Adding valsartan to standard heart failure treatment significantly reduces the combined risk of death and morbidity, according to the results of the Val-HeFT (valsartan in heart failure trial).
The double-blind, placebo-controlled study involved more than 5,000 patients with moderate to severe heart failure, aged over 18 years (average age 63), from 300 centres (16 in the United Kingdom) in 16 countries. Patients were randomised to receive either valsartan, titrated to a maximum dose of 160mg twice daily, or placebo. Patients were continued on their existing heart failure therapy, which included ACE inhibitors, beta-blockers, diuretics and digoxin.
At randomisation the researchers found that two-thirds of patients were taking digoxin, 35 per cent were on beta-blockers, 93 per cent were taking ACE inhibitors and 86 per cent were on diuretics. The trial was continued until 906 deaths had occurred.
Primary outcome measures were all-cause mortality and combined mortality and morbidity (including sudden death with resuscitation, hospitalisation for heart failure and worsening heart failure requiring administration of intravenous inotropic or vasodilating agents).
Discussing the results of the trial, Professor Jay Cohn (professor of medicine, University of Minnesota medical school, Minneapolis) said that a 25 per cent reduction in patients requiring hospitalisation for heart failure was seen for those treated with valsartan.
The researchers also found that in patients receiving valsartan, combined mortality and morbidity from heart failure decreased by 13.3 per cent.
Professor Cohn commented that valsartan was an "effective drug to add to conventional therapy". However, a greater benefit of valsartan on mortality and morbidity was seen in patients who were not taking beta-blockers or ACE inhibitors.
In a press release for Val-HeFT, Novartis Pharmaceuticals said that, based on the results from Val-HeFT, "Novartis will submit an application for a licence for Diovan [valsartan] for the treatment of heart failure in early 2001".