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

Author

Listed:
  • Julia Spoendlin

    (University of Basel
    University Hospital 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
    University Hospital Basel
    Boston University School of Public Health)

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.

Suggested Citation

  • Julia Spoendlin & J. Bradley Layton & Mallika Mundkur & Christian Meier & Susan S. Jick & Christoph R. Meier, 2016. "The Risk of Achilles or Biceps Tendon Rupture in New Statin Users: A Propensity Score-Matched Sequential Cohort Study," Drug Safety, Springer, vol. 39(12), pages 1229-1237, December.
    • Handle: RePEc:spr:drugsa:v:39:y:2016:i:12:d:10.1007_s40264-016-0462-5
    DOI: 10.1007/s40264-016-0462-5
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    Cited by:

    1. Yiqing Zhao & Yue Yu & Hanyin Wang & Yikuan Li & Yu Deng & Guoqian Jiang & Yuan Luo, 2022. "Machine Learning in Causal Inference: Application in Pharmacovigilance," Drug Safety, Springer, vol. 45(5), pages 459-476, May.

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