Novartis' Diovan Reduces Cardiovascular Events By 45%

Published: 02-Sep-2009

Trial conducted on 3,042 Japanese patients with high blood pressure uncontrolled on a previous non-ARB-based regimen

Novartis presented data at the European Society of Cardiology (ESC) Congress in Barcelona, Spain, which demonstrated that the addition of the angiotensin receptor blocker (ARB) Diovan (valsartan) to a non-ARB-based treatment regimen for high blood pressure provided a significant 45% relative reduction in cardiovascular events.

A total of 3,042 Japanese patients with high blood pressure uncontrolled on a previous non-ARB-based regimen and with one or more pre-defined cardiovascular risk factors took part in the study.

The study participants were randomized to receive either Diovan add-on therapy or a non-ARB-based regimen, with dose increases and add-on therapies allowed in both arms to achieve optimal blood pressure-lowering efficacy. The primary study endpoint was a composite of defined cardio- and cerebrovascular events including stroke, myocardial infarction, and hospitalization for heart failure or angina.

Significant, double-digit blood pressure reductions were observed in both treatment arms. However, compared to the non-ARB-based therapy group, significantly fewer individuals in the Diovan add-on group experienced a primary endpoint (83 vs 155, Hazard Ratio (HR)=0.55, 95% CI 0.42–0.72, p=0.00001). The reduction in the composite primary endpoint was largely due to a 45% reduction observed in the risk of stroke (25 vs 46, HR=0.55, 95% CI 0.3–0.9, p<0.05) and a 49% reduction in the risk of angina (22 vs 44, HR=0.51, 95% CI 0.3–0.9, p<0.05)1.

Ameet Nathwani, global head of CVM development at Novartis, said: “We are pleased that this independent study demonstrates once again why Diovan is the number one selling high blood pressure medication in the world. Such confirmatory evidence has not been demonstrated in similar ARB outcome studies, which might point to mechanistic, within-class differences. For this reason, physicians and patients should be confident to continue with Diovan as the foundation of their blood pressure management regimen.”

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