Diovan

OB/GYN News, Oct 15, 2002 by Elizabeth Mechcatie

(valsartan, Novartis)

An angiotensin receptor blocker (ARB) for treating heart failure (New York Heart Association class II-IV) in people who cannot tolerate ACE inhibitors. The first ARB approved for heart failure. Previously approved for hypertension.

* Recommended Dosage: Starting at 40 mg twice a day, titrating up to 80 mg and 160 mg twice a day, to the highest tolerated dose.

* Special Considerations: Concomitant use with an ACE inhibitor and [beta]-blocker not recommended. In the Valsartan Heart Failure Trial (Val-HeFT), triple therapy with Diovan, an ACE inhibitor, and a [beta]-blocker was associated with greater mortality and morbidity. The most common side effects in Val-HeFT were dizziness and hypotension. When taken during pregnancy, drugs that act on the renin-angiotensin system can cause fetal and neonatal morbidity and fatalities.

* Comment: ValHeFT was an international study of more than 5,000 patients with class II, III, or IV heart failure, who were on baseline therapy and were randomized to receive placebo or Diovan. This approval was based on a subgroup of about 370 patients who were not on an ACE inhibitor. In these patients, Diovan therapy was associated with a 49% reduction in morbidity, a 41% reduction in all-cause mortality, and a 57% reduction in first hospitalization for heart failure, said Dr. Jay Cohn, professor of medicine, cardiovascular division, University of Minnesota, Minneapolis. (Some patients were also on a [beta]-blocker.)

The findings are "consistent with the concept that angiotensin is involved in contributing to the progression of heart failure and by blocking angiotensin with valsartan, we slowed progression," said Dr. Cohn, the principal investigator and a consultant to Novartis, which sponsored the trial.

"At the moment, the evidence is quite strong that these [ARBs] are good drugs for heart failure," he said, adding that more information on the use of these drugs in heart failure will become available as other studies are reported in the next 2 years.