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- ItemSomente MetadadadosAn 18-Week, Prospective, Randomized, Double-Blind, Multicenter Study of Amlodipine/Ramipril Combination Versus Amlodipine Monotherapy in the Treatment of Hypertension: the Assessment of Combination Therapy of Amlodipine/Ramipril (ATAR) Study(Elsevier B.V., 2008-09-01) Miranda, Roberto Dischinger [UNIFESP]; Mion, Decio; Rocha, Joao Carlos; Kohlmann, Oswaldo [UNIFESP]; Mota Gomes, Marco Antonio; Kerr Saraiva, Jose Francisco; Amodeo, Celso; Luna Filho, Braulio [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Universidade de São Paulo (USP); Universidade Estadual de Campinas (UNICAMP); Hlth Sci Univ Alagoas; Catholic Univ; Dante Pazzanese Cardiol InstBackground: A combination of antihypertensive agents of different drug classes in a fixed-dose combination (FDC) may offer advantages in terms of efficacy, tolerability, and treatment compliance. Combination of a calcium channel blocker with an angiotensin-converting enzyme inhibitor may act synergistically to reduce blood pressure (BP).Objective: the aim of this study was to compare the efficacy and tolerability of an amlodipine/ramipril FDC with those of amlodipine monotherapy.Methods: This 18-week, prospective, randomized, double-blind study was conducted at 8 centers across Brazil. Patients with stage 1 or 2 essential hypertension were enrolled. After a 2-week placebo run-in phase, patients received amlodipine/ramipril 2.5/2.5 mg or amlodipine 2.5 mg, after which the doses were titrated, based on BP, to 515 then 10/10 mg (amlodipme/ramipril) and 5 then 10 mg (amiodipine). the primary end point was BP measured in the intent-to-treat (ITT) population. Hematology and serum biochemistry were assessed at baseline and study end. Tolerability was assessed using patient interview, laboratory analysis, and physical examination, including measurement of ankle circumference to assess peripheral edema.Results: A total of 222 patients completed the study (age range, 40-79 years; FDC group, 117 patients [mean dose, 7.60/7.60 mg]; monotherapy, 105 patients [mean dose, 7.97 mg]). the mean (SD) changes in systolic BP (SBP) and diastolic BP (DBP), as measured using 24-hour ambulatory blood pressure monitoring (ABPM) and in the physician's office, were significantly greater with combination therapy than monotherapy, with the exception of office DBP (ABPM, -20.76 [1.25] vs -15.80 [1.18] mm Hg and -11.71 [0.78] vs -8.61 [0.74] mm Hg, respectively [both, P = 0.004]; office, -27.51 [1.40] vs -22.84 [1.33] min Hg [P = 0.012] and -16.41 [0.79] vs -14.64 [0.75] mm Hg [P = NS], respectively). in the ITT analysis, the mean changes in ambulatory, but not office-based, BP were statistically significant (ABPM: SBP, -20.21 [1.14] vs -15.31 [1.12] mm Hg and DBP, -11.61 [0.72] vs -8.42 [0.70] mm Hg, respectively [both, P = 0.002]; office: SBP, -26.60 [1.34] vs -22.97 [1.30] mm Hg and DBP, -16.48 [0.78] vs -14.48 [0.75] mm Hg [both, P = NS]). Twenty-nine patients (22.1%) treated with combination therapy and 41 patients (30.6%) treated with monotherapy experienced >= 1 adverse event considered possibly related to study drug. the combmation-therapy group had lower prevalence of edema (7.6% vs 18.7%; P = 0.011) and a similar prevalence of dry cough (3.8% vs 0.8%; P = NS). No clinically significant changes in laboratory values were found in either group.Conclusions: in this population of patients with essential hypertension, the amlodipine/ramipril FDC was associated with significantly reduced ambulatory and office-measured BP compared with amlodipine monotherapy, with the exception of office DBP. Both treatments were well tolerated. (Clin Ther. 2008;30: 1618-1628) (C) 2008 Excerpta Medica Inc.
- ItemSomente MetadadadosAmlodipine 2.5 mg once daily in older hypertensives: a Brazilian multi-centre study(Lippincott Williams & Wilkins, 2004-04-01) Mion, D.; Ortega, K. C.; Gomes, MAM; Kohlmann, O.; Oigman, W.; Nobre, F.; Universidade de São Paulo (USP); Universidade Federal de São Paulo (UNIFESP); Univ State Rio de JaneiroObjectives the use of low-dose amlodipine has not yet been well established in the elderly. This study therefore aimed to evaluate the efficacy and tolerability of low-dose amlodipine in elderly patients with Joint National Committee VI stage I or II hypertension.Patients and methods Sixty-five hypertensive individuals (aged 66.3 +/- 5.3 years) received amlodipine 2.5 mg per day for 12 weeks before and after two periods of 4 weeks of placebo. At weeks 0, 12 and 16, patients were submitted to office, 24 h ambulatory blood pressure monitoring and home blood pressure measurement.Results Office systolic and diastolic blood pressure showed decreases at weeks 8 (153 +/- 17,90 +/- 9 mmHg) and 12 (152 +/- 16, 90 +/- 9 mmHg) compared with weeks 0 (164 +/- 16, 99 +/- 6 mmHg) and 16 (162 +/- 19, 95 +/- 9 mmHg). During ambulatory monitoring, a decrease was observed in the average 24 h systolic and diastolic pressure at week 12 (143 +/- 13, 86 +/- 7 mmHg) compared with weeks 0 (155 +/- 15, 93 +/- 6 mmHg) and 16 (152 +/- 16, 92 +/- 8 mmHg). A daytime and night-time reduction in systolic and diastolic pressure was observed on home blood pressure monitoring at week 12 (146 +/- 16/88 +/- 8, 144 +/- 16/93 +/- 8 mmHg) compared with weeks 0 (1159 +/- 17/94 +/- 8,161 +/- 19/93 +/- 8 mmHg) and 16 (153 +/-16/93 +/- 8, 154 +/- 17/92 +/- 8 mmHg). Adverse reactions were infrequent.Conclusions Amlodipine at a dose of 2.5 mg per day showed efficacy and good tolerability in elderly hypertensives. (C) 2004 Lippincott Williams Wilkins.