Relationship of patient background with macro- and microvascular complications: a 2-year post-marketing surveillance of vildagliptin in nearly 20,000 Japanese diabetic patients

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.

KEYWORDS:

• Japanese patients
• macrovascular complications
• microvascular complications
• post-marketing surveillance
• type 2 diabetes mellitus
• vildagliptin

Acknowledgments

The authors would like to thank James Graham, PhD, of Edanz Medical Writing for providing medical writing assistance, which was funded by Novartis Pharma K.K. The authors also appreciate Tetsuya Kanayama for reviewing the safety data and the overall manuscript.

Declaration of interest

H Murayama, M Toda, I Tsumiyama, Y Shinfuku, T Taniguchi, Y Tanaka, and N Oyama have all received research funding and are employees of the study sponsor, Novartis Pharma K.K. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

IT, YS, and TT contributed to study design, study conduct, data collection, data analysis, and data interpretation. All authors contributed to writing and reviewing the manuscript as well as providing final approval of the manuscript for submission.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This study was funded by Novartis.