Safety and efficacy of vildagliptin: 52-week post-marketing surveillance of Japanese patients with type 2 diabetes in combination with other oral antidiabetics and insulin. (2nd January 2020)

• Record Type: Journal Article
• Authors: Hayashi, Tomoko; Murayama, Hiroki; Shinfuku, Yohei; Taniguchi, Tomoko; Tsumiyama, Isao; Oyama, Naotsugu
• Is Part Of: Expert opinion on pharmacotherapy. Volume 21:Number 1(2020)
• Page Start: 121
• Page End: 130
• Publication Date: 2020-01-02
• Subjects: Vildagliptin -- DPP-4 inhibitor -- post-marketing surveillance -- type 2 diabetes -- Japan; Chemotherapy -- Periodicals; 615.5805
• DOI: 10.1080/14656566.2019.1685500
• Languages: English
• ISSNs: 1465-6566

Abstract

ABSTRACT: Background : Vildagliptin is a dipeptidyl peptidase-4 inhibitor that reduces glycemia in patients with type 2 diabetes mellitus (T2DM). When approved in 2013, data on vildagliptin combined with >750 mg/day metformin in Japanese patients were limited. There is a need to confirm the safety and efficacy of vildagliptin in combination with oral antidiabetic drugs (OADs). Research design and methods : This 52-week post-marketing surveillance (PMS) observational study in Japanese T2DM patients evaluated the safety and efficacy of vildagliptin in combination with OADs including high-dose metformin or insulin but excluding combination with sulfonylureas alone. Results : During this survey of 3006 Japanese T2DM patients, 13.61% of patients experienced adverse events (AEs) and 2.20% reported a serious AE (SAE). The frequency of AEs/SAEs was similar when in combination with biguanides (12.93%/1.46%), metformin ≥1000 mg/day (12.92%/1.22%), metformin <1000 mg/day (12.62%/1.54%), thiazolidine derivatives (16.71%/2.86%), α-glucosidase inhibitors (13.18%/1.90%), rapid-acting insulin secretagogues (glinides) (20.41%/5.71%), or insulin (15.87%/2.47%). The mean ± SD changes from baseline at endpoint in glycated hemoglobin and fasting blood glucose were −0.76 ± 1.27% and −23.3 ± 57.3 mg/dL, respectively, and these changes were consistent, regardless of concomitant OAD. Conclusions : Long-term vildagliptin combination therapy is safe and effective in Japanese T2DM patients in real-world settings.