Comparison of the Effectiveness and Safety of Vildagliptin Add-On to Metformin Versus Other Oral Dual Antidiabetes Agents in Patients with Type 2 Diabetes: The China Prospective Diabetes Study

Abstract

Introduction The efficacy and safety of vildagliptin alone or with metformin is well established by randomized trials, but it is unknown whether it can be extrapolated to the real-world setting in Chinese patients with type 2 diabetes mellitus (T2DM). This study aimed to assess the effectiveness and safety of vildagliptin add-on to metformin versus dual oral antidiabetes drug (OAD), non-vildagliptin combination therapies in real-world Chinese patients with T2DM. Methods The China Prospective Diabetes Study was a post-marketing, prospective, multicenter, observational, real-world study conducted in 52 centers. Patients inadequately controlled with OAD monotherapy and who initiated vildagliptin add-on to metformin (VM cohort) or two OADs other than vildagliptin (comparator cohort) were included for the present analysis. The composite primary endpoint was glycated hemoglobin (HbA1c) < 7% and without tolerability events (hypoglycemia, weight gain ≥ 3%, or discontinuation due to gastrointestinal events) at 12 months. Secondary endpoints included change in HbA1c from baseline, subgroup analysis, and tolerability. Propensity score matching analysis was performed to adjust for baseline covariates imbalance (body mass index (BMI) and HbA1c). Results A total of 604 patients received VM and 670 received comparator therapy. Patients who received VM were younger, more obese, and had a higher baseline HbA1c and a shorter duration of T2DM. After propensity score matching, there were 530 patients per cohort. After 12-month treatment, the success rates of the composite primary endpoint were 50.9% and 33.0% in the VM and comparator cohorts, respectively ( P < 0.001; odds ratio = 2.10, 95% confidence interval (CI) 1.64–2.70). Furthermore, the success rates of the composite endpoint were higher with VM across geographic area, BMI, and baseline HbA1c subgroups. Fewer tolerability events occurred in the VM cohort versus the comparator cohort (8.3% vs. 16.2%, P < 0.001; relative risk = 0.51, 95% CI 0.36–0.72). Conclusion Compared with dual OAD non-vildagliptin combination therapies, vildagliptin add-on to metformin is effective and safe to achieve glycemic control in Chinese patients with T2DM. Funding Novartis. Electronic supplementary material The online version of this article (10.1007/s13300-019-0645-z) contains supplementary material, which is available to authorized users.

Vildagliptin Versus α-Glucosidase Inhibitor as Add-On to Metformin for Type 2 Diabetes: Subgroup Analysis of the China Prospective Diabetes Study

“…Pre-PSM baseline results from our study showed that in this real-life setting in China, compared to patients on VM, those on AM were older, had a lower BMI, a longer disease duration, and lower baseline HbA1c. These characteristics for patients on AM were in general agreement with those for patients on nonvildagliptin combination therapy in China [18] and are consistent with previous real-life data on acarbose use, with East Asian patients on acarbose reported to be older and less obese [22]. The distinct prescription pattern for VM versus that for other dual OAD, non-vildagliptin combination therapies (including AM) in China might be partially attributed to physician preference, which requires further research in the future.…”

“…The composite primary endpoint was defined as glycemic control (hemoglobin A1c \ 7%) at 12 months and without any tolerability event, including hypoglycemia, weight gain C 3%, and gastrointestinal events leading to discontinuation of the treatment. CI Confidence interval, OR odds ratio combination [18]. Pre-PSM baseline results from our study showed that in this real-life setting in China, compared to patients on VM, those on AM were older, had a lower BMI, a longer disease duration, and lower baseline HbA1c.…”

“…The study reported here was a subgroup analysis of the original China PDS, which was a postmarketing, multicenter, prospective, observational real-world study of patients with T2DM recruited from 52 sites in China between June 2013 and April 2017 [18]. The present study was conducted in compliance with the Declaration of Helsinki of 1964 and its later amendments.…”