Endocrine Abstracts

Pregabalin is a highly used drug for the effective treatment of diabetic neuropathic pain. This study compared the efficacy and safety of a controlled-release (CR) Pregabalin tablet (GLA5PR GLARS-NF1) with an immediate-release (IR) Pregabalin capsuleafter 12 week administration in patients with diabetic peripheral neuropathy. In multicenter, randomized, double- blind, active- controlled, parallel- group, phase III study, the primary outcome was to confirm that CR pregabalin with once daily (after meal in the evening) is clinically non-inferior to IR pregabalin with twice daily regimen in improving the meanDaily Pain Rating Scale (DPRS) for the treatment of peripheral neuropathic pain. The efficacy endpoints in patients with diabetic peripheral neuropathic pain which were the target diseases, and patients who received and did not receive restricted concomitant medications during the clinical study were analyzed. 59 subjects in the study group and 58 subjects in the control group was allogated. Themean DPRS adjusted by using the baseline mean DPRS as a covariate was 3.26 ± 0.23 in the study group and 3.41 ± 0.32 in the control group (LS mean difference, −0.16; 95% CI, −0.79 to 0.48), indicating that the study group was not-inferior to the control group. In addition, no consistent trend was seen in comparison of sleep indicator between the groups for each subgroup, but at Week 12 after administration of the investigational product, a tendency of decrease was observed, similar to the result of the primary analysis. The overall adverse event profile of the study groupand control group was similar, and no serious ADR was observed. CR pregabalin treatment for 12 weeks was non-inferior compared to IR pregabalin in improvement of pain in patients with diabetic peripheralneuropathy. CR pregabalin can be used effectively and safely in diabetic peripheral neuropathic pain, and it is expected thattreatment effects can be maximized by improving patients’ treatment compliance since the drug isadministered once daily.