Long-Term Tolerability and Efficacy of the Fixed Combination of Manidipine and Delapril in Patients with Essential Hypertension

Aim: The 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 design: This 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 ≥95mm Hg and ≤110mm Hg were enrolled. During the treatment period systolic blood pressure (SBP) and DBP were assessed by conventional sphygmomanometry. Results: The 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] -18.2; -15) and 9.3mm Hg (95% CI -10.2; -8.4), respectively. At the end of treatment, SiSBP and SiDBP were significantly decreased by 21.8mm Hg [95% CI -23.4; -20.2) and 14.3mm Hg (95% CI -15.3; -13.4), respectively. Pulse pressure (PP) was 61.4 ± 9.8mm Hg at baseline and was reduced to 54.2 ± 10.8mm Hg after the first month of treatment (-7.3mm Hg, 95% CI -8.5; -6); at 50 weeks of treatment the PP was 54 ± 11mm Hg (-7.5mm Hg, 95% CI -8.8; -6.1). The success rate (reduction of SiDBP ≥10mm Hg from baseline or SiDBP ≤90mm Hg) was 86.4%, the normalisation rate (SiDBP ≤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. Conclusion: The 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