PATIENT REPORTED OUTCOMES ARE SUPERIOR IN PATIENTS WITH TYPE 2 DIABETES TREATED WITH LIRAGLUTIDE AS COMPARED TO EXENATIDE, WHEN ADDED TO METFORMIN, SULFONYLUREA OR BOTH
Author(s)
Wolfgang E Schmidt, MD, Professor1, Jens S Christiansen, MD, PhD, Professor2, Mette Hammer, MSc, Associate Director3, Marcin J Zychma, MD, International Medical Director4, John Buse, MD, PhD, Dr51Ruhr University, Bochum, Germany; 2 Århus University Hospital, Århus, Denmark; 3 Novo Nordisk A/S, Bagsværd, Denmark; 4 Novo Nordisk A/S, Bagsvaerd, Denmark; 5 University of North Carolina School of Medicine, Chapel Hill, NC, USA
OBJECTIVES New treatments for T2D are needed to improve glycemic control, reduce side-effects, and improve patient satisfaction. Liraglutide is an OD human GLP-1 analog that has benefits as monotherapy, or in combination with OADs. METHODS The Liraglutide Effect and Action in Diabetes 6 (LEAD-6) trial was an open-label trial comparing liraglutide to exenatide as add-on to OADs. Adults with T2D on metformin and/or sulfonylurea and A1C 7–11% were randomized to liraglutide 1.8 mg OD or exenatide 10µg BD for 26 weeks. This was followed by a 14-week extension phase, in which all patients received liraglutide 1.8mg OD. RESULTS During weeks 0–26, A1C reductions were significantly greater and the incidence of hypoglycemia was significantly lower in the liraglutide-treated group. Patient Reported Outcomes were measured in 379 patients using Diabetes Treatment Satisfaction Questionnaire status (DTSQs) at week 0, 26, 34 and 40 and DTSQ change (DTSQc) at week 26 and 34. The overall treatment satisfaction was highest with liraglutide (p<0.0001); DTSQs score increased from 27.4 at baseline to 32.1 at week 26 compared to exenatide (increase from 27.6 to 29.3). All items on DTSQs except ‘understanding' (ie ‘current treatment', ‘convenience', ‘flexibility', ‘recommend', ‘continue') improved significantly more with liraglutide than exenatide. The proportion of ‘satisfied' patients (defined as DTSQc >6) was 94% in liraglutide, 86% with exenatide (p=0.0176). Patients perceived a greater reduction in hypoglycemia at week 26 with liraglutide (DTSQc -0.9) than with exenatide (-0.4; p=0.0193) and a greater reduction in perceived hyperglycemia (-1.0, -0.3, respectively; p=0.0007). During the extension phase, when all patients received liraglutide, DTSQs scores remained stable in patients who continued on liraglutide and had increased significantly (p=0.0131) at week 40 in those who switched from exenatide to liraglutide at week 26. CONCLUSIONS These results demonstrate significant improvements in patients' treatment satisfaction with liraglutide compared to exenatide.
Conference/Value in Health Info
2009-05, ISPOR 2009, Orlando, FL, USA
Value in Health, Vol. 12, No. 3 (May 2009)
Code
PDB43
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Diabetes/Endocrine/Metabolic Disorders