Alimentary TractEndoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women☆,☆☆,★
Section snippets
Study design
The study was a randomized, evaluator-blinded study conducted at 10 sites in the United States and Canada. The protocol was approved by the appropriate Institutional Review Board or Independent Ethics Committee. The study was conducted in accordance with the International Conference on Harmonisation Guidelines and the Declaration of Helsinki and its amendments, as applicable.
Subjects
The study subjects were postmenopausal women at least 40 years of age. The women were required to be in good health and
Subject disposition, demographics, and exposure to treatment
A total of 515 healthy postmenopausal women were randomly assigned to receive 5 mg risedronate (n = 255) or 10 mg alendronate (n = 260). The treatment groups were similar at baseline with respect to demographic characteristics, tobacco use, and alcohol consumption (Table 2).Parameter Risedronate 5 mg (N = 255) Alendronate 10 mg (N = 260) P valuea Age (yr) Mean ± SD 53 ± 7.4 54 ± 7.2 0.285 Range 40–75 40–78 Race (no. [%] of subjects) White 212 (83.1) 230
Discussion
This large study is the first head-to-head comparison of risedronate and alendronate and provides important new information about the differences in their potential to cause gastrointestinal damage in postmenopausal women. We now show that there are differences between risedronate and alendronate in the potential to damage the upper gastrointestinal mucosa. Gastric ulcers were observed in 9 (4.1%) subjects in the risedronate group compared with 30 (13.2%) subjects in the alendronate group (P <
Acknowledgements
The authors thank Mary G. Royer for assistance in preparing the manuscript.
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Address request for reprint to: Frank L. Lanza, M.D., Houston Institute for Clinical Research, 7777 Southwest Freeway, Suite 720, Houston, Texas 77074. e-mail: [email protected]; fax: (713) 270-9658.
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Supported by Procter & Gamble Pharmaceuticals, Cincinnati, Ohio, and Aventis Pharma, Bridgewater, New Jersey.
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The following institutions and primary investigators participated in the Risedronate Endoscopy Study: J. Breiter, M.D., P. Thibado, Center for Medical Research, Manchester, Connecticut; R. Dabaghi, M.D., Austin Gastroenterology Associates, Austin, Texas; D. Gremillion, M.D., K. Stouton, P. Herrell, C. Glass, Nashville Medical Research, Nashville, Tennessee; J. Marshall, M.D., C. James, McMaster University Medical Centre, Hamilton, Ontario, Canada; M. Kimmey, M.D., B. Tung, M.D., T. Brentnell, M.D., R. Kuver, M.D., University of Washington, Seattle, Washington; F. Sutton, M.D., M.F. Rack, Houston Institute for Clinical Research, Houston, Texas; M. Brannon, M.D., A. Poch, M.D., D. Philips, M.D., R. Barnett, M.D., D. Hatfield, Gastrointestinal Specialists AMC, Shreveport, Louisiana; E. Spiotta, M.D., J. Hawkins K. Hawkins, Southern Medical Research, Memphis, Tennessee; S. Appelman, University of Alberta, Edmonton, Alberta, Canada; S. Veldhuyzen van Zanten, M.D., Ph.D., J. Love, M.D., QEII Health Sciences Center, Halifax, Nova Scotia, Canada.