Exenatide efficacy in unselected patients: Comparison with clinical trials

Abstract

Exenatide is a Glucagon-Like Peptide-1 (GLP-1) analog improving fasting and post-prandial glycaemia, approved in patients treated with a combination of sulfonylureas and metformin and not achieving good metabolic control. This retrospective cohort study compared the efficacy and safety of exenatide in unselected patients with outcomes of FDA trials and other uncontrolled published studies. Exenatide was prescribed in 108 patients between April 2008 and December 2009, 80% of the patients were treated with 10 ug of exenatide twice daily. Mean follow up was 4.5 months for the 1st follow up. Changes in HbA1c (-1.1%), BMI (-1.1) and fasting glucose (-0.61 g/l) from baseline were significant, and coherent with controlled trials. 32% of patients had at least one side effect, often gastro intestinal. 23% stopped the treatment, a quarter (1/4) of which for inefficacity. Patients with a higher BMI (>40) (n = 29) at baseline did not show a better response in HbA1c or weight. Results at the second follow-up show a slight tendency of rising on HbA1c, BMI and fasting blood glucose. Finally, a third follow-up at a mean of 17 months is available for 11 patients, which shows stability in HA1c, BMI and fasting glucose. In our experience, Exenatide was safe and effective in reducing HbA1c and weight in patients who were able to tolerate it. Our results are close to results published elsewhere. There are still gaps in the literature on exenatide, especially on the long term effect, which need to be assessed by more publications.