The Risk of Achilles or Biceps Tendon Rupture in New Statin Users: A Propensity Score-Matched Sequential Cohort Study

Julia Spoendlin, J. Bradley Layton, Mallika Mundkur, Christian Meier, Susan S. Jick and Christoph R. Meier ()
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Julia Spoendlin: University of Basel
J. Bradley Layton: The University of North Carolina at Chapel Hill
Mallika Mundkur: Brigham and Women’s Hospital, Harvard Medical School
Christian Meier: University Hospital Basel
Susan S. Jick: Boston University School of Public Health
Christoph R. Meier: University of Basel

Drug Safety, 2016, vol. 39, issue 12, No 8, 1229-1237

Abstract: Abstract Introduction 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. Methods 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. Results 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. Conclusion 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.

Date: 2016
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DOI: 10.1007/s40264-016-0462-5

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