UTILIZATION PATTERNS AND HYPOGLYCEMIA IN PATIENTS WITH TYPE-2 DIABETES ON CONCOMITANT EXENATIDE AND LONG-ACTING INSULIN THERAPY

Author(s)

Rolin Wade, RPh, MS, Research Operations Director1, Ralph A. Quimbo, MA, Senior Research Analyst2, Rosalind Fabunmi, PhD, Research Scientist3, Amy L. Blickensderfer, PharmD, Sr. Managed Care Liaison3, Manjiri D Pawaskar, PhD, Research Scientist4, Derek Misurski, RPh, PhD, Outcomes Researcher41HealthCore, Inc., Wilmington, DC, USA; 2 HealthCore, Inc., Wilmington, DE, USA; 3 Amylin Pharmaceuticals, Inc., San Diego, CA, USA; 4 Eli Lilly and Company, Indianapolis, IN, USA

OBJECTIVES To examine utilization patterns and hypoglycemia in patients with type-2 diabetes mellitus (T2DM) receiving concomitant exenatide and long-acting insulin therapy over 6 months. METHODS A retrospective analysis was performed using claims data (January 1, 2004 to March 31, 2008) from a large US prescription database. Adult patients with T2DM and no claim for exenatide (index drug) in the previous 12 months were included. At least 12 months pre-index and ≥6 months post-index continuous eligibility were required. Concomitant long-acting insulin use was defined as a claim for NPH, insulin glargine or insulin detemir 100 days pre-index to 15 days post-index. Therapy discontinuation was defined as a >60 day gap between prescription claims. Hypoglycemic events were identified by ICD-9 codes 250.8, 251.0, 251.1, and 251.2. Hypoglycemia generating a claim using these codes is generally severe. RESULTS Concomitant exenatide and long-acting insulin use was identified in 2082 patients. Of these, 38% discontinued both therapies, 15% discontinued exenatide but remained on long-acting insulin, 24% discontinued long-acting insulin but remained on exenatide and 23% continued both therapies. There were no differences in age, gender or Deyo-Charleson comorbidity index score among cohorts. Patients who discontinued exenatide and remained on long acting insulin had a higher mean rate of hypoglycemia (0.10±1.01 events/patient/6-months), compared to patients who discontinued long-acting insulin but remained on exenatide (0.02±0.20), discontinued both therapies (0.04±0.37) or continued both therapies (0.03±0.26; p<0.0001 across groups). Insufficient pre- and post-A1C values were available for an analysis of this endpoint. CONCLUSIONS Patients remaining on concomitant exenatide and long-acting insulin did not experience more hypoglycemic events than patients who remained on either drug alone. However, patients discontinuing exenatide but remaining on long-acting insulin experienced significantly more hypoglycemic events. The increase in hypoglycemic events may have been due to an increase in basal insulin dose and/or the addition of other insulin therapy.

Conference/Value in Health Info

2009-05, ISPOR 2009, Orlando, FL, USA

Value in Health, Vol. 12, No. 3 (May 2009)

Code

PDB15

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Diabetes/Endocrine/Metabolic Disorders

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