Metabolic outcomes of elderly patient populations initiating exenatide BID versus insulin glargine in an ambulatory care setting

Abstract

Aims:

The safety and efficacy of exenatide BID (exenatide) and insulin glargine (glargine) have been studied in clinical trials with few elderly patients. This study examined the clinical effectiveness of exenatide compared to glargine in patients 65 years and older with type 2 diabetes mellitus (T2DM).

Methods:

A retrospective analysis was conducted using the General Electric electronic medical record database. Patients aged 65 years and older with T2DM who initiated exenatide or glargine were identified between November 1, 2006 and April 30, 2009 with 12 months of pre- and post-index continuous eligibility. Propensity-score matching (1:1) was used to balance baseline differences between the cohorts. The effectiveness endpoints were changes in A1C (primary endpoint), weight, body mass index (BMI), and blood pressure (BP). Matched cohorts were compared using paired t tests and nonparametric tests as appropriate.

Results:

The matched exenatide and glargine patients (n = 804 each) were comparable in their baseline characteristics, including age (70 vs. 71 years), and male sex (44.9% vs. 45.2%). In the 12-month follow-up, exenatide patients experienced significantly greater mean reductions in A1C (−0.5 vs. −0.2%), weight (−2.8 vs. −0.2 kg), BMI (−1.0 vs. −0.1 kg/m²), and systolic BP (−2.2 vs. 1.0 mmHg) (all: P < 0.05). More exenatide-treated patients reached the A1C goal of <7% (53.9% vs. 43.0%, P < 0.01). Diastolic BP was similar between the cohorts.

Limitations:

Unmeasured confounding bias may still exist and thus findings should be interpreted as associations instead of causations. Due to incomplete data, adverse events and medication use were not examined.

Conclusion:

Exenatide was associated with significant improvement in A1C, weight, BMI and BP compared to glargine for management of T2DM in an elderly patient population treated in ambulatory care settings.

Key words::

• Clinical effectiveness
• Elderly patient
• Exenatide BID
• Glargine
• Type 2 diabetes

Transparency

Declaration of funding

This study was funded by Eli Lilly and Company and Amylin Pharmaceuticals, Inc.

Declaration of financial/other relationships

M.P. has disclosed that she was employee and stock holder of Eli Lilly and Company at the time of this analysis. Q.L. and M.W.R. have disclosed that they are employees of United BioSource Corp., a company that received funding from Eli Lilly and Amylin Pharmaceuticals to conduct this study.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.