Culver · Archives of internal medicine 2012 · prospective cohort study · n=153840

Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative.

Cited 447 times in the scientific literature.

Level 3 - non-randomized controlled study

Prospective cohort analysis of participants within the Women's Health Initiative

PubMed 22231607 · doi:10.1001/archinternmed.2011.625 · record verified 2026-08-29

What was done

Analyzed prospective cohort data from 153,840 postmenopausal women aged 50 to 79 years without diabetes at baseline enrolled in the Women's Health Initiative across 40 US centers from 1993 to 1998, with follow-up through 2005. Statin use was recorded at enrollment and year 3. Cox proportional hazards models adjusted for propensity scores and confounders were used to estimate incident diabetes risk over 1,004,466 person-years of follow-up.

What was found

At baseline, 7.04% of participants reported statin use, and 10,242 incident cases of self-reported diabetes occurred during follow-up. Statin use at baseline was associated with increased diabetes risk (unadjusted HR, 1.71; 95% CI, 1.61-1.83; multivariate-adjusted HR, 1.48; 95% CI, 1.38-1.59). The increased risk was observed across all statin medication types and confirmed in longitudinal subset analyses of 125,575 women.

Why it matters

Provides large-scale longitudinal evidence that statin therapy is associated with increased risk of incident diabetes in postmenopausal women, suggesting a class effect.

Limits

Diabetes incidence was based entirely on self-report without objective laboratory confirmation (e.g., fasting glucose or HbA1c). Statin use was not randomized, leaving potential for residual confounding by indication. Findings in postmenopausal women may not generalize to men or younger cohorts.

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