Background Actions of angiotensin II may contribute to the progressionof heart failure despite treatment with currently recommendeddrugs. We therefore evaluated the long-term effects of the additionof the angiotensin-receptor blocker valsartan to standard therapyfor heart failure.
Methods A total of 5010 patients with heart failure of New YorkHeart Association (NYHA) class II, III, or IV were randomlyassigned to receive 160 mg of valsartan or placebo twice daily.The primary outcomes were mortality and the combined end pointof mortality and morbidity, defined as the incidence of cardiacarrest with resuscitation, hospitalization for heart failure,or receipt of intravenous inotropic or vasodilator therapy forat least four hours.
Results Overall mortality was similar in the two groups. Theincidence of the combined end point, however, was 13.2 percentlower with valsartan than with placebo (relative risk, 0.87;97.5 percent confidence interval, 0.77 to 0.97; P=0.009), predominantlybecause of a lower number of patients hospitalized for heartfailure: 455 (18.2 percent) in the placebo group and 346 (13.8percent) in the valsartan group (P<0.001). Treatment withvalsartan also resulted in significant improvements in NYHAclass, ejection fraction, signs and symptoms of heart failure,and quality of life as compared with placebo (P<0.01). Ina post hoc analysis of the combined end point and mortalityin subgroups defined according to base-line treatment with angiotensin-convertingenzyme(ACE) inhibitors or beta-blockers, valsartan had a favorableeffect in patients receiving neither or one of these types ofdrugs but an adverse effect in patients receiving both typesof drugs.
Conclusions Valsartan significantly reduces the combined endpoint of mortality and morbidity and improves clinical signsand symptoms in patients with heart failure, when added to prescribedtherapy. However, the post hoc observation of an adverse effecton mortality and morbidity in the subgroup receiving valsartan,an ACE inhibitor, and a beta-blocker raises concern about thepotential safety of this specific combination.
Source Information
From the Cardiovascular Division, Department of Medicine, University of Minnesota Medical School, Minneapolis (J.N.C.); and the Mario Negri Institute, Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico, Milan, Italy (G.T.).
Address reprint requests to Dr. Cohn at the Cardiovascular Division, Mayo Mail Code 508, University of Minnesota Medical School, 420 Delaware St., SE, Minneapolis, MN 55455.
Authors/Task Force Members, , Dickstein, K., Cohen-Solal, A., Filippatos, G., McMurray, J. J.V., Ponikowski, P., Poole-Wilson, P. A., Stromberg, A., van Veldhuisen, D. J., Atar, D., Hoes, A. W., Keren, A., Mebazaa, A., Nieminen, M., Priori, S. G., Swedberg, K., ESC Committee for Practice Guidelines (CPG), , Vahanian, A., Camm, J., De Caterina, R., Dean, V., Dickstein, K., Filippatos, G., Funck-Brentano, C., Hellemans, I., Kristensen, S. D., McGregor, K., Sechtem, U., Silber, S., Tendera, M., Widimsky, P., Zamorano, J. L., Document Reviewers, , Tendera, M., Auricchio, A., Bax, J., Bohm, M., Corra, U., della Bella, P., Elliott, P. M., Follath, F., Gheorghiade, M., Hasin, Y., Hernborg, A., Jaarsma, T., Komajda, M., Kornowski, R., Piepoli, M., Prendergast, B., Tavazzi, L., Vachiery, J.-L., Verheugt, F. W. A., Zamorano, J. L., Zannad, F.
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