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.authorMiranda, Roberto Dischinger [UNIFESP]
dc.contributor.authorMion, Decio
dc.contributor.authorRocha, Joao Carlos
dc.contributor.authorKohlmann, Oswaldo [UNIFESP]
dc.contributor.authorMota Gomes, Marco Antonio
dc.contributor.authorKerr Saraiva, Jose Francisco
dc.contributor.authorAmodeo, Celso
dc.contributor.authorLuna Filho, Braulio [UNIFESP]
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionUniversidade de São Paulo (USP)
dc.contributor.institutionUniversidade Estadual de Campinas (UNICAMP)
dc.contributor.institutionHlth Sci Univ Alagoas
dc.contributor.institutionCatholic Univ
dc.contributor.institutionDante Pazzanese Cardiol Inst
dc.date.accessioned2016-01-24T13:51:40Z
dc.date.available2016-01-24T13:51:40Z
dc.date.issued2008-09-01
dc.description.abstractBackground: 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.description.affiliationUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.affiliationUniv São Paulo, São Paulo, Brazil
dc.description.affiliationUniv Estadual Campinas, Campinas, SP, Brazil
dc.description.affiliationHlth Sci Univ Alagoas, Maceio, Brazil
dc.description.affiliationCatholic Univ, Campinas, SP, Brazil
dc.description.affiliationDante Pazzanese Cardiol Inst, São Paulo, Brazil
dc.description.affiliationUnifespUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.format.extent1618-1628
dc.identifierhttp://dx.doi.org/10.1016/j.clinthera.2008.09.008
dc.identifier.citationClinical Therapeutics. Bridgewater: Elsevier, v. 30, n. 9, p. 1618-1628, 2008.
dc.identifier.doi10.1016/j.clinthera.2008.09.008
dc.identifier.issn0149-2918
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/30884
dc.identifier.wosWOS:000260141900003
dc.language.isoeng
dc.publisherElsevier B.V.
dc.relation.ispartofClinical Therapeutics
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.licensehttp://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dc.subjectamlodipineen
dc.subjectangiotensin-converting enzyme inhibitoren
dc.subjectcalcium channel blockeren
dc.subjectfixed-dose combinationen
dc.subjecthypertensionen
dc.subjectraimprilen
dc.titleAn 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) Studyen
dc.typeinfo:eu-repo/semantics/article
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