Ahmanson Cardiomyopathy Center, UCLA