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Telmisartan/Amlodipine

Single-Pill Combination in Hypertension

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Abstract

Telmisartan/amlodipine is a single-pill combination of telmisartan, an angiotensin II receptor antagonist, and amlodipine, a dihydropyridine calcium channel antagonist, which is taken orally once daily for the treatment of hypertension.

In the US and the EU, single-pill telmisartan/amlodipine can be used as a replacement for separate telmisartan and amlodipine tablets, and by patients not achieving BP goals with amlodipine monotherapy. In addition, the US indication includes patients not achieving BP goals with telmisartan (or another angiotensin II receptor antagonist or calcium channel antagonist other than amlodipine) alone, and as initial therapy in patients considered likely to require multiple drugs to achieve their BP goals.

In an 8-week, randomized, double-blind, factorial-design, placebo-controlled, multicenter study in adult patients with hypertension (n =1461), mean DBP was reduced from baseline to a significantly greater extent in recipients of telmisartan 40 or 80mg/day plus amlodipine 5 or 10mg/day than in those receiving equivalent dosages of telmisartan or amlodipine monotherapy.

Single-pill telmisartan/amlodipine recipients had significantly greater reductions in BP than telmisartan or amlodipine monotherapy recipients in an 8-week, randomized, double-blind, multicenter study in adult patients with severe hypertension (n = 858), and in four 8-week, randomized, double-blind, multicenter trials in patients who had not responded to amlodipine (n = 1097, 947, and 531) or telmisartan (n = 314) monotherapy.

Telmisartan/amlodipine was generally well tolerated in clinical trials, including two 36-week follow-up studies.

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Acknowledgments and Disclosures

The manuscript was reviewed by: C. Borghi, Department of Cardiology, University of Bologna, Bologna, Italy; R. Guthrie, Department of Emergency Medicine, Ohio State University, Columbus, Ohio, USA.

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 offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Marit D. Moen.

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Moen, M.D. Telmisartan/Amlodipine. Am J Cardiovasc Drugs 10, 401–412 (2010). https://doi.org/10.2165/11204880-000000000-00000

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