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Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study)

Journal of Human Hypertension volume 27, pages 445–452 (2013)Cite this article

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Abstract

A prespecified subgroup analysis of an open-label, multicenter, single-arm, dose-titration study is presented. The efficacy and safety of 20-week treatment with an amlodipine (AML)/olmesartan medoxomil (OM)±hydrochlorothiazide (HCTZ) algorithm were assessed in patients with hypertension and type 2 diabetes mellitus (T2DM) who were uncontrolled by antihypertensive monotherapy. Eligible patients received AML/OM 5/20 mg for 4 weeks, followed by stepwise uptitration to AML/OM 5/40 mg, AML/OM 10/40 mg, AML/OM 10/40 mg+HCTZ 12.5 mg and AML/OM 10/40 mg+HCTZ 25 mg at 4-week intervals if blood pressure (BP) remained uncontrolled. The primary end point was the achievement of the seated cuff systolic BP (SeSBP) goal (<140 mm Hg, or <130 mm Hg for patients with T2DM) at week 12. Seated cuff BP was significantly reduced from baseline at all titration dose periods. At week 12, the cumulative SeSBP goal was achieved by 57.9% and 80.1% of patients in the T2DM and non-T2DM subgroups, respectively. Treatment was well tolerated, with low rates of peripheral edema. In summary, switching to a treatment algorithm based on AML/OM±HCTZ after failed monotherapy was safe and improved BP control in patients with hypertension and T2DM.

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Acknowledgements

This study was supported by Daiichi Sankyo, Inc. Medical writing and editorial services were provided by Robert Schupp, PharmD, Latoya M Mitchell, PhD, and Alan J Klopp, PhD, of inScience Communications, Springer Healthcare.

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Authors and Affiliations

  1. Division of Hypertension, UT Southwestern Medical Center, Dallas, TX, USA

    S D Nesbitt

  2. Daiichi Sankyo, Inc., Parsippany, NJ, USA

    A Shojaee & J-F Maa

  3. University of Maryland School of Medicine, Baltimore, MD, USA

    M R Weir

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  1. S D Nesbitt
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Correspondence to S D Nesbitt.

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Competing interests

Shawna D Nesbitt is on the speakers’ bureau for Novartis, Boehringer Ingelheim and Forest Laboratories and serves on an advisory board for Daiichi Sankyo, Inc. Ali Shojaee and Jen-Fue Maa are employees of Daiichi Sankyo, Inc. Matthew R Weir is an ad-hoc scientific consultant for Daiichi Sankyo, Inc., Novartis, Amgen and NicOx.

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Nesbitt, S., Shojaee, A., Maa, JF. et al. Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study). J Hum Hypertens 27, 445–452 (2013). https://doi.org/10.1038/jhh.2012.65

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