Abstract
The antihypertensive efficacy of the angiotensin II receptor blocker olmesartan medoxomil has been shown to compare favourably with that of other antihypertensive agents. This randomized, double-blind study compared the antihypertensive efficacy of the starting dose of olmesartan medoxomil with that of the calcium channel blocker amlodipine besylate (amlodipine) in subjects with mild-to-moderate hypertension. Following a 4-week, single-blind, placebo run-in period, 440 subjects aged ⩾18 years were randomized to the starting dose of olmesartan medoxomil (20 mg/day), amlodipine (5 mg/day), or placebo for 8 weeks. Subjects were evaluated by 24-h ambulatory blood pressure monitoring (ABPM) and by seated cuff blood pressure (BP) measurements at trough. The primary end point was the change from baseline in mean 24-h diastolic blood pressure (DBP) by ABPM at Week 8. Secondary end points included change from baseline in mean 24-h ambulatory systolic blood pressure (SBP) at 8 weeks, change from baseline in mean seated trough cuff DBP and SBP measurements, and response and control rates for DBP <90 and <85 mmHg. Control rates for SBP <140 and <130 mmHg were also calculated. Olmesartan medoxomil and amlodipine produced significantly greater reductions in ambulatory and seated DBP and SBP compared with placebo. Mean reductions in ambulatory and seated BP were similar between the two active agents; however, in the olmesartan medoxomil group, significantly more patients achieved the SBP goal of <130 mmHg and the DBP goal of <85 mmHg. Both drugs were well tolerated at the recommended starting dose. Although amlodipine was associated with a higher incidence of oedema, this did not reach statistical significance. Olmesartan medoxomil is an effective antihypertensive agent, with BP-lowering efficacy at the starting dose similar to that of amlodipine, and is associated with more patients achieving the rigorous BP goals of SBP <130 mmHg and DBP <85 mmHg.
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Sources of research support: Sankyo Pharma Inc.
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Appendix
Appendix
List of study investigators
James Adelman, MD, Greensboro, NC, USA
Michael Azorr, MD, Portland, OR, USA
Norse Bear, MD, Denver, CO, USA
Frederick Bieberdorf, MD, Austin, TX, USA
Scott Bleser, MD, Bellbrook, OH, USA
Rogelio Cattan, MD, Miami, FL, USA
Deanna Cheung, MD, Long Beach, CA, USA
Steven Chrysant, MD, Oklahoma City, OK, USA
Michael Doyle, MD, Birmingham, MI, USA
James Fulmer, MD, Jacksonville, FL, USA
Thomas Garland, MD, FACC, Lawrenceville, NJ, USA
Gumaro Garza, MD, McAllen, TX, USA
Larry Gilderman, DO, Pembroke Pines, FL, USA
Ronald Gilman, MD, East Providence, RI, USA
Stephen Green, MD, Hampton, VA, USA
William Grossman, MD, Charleston, SC, USA
Frank Hampel, Jr., MD, New Braunfels, TX, USA
Stuart Harris, MD, PhD, Miami, FL, USA
William John Henry III, MD, Greer, SC, USA
Jeffrey Herbst, MD, Portland, OR, USA
James Herron, MD, Chicago, IL, USA
Dean Kereiakes, MD, Cincinnati, OH, USA
Marc Kozinn, MD, Amherst, NY, USA
Andrew Lewin, MD, Los Angeles, CA, USA
Martin Lunde, MD, Arden Hills, MN, USA
Frank Maggiacomo, DO, Cranston, RI, USA
Thomas Marbury, MD, Orlando, FL, USA
David Miller, MD, North Dartmouth, MA, USA
Rafael Montoro, MD, Coral Gables, FL, USA
Joel Neutel, MD, Orange, CA, USA
Alan Niederman, MD, FACC, Ft. Lauderdale, FL, USA
Michael Peveler, MD, Louisville, KY, USA
Paul Ratner, MD, San Antonio, TX, USA
Albert Razetti, MD, DeLand, FL, USA
Dennis Ruff, MD, San Antonio, TX, USA
Stephan Sharp, MD, Nashville, TN, USA
Eugene Spiotta, Jr., MD, Memphis, TN, USA
Gary Andrew Tarshis, MD, Colorado Springs, CO, USA
Melvin Tonkon, MD, Anaheim, CA, USA
Timothy Truitt, MD, Melbourne, FL, USA
Suzanne Weakley, MD, Houston, TX, USA
David Williams, MD, Daytona Beach, FL, USA
Laurence Yellen, MD, San Diego, CA, USA
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Chrysant, S., Marbury, T. & Robinson, T. Antihypertensive efficacy and safety of olmesartan medoxomil compared with amlodipine for mild-to-moderate hypertension. J Hum Hypertens 17, 425–432 (2003). https://doi.org/10.1038/sj.jhh.1001577
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DOI: https://doi.org/10.1038/sj.jhh.1001577