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

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dc.contributor.author Miranda, Roberto Dischinger [UNIFESP]
dc.contributor.author Mion, Decio
dc.contributor.author Rocha, Joao Carlos
dc.contributor.author Kohlmann, Oswaldo [UNIFESP]
dc.contributor.author Mota Gomes, Marco Antonio
dc.contributor.author Kerr Saraiva, Jose Francisco
dc.contributor.author Amodeo, Celso
dc.contributor.author Luna Filho, Braulio [UNIFESP]
dc.date.accessioned 2016-01-24T13:51:40Z
dc.date.available 2016-01-24T13:51:40Z
dc.date.issued 2008-09-01
dc.identifier http://dx.doi.org/10.1016/j.clinthera.2008.09.008
dc.identifier.citation Clinical Therapeutics. Bridgewater: Elsevier, v. 30, n. 9, p. 1618-1628, 2008.
dc.identifier.issn 0149-2918
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/30884
dc.description.abstract 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. en
dc.format.extent 1618-1628
dc.language.iso eng
dc.publisher Elsevier B.V.
dc.relation.ispartof Clinical Therapeutics
dc.rights Acesso restrito
dc.subject amlodipine en
dc.subject angiotensin-converting enzyme inhibitor en
dc.subject calcium channel blocker en
dc.subject fixed-dose combination en
dc.subject hypertension en
dc.subject raimpril en
dc.title 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 en
dc.type Artigo
dc.rights.license http://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dc.contributor.institution Universidade Federal de São Paulo (UNIFESP)
dc.contributor.institution Universidade de São Paulo (USP)
dc.contributor.institution Universidade Estadual de Campinas (UNICAMP)
dc.contributor.institution Hlth Sci Univ Alagoas
dc.contributor.institution Catholic Univ
dc.contributor.institution Dante Pazzanese Cardiol Inst
dc.description.affiliation Universidade Federal de São Paulo, São Paulo, Brazil
dc.description.affiliation Univ São Paulo, São Paulo, Brazil
dc.description.affiliation Univ Estadual Campinas, Campinas, SP, Brazil
dc.description.affiliation Hlth Sci Univ Alagoas, Maceio, Brazil
dc.description.affiliation Catholic Univ, Campinas, SP, Brazil
dc.description.affiliation Dante Pazzanese Cardiol Inst, São Paulo, Brazil
dc.description.affiliationUnifesp Universidade Federal de São Paulo, São Paulo, Brazil
dc.identifier.doi 10.1016/j.clinthera.2008.09.008
dc.description.source Web of Science
dc.identifier.wos WOS:000260141900003



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