Abstract
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▴ Amlodipine, a dihydropyridine calcium channel blocker, and valsartan, an angiotensin II receptor blocker, are established antihypertensive agents. Fixed-dose combinations of amlodipine/valsartan are available in several European countries and in the US. Individual dose titration with amlodipine and valsartan is generally recommended before changing to the fixed-dose combination.
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▴ Amlodipine/valsartan, at approved dosage regimens, achieved significantly greater reductions in mean sitting diastolic and systolic blood pressure (BP) than amlodipine or valsartan monotherapy, or placebo in two randomized, double-blind, factorial trials in patients with mild to moderate hypertension.
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▴ Approximately 80–90% of patients receiving approved dosages of amlodipine/valsartan achieved a response, defined as a mean sitting diastolic BP <90 mmHg or a ≥10 mmHg reduction from baseline.
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▴ Subgroup analyses of data from the two trials showed that the antihypertensive efficacy of amlodipine/valsartan in the elderly, Black patients and those with stage 2 hypertension was consistent with that observed in the overall study population.
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▴ Marked reductions in BP were also observed in patients whose BP was previously uncontrolled on monotherapy (with various antihypertensives) who were switched (without washout) to amlodipine/valsartan in a phase IIIb-IV study.
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▴ Amlodipine/valsartan was generally well tolerated in clinical trials. In particular, the incidence of peripheral oedema was significantly lower in patients receiving amlodipine/valsartan than in those treated with amlodipine monotherapy.
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Acknowledgements and Disclosures
The manuscript was reviewed by: J.P. Baguet, Department of Cardiology and Hypertension, Grenoble University Hospital, Grenoble, France; L. Frost, Department of Medicine and Clinical Institute, Silkeborg Hospital, Aarhus University Hospital, Silkeborg, Denmark; M.F. O’Rourke, St Vincent’s Clinic, Carlinghurst, New South Wales, Australia; D. Poldermans, Erasmus Medisch Centrum Rotterdam, Rotterdam, The Netherlands.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was also offered an opportunity to comment on this article. Changes resulting from any comments received were made on the basis of scientific and editorial merit.
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Plosker, G.L., Robinson, D.M. Amlodipine/Valsartan. Drugs 68, 373–381 (2008). https://doi.org/10.2165/00003495-200868030-00008
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DOI: https://doi.org/10.2165/00003495-200868030-00008