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

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.

Safety and effectiveness of linagliptin in Korean patients with type 2 diabetes: A postmarketing surveillance study

“…12 However, in a 52-week PMS study of vildagliptin, another type of DPP-4 inhibitor, the incidence of ADRs was 1.4%, similar to our study. 13 There were also some differences regarding the composition of ADRs between this study and previous studies. While metabolism disorders, mainly uncontrolled T2D, were the dominant ADRs in previous PMS studies of linagliptin, 9,10 gastrointestinal disorders were the most common in our study, and most of the metabolism disorders were cases of hypoglycaemia.…”

“…However, in those previous studies, gastrointestinal disorder was also one of the most frequent ADRs. Furthermore, in the PMS studies of other DPP‐4 inhibitors such as sitagliptin, vildagliptin and teneligliptin, hypoglycaemia and gastrointestinal disorders were the major ADRs 13–15 …”

Long-term safety and effectiveness of linagliptin as add-on therapy in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance

“…Also, there was no major difference in the percentages of patients who were taking each concomitant antidiabetic medication at baseline among the patients starting DPP-4 inhibitor add-on therapy between this PMS and other PMS studies with other DPP-4is [29,30].…”

Cardiovascular safety and effectiveness of vildagliptin in patients with type 2 diabetes mellitus: a 3-year, large-scale post-marketing surveillance in Japan

“…HbA1c, glycated hemoglobin; NGSP, National Glycohemoglobin Standardization Program; SD, standard deviation duration was the only significant patient characteristic. Age was a significant factor in a previous long-term PMS of T2DM Japanese treated with vildagliptin [18], while the incidence rates of ADRs were not significantly different in elderly patients (>65 years) or non-elderly patients (≥65 years) in a 52-week PMS of vildagliptin [19]. Because a higher number of AEs and ADRs are generally attributed to longer-term treatment, a degree of caution is still required when prescribing vildagliptin to patients with these background characteristics.…”

“…Another PMS in a large Japanese T2DM population recently provided real-world efficacy and safety data of vildagliptin used concomitantly with oral antidiabetic drugs and insulin for a period of up to 52 weeks. However, CV outcomes were not specifically evaluated [19]. Thus, further study is necessary to clarify the incidence of CV The supplementary data for this article can be accessed here.…”