Long-Term Tolerability and Efficacy of the Fixed Combination of Manidipine and Delapril in Patients with Essential Hypertension
Source: High Blood Pressure & Cardiovascular Prevention, Volume 10, Number 2, 2003 , pp. 81-86(6)
Publisher: Adis International
Abstract: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.
Document Type: Research Article
Affiliations: 1: 1 1st Medical Department, István Kórház, Budapest, Hungary 2: 2 Medical Department, Chiesi Farmaceutici S.p.A., Parma, Italy 3: 3 Department of Cardiology, II Faculty of Medicine, University of Rome “La Sapienza”, Rome, Italy
Publication date: 2003-01-01