Effects of mirogabalin on tingling or pins & needles in a phase 3 study of diabetic peripheral neuropathy

Abstract

Objectives: In order to examine the effect of mirogabalin on tingling or pins & needles, a post hoc subgroup analysis of the phase 3 study (J303) was performed on patients with only those symptoms. Methods: Patients received placebo, mirogabalin 15 mg, 20 mg or 30 mg/day for 14 weeks. The main endpoints were the change in average daily pain score (ADPS), ADPS responder rate, the change in average daily sleep interference score (ADSIS), patient global impression of change (PGIC) and impressions of subjective symptom for tingling or pins & needles at week 14. Results: The subgroup analysis was made in 168 patients only with tingling or pins & needles. ADPS, ADSIS, PGIC and the impression for tingling or pins & needles showed improvement in 30 mg/day group. Adverse events were mostly mild and the incidence was low. These results were similar to that of J303. Conclusions: Mirogabalin can be effective on tingling or pins & needles in diabetic peripheral neuropathy.