Vita completes final analysis of Ph III trials

Following the successful completion of its Phase III clinical trialsearlier this year (Marketletter March 19), Spain's Grupo Vita has finished the statistical analysis to evaluate the safety and efficacy of the fixed-dose combination of enalapril 10mg and nitrendipine 20mg.

Both studies in the program showed that, after a 12-week period, this fixed-dose combination gave a significant and clinically relevant reduction in both diastolic and systolic blood pressure from baseline values. The mean decrease for DBP was 8.1mm to 8.2mm Hg, and for SBP 9.7mm to 10.5mm, which is similar to those reported for other combinations of ACE inhibitors and calcium blockers, such as benazepril and amlodipine. There are also no serious or unexpected adverse events observed when the two drugs are used in combination, and the addition of enalapril to nitrendipine resulted in a lower incidence of leg edema, which is linked to nitrendipine treatment.

When used as a monotherapy, the fixed-dose combination of enalapril and nitrendipine gave a significant and clinically-relevant additional blood pressure reduction in patients not responding to either drug alone.