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From the Departments of Psychiatry and Behavioral Science (Drs. Li, Peskind, and Tsuang), Epidemiology (Drs. Higdon and Kukull and K. Van Valen Moore), Environmental Health and Biostatistics (Dr. van Belle), Medicine (Drs. McCormick and Larson), Neurology (Dr. Bowen), Psychosocial and Community Health (Dr. Teri), and Geriatrics and Gerontology (Dr. Schellenberg), University of Washington, Seattle; the Mental Illness Research and Education Clinical Center (Drs. Peskind and Tsuang), Geriatric Research, Education and Clinical Center (Dr. Schellenberg), Veterans Affairs Puget Sound Health Care System, Seattle; and the Center for Health Studies (Dr. Larson), Group Health Cooperative, Seattle, WA.
Address correspondence and reprint requests to Dr. Gail Li, VA Puget Sound Health Care System, 1660 S Columbian Way, Mailstop S-116 MIRECC, Seattle, WA 98108; e-mail: gli{at}u.washington.edu
Objective: To assess the association between statin therapy and risk of Alzheimer disease (AD) in a prospective cohort study with documented statin exposure and incident dementia.
Methods: This is a prospective, cohort study of statin use and incident dementia and probable AD. A cohort of 2,356 cognitively intact persons, aged 65 and older, were randomly selected from a health maintenance organization (HMO), and were assessed biennially for dementia. Statin use was identified using the HMO pharmacy database. A proportional hazards model with statin use as a time-dependent covariate was used to assess the statin–dementia/AD association.
Results: Among 312 participants with incident dementia, 168 had probable AD. The unadjusted hazard ratios (HRs) with statin use were 1.33 (95% CI 0.95 to 1.85) for all-cause dementia and 0.90 (CI 0.54 to 1.51) for probable AD. Adjusted corresponding HRs were 1.19 (CI 0.82 to 1.75) and 0.82 (CI 0.46 to 1.46). A subgroup analysis of participants with at least one APOE-
4 allele who entered the study before age 80 produced an adjusted HR of 0.33 (CI 0.10 to 1.04).
Conclusion: Employing time-dependent proportional hazards modeling, the authors found no significant association between statin use and incident dementia or probable AD. In contrast, when the data were analyzed, inappropriately, as a case-control study, the authors found an OR of 0.55 for probable AD, falsely indicating a protective effect of statins. Study design and analytic methods may explain the discrepancy between the current null findings and earlier findings.
Received April 7, 2004. Accepted in final form June 22, 2004.
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