Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: A multicenter, randomized, open-label, crossover study

被引:143
作者
Simon, JA
Lewiecki, EM
Smith, ME
Petruschke, RA
Wang, LX
Palmisano, JJ
机构
[1] Merck & Co Inc, Clin Dev, West Point, PA 19486 USA
[2] George Washington Univ, Sch Med, Washington, DC USA
[3] Womens Hlth Res Ctr, Laurel, MD USA
[4] New Mexico Clin Res & Osteoporosis Ctr Inc, Albuquerque, NM USA
关键词
osteoporosis; alendronate; bisphosphonates; preference; once-weekly dosing; compliance;
D O I
10.1016/S0149-2918(02)80085-6
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Background: Alendronate, an oral bisphosphonate, is available for the treatment of osteoporosis in a 70-mg once-weekly and a 10-mg once-daily formulation. Objectives: This study aimed to determine patient preference for once-weekly versus once-daily dosing with alendronate, and to determine which treatment regimen the patients believed was more convenient and would be easier to comply with for a long period. Methods: This was a multicenter, randomized, open-label, preference study in which postmenopausal women with osteoporosis were enrolled to receive 9 weeks of treatment in crossover fashion (4 weeks with each study regimen separated by a 1-week washout period). The study regimens included once-weekly alendronate 70 mg and once-daily alendronate 10 mg. The primary and secondary end points were, assessed with a questionnaire completed by the patient. Adverse events (AEs) were recorded to assess patient tolerability of the study medications. Results: A total of 324 patients met the eligibility requirements; 288 were randomized to treatment, 287 (mean age, 64.8 years) received treatment, 272 completed the questionnaire, and 266 completed the study. Of the patients who completed the questionnaire, 235 patients preferred the 70-mg once-weekly dosing regimen compared with the 10-mg once-daily regimen (86.4% vs 9.2%; P < 0.001). Most patients also believed that once-weekly dosing was more convenient than once-daily dosing (89.0% vs 7.7%; P < 0.001) and would allow them to achieve better long-term compliance (87.5% vs 8.5%; P < 0.001). Clinical AEs were reported in 30.7% of patients treated with once-weekly alendronate and 30% of patients treated with once-daily alendronate, with no significant differences between treatments. Conclusion: When once-weekly alendronate 70 mg was compared with oncedaily alendronate 10 mg in this study, 70mg once-weekly alendronate was the preferred dosing regimen.
引用
收藏
页码:1871 / 1886
页数:16
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