New Analysis Details Cardiovascular Protective Benefits of Carvedilol In Heart Failure Patients

Patients with heart failure who received the heart medication carvedilol suffered fewer heart attacks and strokes and were less likely to die of these and other vascular events than patients prescribed another beta blocker, metoprolol tartrate. Study investigators looked at whether the effects on vascular events contributed to the beneficial effect of carvedilol in the COMET trial, the longest and largest mortality trial comparing beta-blockers in heart failure patients. Among its key findings, the analysis documented that carvedilol reduced the risk of heart attacks, unstable angina, or stroke by 19% (p = .017). During the study, 106 of the 160 patients on metoprolol tartrate who had a nonfatal heart attack or stroke later died, while 61 of 124 patients on carvedilol who had a nonfatal heart attack or stroke later died.

COMET was a double-blind, randomized parallel group study designed to compare the effects of carvedilol with those of metoprolol tartrate on the risk of death and hospitalizations in patients with congestive heart failure. The study included more than 3,000 patients with heart failure primarily due to ischemic or dilated cardiomyopathy. Study participants were followed for an average of 58 months. According to COMET investigators, the study results suggested that the use of carvedilol in patients with heart failure extended median survival by 1.4 years.*

*The Carvedilol Or Metoprolol European Trial (COMET) compared carvedilol (target dose: 25 mg bid) to metoprolol tartrate (target dose: 50 mg bid). It is not known whether this formulation of metoprolol at any dose or this low dose of metoprolol in any formulation has any effect on survival or hospitalization in patients with heart failure. Metoprolol tartrate is not indicated in the United States for heart failure. COMET did not compare carvedilol to metoprolol succinate (Toprol-XL®*). The efficacy of carvedilol versus metoprolol succinate in heart failure has not been established in a head-to-head outcomes study. The target dose of metoprolol succinate in heart failure is 200 mg qd. Thus this trial extends the time over which carvedilol manifests benefits on survival in heart failure, but it is not evidence that carvedilol improves outcome over the formulation of metoprolol (Toprol-XL) with benefits in heart failure.

COMET data are based on a formulation of carvedilol that patients must take twice-a-day. The FDA recently approved a once-a-day formulation of carvedilol, which is bioequivalent to the twice-a-day version and delivers the appropriate amount of medicine over a 24-hour span. GSK anticipates making this once-a-day heart medication available to physicians and their patients later this month as Coreg CRTM (carvedilol phosphate) Extended-Release Capsules.

About Carvedilol
Carvedilol is marketed by GlaxoSmithKline in the United States as Coreg (carvedilol) and COREG CR. It is the only beta-blocking agent FDA-approved to improve survival in patients with mild to severe heart failure. It also is the only beta-blocker the FDA has approved to reduce cardiovascular mortality in patients who had a heart attack that reduced how well the heart pumps.

COREG CR and COREG are approved to increase survival in patients with heart failure, reduce the risk of death in patients who had a heart attack that reduced how well the heart pumps, and treat hypertension, also known as high blood pressure.
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FACT:
The prevalence of chronic kidney disease is on the rise, according to CDC: In the period from 1999 to 2004, 16.8% of the U.S. population ages 20 and older had chronic kidney disease, up from 14.5% in the period from 1988 to 1994. The difference represents a 15.9% increase based on crude estimates of prevalence.  As would be expected, the prevalence of chronic kidney disease was greater among older men and women, and among those with diabetes, cardiovascular disease, and hypertension. In addition, Mexican Americans and non-Hispanic blacks had a greater prevalence of chronic kidney disease, particularly stage 1 disease, than non-Hispanic whites. “The large disparity in prevalence among those with stage 1 chronic kidney disease might be explained, in part, by racial/ethnic differences in microalbuminuria among non-Hispanic blacks and Mexican Americans. According to the CDC, both the incidence and prevalence of end-stage renal disease have increased during the past 30 year, and both are expected to continue increasing through the year 2010.