Diovan ( Valsartan ) received European Union ( EU ) approval for the treatment of heart attack survivors.
Diovan is now indicated as a potentially life-saving therapy for the more than 750,000 people in the EU who are at risk of a recurrent heart attack or other serious outcomes such as cardiovascular mortality, hospitalization for heart failure, resuscitated cardiac arrest or stroke.
This approval provides physicians with a proven life-saving treatment for these high-risk patients who have suffered a heart attack. Despite continual improvements, mortality after heart attack is still high.
Diovan can help prolong the life of these high-risk heart attack survivors in addition to providing them with excellent blood pressure lowering efficacy.
The post-heart attack indication for Diovan is based on the positive results of the 14,703 patient trial known as VALIANT ( VALsartan In Acute myocardial infarction ) which was one of the largest long-term studies ever conducted in people who have survived a heart attack.
VALIANT demonstrated that Diovan preserved the benefit of Captopril, which is one essential component of the currently recommended standard of care in these patients, meaning it reduced death to the same degree as the proven treatment.
This finding can translate into a 25% reduction in premature death by Diovan in patients at high risk following a heart attack.
Diovan is the only cardiovascular agent ever demonstrated by a head-to-head trial to have matched the proven benefits of an ACE inhibitor in these patients.
VALIANT also showed that Diovan is well-tolerated in post-heart attack patients.
Adverse events were generally related to the underlying disease. 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