Pharmacology
New data on post-MI benefits of valsartan
By Novartis
Sep 7, 2005, 07:26

Diovan� (valsartan) is the first drug of its class (angiotensin receptor blocker or ARB) shown to reduce the chance of cardiovascular events that may be caused by clogged arteries (atherosclerosis) in people who have had a recent heart attack, according to data presented at the European Society of Cardiology Congress (ESC 2005).

The need for new treatments after a heart attack remains significant. More than three million people from the EU and 1.2 million people in the US suffer a heart attack every year. Additionally, one in three people die within one year after their first recognized heart attack.

The data presented at ESC further reinforce the protective effects of Diovan, which is already the No. 1 prescribed ARB worldwide. These findings follow recent marketing authorizations throughout the world for the cardioprotective use of Diovan as a potentially lifesaving treatment for high-risk patients who have had a recent heart attack or people with heart failure. Diovan is the only ARB with both of these indications.

A new analysis of the VALIANT (VALsartan In Acute myocardial iNfarcTion) megatrial confirmed that Diovan is as effective as the ACE inhibitor captopril, a commonly used treatment, in reducing atherosclerotic events, such as heart attacks.

"Until now, the nature of ARB trials have made it difficult to determine whether this class of drugs is effective in preventing atherosclerotic events. We now have further evidence that valsartan is as effective as an ACE inhibitor in preventing atherosclerotic events," said John McMurray, MD, Professor of Medical Cardiology and Honorary Consultant Cardiologist, Clinical Research Initiative in Heart Failure, University of Glasgow, Western Infirmary in the United Kingdom and co-principal investigator in VALIANT, in explaining the benefits of these findings for heart attack survivors.

High blood pressure is a major risk factor for cardiovascular diseases such as heart attack and heart failure. While progress has been made in treating heart attacks, people who survive the acute phase are at greatly increased risk for repeat attacks and other events that can result from clogged arteries, also called atherosclerosis. This condition is the leading cause of morbidity and mortality from cardiovascular disease and can result in heart attacks or stroke. For example, nearly half of all heart attacks are repeat attacks, and one in 12 men and one in nine women will have a stroke within six years of a heart attack.

The new retrospective analysis presented at ESC 2005 demonstrated similar beneficial effects of Diovan, captopril, and their combination on a composite endpoint of events that may be caused by atherosclerosis in the 14,703 patients randomized in the VALIANT trial. There was no significant difference between the effects of Diovan or captopril on the composite endpoint of cardiovascular death, heart attack, angina, revascularization, or stroke (2,175 in the Diovan group, 2,228 in the captopril group, and 2,197 in the combination group; Diovan vs. captopril p=0.286).

VALIANT demonstrated that Diovan is the only cardiovascular agent ever shown by a head-to-head trial to be at least as effective as an ACE inhibitor in these patients. This finding can translate into a 25% reduction by Diovan in premature death in patients at high risk following a heart attack. VALIANT also showed that Diovan is well-tolerated in post-heart attack patients. The percentage of permanent discontinuations due to adverse events was statistically higher in the captopril-treated (7.7%) patients than in the valsartan-treated (5.8%) patients [p less than 0.05].

Recent regulatory approvals for Diovan in people who have had a heart attack are based on the positive results of VALIANT, one of the largest long-term studies ever conducted in people who have survived a heart attack.



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