4.7 Article

Exenatide once weekly improved glycaemic control, cardiometabolic risk factors and a composite index of an HbA1c < 7%, without weight gain or hypoglycaemia, over 52 weeks

Journal

DIABETES OBESITY & METABOLISM
Volume 15, Issue 3, Pages 264-271

Publisher

WILEY
DOI: 10.1111/dom.12026

Keywords

cardiovascular disease; exenatide; GLP-1; glycaemic control; type 2 diabetes

Funding

  1. Amylin Pharmaceuticals, LLC
  2. Eli Lilly Company
  3. Novo Nordisk
  4. Sanofi
  5. Boehringer Ingelheim
  6. Bristol-Myers Squibb
  7. Takeda
  8. Merck

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Aims Type 2 diabetes mellitus (T2DM) is often associated with cardiovascular (CV) risk factors such as obesity, hypertension and dyslipidemia. The objective of this analysis was to evaluate potential effects of exenatide once weekly (ExQW), a GLP-1 receptor agonist, on glycaemic control and CV risk factors. Methods This analysis included 675 Intent-to-Treat patients with T2DM [baseline (mean +/- SD) HbA1c, 8.1 +/- 1.2%; fasting blood glucose (FBG), 166 +/- 48?mg/dl; weight, 94.3 +/- 19.4?kg; systolic/diastolic blood pressure (SBP/DBP), 129 +/- 15/78 +/- 9 mm?Hg; total cholesterol, 178.5 +/- 41.9?mg/dl; low-density lipoprotein (LDL), 100.1 +/- 35.0?mg/dl; high-density lipoprotein (HDL), 44.5 +/- 11.6?mg/dl; triglycerides, 155.6 +/- 3.3?mg/dl; alanine aminotransferase (ALT), 32.1 +/- 19.5 U/l] treated with diet and exercise alone or in combination with metformin, sulfonylurea, and/or thiazolidinedione who received 52?weeks of ExQW in four clinical trials. Results At 52?weeks, ExQW significantly improved HbA1c [mean (SE) change from baseline, -1.3 (0.05)%], FBG [-36.3 (2.02) mg/dl], body weight [-2.6 (0.19) kg], SBP/DBP [-3.6 (0.56) mm?Hg/-1.2 (0.34) mm?Hg], total cholesterol, -4.4 (1.33) mg/dl; LDL, -2.6 (1.08) mg/dl; HDL, 1.1 (0.31) mg/dl; triglycerides, -7 (1.6)%], and ALT [-4.3 (0.71) IU/l] concentrations, with greater improvements in patients with elevated analyte levels at baseline. Improvements were observed across a range of background antihyperglycaemia therapies. Of patients completing 52?weeks, 19% achieved the composite American Diabetes Association goal (HbA1c < 7.0%, BP < 130/80 mm?Hg, LDL?

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