18 MONTH A1C AND WEIGHT OUTCOMES OF EXENATIDE THERAPY IN PATIENTS WITH TYPE-2 DIABETES IN A REAL-WORLD STUDY

Author(s)

Diana Brixner, RPh, PhD, Associate Professor1, Carrie McAdam-Marx, MS, Research Associate1, Xiangyang Ye, MS, Biostatistician1, Derek Misurski, RPh, PhD, Outcomes Researcher2, Matthew Wintle, MD, Clinical Research Physician3, Rosalind Fabunmi, PhD, Research Scientist31University of Utah College of Pharmacy, Salt Lake City, UT, USA; 2 Eli Lilly and Company, Indianapolis, IN, USA; 3 Amylin Pharmaceuticals, Inc., San Diego, CA, USA

OBJECTIVES: Six-month real-world outcomes were previously reported for exenatide, a GLP-1 receptor agonist for the treatment of type- 2 diabetes (T2D). A1C reductions were -0.7%, weight reductions were -2.8 kg, and BMI reductions were -0.94 kg/m2. The current 18 month analysis evaluated A1C, weight, and BMI outcomes to establish real-world durability of glycemic control and weight loss in patients using exenatide. METHODS: Data were extracted from the General Electric electronic medical record database from January 1, 2000 to December 31, 2007. Adults with T2D per ICD-9 codes, ≥2 fasting blood glucose levels ≥126 mg/dL, or A1C >7.0% starting exenatide in or after 2005 were included. Patients had 2+ additional prescription orders including at least one 12 to 18 months after the initial prescription to indicate ongoing therapy, and had prior prescription orders for metformin, a sulfonylurea, or a thiazolidinedione alone or in combination. A1C, weight and BMI were documented at exenatide initiation (-45 to + 15d) and at 18 months (±45d). Outcomes were evaluated in those with baseline and follow-up A1C, weight and BMI measures. RESULTS: In 102 study patients, baseline A1C was 8.2+1.1%, weight was 111 ± 12.3 kg. Baseline BMI was 38.6≥±7.4 kg/m2 in those with baseline and follow up data (n=89). After 18 months of exenatide therapy, mean (±SEM) A1C decrease was -0.7(±0.2)% (p<.001), weight decrease was -4.7(±0.7) kg (p<.001), and BMI decrease was -0.8 (±0.3) kg/m2 (p<.001). A total of 72.0% had an A1C reduction, 76.7% lost weight, and 57.0% had reductions in A1C and weight. Mean A1C reduction was identical and weight loss was approximately 2 kg greater at 18 months relative to 6 month cohort exenatide outcomes. CONCLUSIONS: Exenatide therapy was associated with significant reductions in A1C, weight and BMI at 18 months. These reductions demonstrate treatment durability with exenatide and continuous benefit from long term therapy.

Conference/Value in Health Info

2009-05, ISPOR 2009, Orlando, FL, USA

Value in Health, Vol. 12, No. 3 (May 2009)

Code

PDB6

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Diabetes/Endocrine/Metabolic Disorders

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