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Pattern of risks of systemic lupus erythematosus among statin users: a population-based cohort study
  1. Hilda J I De Jong1,2,3,
  2. Tjeerd P van Staa3,4,
  3. Arief Lalmohamed3,5,
  4. Frank de Vries3,6,7,
  5. Rob J Vandebriel1,
  6. Henk Van Loveren1,8,
  7. Olaf H Klungel3,
  8. Jan Willem Cohen Tervaert2,9
  1. 1Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands
  2. 2School for Mental Health and Neuroscience, Maastricht University Medical Center, Maastricht, The Netherlands
  3. 3Division of Pharmacoepidemiology and Clinical Pharmacology, Department of Pharmaceutical Sciences, Faculty of Sciences, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands
  4. 4Health eResearch Centre, Farr Institute for Health Informatics Research, University of Manchester, Manchester, UK
  5. 5Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands
  6. 6Department of Clinical Pharmacy & Toxicology, Maastricht University Medical Center, Maastricht, The Netherlands
  7. 7Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
  8. 8Department of Toxicogenomics, Maastricht University Medical Center, Maastricht, The Netherlands
  9. 9Department of Clinical and Experimental Immunology, Maastricht University, Maastricht, The Netherlands
  1. Correspondence to Dr Olaf H Klungel, Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, 3508 TB Utrecht, The Netherlands; o.h.klungel{at}uu.nl

Abstract

Objectives To examine the association between the use of statins and the risk of systemic lupus erythematosus (SLE) with focus on describing the patterns of risks over time.

Setting A population-based cohort study using the UK Clinical Practice Research Datalink.

Participants All patients aged 40 years or older who had at least one prescription of statins during the period 1995–2009 were selected and matched by age, sex, practice and date of first prescription to non-users. The follow-up period of statin users was divided into periods of current, recent and past exposure, with patients moving among these three exposure categories over time. Current statin users were also stratified into ≤1 year or >1 year of use.

Main outcome measures Time-dependent Cox models were used to calculate HRs of SLE, adjusted for disease history and previous drug exposure.

Results We included 1 039 694 patients, of whom 519 847 were statin users. Current statin users did not have an increased risk of developing SLE among patients aged ≥40 years (HRadjusted 0.75, 95% CI 0.53 to 1.07). Current statin users who continued the therapy for >1 year had a 38% lower risk of developing SLE (HRadjusted 0.62, 95% CI 0.42 to 0.93). When more specific definitions for SLE were used, this latter finding, however, was not observed.

Conclusions Our findings showed no effect of statins on the risk of developing SLE among patients aged ≥40 years. Further research is needed to study the long-term effects of statins on SLE.

  • systemic lupus erythematosus
  • statins
  • epidemiology
  • population-based
  • immunomodulation

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Footnotes

  • Contributors HJIDJ contributed to the concept and design of the study, performed the data analysis, contributed to the interpretation of the results and drafted the manuscript. TVS initiated and obtained the funding for the project to which the study presented belongs, contributed to the concept and design of the study and interpretation of the results, provided background information for the study and reviewed the manuscript. AL and FDV contributed to the concept and design of the study, performed the data analysis and reviewed the manuscript. RJV provided background information for the study and reviewed the manuscript. HVL initiated and obtained the funding for the project to which the study presented belongs, provided background information for the study and reviewed the manuscript. OHK contributed to the concept and design of the study and interpretation of the results, provided background information for the study and reviewed the manuscript. JWCT contributed to the concept and design of the study and interpretation of the results, provided background information for the study and drafted and reviewed the manuscript.

  • Funding This work was supported by the research grant S340040 from the National Institute for Public Health and the Environment. The funder had no role in study design, in the analysis and interpretation of data, in the writing of the manuscript or in the decision to submit the manuscript for publication.

  • Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare financial support from the National Institute for Public Health and the Environment (RIVM; research grant S340040) for the submitted work. Dr Klungel has received funding for pharmacoepidemiological research from the Dutch private@public Top Institute Pharma (Grant T6.101 Mondriaan) and the Innovative Medicines Initiative Joint Undertaking under Grant Agreement No 115004, resources of which comprise financial contribution from the European Union's Seventh Framework Program (FP7/2007-2013) and EFPIA companies' in kind contribution. OHK had full access to all of the data in this study and takes responsibility for the integrity of the data and accuracy of the data analysis. All authors had final responsibility for the decision to submit the manuscript for publication.

  • Patient consent For the present study, a separate ethical approval was not required, since the patients were not directly involved in formulating the research question nor were patients actively involved in the design and/or conduct of the research. The CPRD Group has obtained ethical approval from a National Research Ethics Service Committee for all purely observational research using anonymised CPRD data, namely, studies which do not include patient involvement (which is the vast majority of CPRD studies).

  • Ethics approval National Research Ethics Service Committee (NRES); CPRD Independent Scientific Advisory Committee (ISAC)

  • Provenance and peer review Not commissioned; externally peer reviewed.

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