An 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

An 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

Autor Miranda, Roberto Dischinger Autor UNIFESP Google Scholar
Mion, Decio Google Scholar
Rocha, Joao Carlos Google Scholar
Kohlmann, Oswaldo Autor UNIFESP Google Scholar
Mota Gomes, Marco Antonio Google Scholar
Kerr Saraiva, Jose Francisco Google Scholar
Amodeo, Celso Google Scholar
Luna Filho, Braulio Autor UNIFESP Google Scholar
Instituição 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 Inst
Resumo Background: 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.
Palavra-chave amlodipine
angiotensin-converting enzyme inhibitor
calcium channel blocker
fixed-dose combination
hypertension
raimpril
Idioma Inglês
Data de publicação 2008-09-01
Publicado em Clinical Therapeutics. Bridgewater: Elsevier, v. 30, n. 9, p. 1618-1628, 2008.
ISSN 0149-2918 (Sherpa/Romeo, fator de impacto)
Publicador Elsevier B.V.
Extensão 1618-1628
Fonte http://dx.doi.org/10.1016/j.clinthera.2008.09.008
Direito de acesso Acesso restrito
Tipo Artigo
Web of Science WOS:000260141900003
Endereço permanente http://repositorio.unifesp.br/handle/11600/30884

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