Drugs Xagena
The FDA ( Food and Drug Administration ) approved Diovan ( Valsartan ), an ARB ( angiotensin receptor blocker ), for a new indication to reduce cardiovascular death in patients at high risk ( with left ventricular failure or left ventricular dysfunction ) following a heart attack.
FDA also expanded the drug's heart failure labeling. Diovan can now be prescribed in a broader range of heart failure patients and is no longer limited to those intolerant of ACE inhibitors.
Diovan is now the only agent in its class across the world indicated to treat high blood pressure, high-risk heart attack survivors and people with heart failure.
The approvals of Diovan to reduce cardiovascular death in high-risk heart attack survivors are based on the results of VALIANT ( VALsartan In Acute myocardial infarction ).
VALIANT was a rigorous comparison of Valsartan vs. Captopril ( an ACE inhibitor ) vs. the combination of both in 14,703 patients at high risk for death following a heart attack.
In the VALIANT trial Valsartan was reported to improve survival and reduce cardiovascular events including recurrent heart attack and hospitalizations for heart failure in these patients. There were no differences observed in overall mortality among the treatment groups.
Source: Novartis, 2005
XagenaMedicine_2005
