• Ann. Intern. Med. · Jan 2009

    Randomized Controlled Trial Multicenter Study

    Association between statin use and risk for keratinocyte carcinoma in the veterans affairs topical tretinoin chemoprevention trial.

    • David D Dore, Kate L Lapane, Amal N Trivedi, Vincent Mor, and Martin A Weinstock.
    • i3 Drug Safety, Waltham, Massachusetts 02451, USA. david.dore@i3drugsafety.com
    • Ann. Intern. Med. 2009 Jan 6; 150 (1): 9-18.

    BackgroundRecent evidence suggests that statins may prevent cancer.ObjectiveTo quantify the association between statin use and the occurrence of keratinocyte carcinoma in high-risk veterans.DesignCohort study.Setting6 Veterans Affairs medical centers.Participants1037 participants of the Veterans Affairs Topical Tretinoin Chemoprevention Trial, a randomized, multicenter, double-blind, vehicle-controlled trial of topical tretinoin, 0.1%, for prevention of keratinocyte carcinoma conducted from November 1998 to November 2004.MeasurementsTime to first occurrence of keratinocyte carcinoma on the face or ears. Participants using a statin at randomization, according to the Veterans Affairs Pharmacy Benefits Management database, were considered exposed. Study dermatologists conducted physical examinations at baseline and every 6 months during follow-up. The association between statin use at randomization and the outcome was evaluated by using propensity score matching (n = 608) and Cox proportional hazards regression (n = 1037).ResultsAmong the 1037 participants, 37% used a statin at randomization (n = 397) for a median duration of at least 900 days over a median follow-up of 3.5 years. In the propensity score-matched analysis, statin use at randomization was not associated with keratinocyte carcinoma (rate ratio, 0.92 [95% CI, 0.73 to 1.16]), a finding that was consistent with the estimates derived from the Cox proportional hazards regression (rate ratio, 0.84 [CI, 0.70 to 1.02]).LimitationsThe extent of residual confounding is unknown, and the confidence bounds around the measures of association were wide. These data may not be generalizable to lower-risk populations.ConclusionThese data show no conclusive or consistent relationship between long-term statin use and risk for keratinocyte carcinoma.

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