Published on October 19, 2013 at 6:14 AM
Patients who have painful DPN can also have pain while walking. The study in patients with painful DPN who also had pain on walking (A0081269) was a multicenter, double-blind, randomized, placebo-controlled cross-over efficacy and safety study. The co-primary endpoints were DPN pain assessed by diary-based, daily pain scores and pain on walking assessed after walking 50 feet on a flat surface. The study enrolled 205 patients who were randomized to receive Lyrica (150 or 300 mg/day) or placebo during a six-week double-blind phase, followed by a two-week, washout period, and then crossed over to the opposite treatment for an additional six weeks.
Painful DPN and pain on walking were reduced in patients treated with Lyrica or placebo. The study did not show a statistically significant difference between Lyrica and placebo in the co-primary endpoints. The safety profile of Lyrica was consistent with previous studies and current product labeling. The most common adverse events in this study included dizziness, somnolence and fatigue.
Results from these studies are expected to be submitted for presentation at upcoming scientific congresses and for publication in peer-reviewed medical journals.
Source: Pfizer Inc.