In: Health8 Jul 2010
Speaker: Hugo A. Katus, MD, Professor of Medicine, Universitaets-Klinkenshubeck, Luebeck, Germany.
Meeting Highlights: American College of Cardiology
A subgroup analysis of data from the COPERNICUS (Carvedilol Prospective Randomized Cumulative Survival) trial demonstrated that treatment with the beta blocker carvedilol (Glaxo SmithKline) is effective and well-tolerated in patients with severe heart failure (HF) symptoms and an extremely depressed left ventricular ejection fraction (LVEF).
Overall, the study encompassed 2,289 HF patients with symptoms at rest or minimal exertion and an LVEF of less than 25%, who were randomly assigned to placebo or carvedilol and followed for up to 29 months. The primary end-point was death from any cause; treatment with canadian carvedilol resulted in a highly significant decrease of 35%. Despite the demonstrated survival benefit of beta blockers in HF, many physicians still avoid the use of these drugs in patients with extremely depressed LVEF because of the belief that such patients might be adversely affected by beta-blocker treatment. This analysis, therefore, was carried out to determine the value of carvedilol under such circumstances.
Of the total COPERNICUS population, 371 patients had a baseline LEVF of less than 15%. These patients had a lower mean systolic blood pressure (117 mm Hg) than other persons in the study (125 mm Hg) and were more likely to be given digitalis (75% vs. 65%) than patients with higher LVEF.
Other baseline characteristics were similar in both patient populations. The effects of carvedilol on all-cause mortality in patients with LVEF of less than 15% was comparable to that seen in patients with higher LVEF (reductions in risk of 30% and 35%, respectively). Comparable findings were reported for the composite endpoint of death or hospitalization for any reason for a specific cause. In addition, reduced the risk of permanent discontinuation of the study drug in patients with LVEF below 15% and in those with higher LVEF (32% and 19%, respectively).
ARB Treatment and CHF Quality of Life
Speaker: Luigi Tavazzi, MD, Head, Department of Cardiology, IRCCS Policlinico S. Matteo, Pavia, Italy.
A post-hoc analysis of data from the Valsartan Heart Failure Trial (Val-HeFT), revealed that added to standard congestive heart failure (CHF) therapy provides a significant beneficial effect on quality of life (QOL) compared to placebo.
The Val-HeFT was a double-blind, randomized multi-country trial carried out to compare the effect of the selective angiotensin II-receptor blocker valsartan (Diovan, Novartis) against placebo in 5,010 patients with CHF, when added to standard heart failure therapy, for approximately two years. The primary endpoints were all-cause mortality and combined all-cause mortality and morbidity. Overall, the rate of all-cause mortality was similarly low in both study groups (19.7% on val-sartan and 19.4% on placebo). Valsartan, however, reduced morbidity from heart failure by 13.2% and hospitalizations for heart failure by 27.5%, compared to placebo.
Improving the QOL for patients with chronic conditions and poor short-term survival, such as CHF, is a common goal in new drug development. For this reason, an analysis of Val-HeFT data was assessed to examine the relationship between QOL and morbidity and mortality in this trial. The scores of QOL were measured using the Minnesota Living with Heart Failure (MLWHF) Questionnaire at one, four, and six months, and every three months thereafter. A lower score indicates improved QOL. Scoring is related to the patient’s perception of future clinical events. The total sample size for the QOL analysis was 3,010 patients.
The patients in the valsartan group had significantly improved overall MLWHF scores compared to placebo at study endpoint—scores that related to the clinical benefits reported in valsartan treated individuals. Overall, higher MLWHF scores at baseline, months four and 12, and study endpoint were all associated with a higher risk of morbid events, regardless of study treatment. Similar associations were observed between MLWHF score and mortality. As would be expected, lower MLWHF scores were linked to a reduction in the risk of morbidity and mortality.
Human BNP for Acute Decompensated CHF
Speaker: James B. Young, MD, Medical Director of the Kaufman Center for Heart Failure, and Head, Section of Heart Failure and Cardiac Transplant Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio.
Nesiritide (Natrecor, Scios, Inc.), a recombinant form of endogenous human B-type natriuretic peptide, but not intravenous (IV) nitroglycerin, has been shown to effectively and rapidly reduce pulmonary pressures in patients with acute congestive heart failure (CHF) and elevated pulmonary pressures.
Initially, a total of 498 hospitalized patients were enrolled in the Vasodilation in the Management of Acute Congestive Failure (VMAC) trial with acutely decompensated CHF and dyspnea at risk to determine the relative hemodynamic and clinical effects and safety of either fixed or adjustable dose nesiritide compared to placebo and IV nitroglycerin, in addition to standard care. A total of 489 patients were stratified by the investigator-determined use of a pulmonary artery catheter for management of their CHF, and then randomized. Enrolled patients who received catheters were randomized to nesiritide (n=124), placebo (n=62), or IV nitroglycerin (n=60). From the VMAC database, the pulmonary artery pressures in catheterized patients during the first three hours of placebo-controlled treatment in patients randomized to nesiritide, IV nitroglycerin, or placebo were compared. After three hours, the placebo patients were randomized to nitroglycerin or nesiritide and monitored for up to 48 hours. canadian pharmacy generic viagra
Mean pulmonary artery systolic (PAS) and diastolic (PAD) pressures were elevated at baseline (59.2 ± 12.9 and 28.4 ± 7.09 mm Hg, respectively), but were comparable in all three treatment arms. During the placebo-controlled period, nesiritide was superior to placebo at all time points, and to IV nitroglycerin at most time points, at reducing PAD and PAS pressures. Nesiri-tide continued to be more effective than IV nitroglycerin in reducing pulmonary artery pressures for up to 36 hours.
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