AimThe aim of this study was to assess the long-term tolerability and efficacy of a fixed combination of manidipine 10mg and delapril 30mg (M+D) as an antihypertensive treatment in patients with mild to moderate hypertension.Study designThis was a multicentre open study, with a two-week placebo run-in period, followed by a 50-week active treatment period. Three hundred and nine patients with a mean age of 56.4 years and a sitting (Si) diastolic blood pressure (DBP) of ge;95mm Hg and le;110mm Hg were enrolled. During the treatment period systolic blood pressure (SBP) and DBP were assessed by conventional sphygmomanometry.ResultsThe decreases in SiSBP and SiDBP were clinically relevant after 4 weeks of treatment, with a mean reduction of 16.6mm Hg (95 confidence interval CI minus;18.2; minus;15) and 9.3mm Hg (95 CI minus;10.2; minus;8.4), respectively. At the end of treatment, SiSBP and SiDBP were significantly decreased by 21.8mm Hg 95 CI minus;23.4; minus;20.2) and 14.3mm Hg (95 CI minus;15.3; minus;13.4), respectively. Pulse pressure (PP) was 61.4 plusmn; 9.8mm Hg at baseline and was reduced to 54.2 plusmn; 10.8mm Hg after the first month of treatment (minus;7.3mm Hg, 95 CI minus;8.5; minus;6); at 50 weeks of treatment the PP was 54 plusmn; 11mm Hg (minus;7.5mm Hg, 95 CI minus;8.8; minus;6.1). The success rate (reduction of SiDBP ge;10mm Hg from baseline or SiDBP le;90mm Hg) was 86.4, the normalisation rate (SiDBP le;90mm Hg) was 80.6. Forty-four patients (14.2) reported adverse drug-related events. No clinically significant changes in heart rate, ECG or laboratory tests were found.ConclusionThe fixed combination M+D is effective in reducing blood pressure levels in patients with hypertension and in maintaining the reduction throughout the study period, with a good tolerability profile.
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