PMID- 24944393 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20140619 LR - 20211021 IS - 0011-393X (Print) IS - 0011-393X (Linking) VI - 64 IP - 7 DP - 2003 Jul TI - Effects of the fixed combination of manidipine plus delapril in the treatment of hypertension inadequately controlled by monotherapy with either component: a phase III, multicenter, open-label, clinical trial. PG - 422-33 LID - 10.1016/S0011-393X(03)00109-7 [doi] AB - BACKGROUND: Failure to achieve good blood pressure (BP) control is probably the most important reason for high rates of morbidity and mortality in patients with hypertension. Combination therapy has been shown to increase the percentage of patients in whom BP control is achieved. One combination is a calcium channel blocker (CCB) and an angiotensin-converting enzyme inhibitor (ACE-I). OBJECTIVE: The aim of this study was to assess the effects of the fixed combination of the CCB manidipine and the ACE-I delapril in the treatment of hypertensive patients already given monotherapy with either component but with poor results (ie, insufficient BP control or adverse events [AEs]). METHODS: In this Phase III, multicenter, open-label, clinical trial, patients with mild to moderate hypertension were assigned to 1 of 2 groups. Group 1 comprised patients whose diastolic BP (DBP) was >90 mm Hg or who experienced AEs with manidipine 20 mg once daily. Group 2 comprised patients who had a DBP >90 mm Hg or who experienced AEs with delapril 30 mg BID. In both groups, patients aged <65 years were to be treated with a fixed combination of manidipine 10 mg plus delapril 30 mg once daily for 12 weeks, whereas patients aged >/=65 years were to be treated with manidipine 5 mg plus delapril 15 mg once daily for 2 weeks and then manidipine 10 mg plus delapril 30 mg once daily for 10 weeks. Patients were assessed at baseline and at 2, 4, 8, and 12 weeks of treatment. At each visit, systolic blood pressure (SBP), DBP, and heart rate were measured 24 hours after dosing, and AEs were recorded. RESULTS: Group 1 included 154 patients (80 men, 74 women; mean [SD] age, 55 [6] years); group 2 included 158 patients (79 men, 79 women; mean [SD] age, 56 [5] years). Mean BP decreased significantly in both groups (P<0.01). Compared with baseline values, mean SBP/DBP decreased 16.2 (3.8)/10.1 (1.9) mm Hg in group 1 and 15.8 (3.1)/11.0 (1.5) mm Hg in group 2 at the last visit. The success rate-rate of normalized DBP (/=10 mm Hg)-was 79% in group 1 and 82% in group 2. The rates of treatment-related AEs were 11% in group 1 and 8% in group 2. In group 1, heart rate significantly increased from baseline only at 2 weeks (P<0.05); in group 2, at each visit (P<0.05) except at week 12. However, none of these differences were clinically significant. CONCLUSION: In this study population of patients whose BP was not adequately controlled by monotherapy, the fixed combination of manidipine 10 mg plus delapril 30 mg, once daily, was effective and well tolerated. FAU - Zoppi, Annalisa AU - Zoppi A AD - Department of Internal Medicine and Therapeutics, Medical Clinic, Istituto Ricovero Cura Caraltere Scientifico Policlinico S. Matteo, University of Pavia, Pavia, Italy. FAU - Mugellini, Amedeo AU - Mugellini A AD - Department of Internal Medicine and Therapeutics, Medical Clinic, Istituto Ricovero Cura Caraltere Scientifico Policlinico S. Matteo, University of Pavia, Pavia, Italy. FAU - Preti, Paola AU - Preti P AD - Department of Internal Medicine and Therapeutics, Medical Clinic, Istituto Ricovero Cura Caraltere Scientifico Policlinico S. Matteo, University of Pavia, Pavia, Italy. FAU - Rinaldi, Andrea AU - Rinaldi A AD - Department of Internal Medicine and Therapeutics, Medical Clinic, Istituto Ricovero Cura Caraltere Scientifico Policlinico S. Matteo, University of Pavia, Pavia, Italy. FAU - Celentano, Aldo AU - Celentano A AD - Medical Clinic, University of Naples, Naples, Italy, and. FAU - Arezzi, Emma AU - Arezzi E AD - Medical Clinic, University of Naples, Naples, Italy, and. FAU - Alberici, Marco AU - Alberici M AD - Medical Department, Chiesi Farmaceutici S.p.A., Parma, Italy. FAU - Fogari, Roberto AU - Fogari R AD - Department of Internal Medicine and Therapeutics, Medical Clinic, Istituto Ricovero Cura Caraltere Scientifico Policlinico S. Matteo, University of Pavia, Pavia, Italy. LA - eng PT - Journal Article PL - United States TA - Curr Ther Res Clin Exp JT - Current therapeutic research, clinical and experimental JID - 0372621 PMC - PMC4053015 OTO - NOTNLM OT - delapril OT - hypertension therapy OT - manidipine EDAT- 2003/07/01 00:00 MHDA- 2003/07/01 00:01 PMCR- 2003/07/01 CRDT- 2014/06/20 06:00 PHST- 2003/04/09 00:00 [accepted] PHST- 2014/06/20 06:00 [entrez] PHST- 2003/07/01 00:00 [pubmed] PHST- 2003/07/01 00:01 [medline] PHST- 2003/07/01 00:00 [pmc-release] AID - S0011-393X(03)00109-7 [pii] AID - 10.1016/S0011-393X(03)00109-7 [doi] PST - ppublish SO - Curr Ther Res Clin Exp. 2003 Jul;64(7):422-33. doi: 10.1016/S0011-393X(03)00109-7.