EXSCEL-Once-Weekly Exenatide Reduces Medical Resource Utilization in Patients with Type 2 Diabetes Mellitus

Objectives: To evaluate the effect of exenatide 2mg once-weekly vs. placebo in addition to usual care on medical resource use among 14,572 patients with type 2 diabetes enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL), which demonstrated a statistically non-significant reduction in major adverse cardiovascular events and a nominally significant reduction in all-cause mortality with exenatide once-weekly administration. Methods: Data on medical resource use were collected from randomization to study end. Hierarchical generalized linear models were used to compare medical resource use between groups, with an offset to account for patient-level of follow-up duration. Random intercepts modeled country-specific variations in resource use and a fixed effect modeled the relative impact of exenatide vs. placebo. Results: Mean follow-up was 3.3 years in both groups. The mean number of hospitalizations was similar between the two groups (0.83 in the exenatide group vs. 0.84 in the placebo group; p=0.31), as were annual hospitalization rates, ranging from 0.24-0.29 per person-year from Year 1 to Year 5. The mean cumulative number of inpatient days over the trial follow-up period was 0.41 days lower in the exenatide group than in the placebo group (7.days vs. 7.46 days, respectively; relative rate ratio: 0.910; p=0.048). Patients treated with exenatide had an average of 8.88 outpatient visits to usual diabetes care providers compared to 9.14 for patients treated with placebo (p=0.048). Outpatient visits to other healthcare providers were similar at 12.19 for the exenatide group vs. 11.78 for the placebo group (p=0.80). Country-level variations in resource use were significant. Conclusions: Type 2 diabetes patients treated with exenatide in addition to usual care incurred significant reductions in inpatient hospital days and outpatient visits to their diabetes care providers compared to patients treated with placebo in addition to usual care. Disclosure S.D. Reed: Research Support; Self; AstraZeneca, Merck & Co., Inc.. Y. Li: None. H.A. Dakin: Research Support; Self; AstraZeneca, Pfizer Inc.. F. Becker: None. J. Leal: None. S. Gustavson: Employee; Self; AstraZeneca. Employee; Spouse/Partner; AstraZeneca. B. Kartman: Employee; Self; AstraZeneca. E.T. Wittbrodt: Employee; Self; AstraZeneca. R.J. Mentz: Research Support; Self; AstraZeneca, GlaxoSmithKline plc., Merck & Co., Inc. N. Pagidipati: Research Support; Self; AstraZeneca, Novartis Pharmaceuticals Corporation, Sanofi, Amgen Inc., Novo Nordisk Inc., Intarcia Therapeutics, Inc. M. Bethel: Research Support; Self; AstraZeneca, Merck Sharp & Dohme Corp., Merck Serono. Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Novo Nordisk Inc.. Advisory Panel; Self; AstraZeneca. Other Relationship; Self; Sanofi. Consultant; Self; Theracos, Inc.. Research Support; Self; GlaxoSmithKline plc. A.M. Gray: Advisory Panel; Self; Novo Nordisk A/S. Speaker9s Bureau; Self; Novartis AG. R.R. Holman: Research Support; Self; AstraZeneca, Merck & Co., Inc., Bayer AG. Advisory Panel; Self; Elcelyx Therapeutics, Inc., Novartis AG, Novo Nordisk A/S. Other Relationship; Self; Bayer AG. Advisory Panel; Self; Merck & Co., Inc.. Other Relationship; Self; AstraZeneca. A.F. Hernandez: Research Support; Self; AstraZeneca, GlaxoSmithKline plc., Merck & Co., Inc.. Consultant; Self; Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc.. Research Support; Self; Janssen Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation.