Spoendlin Julia, Layton J Bradley, Mundkur Mallika, Meier Christian, Jick Susan S, Meier Christoph R
Basel Pharmacoepidemiology Unit, Division of Clinical Pharmacy and Epidemiology, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland.
Basel Pharmacoepidemiology Unit, Hospital Pharmacy, University Hospital Basel, Spitalstrasse 26, 4031, Basel, Switzerland.
Drug Saf. 2016 Dec;39(12):1229-1237. doi: 10.1007/s40264-016-0462-5.
Case reports and pharmacovigilance data reported cases of tendon ruptures in statin users, but evidence from observational studies is scarce and inconclusive. We aimed to assess the association between new statin use and tendon rupture.
We performed a propensity score (PS)-matched sequential cohort study, using data from the Clinical Practice Research Datalink. Patients aged ≥45 years with at least one new statin prescription between 1995 and 2014 were PS-matched within 2-year entry blocks to patients without a statin prescription during the block. We followed patients until they had a recorded Achilles or biceps tendon rupture, completed 5 years of follow-up, or were censored for change in exposure status or another censoring criterion. We calculated hazard ratios (HRs) with 95 % confidence intervals (CIs), applying Cox proportional hazard analyses in the overall cohort (crude and multivariable) and in the PS-matched cohort. We performed subgroup analyses by sex, age, treatment duration, and statin dose.
We observed a crude HR of 1.32 (95 % CI 1.21-1.44) in the overall cohort, which attenuated after multivariable adjustment (HR 1.02, 95 % CI 0.92-1.12) and after PS-matching (HR 0.95, 95 % CI 0.84-1.08). Crude HRs were higher in women than in men, but remained around null in both sexes after multivariable adjustment and PS-matching. Subgroup analyses by age, treatment duration, and statin dose revealed null results across all subgroups.
The results of this cohort study suggest that statin use does not increase the risk of tendon rupture, irrespective of gender, age, statin dose, or treatment duration.
病例报告和药物警戒数据报道了他汀类药物使用者出现肌腱断裂的病例，但观察性研究的证据稀少且尚无定论。我们旨在评估新使用他汀类药物与肌腱断裂之间的关联。
我们利用临床实践研究数据链中的数据进行了一项倾向评分（PS）匹配的序贯队列研究。将1995年至2014年间年龄≥45岁且至少有一张新他汀类药物处方的患者，在2年的入组时间段内与该时间段内无他汀类药物处方的患者进行PS匹配。我们对患者进行随访，直至他们记录有跟腱或肱二头肌肌腱断裂、完成5年随访，或因暴露状态改变或其他审查标准而被审查。我们计算了风险比（HRs）及95%置信区间（CIs），在整个队列（粗分析和多变量分析）以及PS匹配队列中应用Cox比例风险分析。我们按性别、年龄、治疗持续时间和他汀类药物剂量进行了亚组分析。
在整个队列中，我们观察到粗HR为1.32（95%CI 1.21 - 1.44），多变量调整后（HR 1.02，95%CI 0.92 - 1.12）以及PS匹配后（HR 0.95，95%CI 0.84 - 1.08）有所减弱。女性的粗HR高于男性，但在多变量调整和PS匹配后，两性的HR均接近零。按年龄、治疗持续时间和他汀类药物剂量进行的亚组分析在所有亚组中均显示为阴性结果。
这项队列研究的结果表明，无论性别、年龄、他汀类药物剂量或治疗持续时间如何，使用他汀类药物均不会增加肌腱断裂的风险。
