Evidence map›Paper›PMID 27677637›Full record

ArticleDrug safety2016

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, Christoph R Meier

Abstract read
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In one paragraph

Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 25 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Julia SpoendlinBasel Pharmacoepidemiology Unit, Division of Clinical Pharmacy and Epidemiology, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland.
J Bradley LaytonDepartment of Epidemiology, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Mallika MundkurDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Christian MeierDivision of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland.
Susan S JickBoston Collaborative Drug Surveillance Program, Boston University School of Public Health, Lexington, MA, USA.
Christoph R MeierBasel Pharmacoepidemiology Unit, Division of Clinical Pharmacy and Epidemiology, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland. christoph.meier@usb.ch.
University Hospital of Basel · CHBoston Collaborative Drug Surveillance Program · USHarvard University · USUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCase 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.

methodsWe 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.

resultsWe 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.

conclusionThe 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.

Indexed as

Adverse Drug Reaction Reporting SystemsAgedCohort StudiesFemaleHamstring TendonsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedObservational Studies as TopicPropensity ScoreRisk AssessmentRupture, SpontaneousUnited KingdomHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID27677637
OpenAlexW2525414060

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.