The Risk of Achilles or Biceps Tendon Rupture in New Statin Users: A Propensity Score-Matched Sequential Cohort Study.
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.
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.
Julia
J
Spoendlin
Department of Epidemiology, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
J Bradley
JB
Layton
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Mallika
M
Mundkur
Division of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.
Christian
C
Meier
Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Lexington, MA, USA.
Susan S
SS
Jick
Basel Pharmacoepidemiology Unit, Division of Clinical Pharmacy and Epidemiology, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland. christoph.meier@usb.ch.|Basel Pharmacoepidemiology Unit, Hospital Pharmacy, University Hospital Basel, Spitalstrasse 26, 4031, Basel, Switzerland. christoph.meier@usb.ch.|Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Lexington, MA, USA. christoph.meier@usb.ch.
Christoph R
CR
Meier
D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D015331:Cohort Studies; D005260:Female; D000070632:Hamstring Tendons / Q000293:injuries*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D064887:Observational Studies as Topic; D057216:Propensity Score; D018570:Risk Assessment; D012422:Rupture, Spontaneous / Q000139:chemically induced / Q000453:epidemiology; D006113:United Kingdom / Q000453:epidemiology
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
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