Data were pooled from 3 double-blind, placebo-controlled studies in adult patients with DPNP. Patients were randomized to duloxetine (DLX) 60 mg QD (N=344), 60 mg BID (N=341), or placebo (PBO) (N=339) for 12 weeks. Safety assessments included discontinuation rates, treatment-emergent adverse events (TEAEs), and changes in BP.

Mean age of patients with Hx/co-morbid CV conditions (n=762) was 61.1 yrs and in patients without Hx/co-morbid CV conditions (n=262) was 56.1 yrs. The most common Hx/co-morbid CV conditions were hypertension, coronary artery disease, and myocardial infarction. Other than diabetes medications and antihypertensives, the most common concomitant medications used by all patients included cholesterol-lowering agents, analgesics, and levothyroxine. Rates of discontinuation due to AEs were higher for DLX vs. PBO in both subgroups (13.5% DLX, 6.0% PBO and 14.3% DLX, 3.4% PBO respectively) in patients with and without Hx/co-morbid CV conditions. Rates of CV-related TEAEs in patients with (8.4% DLX; 9.9% PBO) and without (8.6% DLX; 6.0% PBO) Hx/co-morbid CV conditions were similar. The effect of DLX vs. PBO on mean changes in SBP and DBP between patients with and without Hx/co-morbid CV conditions was not statistically significant (p>.1 for tx by subgroup interaction). Rates of sustained hypertension were similar between patients with (2.4% DLX; 2.8% PBO) and without (2.9% DLX; 4.7% PBO) Hx/co-morbid CV conditions (p>.1 for tx by subgroup interactions). National or institutional review boards at study sites approved protocols and all patients provided signed informed consents.

In this analysis, the safety of duloxetine in patients with DPNP was not significantly different between patients with and without historical or co-morbid CV conditions.