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Research Paper | Health and Medical Sciences | India | Volume 14 Issue 3, March 2025 | Rating: 7.2 / 10
Evaluation of the Efficacy and Safety of Topical Pregabalin Gel 8% versus Oral Pregabalin in Diabetic Neuropathic Pain: A Phase III, Multicentric, Placebo Controlled Study
Dr. Rajan Samant, Kunal Gandhi, Dr. Viral Shah, Dr. Manjusha Patankar
Abstract: Background: Painful diabetic peripheral neuropathy (DPN) occurs in up to one-third of patients with diabetes mellitus. Oral pregabalin is approved as a first line drug to treat painful diabetic neuropathy. But, oral pregabalin in relieving neuropathic pain is associated with central nervous system adverse effects such as, dizziness, somnolence , and fatigue. These adverse effects often lead to discontinuation of treatment and poor patient adherence. Topical pregabalin 8% w/w was developed to overcome the limitations of oral pregabalin. Aim: To evaluate the efficacy and safety of 'Pregabalin Gel 8% w/w' in comparison with Pregabalin Capsule as a standard of care in patients with diabetic neuropathic pain. Methodology: This was a phase III randomized, double blinded, double dummy, parallel group, placebo controlled, two arm, multicenter clinical study. 220 patients with painful diabetic neuropathy. The patients were randomized into either of two treatment groups namely: Group A (Topical application of Pregabalin Gel 8 % w/w twice a day with Oral Placebo Capsule thrice a day; N=110) or Group 'B' ( oral Pregabalin Capsule as a standard of care thrice a day with Topical Placebo Gel twice a day ; N=110) for 63 days . The primary end point was ?50 % change in Visual Analogue Scale (VAS). The secondary end points were ?50 % change in Leeds Assessment of Neuropathic Symptoms; ?50 % change in Patient Global Impression of Change (PGIC); ?50 % change in Clinicians Global Impression of change (CGIC); ?50 % change in DN4 Questionnaire; ?50 % change in Quality-of-life Questionnaire; and ?50 % change in Sleep Disturbance? Adults Scale.Safety assessments. Results: In group A, 91.7% had ? 50% change in Visual Analogue Scale after 63 Days of treatment with topical pregabalin. In group B, 93.5% had ? 50% change in Visual Analogue Scale after 63 Days of treatment with oral pregabalin The difference between the two treatment groups was not significant (p = 0.630). There was no difference in the secondary endpoints between the two treatment groups. There was no development of tolerance to the efficacy of pregabalin over 63 days. Conclusion: Topical pregabalin has analgesic efficacy comparable to oral pregabalin but it is better tolerated. Topical pregabalin was associated with significantly lesser somnolence and dizziness as compared to oral pregabalin.
Keywords: Diabetic neuropathic pain, Pregabalin, Somnolence, Dizziness
Edition: Volume 14 Issue 3, March 2025,
Pages: 1643 - 1647