Association Between Statins and Cancer Incidence in Diabetes: a Cohort Study of Japanese Patients with Type 2 Diabetes

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Center for Postgraduate Training, Nara Medical University, Nara, Japan; 2Department of Cardiovascular Medicine, Nara Medical University, 840 Shijo, Kashihara, Nara, Japan; 3Department of Diabetes and Endocrinology, Nara Medical University, Nara, Japan; 4Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan; 5National Cerebral and Cardiovascular Center, Osaka, Japan; 6 Department of Cardiology, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan; 7Department of Cardiology, Center for Health Surveillance & Preventive Medicine, Tokyo Medical University Hospital, Tokyo, Japan; 8Nakayama Cardiovascular Clinic, Kumamoto, Japan; 9Department of Cardiovascular Medicine, Nara Prefectural Seiwa Medical Center, Nara, Japan; 10Department of Internal Medicine, Jinnouchi Hospital Diabetes Care Center, Kumamoto, Japan; 11Department of Internal Medicine, Division of Endocrinology and Metabolism, Shizuoka City Shizuoka Hospital, Shizuoka, Japan; 12Medical Examination Center, Takeda Hospital, Kyoto, Japan.

BACKGROUND: The antitumor effect of statins has been highlighted, but clinical study results remain inconclusive. While patients with diabetes are at high risk of cancer, it is uncertain whether statins are effective for cancer chemoprevention in this population. OBJECTIVE: This study evaluated the association between statins and cancer incidence/mortality in patients with type 2 diabetes. DESIGN: This study was a follow-up observational study of the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial, which was a randomized controlled trial of low-dose aspirin in Japanese patients with type 2 diabetes. PARTICIPANTS: This study enrolled 2536 patients with type 2 diabetes, age 30–85 years, and no history of atherosclerotic cardiovascular disease, from December 2002 until May 2005. All participants recruited in the JPAD trial were followed until the day of any fatal event or July 2015. We defined participants taking any statin at enrollment as the statin group (n = 650) and the remainder as the no-statin group (n = 1886). MAIN MEASURES: The primary end point was the first occurrence of any cancer (cancer incidence). The secondary end point was death from any cancer (cancer mortality). KEY RESULTS: During follow-up (median, 10.7 years), 318 participants developed a new cancer and 123 died as a result. Cancer incidence and mortality were 10.5 and 3.7 per 1000 person-years in the statin group, and 16.8 and 6.3 per 1000 person-years in the no-statin group, respectively. Statin use was associated with significantly reduced cancer incidence and mortality after adjustment for confounding factors (cancer incidence: adjusted hazard ratio

Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11606-020-06167-5) contains supplementary material, which is available to authorized users. Received March 10, 2020 Accepted August 14, 2020

[HR], 0.67; 95% CI, 0.49–0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95%