Results have been published in The Lancet from the eagerly-awaited VALUE (Valsartan Antihypertensive Long-term Use Evaluation) trial, which compared Novartis' angiotensin II receptor blocker Diovan (valsartan) with Pfizer's calcium antagonist Norvasc (amlodipine) in hypertensive patients at high cardiovascular risk.
The prospective, double-blind, randomized, active-controlled study involved 15,245 high blood pressure patients at risk for cardiovascular complications because of co-existing diseases or risk factors such as diabetes, history of stroke and coronary heart disease. The trial was primarily designed to evaluate, for the same level of blood pressure control, whether a Diovan-based regimen would be more effective than one containing amlodipine in reducing cardiac mortality and morbidity in these high risk patients.
Subjects received either once-daily Diovan 80mg or amlodipine 5mg, with no wash-out period, and the blood pressure goal was <140/90mmHg. If this was not achieved, drug doses were adjusted and, if required, other antihypertensives used (excluding calcium channel blockers or angiotensin II antagonists). Patients were followed up for a mean of 4.2 years.
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