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

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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.

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Acknowledgements

The study was supported by a grant from Chiesi Farmaceutici — Parma, Italy.

The list of the study sites and members of this study is as follows: Prof. Karpati and Dr Imre Lukás, Istvan Kórház, 1096 — Budapest, Nagyvárad tér 1; Prof. Dr Gyorgy Jermendy, Bajcsy-Zsilinszky Kórház, 1106 — Budapest, Maglódi u. 89–91; Dr Lászlo Szilágyi, Erzsébet Kórház, 1074 — Budapest, Alsóerdosor u. 7; Dr Károly Tóth, Jahn Ferenc Dél-pesti Kórház, 1204 — Budapest, Koves u. 2–4; Dr Sándor Tímár, Bács-Kiskun Megyei Onkormányzat Kórháza, 6000 — Kecskemé, Nyíri u. 38; Dr Gyorgy Sallai, Dél-pesti Kórháza, 1204 — Budapest, Podmaniczky 111; Dr Péter Dános, Máv Kórház, 1062 — Budapest, Podmaniczky 111; Dr Béla Oze, Toldy Ferenc Kórház, 2701 — Cegléd, Torteli u. 1–3; Dr János Tóth, Jávorsky Odon Kórház, 2600 — Vác, Jókay u. 10; Dr Gábor Veress, Állami Kórház, 8230 — Balatonfured, Gyógy tér 2; Dr Péter Voros, István Kórház, 1096 — Budapest, Nagyvárad tér 1; Dr Lászlo Regos, Károlyi Sándor Kórház, 1045 — Budapest, Nyár u. 103; Dr Mátyás Sereg, Szent Gyorgy Kórház, 8000 — Székesfehérvár, Seregélyesi u.; Dr Béla Pálossy, Fovarosí Onkormányzat Uzsoki utcai Kórháza, 1145 — Budapest, Uzsoki u. 29; Dr Gábor Déak, Fundamed Háziorvosi Szovetkeze t Érd, 2030 Bajcsy — Zsilinszky út 47.

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Correspondence to Dr Francesco Cosentino.

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Karpati, P., Alberici, M., Tocci, G. et al. Long-Term Tolerability and Efficacy of the Fixed Combination of Manidipine and Delapril in Patients with Essential Hypertension. High Blood Press Cardiovasc Prev 10, 81–86 (2003). https://doi.org/10.2165/00151642-200310020-00004

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Keywords

  • Pulse Pressure
  • Fixed Combination
  • Moderate Essential Hypertension
  • Manidipine
  • Hypertensive Retinopathy