Cramer Joyce A, Lynch Niall O, Gaudin Anne-Francoise, Walker Mel, Cowell Warren
Department of Psychiatry, Yale University School of Medicine, West Haven, Connecticut 06516-2770, USA.
Clin Ther. 2006 Oct;28(10):1686-94. doi: 10.1016/j.clinthera.2006.10.013.
The aim of this study was to determine the effect of dose frequency on compliance and persistence with bisphosphonate therapy in postmenopausal women and to compare findings from 3 different health care systems.
Three independently performed retrospective cohort analyses were performed using observational data sources. In the United States, bisphosphonate-naive postmenopausal women were identified from a database providing information on health plan prescription drug claims; in the United Kingdom and France, bisphosphonate-naive postmenopausal women were identified from a database of medical records supplied by general practice physicians. The women were grouped into 2 cohorts: those who were initiated on a weekly regimen of alendronate 70 mg or risedronate 35 mg and those initiated on a daily regimen of alendronate 5 or 10 mg or risedronate 5 mg. Compliance was measured in terms of the medication possession ratio (MPR), which was defined as the proportion of days in the 12-month follow-up period for which patients were covered by prescriptions for bisphosphonates. Persistence was measured as the number of days from the date of the index prescription to the last day of prescription coverage within the followup period. Women were classified as nonpersistent if the gap between prescriptions was > 30 days.
The study included 2741 postmenopausal women with osteoporosis from the United States, 7567 from the United Kingdom, and 5332 from France. The mean (SD) age of the women was 73.0, 71.7, and 69.7 years in the 3 countries, respectively. The overall MPR was 61% in the United States, 74% in the United Kingdom, and 58% in France. In all 3 countries, women on a weekly regimen had a significantly greater MPR than women on a daily regimen (69% vs 58%, respectively, in the United States; 76% vs 64% in the United Kingdom; and 59% vs 53% in France; all, P < 0.001). Women on a weekly regimen of bisphosphonates persisted with treatment significantly longer than women on a daily regimen (227 vs 185 days, respectively, in the United States; 249 vs 208 in the United Kingdom; and 179 vs 155 in France; all, P < 0.001). A significantly greater proportion of the women on a weekly regimen persisted with treatment for 12 months compared with those on a daily regimen (44% vs 32%, respectively, in the United States; 52% vs 40% in the United Kingdom; and 51% vs 44% in France; all, P < 0.001).
In all 3 countries, postmenopausal women prescribed a weekly regimen of bisphosphonates had significantly greater rates of compliance than women prescribed a daily regimen, and they persisted longer with treatment. However, compliance and persistence rates were suboptimal for both regimens.
本研究旨在确定给药频率对绝经后女性双膦酸盐治疗依从性和持续性的影响，并比较来自3种不同医疗保健系统的研究结果。
利用观察性数据源进行了3项独立的回顾性队列分析。在美国，从一个提供健康计划处方药索赔信息的数据库中识别出未使用过双膦酸盐的绝经后女性；在英国和法国，从未使用过双膦酸盐的绝经后女性是从全科医生提供的病历数据库中识别出来的。这些女性被分为2个队列：开始使用阿仑膦酸钠70mg或利塞膦酸钠35mg每周方案的女性，以及开始使用阿仑膦酸钠5mg或10mg或利塞膦酸钠5mg每日方案的女性。依从性通过药物持有率（MPR）来衡量，MPR定义为在12个月随访期内患者有双膦酸盐处方覆盖的天数比例。持续性以从索引处方日期到随访期内处方覆盖最后一天的天数来衡量。如果处方间隔>30天，则女性被归类为非持续性。
该研究纳入了来自美国的2741名绝经后骨质疏松女性、来自英国的7567名以及来自法国的5332名。这3个国家女性的平均（标准差）年龄分别为73.0岁、71.7岁和69.7岁。总体MPR在美国为61%，在英国为74%，在法国为58%。在所有3个国家，每周方案的女性MPR均显著高于每日方案的女性（美国分别为69%对58%；英国为76%对64%；法国为59%对53%；均P<0.001）。双膦酸盐每周方案的女性坚持治疗的时间显著长于每日方案的女性（美国分别为227天对185天；英国为249天对208天；法国为179天对155天；均P<0.001）。与每日方案的女性相比，每周方案的女性坚持治疗12个月的比例显著更高（美国分别为44%对32%；英国为52%对40%；法国为51%对44%；均P<0.001）。
在所有3个国家，处方双膦酸盐每周方案的绝经后女性依从率显著高于处方每日方案的女性，且她们坚持治疗的时间更长。然而，两种方案的依从性和持续性率均未达到最佳。
