Modi Ankita, Sajjan Shiva, Michael Lewiecki E, Harris Steven T, Papadopoulos Weaver Jessica
Center for Observational and Real-World Evidence, Merck & Co, Inc, Kenilworth, New Jersey.
Center for Observational and Real-World Evidence, Merck & Co, Inc, Kenilworth, New Jersey.
Clin Ther. 2016 May;38(5):1074-80. doi: 10.1016/j.clinthera.2016.03.027. Epub 2016 Apr 21.
A large proportion of women with osteoporosis do not comply with current osteoporosis therapies, resulting in diminished therapeutic effect. Noncompliance may be due to the occurrence of gastrointestinal (GI) events during the course of therapy. The objective of this study was to estimate the rate of GI events among women taking oral bisphosphonates and to determine the association between GI events and compliance with bisphosphonate therapy.
This was a retrospective analysis of data from a US Medicare claims database (HUMANA). The study period was from January 2007 to June 2013. The index date was the date of the first oral bisphosphonate prescription (alendronate, ibandronate, or risedronate) occurring between January 2008 and June 2012. The pre- and postindex periods were the 1-year periods before and after the index date, respectively. The analysis included women 65 years of age and older who were naïve to all osteoporosis treatments before the index date. GI events included nausea/vomiting; dysphagia; esophagitis; esophageal reflux; esophageal, gastric, duodenal, and peptic ulcer; stricture, perforation, or hemorrhage of the esophagus; acute gastritis; and GI hemorrhage. GI events were assessed during the preindex period and at 3, 6, and 12 months in the postindex period. Compliance was defined as a medication possession ratio of ≥80%. The medication possession ratio was calculated as the total days׳ supply of bisphosphonate in the postindex period divided by 365 days. The association of postindex GI events with compliance was assessed using multivariate logistic regression.
The analysis included 37,886 women initiating oral bisphosphonate therapy. In the preindex year, 37.5% of the women experienced a GI event, and in the postindex year, 38.9% had a GI event. Patients with preindex GI events had numerically higher rates of postindex GI events than patients without preindex GI events (61.8% vs 25.1% at 12 months postindex). Patients who experienced postindex GI events were less likely to be compliant with bisphosphonate therapy, with odds of compliance of 0.76 (95% CI, 0.72-0.80) after 12 months.
Among US women who were prescribed oral bisphosphonates, on-treatment GI events were associated with decreased compliance at 1 year.
很大一部分骨质疏松症女性不遵守当前的骨质疏松症治疗方案，导致治疗效果降低。不遵守治疗方案可能是由于治疗过程中发生胃肠道（GI）事件。本研究的目的是估计服用口服双膦酸盐的女性中GI事件的发生率，并确定GI事件与双膦酸盐治疗依从性之间的关联。
这是一项对美国医疗保险索赔数据库（HUMANA）数据的回顾性分析。研究期间为2007年1月至2013年6月。索引日期为2008年1月至2012年6月期间首次开具口服双膦酸盐处方（阿仑膦酸钠、伊班膦酸钠或利塞膦酸钠）的日期。索引前和索引后时期分别为索引日期之前和之后的1年时间。分析纳入了在索引日期之前未接受过所有骨质疏松症治疗的65岁及以上女性。GI事件包括恶心/呕吐；吞咽困难；食管炎；食管反流；食管、胃、十二指肠和消化性溃疡；食管狭窄、穿孔或出血；急性胃炎；以及GI出血。在索引前时期以及索引后时期的3个月、6个月和12个月时评估GI事件。依从性定义为药物持有率≥80%。药物持有率的计算方法是索引后时期双膦酸盐的总供应天数除以365天。使用多因素逻辑回归评估索引后GI事件与依从性之间的关联。
分析纳入了37886名开始口服双膦酸盐治疗的女性。在索引前一年，37.5%的女性发生了GI事件，在索引后一年，38.9%的女性发生了GI事件。索引前发生GI事件的患者在索引后发生GI事件的比例在数值上高于未发生索引前GI事件的患者（索引后12个月时为61.8%对25.1%）。经历索引后GI事件的患者不太可能遵守双膦酸盐治疗方案，12个月后的依从性几率为0.76（95%CI，0.72 - 0.80）。
在美国开具口服双膦酸盐处方的女性中，治疗期间的GI事件与1年时依从性降低有关。
