Relationship of patient background with macro- and microvascular complications: a 2-year post-marketing surveillance of vildagliptin in nearly 20, 000 Japanese diabetic patients. (24th May 2019)

• Record Type: Journal Article
• Authors: Murayama, Hiroki; Toda, Mitsutoshi; Tsumiyama, Isao; Shinfuku, Yohei; Taniguchi, Tomoko; Tanaka, Yoshio; Oyama, Naotsugu
• Is Part Of: Expert opinion on pharmacotherapy. Volume 20:Number 8(2019)
• Page Start: 1037
• Page End: 1047
• Publication Date: 2019-05-24
• Subjects: Japanese patients -- macrovascular complications -- microvascular complications -- post-marketing surveillance -- type 2 diabetes mellitus -- vildagliptin; Chemotherapy -- Periodicals; 615.5805
• DOI: 10.1080/14656566.2019.1585802
• Languages: English
• ISSNs: 1465-6566

Abstract

ABSTRACT: Background : Vildagliptin is indicated for type 2 diabetes mellitus (T2DM); however, the onset and exacerbation of diabetic complications in Japanese T2DM patients treated with vildagliptin is unknown. Research design and methods : This 2-year post-marketing surveillance (PMS) assessed the real-world safety and efficacy of vildagliptin therapy in 19, 218 Japanese T2DM patients. The relationship between the incidence of macro- and microvascular complications with patient characteristics and changes in glycemic control (HbA1c) were evaluated. Results : The incidences of macro- and microvascular diseases were 1.14% and 3.09%, respectively. Patients with HbA1c ≥8.4% had a higher odds ratio (OR) for micro- and macrovascular disease (OR: 2.02 and 1.90) compared with patients with HbA1c <6.9%. Patient characteristics (OR, 95% CI) associated with macrovascular disease were age (1.04, 1.01–1.07) and a history of macrovascular disease (3.38, 1.98–5.75). Microvascular disease was associated with a final HbA1c level ≥7.0% (1.48, 1.11–1.98) and previous diabetic nephropathy (1.42, 1.05–1.93). The mean (SD) HbA1c decreased from 7.89% (1.46%) to 7.05% (0.99%) after 24 months. Conclusions : Vildagliptin elicited no increases/exacerbations of diabetic complications; this PMS suggested that the incidence of diabetic complications tends to be low in subjects with good HbA1c control.