Association between statin use and risk for keratinocyte carcinoma in the veterans affairs topical tretinoin chemoprevention trial.
BACKGROUND
Recent evidence suggests that statins may prevent cancer.


OBJECTIVE
To quantify the association between statin use and the occurrence of keratinocyte carcinoma in high-risk veterans.


METHODS
Cohort study.


METHODS
6 Veterans Affairs medical centers.


METHODS
1037 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.


METHODS
Time 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).


RESULTS
Among 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]).


CONCLUSIONS
The 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.


CONCLUSIONS
These data show no conclusive or consistent relationship between long-term statin use and risk for keratinocyte carcinoma.
Dore
David D
DD
i3 Drug Safety, Waltham, Massachusetts 02451, USA. david.dore@i3drugsafety.com
Lapane
Kate L
KL
Trivedi
Amal N
AN
Mor
Vincent
V
Weinstock
Martin A
MA
D000287:Administration, Topical; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002280:Basal Cell Carcinoma / Q000453:epidemiology / Q000517:prevention & control*; D002294:Carcinoma, Squamous Cell / Q000453:epidemiology / Q000517:prevention & control*; D015986:Confounding Factors, Epidemiologic; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004428:Ear Neoplasms / Q000453:epidemiology / Q000517:prevention & control; D005153:Facial Neoplasms / Q000453:epidemiology / Q000517:prevention & control; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000517:prevention & control; D012307:Risk Factors; D012878:Skin Neoplasms / Q000453:epidemiology / Q000517:prevention & control*; D014212:Tretinoin / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D014212:Tretinoin