INTERIM RESULTS OF THE POST-MARKETING SURVEY OF VILDAGLIPTIN IN FRANCE
Author(s)
Bringer J1, Attali C2, Simon D3, Eschwège E4, Kind B5, Quere S6, Dejager S6, Bouée S7, Detournay B81CHRU Montpellier, Montpellier, France, 2Cabinet Médical de Groupe, Epinay sous sénart, France, 3Hôpital de la Pitié, Paris, France, 4INSERM, Villejuif, France, 5Novartis, Rueil-Malmaison, France, 6Novartis Pharma, Rueil Malmaison, France, 7Cemka, Bourg La Reine, France, 8Cemka, Bourg la Reine, France
OBJECTIVES: To assess the effectiveness, tolerability and treatment adherence of vildagliptin in type 2 diabetes patients under real-life conditions of care in France, following a request by the French Health Technology Agency. METHODS: A representative sample of type 2 diabetes patients initiating a treatment with vildagliptin was enrolled in a 2 years follow up observational cohort in 2010 by a national sample of endocrinologists and general practitioners. Data collected included socio-demographic characteristics, clinical history, treatment and laboratory data. We report here an interim follow up analysis. RESULTS: A total of 482 GPs and 84 endocrinologists have included 1,702 patients and 1,463 are analyzed in these interim results up to 18 months (1,246 at 12 months and 700 at 18 months). 60% were males, mean age was 63 (±9) years, and mean disease duration was 7 (±6.5) years. The mean HbA1c level decreased rapidly from 7.8% (sd=1.3) before vildagliptin prescription to 7.1% (sd=1.0) at 6 months and remained stable thereafter, respectively 7.0% (sd=1.1), and 6.9% (sd=0.9) at 12 and 18 months after vildagliptin initiation. The percentages of patients with alanine or aspartate aminotransferase above 120 UI were 0.5% before vildagliptin prescription and respectively 0.3%, 0.5% and 0.2% at 6, 12, and 18 months after vildagliptin prescription. The mean glomerular filtration rate as calculated with the MDRD formula was 94.7 ml/minute before vildagliptin prescription and 95.1, 95.3, and 95.1, respectively at 6, 12, and 18 months after vildagliptin prescription. The incidence of severe hypoglycemia (requiring third party assistance) has been estimated at 0.24/ 100vildagliptin treated patients years (CI95%=[0.07,0.55]). The proportion of patients treated with vildagliptin remained high over the course of the study: 96.6% (CI95%[95.6,97.5]) after 6 months and 91.6% (CI95%=[90.1%,93.1%]) after one year. CONCLUSIONS: Vildagliptin showed sustained effectiveness in terms of reduction in HbA1c over 18 months, with a low incidence of hypoglycemia.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PDB13
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Diabetes/Endocrine/Metabolic Disorders