A retrospective cohort study of a new therapy? Rockville, MD, USA: Agency for Healthcare Research and Quality.
Johns Hopkins University, Baltimore, MD, USA
BACKGROUND: Exenatide was approved by the Food and Drug Administration (FDA) in April, 2005 as adjunctive therapy for type 2 diabetes mellitus (DM). We evaluated whether early use of this drug was consistent with the FDA-approved indications for use.
METHODS: We assembled a retrospective cohort of patients with DM from among a population of employed persons and their dependents. The data, from i3Innovus, includes pharmacy claims and inpatient and outpatient services. The dataset included patients with a diagnosis of DM, or a claim for a drug used to treat DM, between June 1, 2004 and December 31, 2005. We categorized patients by medication use and by their first fill-date of exenatide, and described the patients prior to exenatide use.
RESULTS: We studied 206,345 individuals ages18 to 64 years (mean 51.3 years); 54% were male. Exenatide was filled by 3,225 people, beginning in June 2005. Fifty-three percent of the early users (first 3 months) were female. Twenty-two percent of users were obese, compared to 11 to 15% using other medications. Fourteen percent of users had used no other medication for DM in the preceding year, suggesting that exenatide was their initial therapy. Thirty percent filled a thiazolidinedione prescription within 60 days of filling exenatide.
CONCLUSIONS: Exenatide was used frequently early after its approval as monotherapy or with a thiazolidinedione; neither is an FDA approved indication. Exenatide-users had a higher prevalence of obesity than patients using other therapies, suggesting that its weight-lowering benefits may be widely known.
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