The first phase III data for Exforge (amlodipine besylate/valsartan) showed patients with high BP treated with the investigational medicine experienced strong reductions of blood pressure - some even up to 43 mmHg - with excellent tolerability, according to the data on efficacy of two new investigational high blood pressure medicines being developed by Novartis Pharmaceuticals Corporation.
The Exforge data, presented at the American Society of Hypertension, Inc., Annual Scientific Meeting and Exposition (ASH 2006) in New York, also showed that the two complementary mechanisms of action helped more than 80% of patients studied reach their recommended blood pressure goals. Exforge was shown to be safe and well tolerated in the overall clinical trial program involving 5,000 patients.
Exforge is the first high blood pressure medication to combine the most commonly prescribed branded high blood pressure medicines in their respective classes - the calcium channel blocker (CCB) amlodipine besylate and the angiotensin receptor blocker (ARB) valsartan. Submissions for US and EU approval were completed earlier in 2006.
"Many patients need three or more medicines to control their high blood pressure, which is considered the world's leading killer. Exforge has been shown to be a highly effective and well tolerated blood pressure-lowering agent in a broad range of patients, particularly those who have the most severe high blood pressure and are among the most challenging to treat," said Dr. James Shannon, head of development at Novartis Pharma AG.
According to the company release, Exforge has the potential to be an optimal way to use amlodipine due to a lower incidence of peripheral edema (fluid retention) in patients taking Exforge compared to those taking amlodipine alone. The single-tablet combination also provides the additional efficacy and potential end-organ protection of valsartan, the active ingredient in Diovan.
The results also showed that 80% of patients treated with Exforge for six weeks reached the recommended goal of mean sitting diastolic blood pressure of less than 90 mmHg.
"Reductions in average blood pressure ranging from 35 mmHg to 43 mmHg were significant with amlodipine besylate/valsartan," said Dr. Don Poldermans, of the Erasmus Medisch Centrum in the Netherlands. "We were particularly impressed by the drug's efficacy in patients having a systolic blood pressure over 180 mmHg. These findings are important in patients with uncontrolled hypertension since every decrease of 20/10 mmHg in blood pressure halves the risk of cardiovascular events," he added.