Modi Ankita, Siris Ethel S, Tang Jackson, Sajjan Shiva, Sen Shuvayu S
Center for Observational and Real-World Evidence, Merck & Co., Inc, Kenilworth, NJ, USA.
Toni Stabile Osteoporosis Center, Columbia University Medical Center, NY Presbyterian Hospital, New York, NY, USA.
Clinicoecon Outcomes Res. 2015 Nov 25;7:603-13. doi: 10.2147/CEOR.S83227. eCollection 2015.
Preexisting gastrointestinal (GI) events may deter the use of pharmacologic treatment in patients diagnosed with osteoporosis (OP). The objective of this study was to examine the association between preexisting GI events and OP pharmacotherapy initiation among women diagnosed with OP.
The study utilized claims data from a large US managed care database to identify women aged ≥55 years with a diagnosis code for OP (index date) during 2002-2009. Patients with a claim for pharmacologic OP treatment in the 12-month pre-index period (baseline) were excluded. OP treatment initiation in the post-index period was defined as a claim for bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid), calcitonin, raloxifene, or teriparatide. During the post-index period (up to 12 months), GI events were identified before treatment initiation. A time-dependent Cox regression model was used to investigate the likelihood of initiating any OP treatment. Among patients initiating OP treatment, a discrete choice model was utilized to assess the relationship between post-index GI events and likelihood of initiating with a bisphosphonate versus a non-bisphosphonate.
In total, 65,344 patients (mean age 66 years) were included; 23.7% had a GI event post diagnosis and before treatment initiation. Post-index GI events were associated with a 75% lower likelihood of any treatment initiation (hazard ratio 0.25; 95% confidence interval 0.24-0.26). Among treated patients (n=23,311), those with post-index GI events were 39% less likely to receive a bisphosphonate versus a non-bisphosphonate (odds ratio 0.61; 95% confidence interval 0.54-0.68).
GI events after OP diagnosis were associated with a decreased likelihood of OP treatment initiation and an increased likelihood of treatment initiation with a non-bisphosphonate versus a bisphosphonate.
既往存在的胃肠道(GI)事件可能会阻碍骨质疏松症(OP)患者使用药物治疗。本研究的目的是探讨既往存在的GI事件与被诊断为OP的女性开始使用OP药物治疗之间的关联。
该研究利用来自美国一个大型管理式医疗数据库的索赔数据,以识别2002年至2009年期间年龄≥55岁且有OP诊断代码(索引日期)的女性。排除在索引前12个月(基线)有OP药物治疗索赔的患者。索引后时期的OP治疗开始定义为双膦酸盐(阿仑膦酸钠、伊班膦酸钠、利塞膦酸钠、唑来膦酸)、降钙素、雷洛昔芬或特立帕肽的索赔。在索引后时期(长达12个月),在开始治疗前识别GI事件。使用时间依赖性Cox回归模型来研究开始任何OP治疗的可能性。在开始OP治疗的患者中,采用离散选择模型来评估索引后GI事件与开始使用双膦酸盐而非非双膦酸盐治疗的可能性之间的关系。
总共纳入了65344名患者(平均年龄66岁);23.7%的患者在诊断后且开始治疗前发生了GI事件。索引后GI事件与任何治疗开始的可能性降低75%相关(风险比0.25;95%置信区间0.24 - 0.26)。在接受治疗的患者(n = 23311)中,与未发生索引后GI事件的患者相比,发生索引后GI事件的患者接受双膦酸盐治疗而非非双膦酸盐治疗的可能性降低39%(优势比0.61;95%置信区间0.54 - 0.68)。
OP诊断后的GI事件与OP治疗开始的可能性降低以及开始使用非双膦酸盐而非双膦酸盐治疗的可能性增加相关。