Treatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study
Treatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study
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DOI：
10.1111/j.1742-1241.2006.01059.x
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发表时间：
2006-08-01
影响因子：
2.6
通讯作者：
Brankin, E.
中科院分区：
文献类型：
--
作者：
Cooper, A.;Drake, J.;Brankin, E.
骨质疏松症是一种常见的和衰弱的条件与显着的发病率和死亡率。口服双膦酸盐治疗骨质疏松症的疗效和安全性已得到充分证实。然而，患者对治疗的依从性和持久性是次优的。这项为期6个月的随机开放标签多中心研究比较了接受伊班膦酸盐每月一次+患者支持计划（PSP）或阿仑膦酸盐每周一次治疗的绝经后骨质疏松症女性的治疗持续性。为了避免与临床试验相关的持续率假性升高，该研究旨在反映英国的日常临床实践，随访访视仅限于与初级保健环境一致。主要终点分析显示，伊班膦酸钠/PSP组的持续性显著高于阿仑膦酸钠组（p < 0.0001）。伊班膦酸盐/PSP组和阿仑膦酸盐组6个月时坚持治疗的患者比例估计分别为56.6%（306/541）和38.6%（198/513）。因此，与阿仑膦酸钠相比，伊班膦酸钠/PSP组中坚持治疗的患者比例相对改善了47%。依从性的次要终点测量值（例如，研究结束时仍在接受治疗的患者比例;退出研究的患者比例）也存在显著差异，有利于伊班膦酸盐加患者支持。总之，PERSIST研究表明，与每周一次的阿仑膦酸钠相比，每月一次的伊班膦酸钠加患者支持的患者治疗持久性增加。增加双膦酸盐治疗的持续性有望改善患者结局，并减少骨质疏松症的社会和经济负担。
Osteoporosis is a common and debilitating condition associated with significant morbidity and mortality. The efficacy and safety of oral bisphosphonates for the treatment of osteoporosis are well established. However, patient adherence and persistence on treatment are suboptimal. This randomised open-label multi-centre study of 6-months' duration compared persistence on treatment in postmenopausal women with osteoporosis receiving either once-monthly ibandronate plus a patient support programme (PSP), or once-weekly alendronate. To avoid falsely elevated persistence rates often associated with clinical trials, the study was designed to reflect everyday clinical practice in the UK and follow-up visits were limited to be consistent with the primary care setting. Analysis of the primary endpoint showed that persistence was significantly higher in the ibandronate/PSP group compared with the alendronate group (p < 0.0001). The estimated proportion of patients persisting with treatment at 6 months was 56.6% (306/541) and 38.6% (198/513) in the ibandronate/PSP and alendronate groups, respectively. Therefore, compared with alendronate, there was a 47% relative improvement in the proportion of patients persisting with treatment in the ibandronate/PSP group. Secondary endpoint measurements of adherence (e.g. proportion of patients remaining on treatment at study end; proportion of patients discontinuing from the study) were also significantly different in favour of ibandronate plus patient support. In summary, the PERSIST study demonstrated that persistence on treatment was increased in patients receiving once-monthly ibandronate plus patient support compared with once-weekly alendronate. Increased persistence on bisphosphonate treatment is expected to improve patient outcomes and decrease the social and economic burden of osteoporosis.