Exforge cuts mean bp 20mmHg in Ph III trial

Swiss drug major Novartis says that new clinical data indicates that its drug Exforge (amlodipine and valsartan) can help 90% of non-diabetic patients achieve blood pressure goals where previous single-drug regimens have failed. The results, which were announced at the annual scientific meeting of the American Society of Hypertension in Chicago, showed that those taking the drug experienced an average 20mmHg greater drop in systolic blood pressure than that brought about by their previous medication.

The findings are from a study of the agent in 894 high blood pressure sufferers who had not responded sufficiently to alternate therapies, 145 of whom were also affected by diabetes. Participants were randomized to receive one of two doses of the drug (160/5mg or 160/10mg) daily for 16 weeks. The primary efficacy endpoint was defined as the proportion of patients, after eight and 16 weeks, who had reached a blood pressure target of less than 140/90mmHg. The number of subjects who surpassed the more challenging 130/80mmHg goal was also recorded.

Novartis reported that patients who had previously failed to reach 140/90mmHg with a range of monotherapies could attain this goal with Exforge regardless of prior treatment. In addition, 50% of the 145 subjects with type 2 diabetes achieved the 130/80mmHg blood pressure target.