Frampton James E
Wolters Kluwer Health, Adis, Auckland, New Zealand.
Drugs Aging. 2009;26(4):355-62. doi: 10.2165/00002512-200926040-00006.
Risedronate, an orally administered pyridinal bisphosphonate, is effective in the treatment and prevention of postmenopausal osteoporosis. Efforts to optimize patient adherence and persistence with, and hence the effectiveness of, therapy have led to the development of a 75 mg tablet to be taken on two consecutive days each month (2CDM). After 1 year of treatment, risedronate 75 mg 2CDM was noninferior to risedronate 5 mg once daily in improving lumbar spine bone mineral density (BMD) in an ongoing (2-year) randomized, double-blind, parallel-group, multinational trial in 1229 postmenopausal women with osteoporosis. Mean percentage increases in BMD from baseline at 12 months were 3.4% and 3.6% in the 75 mg 2CDM and 5 mg once-daily groups; the upper limit of the 95% confidence interval for the treatment difference (5 mg once daily - 75 mg 2CDM; -0.19%, 0.62%) did not exceed the predefined noninferiority margin (1.5%). In general, improvements in hip BMD and reductions in bone turnover markers with the 75 mg 2CDM regimen were not significantly different from those with the 5 mg once-daily regimen; there was no significant between-group difference in the incidence of new vertebral fractures at 12 months. The tolerability profile (including the incidence of upper gastrointestinal tract adverse events) of risedronate 75 mg 2CDM in postmenopausal women with osteoporosis was similar to that of risedronate 5 mg once daily.
利塞膦酸盐是一种口服的吡啶双膦酸盐,在治疗和预防绝经后骨质疏松症方面有效。为了优化患者对治疗的依从性和持续性,从而提高治疗效果,已研发出一种每月连续两天服用的75毫克片剂(2CDM)。在一项针对1229名绝经后骨质疏松症女性进行的正在进行的(为期2年)随机、双盲、平行组、多国试验中,治疗1年后,75毫克2CDM利塞膦酸盐在改善腰椎骨密度(BMD)方面不劣于每日一次服用5毫克利塞膦酸盐。75毫克2CDM组和每日一次5毫克组在12个月时BMD较基线的平均百分比增加分别为3.4%和3.6%;治疗差异(每日一次5毫克 - 75毫克2CDM;-0.19%,0.62%)的95%置信区间上限未超过预先定义的非劣效性界值(1.5%)。总体而言,75毫克2CDM方案在髋部BMD改善和骨转换标志物降低方面与每日一次5毫克方案无显著差异;12个月时新椎体骨折发生率在组间无显著差异。75毫克2CDM利塞膦酸盐在绝经后骨质疏松症女性中的耐受性特征(包括上消化道不良事件的发生率)与每日一次5毫克利塞膦酸盐相似。