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



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.


This study evaluated the association between statins and cancer incidence/mortality in patients with type 2 diabetes.


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.


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 [HR], 0.67; 95% CI, 0.49–0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95% CI, 0.36–0.98, P = 0.04).


Statin use was associated with a reduced incidence and mortality of cancer in Japanese patients with type 2 diabetes.

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The authors thank M. Ohtorii for her roles in data management and statistical analyses. The authors also thank M. Nagahiro, M. Okamoto, and M. Aoyama, and Y. Wada, Y. Kamada, and M. Miyagawa for their secretarial work. The authors also thank all members of the JPAD trial investigators, described in the Appendix, for data collection.

This study was supported by the Ministry of Health, Labour and Welfare of Japan (H16-Junkanki-004, and H27-Junkanki-Ippan-001), the Japan Heart Foundation, and JSPS KAKENHI Grant Number 17K18022.

This study has not been presented at any conference.

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Correspondence to Yoshihiko Saito MD, PhD.

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Conflict of Interest

Dr. Okada reports personal fees from Novo Nordisk, Mitsubishi Tanabe, Sumitomo Dainippon, Arkray, Bayer, Eli Lilly, Boehringer Ingelheim, Ono, AstraZeneca, Sanofi, and Takeda, outside the submitted work. Dr. Morimoto reports personal fees from AstraZeneca, Bayer, Daiichi Sankyo, Japan Lifeline, Kyocera, Mitsubishi Tanabe, Novartis, Pfizer, Asahi Kasei, Bristol-Myers Squibb, and Boston Scientific, outside the submitted work. Dr. Ogawa reports personal fees from MSD, Daiichi Sankyo, Ono, Mochida, AstraZeneca, Pfizer, Bristol-Myers Squibb, Mitsubishi Tanabe, Kyowa Kirin, Sanofi, and Medtronic, outside the submitted work. Dr. Soejima reports grants from Boehringer Ingelheim, outside the submitted work. Dr. Matsumoto has nothing to disclose. Dr. Sakuma reports personal fees from Enomoto Pharmaceutical, outside the submitted work. Dr. Nakayama reports personal fees from Bayer, Shionogi, Takeda, Daiichi Sankyo, Sanofi, Boehringer Ingelheim, Sumitomo Dainippon, Fujifilm Medical, Kowa, Pfizer, and Astellas, outside the submitted work. Dr. Doi reports personal fees from Daiichi Sankyo, Mitsubishi Tanabe, Takeda, Otsuka, Astellas, Boehringer Ingelheim, Abbott, Bayer, Medtronic, Pfizer, Kowa, MSD, and Actelion, outside the submitted work. Dr. Jinnouchi reports grants and personal fees from MSD, Boehringer Ingelheim, Novo Nordisk, Daiichi Sankyo, Takeda, Taisho Toyama, Astellas, Bayer, Sanofi, Sanwa Kagaku Kenkyusho, Eli Lilly, AstraZeneca; grants from Chugai, GlaxoSmithKline, Ono, Pfizer, Shionogi; personal fees from Abbott, Terumo, Kyowa Kirin, Teijin, Mitsubishi Tanabe, outside the submitted work. Dr. Waki reports grants and personal fees from Sanofi, AstraZeneca; personal fees from MSD, Astellas, Amgen Astellas BioPharma, Otsuka, Ono, Kowa, Kyowa Kirin, Novartis, Sanwa Kagaku Kenkyusho, Johnson & Johnson, Daiichi Sankyo, Taisho Toyama, Sumitomo Dainippon, Takeda, Mitsubishi Tanabe, Teijin, Eli Lilly, Novo Nordisk, Bayer, Pfizer, Boehringer Ingelheim, Abbott, outside the submitted work. Dr. Masuda reports personal fees from AstraZeneca, Ono, Takeda, Astellas, Bayer, Boehringer Ingelheim, Eli Lilly, Daiichi Sankyo, Kowa, Kyowa Kirin, MSD, Novartis, Shionogi, Mitsubishi Tanabe, outside the submitted work. Dr. Saito reports grants and personal fees from Bayer, Otsuka, Novartis, Ono, Mitsubishi Tanabe, Astellas, Asahi Kasei, Daiichi Sankyo, Sumitomo Dainippon, Fuji Yakuhin, Kowa, Kyowa Kirin, MSD, Sanofi, Takeda; grants from Terumo, Amgen Astellas BioPharma, Shionogi, Teijin, St. Jude Medical, Actelion, Boston Scientific, Chugai, Eisai, Medtronic, Nihon Medi-Physics, Zeria; personal fees from Boehringer Ingelheim, Pfizer, Taisho Toyama, Toa Eiyo, outside the submitted work.

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Okada, S., Morimoto, T., Ogawa, H. et al. Association Between Statins and Cancer Incidence in Diabetes: a Cohort Study of Japanese Patients with Type 2 Diabetes. J GEN INTERN MED (2020).

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  • statin
  • cancer
  • diabetes