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

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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.

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Acknowledgments

We thank Pascal Egger for data withdrawal from the database and for his support with data management.

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Authors and Affiliations

  1. Basel Pharmacoepidemiology Unit, Division of Clinical Pharmacy and Epidemiology, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland

    Julia Spoendlin & Christoph R. Meier

  2. Basel Pharmacoepidemiology Unit, Hospital Pharmacy, University Hospital Basel, Spitalstrasse 26, 4031, Basel, Switzerland

    Julia Spoendlin & Christoph R. Meier

  3. Department of Epidemiology, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    J. Bradley Layton

  4. Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    Mallika Mundkur

  5. Division of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland

    Christian Meier

  6. Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Lexington, MA, USA

    Susan S. Jick & Christoph R. Meier

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  1. Julia Spoendlin
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Corresponding author

Correspondence to Christoph R. Meier.

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Funding

No funding has been received for this study.

Conflicts of interest

Julia Spoendlin has no conflicts of interest that are directly relevant to the content of this study. J. Bradley Layton has no conflicts of interest that are directly relevant to the content of this study. Mallika Mundkur has no conflicts of interest that are directly relevant to the content of this study. Christian Meier has no conflicts of interest that are directly relevant to the content of this study. Susan S. Jick has no conflicts of interest that are directly relevant to the content of this study. Christoph R. Meier has no conflicts of interest that are directly relevant to the content of this study.

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Spoendlin, J., Layton, J.B., Mundkur, M. et al. The Risk of Achilles or Biceps Tendon Rupture in New Statin Users: A Propensity Score-Matched Sequential Cohort Study. Drug Saf 39, 1229–1237 (2016). https://doi.org/10.1007/s40264-016-0462-5

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  • DOI: https://doi.org/10.1007/s40264-016-0462-5

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