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Association Between Statin Use and Risk for Keratinocyte Carcinoma in the Veterans Affairs Topical Tretinoin Chemoprevention Trial

David D. Dore, PharmD, PhD; Kate L. Lapane, PhD; Amal N. Trivedi, MD, MPH; Vincent Mor, PhD; and Martin A. Weinstock, MD, PhD
[+] Article and Author Information

ClinicalTrials.gov registration number: NCT00007631.


From i3 Drug Safety, Waltham, Massachusetts; The Warren Alpert Medical School of Brown University, Providence Veterans Affairs Medical Center; and Rhode Island Hospital, Providence, Rhode Island; and Virginia Commonwealth University, Richmond, Virginia.


Acknowledgment: The authors thank Kimberly Marcolivio, MEd; Robert Dyer, MD, MPH; and Margaret M. Boyle for their thoughtful assistance. They also acknowledge members of the VATTC trial group: study chairman Martin A. Weinstock, MD, PhD; Executive Committee members Martin A. Weinstock, MD, PhD, Russell P. Hall, MD, Mark F. Naylor, MD, Julia E. Vertrees, PharmD, John J. DiGiovanna, MD, and Stephen F. Bingham, PhD; study dermatopathologists Clifford R. White, Jr., MD, and Michael Piepkorn, MD; site investigators Russell P. Hall, MD, Mark F. Naylor, MD, David Eilers, MD, Jonette E. Keri, MD, James Kalivas, MD, Gary W. Cole, MD, Catherine Yanna, PA-C, and Robert S. Kirsner, MD; and study coordinator Kimberly Marcolivio, MEd.

Grant Support: Dr. Weinstock was supported by the Department of Veterans Affairs Office of Research and Development (CSP 402), and Dr. Dore was supported by the Agency for Healthcare Research and Quality (grant 5T32HS000011-21). Additional support was received from the American Cancer Society. Dr. Weinstock also received support from the National Institutes of Health (grants R01CA106592, R01CA106807, R25CA087972, and R01AR49342).

Potential Financial Conflicts of Interest:Consultancies: D.D. Dore (Pfizer). Grants received: K.L. Lapane (Pfizer).

Reproducible Research Statement:Study protocol and statistical code: Available from Dr. Dore (e-mail, david_dore@brown.edu). Data set: Not available.

Requests for Single Reprints: David D. Dore, PharmD, PhD, i3 Drug Safety, 950 Winter Street, Suite 3800, Waltham, MA 02451; e-mail, david.dore@i3drugsafety.com.

Current Author Addresses: Dr. Dore: i3 Drug Safety, 950 Winter Street, Suite 3800, Waltham, MA 02451.

Drs. Lapane, Trivedi, and Mor: Brown University, Box G-ST, 121 South Main Street, Providence, RI 02903.

Dr. Weinstock: Dermatoepidemiology Unit, Veterans Affairs Medical Center, 111D, 830 Chalkstone Avenue, Providence, RI 02908.

Author Contributions: Conception and design: D.D. Dore, K.L. Lapane, V. Mor, M.A. Weinstock.

Analysis and interpretation of the data: D.D. Dore, K.L. Lapane, A.N. Trivedi, M.A. Weinstock.

Drafting of the article: D.D. Dore.

Critical revision of the article for important intellectual content: D.D. Dore, K.L. Lapane, A.N. Trivedi, V. Mor, M.A. Weinstock.

Final approval of the article: D.D. Dore, K.L. Lapane, A.N. Trivedi, V. Mor, M.A. Weinstock.

Provision of study materials or patients: M.A. Weinstock.

Statistical expertise: D.D. Dore, K.L. Lapane.

Obtaining of funding: M.A. Weinstock.

Administrative, technical, or logistic support: D.D. Dore, K.L. Lapane, V. Mor, M.A. Weinstock.


Ann Intern Med. 2009;150(1):9-18. doi:10.7326/0003-4819-150-1-200901060-00004
Text Size: A A A

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.

Design: Cohort study.

Setting: 6 Veterans Affairs medical centers.

Participants: 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.

Measurements: 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]).

Limitations: 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.

Conclusion: These data show no conclusive or consistent relationship between long-term statin use and risk for keratinocyte carcinoma.

Funding: Department of Veterans Affairs, Agency for Healthcare Research and Quality, American Cancer Society, and National Institutes of Health.

Figures

Grahic Jump Location
Figure 1.
Study flow diagram.

VATTC = Veterans Affairs Topical Tretinoin Chemoprevention.

* Includes 98 statin users and 331 nonusers.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Crude cumulative incidence of keratinocyte carcinoma among statin users and nonusers in the Veterans Affairs Topical Tretinoin Chemoprevention Trial.
Grahic Jump Location

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