MedWire News: Results of a “real-world,” observational study indicate that exenatide treatment is associated with similar reductions in glycated hemoglobin (HbA1c), weight, blood pressure, and lipids to those achieved with the drug in registration clinical trials.
The retrospective cohort study used the General Electric Centricity electronic medical record research database for the period from January 2000 to December 2007 to evaluate exenatide treatment outcomes at 6 months.
“Validation of efficacy data from clinical trials by effectiveness data from large patient populations is important in establishing physician–patient confidence in drug therapy,” explain Diana Brixner (University of Utah College of Pharmacy, Salt Lake City, USA) and co-workers.
The authors identified 14,409 patients with Type 2 diabetes in the database who had a baseline prescription order for exenatide. Of these, 1709 met the study inclusion criteria of previous treatment with metformin, a sulfonylurea and/or thiazolidinedione; age of at least 18 years; and a baseline HbA1c of at least 7.0%.
Individuals were similar in terms of baseline patient and clinical characteristics to those enrolled in the registration clinical trials except regarding weight – patients were heavier than those studied in registration trials.
Baseline clinical measures at exenatide initiation and follow-up measures at 6 months were documented.
Efficacy on outcome measures was similar to those achieved in the exenatide registration trials, with mean reductions of 0.8% in HbA1c, 3.2 kg in body weight, 1.9 mmHg in systolic blood pressure, 0.5 mmHg in diastolic blood pressure, 7.4 mg/dl in low-density lipoprotein cholesterol, and 23.2 mg/dl in triglycerides.
Weight loss was greater in this study than in the exenatide clinical trials, which the authors suggest may be due in part to the higher mean body mass index at baseline in this real-world cohort.
“Patients with Type 2 diabetes who are having difficulty bringing their diabetes under control and need to avoid further weight gain and worsening of cardiovascular risk factors may benefit from exenatide therapy,” conclude the authors in the journal Diabetes, Obesity and Metabolism.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009
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