Abstract
This was a double-blind, randomized, placebo-controlled multicenter, titration-to-effect study of eprosartan in patients ⩾60 years of age with isolated systolic hypertension. The study consisted of a 3 to 5-week placebo run-in period, a 13-week double-blind treatment period (6-week titration with eprosartan 600–1200 mg/day, 3-week maintenance, 4-week combination therapy with hydrochlorothiazide/HCTZ 12.5 mg), and a follow-up period within 5–7 days of last treatment dose. Overall, 283 patients (placebo/P: 135; eprosartan /E: 148) were randomized [female patients—P: 55.6%, E:54.7%; white—P:66.7%, E:67.6%). Mean sitting systolic blood pressure (SitSBP) at baseline was comparable (P: 170±0.8 mmHg; E: 171±0.8 mm Hg). At monotherapy end point, eprosartan produced a significant reduction in SitSBP (E: 16.1 mmHg vs P: 8.4 mmHg; P <0.0001). In all, 57.4% of patients responded to eprosartan monotherapy. Among nonresponders, the addition of HCTZ resulted in a decrease in SitSBP from baseline (E: 21.7 mmHg; P: 14.4 mmHg; P <0.002). Reductions were also noted in Standing SBP (monotherapy: P <0.001; combination therapy: P=0.03). No reductions in SitDBP >4 mmHg were found during the study. Age, gender, and race did not have any impact on the results. Post hoc analysis showed a reduction in pulse pressure from 87.3 to 78.2 mmHg with placebo and from 87.6 to 70.7 mmHg with eprosartan monotherapy. Treatment with eprosartan in once-daily doses up to 1200 mg alone or in combination with HCTZ was well tolerated, with dizziness and asthenia being the most common side effects.
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Acknowledgements
This study was supported by a grant from SmithKlineBeecham.
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Appendix A: Investigators/affiliations
Appendix A: Investigators/affiliations
United States
Martin S Chattam
Arizona Clinical Trials, Inc., Scottsdale, AZ, USA
Steven D Hsi*
Albuquerque Clinical Trials, Inc., Albuquerque, NM, USA
John D Norton
The Penrose-St. Francis Medical Group, P.C., Colorado Springs, CO, USA
Thomas O'Barr, Jr.
Primary Care Associates, Marietta, GA, USA
Deepak Sant Ram
Sant Ram Medical Associates, West Grove, PA, USA
Oscar C Oandasan
R/D Clinical Research, Inc., Lake Jackson, TX, USA
Dale P Murphy
Summa Health Systems,
Akron, OH, USA
William B White
University of Connecticut Health Center,
Farmington, CT, USA
Andrew J Lewin
National Research Institute, Los Angeles, CA, USA
Albert A Carr
Southern Clinical Research and Management, Inc., Augusta, GA, USA
*Dr. Kristine Bordenave took over responsibility for the study after Dr. Hsi died.
Larry I Gilderman
University Clinical Research, Inc., Pembroke Pines, FL, USA
Paul G Hammond
Loma Linda VA Medical Center, Loma Linda, CA, USA
Marc S Weinberg
Hypertension and Nephrology, Inc., Providence, RI, USA
Steven C Bowman
Tampa Bay Medical Research, Inc., Clearwater, FL, USA
Ramon Vargas
Clinical Research Center, New Orleans, LA, USA
Henry A Punzi
Trinity Hypertension Research Center, Carrollton, TX, USA
C Andrew DeAbate
Woodmere Medical Center, Harvey, LA, USA
Daniel T O'Connor
University of California at San Diego, Division of Nephrology-Hypertension, San Diego, CA, USA
J Rodney Schmidt
Puget Sound Medical Center, Tacoma, WA, USA
Thomas W Littlejohn
Piedmont Medical Research Associates, Winston-Salem, NC, USA
David A Calhoun
University of Alabama at Birmingham, Birmingham, AL, USA
Joseph M Sutton
Northern Ohio Medical Services, Inc., Garfield Heights, OH, USA
Gabriel B Habib
Veterans Affairs Medical Center, Houston, TX, USA
William A Esper
Erie Heart and Lung Center, Erie, PA, USA
Joel M Neutel
Orange County Research Center, Orange, CA, USA
Joseph A Caplan
Del E. Webb Memorial Hospital, Peoria, AZ, USA
William J Elliot
Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL, USA
R Walter Powell
Health Care, Inc., Newark, DE, USA
Colby H Grossman
Palmetto Clinical Research, Summerville, SC, USA
Jose L Cangiano
San Juan Veterans Hospital, San Juan, PR, USA
William G Gamel
Austin Clinical Research, Inc., Austin, TX, USA
Robert J Weiss
St. Mary's Regional Medical Center, Auburn, ME, USA
Bruce J Iteld
Lakeland Medical Center, New Orleans, LA, USA
Mexico
Jamie H Acosta
Instituto National de Cardiologia, Ignacio Chávez-Juan Badiano No. 1, Mexico City, Mexico
Margarita F Lopez
Instituto Nac. de la Nutrición, Mexico City, Mexico
Ernesto G Munoz
Cardiovascular Research Center, Regional Hospital, Guadalajara, Mexico
Netherlands
Theodor M Erwteman
Private Practice, Amsterdam, The Netherlands
France
Francois Spilthooren
Private Practice, 27000 Evreux, France
Alain Boye
Private Practice, 44300 Nantes, France
Dominique Dubourg
Private Practice, 44320 Saint Viad, France
Jacque Marty
Private Practice, 49610 Muts Erigne, France
Jacque Angotti
Private Practice, 4700 Argen, France
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Punzi, H., Punzi, C. & and the Eprosartan Investigation Group. Once-daily eprosartan mesylate in the treatment of elderly patients with isolated systolic hypertension: data from a 13-week double-blind, placebo-controlled, parallel, multicenter study. J Hum Hypertens 18, 655–661 (2004). https://doi.org/10.1038/sj.jhh.1001704
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DOI: https://doi.org/10.1038/sj.jhh.1001704
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