THE REAL-WORLD OBSERVATIONAL PROSPECTIVE STUDY OF HEALTH OUTCOMES WITH DULAGLUTIDE & LIRAGLUTIDE IN TYPE 2 DIABETES PATIENTS (TROPHIES)- DESIGN AND BASELINE CHARACTERISTICS
Author(s)
García-Pérez LE1, Sapin H2, Norrbacka K3, Guerci B4, Giorgino F5, Aigner U6, Orsini Federici M7, Gentilella R8, Heitmann E9, Jung H9, Rosilio M10, Boye K11
1Lilly, S.A., Alcobendas, Spain, 2Lilly France SAS, Neuilly Sur Seine , France, 3Eli Lilly and Company, Helsinki, Finland, 4Hôpital Brabois Adultes, CHRU de Nancy, France, 5University of Bari Aldo Moro, Bari, Italy, 6Versdias GmbH, Sulzbach-Rosenberg, Germany, 7Eli Lilly Company Italia SpA, Florence, Italy, 8Former employee of Eli Lilly Company Italia SpA, Florence, Italy, 9Lilly Deutschland GmbH, Bad Homburg, Germany, 10Lilly France SAS, Neuilly Sur Seine, France, 11Eli Lilly and Company, Greenwood, IN, USA
OBJECTIVES: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are usually recommended as the first injectable therapy for type 2 diabetes (T2D). Although randomized clinical trials are the standard for assessing efficacy and safety, observational studies are valuable to understand GLP-1 RA use in clinical practice. The TROPHIES study design and baseline characteristics of patients are described in this abstract. METHODS: TROPHIES is a 24-month, prospective, observational study in France, Germany and Italy in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide or once-daily liraglutide. The primary outcome, time on the first GLP-1 RA without significant treatment change due to T2D-related factors, is defined as discontinuation of this GLP-1RA or intensification of glucose-lowering treatment. At baseline, demographics, duration of T2D, HbA1c levels, reported HbA1c targets, pre-existing diabetes-related diagnoses and concomitantly used oral glucose-lowering medications were assessed. RESULTS: To date, data from 2065 patients initiating dulaglutide (1089) or liraglutide (976) have been analyzed. In patients initiating dulaglutide or liraglutide, mean age was 58.9 and 59.4 years, 55.3% and 57.4% were male, mean duration of T2D was 8.7 and 8.3 years, and mean BMI was 33.8 and 34.1 kg/m2, respectively. Mean baseline HbA1c level was 8.2% (dulaglutide) and 8.3% (liraglutide) and exceeded the reported mean HbA1c target (6.9%). Macrovascular and microvascular diabetes‑related conditions were reported in 8.2% and 17.7% (dulaglutide) and 11.5% and 15.5% (liraglutide) of patients, respectively. Of the patients initiating dulaglutide or liraglutide, 27.5% and 25.5% had taken ≥2 concomitant oral glucose-lowering medications, respectively, and biguanides were the most common. CONCLUSIONS: In patients of both groups, BMI reflected obesity. HbA1c levels exceeded the reported targets justifying treatment intensification with GLP-1 RA after ~8.5 years of diabetes. Thus, this study helps to understand profiles of patients being prescribed dulaglutide or liraglutide in France, Germany and Italy.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PDB116
Disease
Diabetes/Endocrine/Metabolic Disorders