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New head-to-head study shows valsartan having an edge over captopril
Our Bureau, Mumbai | Saturday, November 29, 2003, 08:00 Hrs  [IST]

In a recent study called Valiant, conducted by the American Heart Association, valsartan (Angiotensin Receptor Blocker drug) was found to be equally life saving as Captopril (Angiotensin Converting Enzyme (ACE) inhibitor drug), with lesser side effects. The study was published in the New England Journal of Medicine. Both drugs are used to lower blood pressure after high incidences of hypertension.

Valiant was a prospective, multinational, randomized, active-controlled, parallel group trial conducted at 931 centres in 24 countries. The study was conducted on 15,000 patients where 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 (transfer) heart failure and/or abnormal pumping of the heart (left ventricular systolic dysfunction). Here 5,000 patients were treated with captopril, another 5,000 were treated with losartan and the remaining 5,000 were treated with a combination of both the drugs. In addition to either valsartan and/or captopril, patients also received recommended background therapy including aspirin, cholesterol-lowering agents (statins) and beta blockers.

Valiant demonstrated that valsartan has all the established life-saving benefits of captopril in heart attack patients - and was at least as effective as the ACE inhibitor in reducing cardiac events following a heart attack, including repeat heart attacks and hospitalizations for heart failure. It is the only cardiovascular agent ever demonstrated by a head-to-head trial to have all of the proven benefits of an ACE inhibitor in patients following a heart attack. No added benefits were seen with combination treatment.

Valiant further strengthens the profile of valsartan in cardiovascular disease across key standard of care measures like cardiovascular protection, tolerability, blood pressure lowering efficacy and patient persistency with therapy.

Valiant demonstrates that valsartan is well-tolerated in post-heart attack patients. In valiant, discontinuations due to adverse events were lowest in the valsartan group and highest in the combination group. Hypotension and renal side effects were limited in number and most common in the group that received both medications together than in either group receiving valsartan or captopril alone. The rate of hypotension and renal dysfunction was slightly higher in the valsartan group than in the captopril group. Reducing the dose of study drug allowed a majority of patients who experienced hypotension or renal dysfunction to continue on study medication, and thus remain on life-saving therapy. Overall, there was a statistically significant higher rate of patient discontinuations due to adverse events in the captopril group, where more treatment-limiting side effects occurred, including cough, rash and taste disturbance, compared to the valsartan group.

Novartis Pharma AG discovered Valsartan in 1993. Novartis' Diovan is the world's largest selling valsartan brand, with estimated sales worth $ 2 billion.

In India Novartis launched the tablet version of Diovan in early 2003. Copycat versions of Diovan from Ranbaxy, Lupin and Torrent are already available in the market today.

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