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Addition of valsartan significantly improves outcomes in chronic heart failure

WESTPORT, CT (Reuters Health) – In patients with chronic heart failure, addition of the angiotensin-receptor blocker valsartan to other prescribed therapy generally reduces morbidity and mortality significantly, according to data from a 302-center trial. However, valsartan was not effective in patients who also received both beta-blockers and angiotensin-converting enzyme (ACE) inhibitors.

Dr. Jay N .Cohn from the University of Minnesota Medical School, in Minneapolis, and Dr. Gianni Tognoni from the Mario Negri Institute, in Milan, and colleagues from the Valsartan Heart Failure Trial randomly assigned 5010 patients with NYHA class II to IV heart failure to 160 mg valsartan twice daily or placebo. At baseline they had been on a fixed-dose regimen of ACE inhibitors, diuretics, digoxin and/or beta-blockers for at least 2 weeks.

Although the overall mortality rate was similar in the two groups, among those receiving valsartan, the incidence of the combined endpoint (nonfatal cardiac arrest, hospital admission for heart failure, or inotropic or vasodilator therapy for at least 4 hours without hospitalization) was 13.2% lower compared with patients receiving placebo (relative risk 0.87, p = 0.009).

The difference was mostly due to fewer valsartan-treated patients being hospitalized for heart failure, 13.8% versus 18.2% in the placebo group (p < 0.001), the researchers explain in the December 6th issue of The New England Journal of Medicine. Also, compared with placebo, valsartan therapy produced significant improvements in NYHA class, ejection fraction, heart failure signs and symptoms, and quality of life (p < 0.01).

But subgroup analysis showed that among patients taking both beta-blockers and ACE inhibitors at baseline, "valsartan had an adverse effect on mortality (p = 0.009) and was associated with a trend toward an increase in the combined endpoint of mortality and morbidity (p = 0.10)." Valsartan had a favorable effect on the combined endpoint in all other subgroups.

N Engl J Med 2001;345:1667-1675.

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