Use of Vildagliptin in Management of Type 2 Diabetes: Effectiveness, Treatment Persistence and Safety from the 2-Year Real-Life VILDA Study

Abstract

IntroductionThere is an increasing interest for real-life data on drug use in many countries. Reimbursement authorities more and more request observational studies to assess the conditions of use of the products but also to improve knowledge about efficacy and safety in the real world and on a longer term than in clinical trials.AimTo evaluate the effectiveness, treatment persistence and tolerability of vildagliptin in clinical practice.MethodsThis observational, 2-year prospective cohort study was conducted in France on request of the Health Authorities [Haute Autorite de Sante (HAS)]. Type 2 diabetic mellitus (T2DM) patients initiating vildagliptin (including the fixed combination vildagliptin-metformin) or treated for <6 months were recruited through a national representative sample of general practitioners (GPs) (n = 482) and diabetologists (n = 84) between March 2010 and December 2011. At inclusion and each follow-up visit at ~ 6, 12, 18 and 24 months, a questionnaire was completed by the physician collecting information on socio-demographic, clinical and biological data, treatments and adverse events.Results1,700 patients were included: 60% were males, aged 63 ± 11 years, with diabetes duration 7 ± 6 years and body mass index (BMI) 30 ± 6 kg/m2. 45% were obese, 70% treated for hypertension and 66% for dyslipidemia. 64% of the patients received vildagliptin in dual therapy with metformin. 82% of patients completed the 2-year follow-up. Glycosylated hemoglobin (HbA1c) decreased from a mean baseline of 7.8 ± 1.2% when vildagliptin was started, to 7.0 ± 1.1% at 6 months and remained stable thereafter over 2 years. Mean weight, glomerular filtration rate, liver enzymes, and lipid parameters were unchanged over the study period. Eight patients (0.5%), all concomitantly treated with insulin and/or sulphonylureas, reported one severe hypoglycemia and 47 (2.9%) patients reported 64 non-severe symptomatic hypoglycemia (59% occurred when patients were treated with insulin and/or sulphonylureas). At 6 months, 44.9% of vildagliptin-treated patients reached an HbA1c <7% without hypoglycemia and no weight gain, and this percentage increased to 49.7% at 24 months. Vildagliptin treatment maintenance at 2 years was 88.8% [95% CI (87.2%; 90.4%)], with 4% of patients discontinuing for adverse events.ConclusionsIn everyday conditions of care, vildagliptin efficacy was in line with existing data from randomized clinical trials, sustained over 2 years, with low discontinuation rate and low hypoglycemia risk.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-014-0064-0) contains supplementary material, which is available to authorized users.

Treatment maintenance duration of dual therapy with metformin and sitagliptin in type 2 diabetes: The ODYSSEE observational study

“…However, data on HbA 1c were missing for a significant minority of patients, which means that these data should be interpreted with caution. The efficacy of sitagliptin observed in our study is similar to the efficacy reported in previous interventional trials [7,9], and is also very similar to that reported in the real-life VILDA study [8].…”

“…Another French observational study (VILDA) evaluated treatment maintenance with a different DPP-4 inhibitor, vildagliptin [8], with maintenance defined less stringently as discontinuation of vildagliptin. In that study, 11% of patients had discontinued vildagliptin after 2 years, a somewhat higher rate than that observed in our present study.…”

Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study)

“…Similarly, patients treated with vildagliptin in addition to metformin exhibited no significant differences in the glycemic target achievement rates (HbA1c < 7%) in comparison with those treated with other active comparators [ 9 ]. Data from the VICTORY study are consistent with the key findings of these RCTs [ 9 ] and findings from previous real-life vildagliptin studies conducted in other regions [ 13 – 15 ]. The VICTORY study revealed that the mean reduction in HbA1c with vildagliptin as an add-on to metformin was −0.8% at the first follow-up visit at 12 weeks, which further improved to −1.0% at 24 weeks after treatment initiation.…”

“…Moreover, drug adherence is a critical factor to consider in the management of T2DM. The discontinuation of antidiabetic medication leads to a significant cost burden on the healthcare system and is frequently encountered in primary care patients [ 15 , 27 ]. Furthermore, patients with T2DM often have metabolic comorbid conditions such as hypertension and dyslipidemia [ 28 ].…”

A nomogram to estimate the HbA1c response to different DPP-4 inhibitors in type 2 diabetes: a systematic review and meta-analysis of 98 trials with 24 163 patients

“…In another observational, 2-year prospective cohort study conducted in France, at the request of local health authorities, patients with type 2 diabetic mellitus initiating vildagliptin or treated for <6 months were recruited through a national representative sample of general practitioners (n=482) and diabetologists (n=84) between March 2010 and December 2011. 28 Of the 1700 patients included, vildagliptin treatment maintenance at 2 years was 88.8%; in everyday conditions of care, vildagliptin efficacy was in line with existing data from randomised clinical trials, sustained over 2 years, with low discontinuation rate and low hypoglycaemia risk. In a real-world analysis of administrative claims data from patients in the US, the predicted change in HbA1c from baseline equalled the results from head-to-head RCTs.…”