Statins and Risk of Polyneuropathy Information

Neurology 2002;58:1333-1337
© 2002 American Academy of Neurology

Statins and risk of polyneuropathy
A case-control study

D. Gaist, MD PhD, U. Jeppesen, MD PhD, M. Andersen, MD PhD, L. A. García Rodríguez, MD MSc, J. Hallas, MD PhD and S. H. Sindrup, MD PhD

From the Department of Neurology (Drs. Gaist, Jeppesen, and Sindrup), Odense University Hospital; Epidemiology (Dr. Gaist) and Clinical Pharmacology (Drs. Andersen, Hallas, and Sindrup), Institute of Public Health, University of Southern Denmark; and Centro Español de Investigación Farmacoepidemiológica (Dr. García Rodríguez), Madrid, Spain.

Address correspondence and reprint requests to Dr. David Gaist, Epidemiology, Institute of Public Health, University of Southern Denmark, Sdr Boulevard 23A, 5000 Odense C, Denmark; e-mail: dgaist@health.sdu.dk or dg@dadlnet.dk

Background: Several case reports and a single epidemiologic study indicate that use of statins occasionally may have a deleterious effect on the peripheral nervous system. The authors therefore performed a population-based study to estimate the relative risk of idiopathic polyneuropathy in users of statins.

Method: The authors used a population-based patient registry to identify first-time-ever cases of idiopathic polyneuropathy registered in the 5-year period 1994 to 1998. For each case, validated according to predefined criteria, 25 control subjects were randomly selected among subjects from the background population matched for age, sex, and calendar time. The authors used a prescription register to assess exposure to drugs and estimated the odds ratio of use of statins (ever and current use) in cases of idiopathic polyneuropathy compared with control subjects.

Results: The authors verified a diagnosis of idiopathic polyneuropathy in 166 cases. The cases were classified as definite (35), probable (54), or possible (77). The odds ratio linking idiopathic polyneuropathy with statin use was 3.7 (95% CI 1.8 to 7.6) for all cases and 14.2 (5.3 to 38.0) for definite cases. The corresponding odds ratios in current users were 4.6 (2.1 to 10.0) for all cases and 16.1 (5.7 to 45.4) for definite cases. For patients treated with statins for 2 or more years the odds ratio of definite idiopathic polyneuropathy was 26.4 (7.8 to 45.4).

Conclusions: Long-term exposure to statins may substantially increase the risk of polyneuropathy.