P-222: Efficacy and safety of the fixed combination of manidipine and delapril in the treatment of hypertension inadequately controlled by monotherapy with either component

This study aimed to evaluate efficacy and tolerability of the fixed combination of the calcium channel blocker (CCB) manidipine and the angiotensin converting enzyme inhibitor (ACE-I) delapril in the treatment of hypertensive patients inadequately controlled by monotherapy with either component. Two groups of patients were studied: group 1 included 154 mild to moderate hypertensive patients, 80 males and 74 females with a mean age of 55.4 years, whose blood pressure (BP) values were not adequately controlled by monotherapy with manidipine 20 mg o.d.; group 2 included 158 patients, whose BP values were not adequately controlled by monotherapy with delapril 30 mg b.i.d. In both groups patients were treated with the fixed combination of manidipine 10 mg and delapril 30 mg administered o.d. for 12 weeks. Patients were checked before the beginning of the fixed association therapy and after 2, 4, 8 and 12 weeks of treatment. At each visit BP (by mercury sphygmomanometer, Korotkoff I and V) and HR (by pulse palpation) were measured 24 hours post dose and adverse events were recorded. At the first and the last visit laboratory parameters and ECG were also evaluated. A statistically and clinically significant reduction of BP levels was obtained in both groups of patients. The mean decreases from baseline in systolic/diastolic BP at the last visit were 16.2/10.1 mmHg in group 1 and 15.8/11.0 in group 2. The success rates (inclusive of normalised and responder rates) were 78,9% in group 1 and 81.9% in group 2. Adverse drug reaction incidence was 9.7% in group 1 and 5.0% in group 2. No significant change in laboratory parameters was observed. These results indicate that low-dose fixed combination of manidipine and delapril is effective and well tolerated and can be a rational and valid alternative to full dose monotherapy with either component in the treatment of mild to moderate hypertension.