BACKGROUND: Exenatide was approved by the US Food and Drug Administration (FDA) in April 2005 as adjunctive therapy to @entity2449 or a @entity4136 for the treatment of @entity6 ( @entity6 ). OBJECTIVE: We evaluated whether use of exenatide soon after its approval was consistent with the FDA- approved indications. METHODS: We assembled a retrospective cohort of @entity1 with @entity6 using data from a population of employed @entity1 and their dependents, including pharmacy claims and claims for inpatient and outpatient services, provided by i3 Innovus. The data set included @entity1 aged between 18 and 64 years with a diagnosis of @entity6 or a claim for a @entity6 drug from June 1, 2004, to December 31, 2005. Laboratory data were available for a subgroup of @entity1 tested at specific commercial laboratories from June 1, 2003, to December 31, 2005. In addition, we requested data for @entity1 with a diagnosis of @entity28 , regardless of a diagnosis of @entity6 , to assess early off-label use of this medication. @entity1 were categorized by @entity6 medication use and by their first fill date for exenatide, and their clinical characteristics were described. Early use was defined as filling a prescription for exenatide in the first 3 months after its approval. For descriptive purposes, we reported the means and percentages for the variables described. RESULTS: The study included data for 206,345 individuals (mean age, 51.3 years), of whom 54.0% were male. Starting in June 2005, prescriptions for exenatide were filled by 3225 (1.6%) individuals. Fifty-three percent of early users were @entity1 . Among those who filled a prescription for exenatide, 21.9% were @entity28 , compared with 10.9% to 15.1% of those filling prescriptions for other @entity6 medications. The proportion of @entity1 filling a prescription for exenatide who had not received a prescription for any other @entity6 medication in the preceding year was 14%, suggesting that exenatide was their initial therapy. A prescription for a @entity12585 was filled by 29.9% of @entity1 within 60 days of filling a prescription for exenatide. CONCLUSIONS: Soon after its approval, exenatide was frequently used as monotherapy or in combination with a @entity12585 , neither of which is an FDA- approved indication. The observation that those filling a prescription for exenatide had a higher prevalence of @entity28 than those receiving prescriptions for other therapies may reflect awareness of the weight-lowering effects of exenatide.

Diffusion into use of exenatide for glucose control in XXXX : a retrospective cohort study of a new therapy.

@entity1 :: ('9606', 'Species') :: ['women', 'Patients', 'patients', 'persons'] @entity28 :: ('MESH:D009765', 'Disease') :: ['obesity', 'obese'] @entity6 :: ('MESH:D003920', 'Disease') :: ['DM', 'type 2 diabetes mellitus'] @entity12585 :: ('MESH:C089946', 'Chemical') :: ['thiazolidinedione'] @entity4136 :: ('CHEBI:26831', 'Chemical') :: ['sulfonylurea'] @entity2449 :: ('MESH:D008687', 'Chemical') :: ['metformin']
@entity6 :: (MESH:D003920,Disease) :: ['diabetes mellitus']
