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Wednesday 17 May 2006

Novartis announces efficacy data on new investigational high blood pressure therapies at the American Society of Hypertension annual meeting

 

Comparative safety and blood pressure (BP)-lowering efficacy of a combination of amlodipine + valsartan and lisinopril + hydrochlorothiazide (HCTZ) in patients with stage 2 hypertension"

In a multi-center, randomized study of 130 patients with stage 2 high blood pressure (at least 110 mm Hg), patients treated with amlodipine besylate/valsartan achieved an average reduction of 35.8 mm Hg in systolic blood pressure compared to 31.8 mm Hg in patients treated with a lisinopril/HCTZ combination. In addition, a sub-group of patients with systolic blood pressure of at least 180 mm Hg experienced an average systolic blood pressure reduction of 43 mm Hg when treated with amlodipine besylate/valsartan compared to a 31.2 mm Hg reduction in patients receiving the lisinopril/HCTZ combination.

"Reductions in average systolic blood pressure ranging from 35 mm Hg to 43 mm Hg were clinically significant in the amlodipine besylate and valsartan arm" said Don Poldermans, M.D., Erasmus Medisch Centrum, Netherlands. "We were particularly impressed by the drug's efficacy in patients having a systolic blood pressure over 180 mm Hg. People with high systolic blood pressure are at an elevated risk of cardiovascular events"

Importantly, 80% of patients treated with amlodipine besylate/valsartan for six weeks reached the mean sitting diastolic blood pressure goal of under 90 mm Hg. The average drop in diastolic blood pressure was 28.6 among patients treated with amlodipine besylate/valsartan, which was numerically higher than the 27.6 reduction among those treated with lisinopril/HCTZ. Both treatment regimens were well tolerated. Adverse events were seen in 26 patients treated with amlodipine besylate/valsartan and 21 patients receiving the lisinopril/HCTZ combination. Most events were mild to moderate in severity and were not suspected to be study drug related. The most common adverse events in the amlodipine besylate/valsartan group were headache and peripheral edema, while diarrhea and pharyngitis were most frequently reported in the lisinopril/HCTZ (Hydroclorthiazide )
arm.

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