Janssen Research & Development LLC, 920 Route 202, Raritan, NJ, 08869, USA.
Observational Health Data Sciences and Informatics (OHDSI), OHDSI Collaborators, New York, NY, USA.
Drug Saf. 2022 Jul;45(7):791-807. doi: 10.1007/s40264-022-01198-9. Epub 2022 Jul 9.
Hip fractures among older people are a major public health issue, which can impact quality of life and increase mortality within the year after they occur. A recent observational study found an increased risk of hip fracture in subjects who were new users of tramadol compared with codeine. These drugs have somewhat different indications. Tramadol is indicated for moderate to severe pain and can be used for an extended period; codeine is indicated for mild to moderate pain and cough suppression.
In this observational study, we compared the risk of hip fracture in new users of tramadol or codeine, using multiple databases and analytical methods.
Using data from the Clinical Practice Research Datalink and three US claims databases, we compared the risk of hip fracture after exposure to tramadol or codeine in subjects aged 50-89 years. To ensure comparability, large-scale propensity scores were used to adjust for confounding.
We observed a calibrated hazard ratio of 1.10 (95% calibrated confidence interval 0.99-1.21) in the Clinical Practice Research Datalink database, and a pooled estimate across the US databases yielded a calibrated hazard ratio of 1.06 (95% calibrated confidence interval 0.97-1.16).
Our results did not demonstrate a statistically significant difference between subjects treated for pain with tramadol compared with codeine for the outcome of hip fracture risk.
老年人髋部骨折是一个主要的公共卫生问题,会影响生活质量,并增加骨折发生后一年内的死亡率。最近的一项观察性研究发现,与可待因相比,曲马多的新使用者发生髋部骨折的风险增加。这些药物的适应证略有不同。曲马多用于治疗中重度疼痛,可长期使用;可待因用于治疗轻中度疼痛和咳嗽抑制。
本观察性研究使用多个数据库和分析方法比较了新使用曲马多或可待因的患者发生髋部骨折的风险。
使用来自临床实践研究数据库和三个美国索赔数据库的数据,我们比较了 50-89 岁患者在暴露于曲马多或可待因后发生髋部骨折的风险。为了确保可比性,我们使用大规模倾向评分来调整混杂因素。
我们在临床实践研究数据库中观察到校准后的风险比为 1.10(95%校准置信区间 0.99-1.21),在美国数据库的汇总估计中得出校准后的风险比为 1.06(95%校准置信区间 0.97-1.16)。
我们的结果并未表明在疼痛治疗中使用曲马多与可待因的患者发生髋部骨折风险的结果存在统计学上的显著差异。