Pregabalin is a highly used drug to treat diabetic neuropathic pain effectively. The present study compared the efficacy and safety of a controlled-release (CR) Pregabalin tablet with an immediate-release (IR) Pregabalin capsule after 12 weeks of administration in diabetic peripheral neuropathy patients. 

 The study evaluated if CR pregabalin once daily (after a meal in the evening) is clinically non-inferior to IR pregabalin with a twice-daily regimen in improving the mean Daily Pain Rating Scale (DPRS) for treating peripheral neuropathic pain. It analyzed efficacy endpoints in patients with diabetic peripheral neuropathic pain and patients who received and did not receive limited concomitant medications during the clinical study.

The results revealed:

• The study included 59 subjects in the study group and 58 subjects in the control group. 
• The mean DPRS adjusted by using the baseline mean DPRS as a covariate showed the study group to be non-inferior to the control group. 
• It found no consistent trend in comparison of sleep indicators between the groups for each subgroup; however, after 12 weeks of administration of the investigational product, it showed a tendency to decrease.
• The overall adverse event profile of the study and control groups was similar, with no serious Adverse Drug reactions. 

Thus, treatment with CR pregabalin for 12 weeks is non-inferior to IR pregabalin in improving pain in patients with diabetic peripheral neuropathy. 

CR pregabalin can be used effectively and safely in diabetic peripheral neuropathic pain. Further, it may heighten the treatment effects by improving treatment compliance as drug administration is required once daily.

Endocrine Abstracts. 2020;70. AEP249. DOI: 10.1530/endoabs.70.AEP249