Prevalence of diabetic peripheral neuropathy and relation to glycemic control therapies at baseline in the BARI 2D cohort

We evaluated the associations between glycemic therapies and prevalence of diabetic peripheral neuropathy (DPN) at baseline among participants in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial on medical and revascularization therapies for coronary artery disease (CAD) and on insulin-sensitizing vs. insulin-providing treatments for diabetes. A total of 2,368 patients with type 2 diabetes and CAD was evaluated. DPN was defined as clinical examination score > 2 using the Michigan Neuropathy Screening Instrument (MNSI). DPN odds ratios across different groups of glycemic therapy were evaluated by multiple logistic regression adjusted for multiple covariates including age, sex, hemoglobin A1c (HbA1c), and diabetes duration. Fifty-one percent of BARI 2D subjects with valid baseline characteristics and MNSI scores had DPN. After adjusting for all variables, use of insulin was significantly associated with DPN (OR = 1.57, 95% CI: 1.15-2.13). Patients on sulfonylurea (SU) or combination of SU/metformin (Met)/thiazolidinediones (TZD) had marginally higher rates of DPN than the Met/TZD group. This cross-sectional study in a cohort of patients with type 2 diabetes and CAD showed association of insulin use with higher DPN prevalence, independent of disease duration, glycemic control, and other characteristics. The causality between a glycemic control strategy and DPN cannot be evaluated in this cross-sectional study, but continued assessment of DPN and randomized therapies in BARI 2D trial may provide further explanations on the development of DPN.

National Heart, Lung and Blood Institute (NHLBI/NIH)[U01 HL061746]

National Heart, Lung and Blood Institute (NHLBI/NIH)[U01 HL061748]

National Heart, Lung and Blood Institute (NHLBI/NIH)[U01 HL063804]

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH)[U01 HL061744]

GlaxoSmithKline

Bristol-Myers Squibb Medical Imaging, Inc.

Astellas Pharma US, Inc.

Merck Co., Inc.

Abbott Laboratories, Inc.

Pfizer, Inc.

Abbott Laboratories Ltd.

MediSense Products

Bayer Diagnostics

Beckton, Dickinson and Company

J.R. Carlson Laboratories, Inc.

Centocor, Inc.

Eli Lilly and Company

LipoScience, Inc.

Merck Sante

Novartis Pharmaceuticals Corporation

Novo Nordisk, Inc.