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Evaluation of the efficacy and tolerability of the combination delapril plus indapamide in the treatment of mild to moderate essential hypertension: a randomised, multicentre, controlled study

  • E A Rosei1 &
  • D Rizzoni1 on behalf of
  • —on behalf of DIMS II (Delapril–Indapamide Multicenter Study II)

Journal of Human Hypertension volume 17, pages 139–146 (2003)Cite this article

Abstract

The aim of the study was to evaluate efficacy and tolerability of two different fixed combinations of an angiotensin-converting enzyme inhibitor and a diuretic: delapril+indapamide (D+I) and captopril+hydrochlorothiazide (C+H) administered for 6 months to patients with mild to moderate essential hypertension. In all, 96 centres participated in this randomised, parallel groups, controlled study. A total of 829 patients with uncomplicated mild to moderate hypertension were randomised, and 790 were eligible for the analysis of efficacy (intention to treat). Patients of both sexes, aged 18–75 years, newly diagnosed or untreated during the last month were included in the study if their diastolic blood pressure (DBP) was ⩾95 and ⩽114 mmHg. The starting doses of the drugs were delapril 30 mg+indapamide 1.25 mg tablets o.d. or captopril 50 mg+hydrolchlorothiazide 15 mg tablets o.d. After a 1-month treatment period, nonresponders (DBP >90 mmHg, or decrease in DBP <10 mmHg) had the daily dose increased to either delapril 30 mg+indapamide 2.5 mg or captopril 50 mg+hydrochlorothiazide 25 mg tablets for a further 5 months. The primary assessment of antihypertensive efficacy was the percentage of patients who responded after a 6-month drug treatment. The responder rates were 72.6% with D+I and 62.9% with C+H (P=0.004 between treatments) after 60 days of treatment, and 92.6% in the D+I and 85.2% in the C+H (P<0.001 between treatments) at the end of the treatment period. The final value of systolic blood pressure was 134.5±13.1 mmHg with D+I and 138.3±14.0 mmHg with C+H (P<0.001 between treatments). At the final visit, DBP was 84.57±7.0 mmHg in the D+I group and 85.57±8.0 mmHg in the control group (P=0.017 between treatments). In all, 11 patients in the D+I group and 19 patients in the C+H group were withdrawn from the study because of adverse events. In all, 30 patients (7.6%) with D+I and 32 patients (8.1%) with C+H experienced adverse events. In conclusion, D+I was more effective than C+H in terms of overall reduction in blood pressure and response rate. Greater efficacy was obtained without any increase in adverse effects, since both treatments were equally well tolerated.

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Acknowledgements

This study was supported by a grant from Chiesi Farmaceutici S.p.A., Parma, Italy.

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Authors and Affiliations

  1. Department of Medical and Surgical Sciences, University of Brescia, Brescia, Italy

    E A Rosei & D Rizzoni

Authors
  1. E A Rosei
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  2. D Rizzoni
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Consortia

—on behalf of DIMS II (Delapril–Indapamide Multicenter Study II)

Corresponding author

Correspondence to E A Rosei.

Additional information

Addendum

Centres that provided the cases

Div. I^ Medicina Generale Osp. Galliera—Genova; Servizio di Cardiologia Osp. Sacro Cuore—Negrar; U.O. Medicina Interna I Pres. Osp. Della Misericordia—Grosseto; Servizio di Cardiologia Osp. Civile— Policoro; Div. di Cardiologia Osp. Civile—Francavilla Fontana; I Divisione di Medicina Ospedali Riuniti—Foggia; Divisione di Cardiologia Osp. Civile—Carbonia; Azienda Ospedaliera S. Martino—Genova; Serv. Autonomo di Cardiologia Osp. Civile A. Tortora—Pagani; Div. di Dialisi e Nefrologia Osp. S. Raffaele—Milano; Rep. di Medicina e Geriatria Presidio Ospedaliero—Montagnana; Div. di Medicina I Osp. Civile Castello S.G. e Paolo—Venezia; Istituto di Patologia Speciale Medica Osp. Le Scotte—Siena; Div. di Cardiologia Osp. S. Giuseppe da Copertino—Copertino; Serv. Autonomo Cardiologia Presidio Ospedaliero—Polistena; Divisione di Medicina Osp. Civile A.G. Mastino—Bosa; Div. di Medicina Osp. Civile—Asti; Serv. di Cardiologia Osp. Civile—Modica; Div. di Cardiologia Osp. Civile—Partinico; Serv di Cardiologia Osp. Civile S. Salvatore—Pesaro; Div. di Medicina Osp. Gen. Reg. Miulli—Acquaviva delle Fonti; Serv. di Cardiol. e Prev. Malattie Cardiovascolari Pres. Osp. San Felice—Arienzo; Div. di Cardiologia Osp. Maggiore—Lodi; Fond. Salvatore Maugeri Clinica del Lavoro e Riab. —Pavia; Serv. di Cardiologia Osp. Civile Portogruaro; Centro Ipertensione Osp. S. Giovanni Battista—Torino; Serv. di Cardiologia Pres. Ospedaliero—Mesoraca; Div. di Cardiologia II Az. Ospedaliera S. Maria Nuova—Reggio Emilia; Istit. Clin.Medica Generale Terapia Medica IV—Firenze; Serv. di Cardiologia Osp. San. Carlo —Potenza; Rep. Med. Generale Az. Ospedaliera—Fano; Reparto di Med. II Osp. Civile—Saronno; Div. di Cardiologia Osp. Civile—Asti; Divisone II Medicina Generale Az. Osp. Maggiore della Caritá—Novara; Serv. di Cardiologia Az. Ospedaliera—Lugo; Div. di Cardiologia Pres. Osp.— Foligno; Div. di Angiologia Medica Az. Osp. Piemonte— Messina; Div. di Cardiologia Osp. Civile—Guastalla; Div. di Medicina Azienda Ospedaliera—Forlimpopoli; Div. di Cardiologia Az. Ospedaliera S. Maria—Terni; Div. di Cardiologia Az. Osp. M. Giannuzzi—Manduria; Div. di Medicina Az. Osp. Felice Villa—Mariano Comense; Div. II di Medicina Az. Ospedaliera Martini- Torino; Istit. Patol. Medica Univ. La Cattolica A. Gemelli—Roma; Catt. di Med. Interna Osp. S. Paolo-Milano; U.O. I^ Div. Med. Gen.le Osp. San. Giovanni di Dio—Firenze; Div di Medicina Gen.le Az. Osp. Villa Scassi—Sampierdarena; Serv. di Prevenzione Azienda Ospedaliera—Caserta; Div. di Cardiologia Az. Ospedaliera Estense—Modena; Div. di Cardiologia Osp. Civile di Mirandola—Mirandola; Div. di Medicina I^—Osp. Civile SS. Trinitá—Cagliari; Div. di Nefrologia Osp. Civile — Treviglio; Div. di Cardiologia Az. Osp. S. Giuseppe Moscati—Avellino; Div. di Cardiologia-Stabilimento Ospedaliero—Castelfranco Veneto; Rep. di Cardiologia Policlinico Casilino—Roma; Div. di Cardiologia Osp. Civile—Esine; Div. di Medicina I Osp. S. Maria Nuova—Firenze; Div. di Medicina Interna Az. Osp. Pol. S. Orsola—Malpighi—Bologna; Div. di Cardiologia Pres. Osp. A. Maresca—Torre del Greco; Div. di Med. Gen.le Pres. Osp. S. Antonio Abate—Pontremoli; XX Div. di Medicina Az. Osp. A. Cardarelli—Napoli; Div. di Cardiologia Osp. S. Timoteo —Termoli; Div. di Medicina III Osp. Civile —Prato; Div. di Medicina Gen.le Osp. Civile—Voghera; Div. di Medicina Gen.le Osp. Civile S. Francesco—Paola; Div. di Cardiologia Osp. Civile—Manerbio; II^ Div. di Cardiologia Osp. Niguarda Cá Granda—Milano; Istit. di Medicina Interna Az. Osp. Arcispedale S. Anna—Ferrara; II^ Div. Di Medicina Osp. S. Andrea—La Spezia; Div. di Nefrologia Az. Osp.—Lecco; Div. di Cardiologia Osp. Trabattoni-Ronzoni — Seregno; Div. di Cardiologia Pres. Osp.—Tradate; Div. di Cardiologia Az. Ospedaliera—Senigallia; Div. "A" di Med. Gen.le—Az. Osp. S. Anna—Como; Div. Med. Interna Az. Osp. Civili Riuniti—Sciacca; Div. di Cardiologia Az. Osp. Vitt. Emanuele III—Gela; Div. di Medicina Gen.le P.O. San Carlo—Voltri/Genova; Div. di Cardiologia Az. Osp. S. Filippo Neri—Roma; I Div. di Medicina Interna Az Osp. Monaldi—Cotugno— Napoli; Centro Ipertensione—Presidio Osp. Belcolle—Viterbo; Div. di Cardiologia Osp. Civile—Cittadella; IX Div. Di Med. Gen.le Az. Osp. San Camillo—Roma; Div. di Cardiologia Az. Osp. A. Angelucci—Subiaco; IV Div. Di Medicina Az. Osp. A. Cardarelli—Napoli; Div. di Medicina Interna—Az. Osp. San Cimino—Termini Imerese; Div. di Medicina Interna Az Osp.—Iseo; Div. di Cardiologia Osp Civile—Legnago; Div. di Cardiologia Osp. – Civile—Sulmona; Div. di Cardiologia Osp. Civile—Busto Arsizio; Div. di Medicina Osp. Civile Garibaldi—Catania; Div. di Cardiologia Osp. Civile—Gubbio; Div. di Medicina I^ Osp. Civile—Pozzuoli; Div. di Medicina Osp. Civile S. Marco—Argentano; Div. di Cardiologia Osp. Civile—Teramo; Serv. di cardiologia Azienda Ospedaliera San Francesco—Nuoro; Dip. Scienze Biomediche Serv. Med. Int.Policlinico— Bari; Div. di Cardiologia Osp. M. Vittoria—Torino; Dip.di Med.Clinica Sperimentale Ricerca Clinica Medica I—Policlinico— Padova.

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Rosei, E., Rizzoni, D. & —on behalf of DIMS II (Delapril–Indapamide Multicenter Study II). Evaluation of the efficacy and tolerability of the combination delapril plus indapamide in the treatment of mild to moderate essential hypertension: a randomised, multicentre, controlled study. J Hum Hypertens 17, 139–146 (2003). https://doi.org/10.1038/sj.jhh.1001514

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