Abstract

The burden of painful diabetic peripheral neuropathy (DPN) is a common complication of diabetes. This study expanded on the human burden of painful DPN by quantifying functional and health status impairments among international patients from a randomized, double-blind, placebo-controlled trial of painful DPN. Evaluated outcomes measures included: Brief Pain Inventory-Short Form (mBPI-sf), EuroQOL 5D, Hospital Anxiety and Depression Scale, and Medical Outcomes Study Sleep Scale. Outcomes were stratified by pain severity using cut-points: 0 to 10 numeric rating scale (NRS) for average pain (0 to 3: none/mild, 4 to 6: moderate, 7 to 10: severe). Study sample is: 401 patients (163 in Asia, 110 in Latin America and 128 in the Middle East), mostly female (61%) (+/- standard deviation, SD), age of 57 +/- 10 years. Participants reported at least moderate levels of pain severity (mean [+/- SD] scores on a 0 to 10 NRS for average pain of 5.9 +/- 1.8 for Asia, 6.7 +/- 1.6 for Latin America, and 6.6 +/- 1.7 for the Middle East). Mean (+/- SD) values on the mBPI-sf Pain Interference Index were 4.7 +/- 2.3 for Asia, 5.6 +/- 2.1 for Latin America, and 5.5 +/- 2.3 for the Middle East. Patients in all 3 regions reported difficulties with functioning, sleep, and overall health status, which increased with higher pain severity levels. Patients in Asia had substantial impairments; however, they reported less serious problems than the other regions. These data are consistent with painful DPN being a burdensome condition worldwide: people with poorly managed neuropathic pain report a substantial burden of disease.