Real-World Data on the Incidence of Macrovascular Complications in Japanese Patients with Type 2 Diabetes: The Sitagliptin Registration Type 2 Diabetes-Juntendo Collaborating Project

Hirotoshi Ohmura; Tomoya Mita; Joe Matsuoka; Shuko Nojiri; Yuji Nishizaki; Hirotaka Watada; Hiroyuki Daida; SPIRITS-J Study Investigators

doi:10.1007/s13300-019-0626-2

Real-World Data on the Incidence of Macrovascular Complications in Japanese Patients with Type 2 Diabetes: The Sitagliptin Registration Type 2 Diabetes-Juntendo Collaborating Project

Diabetes Ther. 2019 Jun;10(3):1099-1111. doi: 10.1007/s13300-019-0626-2. Epub 2019 Apr 26.

Authors

Hirotoshi Ohmura¹, Tomoya Mita², Joe Matsuoka³, Shuko Nojiri³, Yuji Nishizaki³, Hirotaka Watada², Hiroyuki Daida⁴; SPIRITS-J Study Investigators

Affiliations

¹ Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, 113-8421, Japan. hohmura@juntendo.ac.jp.
² Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, 113-8421, Japan.
³ Department Center for Lifetime Cancer Education, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan.
⁴ Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, 113-8421, Japan.

Abstract

Introduction: Type 2 diabetes is associated with vascular complications that deteriorate the quality of life and decrease the life expectancy of individuals. We previously reported the efficacy of sitagliptin for glucose control in patients with type 2 diabetes in the Sitagliptin Registration Type 2 Diabetes-Juntendo Collaborating Project (SPIRITS-J). Through the results of the SPIRITS-J study, we expected that optimal comprehensive management of type 2 diabetes according to current clinical practice guidelines in addition to achieving individualized glycemic goals would reduce macrovascular complications and all-cause mortality in Japan. The aim of this study was to evaluate this hypothesis.

Methods: We investigated the clinical outcomes prospectively in the extended SPIRITS-J study and compared these to previous Japanese cohort studies in the era before widespread use of guidelines. The primary clinical outcome was a composite of myocardial infarction (MI), stroke, and all-cause mortality.

Results: Mean duration of follow-up was 3.5 ± 1.3 years. The crude incidence of the primary outcome per 1000 person-years was 13.9 (non-fatal MI 1.44, non-fatal stroke 4.22, all-cause mortality 8.79 per 1000 person-years, respectively). It is noteworthy that the incidence of MI in the SPIRITS-J study was very much lower than that in a previous Japanese cohort study. In multivariate analysis, both the history of coronary artery disease and low-density lipoprotein cholesterol (LDL-C) were independently associated with incidence of primary clinical outcome.

Conclusion: The extended SPIRITS-J study demonstrated that optimal comprehensive management in patients with type 2 diabetes according to the recent practice guidelines has succeeded in preventing macrovascular complications in Japan. This study suggests that more intensive LDL-C-lowering therapy is important for further prevention of macrovascular complications even in Japanese patients with type 2 diabetes (UMIN 000004121).

Keywords: All-cause mortality; Cancer; Low-density lipoprotein cholesterol (LDL-C); Macrovascular complications; Myocardial infarction; Stroke; Type 2 diabetes.