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Association between statin use and lupus-like syndrome using spontaneous reports
Hilda J I de Jong1, Jan Willem Cohen Tervaert, Siti R F Saldi
1Laboratory for Health Protection Research, National Institute for Public Health and Environment, Bilthoven, Netherlands.
Seminars in Arthritis and Rheumatism
|August 27, 2011
Summary
Statins may be associated with lupus-like syndrome, a rare autoimmune condition. This study found a higher reporting rate of statins in lupus-like syndrome cases compared to other adverse drug reactions.
Area of Science:
- Pharmacovigilance
- Autoimmunology
- Drug Safety
Background:
- Case reports suggest statins may trigger lupus-like syndrome.
- Limited data exists on the association between statin use and lupus-like syndrome.
Purpose of the Study:
- To investigate the association between statin use and the occurrence of lupus-like syndrome.
Main Methods:
- A case/noncase study utilizing World Health Organization's VigiBase individual case safety reports.
- Cases defined as lupus-like syndrome reports, matched with noncases by demographics and reporting time.
- Multivariate logistic regression analyzed reporting odds ratios for statin association.
Main Results:
- Identified 3362 lupus-like syndrome cases and 27,092 noncases.
- Statins were reported more frequently in lupus-like syndrome cases (3.2%) versus noncases (1.5%).
- Adjusted analysis revealed a significant association between statins and lupus-like syndrome (POR 2.01; 95% CI 1.61-2.51).
Conclusions:
- An association exists between statin reporting and lupus-like syndrome.
- Further research is required to confirm these findings and establish causality.
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