Leading High Blood Pressure Drug Diovan(R) (Valsartan) Is Also Potentially a Life-Saving Treatment After Heart Attack, Major New Study Finds

Market Wire, 20050229

VALIANT was a prospective , multinational, randomized, parallel group trial conducted at 931 centers in 24 countries. Patients in VALIANT were men and women aged 18 and over (not of child-bearing potential) enrolled between 12 hours and 10 days after they suffered a heart attack complicated by temporary (transient) heart failure and/or abnormal pumping of the heart (left ventricular systolic dysfunction). In addition to Diovan and/or captopril, patients also received recommended background therapy including aspirin, cholesterol-lowering agents (statins) and beta blockers.

Diovan cardiovascular program continues with introduction of VAL-MARC

Based on the cumulative clinical evidence gathered for Diovan in hypertension, and now with VALIANT, Novartis will accelerate clinical studies designed to explore whether Diovan has blood pressure lowering, patient persistency with therapy and vascular health benefits beyond ACE inhibitors.

Novartis also announced it will conduct VAL-MARC (Valsartan -- Managing Blood Pressure Effectively and Reducing CRP), a major new study with Diovan. An open-label study of the effects of Diovan on CRP (c-reactive protein) in 5,610 high blood pressure patients, VAL-MARC will better define the relationship between blood pressure reduction and CRP levels. CRP is a strong independent predictor of cardiovascular risk.

Diovan is one of the most widely studied cardiovascular agents. The Diovan clinical research program is designed to involve 50,000 patients, including 8,000 patients with diabetes, in several ongoing trials investigating potential new applications for Diovan across the cardiovascular continuum from pre-diabetes (impaired glucose tolerance) to heart failure. Val-HeFT (Valsartan Heart Failure Trial), which remains one of the largest studies ever conducted in heart failure, led to the approval of Diovan for the treatment of heart failure in patients who cannot tolerate ACE inhibitors. The next trial to report will be VALUE (Valsartan Antihypertensive Long-Term Use Evaluation), a study of 15,314 hypertensive patients with at least one additional risk factor for cardiovascular events.

Approved for the first-line treatment of high blood pressure in the US, Diovan is the most widely prescribed drug in its class (angiotensin II receptor blocker, or ARB) -- and the fastest growing branded high blood pressure treatment today. Diovan has been shown to provide highly effective blood pressure lowering and proven efficacy in special high-risk and difficult-to-treat patient populations.

Diovan is indicated for treatment of hypertension. It is also indicated for treatment of heart failure in patients who cannot tolerate ACE inhibitors. All ARBs and ACE inhibitors carry a warning that the drug should not be used in pregnant women due to the risk of injury and even death to the fetus. In patients with heart failure, concomitant use of Diovan, an ACE inhibitor and a beta blocker is not recommended. In Val-HeFT, this triple combination was associated with an unfavorable heart failure outcome. Because of the risk of hypotension, caution should be observed when initiating therapy in post-myocardial infarction patients and heart failure patients. Evaluation of post-myocardial infarction and heart failure patients should always include assessment of renal function. The most common side effects in heart failure patients with Diovan were dizziness, hypotension and diarrhea.