Efficacy and Safety of Treating Stage 2 Systolic Hypertension With Olmesartan and Olmesartan/HCTZ: Results of an Open-Label Titration Study

Authors

  • Joseph L. Izzo Jr MD,

    1. From the State University of New York at Buffalo, Buffalo, NY;1Orange County Research Center, Tustin, CA;2 and Daiichi Sankyo, Inc, Parsippany, NJ 3*Listed in the Appendix.
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  • 1 Joel M. Neutel MD,

    1. From the State University of New York at Buffalo, Buffalo, NY;1Orange County Research Center, Tustin, CA;2 and Daiichi Sankyo, Inc, Parsippany, NJ 3*Listed in the Appendix.
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  • 2 Tonous Silfani PhD,

    1. From the State University of New York at Buffalo, Buffalo, NY;1Orange County Research Center, Tustin, CA;2 and Daiichi Sankyo, Inc, Parsippany, NJ 3*Listed in the Appendix.
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  • 3 Robert Dubiel RPh,

    1. From the State University of New York at Buffalo, Buffalo, NY;1Orange County Research Center, Tustin, CA;2 and Daiichi Sankyo, Inc, Parsippany, NJ 3*Listed in the Appendix.
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  • 3 Findlay Walker MD,

    1. From the State University of New York at Buffalo, Buffalo, NY;1Orange County Research Center, Tustin, CA;2 and Daiichi Sankyo, Inc, Parsippany, NJ 3*Listed in the Appendix.
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  • and 3 on behalf of the Study Investigators

    1. From the State University of New York at Buffalo, Buffalo, NY;1Orange County Research Center, Tustin, CA;2 and Daiichi Sankyo, Inc, Parsippany, NJ 3*Listed in the Appendix.
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Joseph L. Izzo, Jr, MD, State University of New York at Buffalo, Department of Medicine, 462 Grider Street, Buffalo, NY 14215
E-mail: jizzo@ams.ecmc.edu

Abstract

This study investigated an aggressive treatment program for stage 2 systolic hypertension (pretreatment systolic blood pressure [SBP] ≥160 mm Hg) using the angiotensin receptor blocker olmesartan medoxomil (OM) and hydrochlorothiazide (HCTZ). In this open-label, 16-week trial, 170 subjects received OM 20 mg/d for 3 weeks. If seated SBP/diastolic BP remained ≥120/80 mm Hg, subjects were advanced to successive 3-week courses of OM 40 mg/d, OM/HCTZ 40/12.5 mg/d, and OM/HCTZ 40/25 mg/d. OM 20 mg/d reduced mean SBP by 16.9 mm Hg (P<.001), and there were further dose-dependent decreases in mean SBP to a maximum of 34.5 mm Hg with OM/HCTZ 40/25 mg/d. At study end, 75.1% of subjects achieved SBP goal (<140 mm Hg) and 16.0% achieved SBP normalization (<120 mm Hg). Treatment was well tolerated at all doses. The addition of HCTZ did not change serum potassium levels but resulted in a dose-independent but not symptomatic increase in serum glucose and uric acid. The authors conclude that an OM-based regimen, with or without HCTZ in conventional doses, is effective in controlling and normalizing BP in stage 2 systolic hypertension.

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