Efficacy and Safety of Once-Daily Prolonged-Release Pregabalin for the Treatment of Patients With Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Active, and Placebo-Controlled Trial.

IF 2.7 3区医学 Q2 ANESTHESIOLOGY

Pain Practice Pub Date : 2025-09-01 DOI:10.1111/papr.70061

Shilpi Dhawan, Amol Bongirwar, Marta Muñoz-Tudurí, Aman Khanna Romesh, Prakash H Kurmi, Rahul Tulshidas Jankar

{"title":"Efficacy and Safety of Once-Daily Prolonged-Release Pregabalin for the Treatment of Patients With Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Active, and Placebo-Controlled Trial.","authors":"Shilpi Dhawan, Amol Bongirwar, Marta Muñoz-Tudurí, Aman Khanna Romesh, Prakash H Kurmi, Rahul Tulshidas Jankar","doi":"10.1111/papr.70061","DOIUrl":null,"url":null,"abstract":"Purpose: To compare the efficacy and safety of a once-daily prolonged release (PR) pregabalin formulation to pregabalin immediate release (IR) in patients with diabetic peripheral neuropathy (DPN).Patients and methods: This was a non-inferiority, randomized, double-blind, double-dummy, multiple-dose, multicenter, active and placebo controlled, three-arm, parallel study. Patients were randomly assigned in a 1:1:1 ratio to receive pregabalin PR tablet, pregabalin IR hard capsule (Lyrica) or placebo at an optimized dose based on individual subject's response and tolerability for 13 weeks. The primary efficacy outcome was the change in the mean weekly pain score from baseline to end of treatment.Results: Overall, 453 patients were randomized. In the per protocol (PP) analysis set, the least square mean (LSM) difference between test and reference treatment for the change in weekly pain score from baseline to end of treatment was 0.06 (95% CI: -0.28, 0.41, p = 0.7121), indicating that pregabalin PR was non-inferior to pregabalin IR. In the Full Analysis Set (FAS), the LSM of change in mean weekly pain score from baseline to end of treatment for test, reference, and placebo groups were -3.43, -3.49, and -3.04, respectively. Test and reference products were superior to placebo (p = 0.0158 and 0.0047, respectively).Conclusion: The efficacy and safety of pregabalin PR was comparable to pregabalin IR for the treatment of pain in patients with DPN.","PeriodicalId":19974,"journal":{"name":"Pain Practice","volume":"25 7","pages":"e70061"},"PeriodicalIF":2.7000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain Practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/papr.70061","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Purpose: To compare the efficacy and safety of a once-daily prolonged release (PR) pregabalin formulation to pregabalin immediate release (IR) in patients with diabetic peripheral neuropathy (DPN).

Patients and methods: This was a non-inferiority, randomized, double-blind, double-dummy, multiple-dose, multicenter, active and placebo controlled, three-arm, parallel study. Patients were randomly assigned in a 1:1:1 ratio to receive pregabalin PR tablet, pregabalin IR hard capsule (Lyrica) or placebo at an optimized dose based on individual subject's response and tolerability for 13 weeks. The primary efficacy outcome was the change in the mean weekly pain score from baseline to end of treatment.

Results: Overall, 453 patients were randomized. In the per protocol (PP) analysis set, the least square mean (LSM) difference between test and reference treatment for the change in weekly pain score from baseline to end of treatment was 0.06 (95% CI: -0.28, 0.41, p = 0.7121), indicating that pregabalin PR was non-inferior to pregabalin IR. In the Full Analysis Set (FAS), the LSM of change in mean weekly pain score from baseline to end of treatment for test, reference, and placebo groups were -3.43, -3.49, and -3.04, respectively. Test and reference products were superior to placebo (p = 0.0158 and 0.0047, respectively).

Conclusion: The efficacy and safety of pregabalin PR was comparable to pregabalin IR for the treatment of pain in patients with DPN.

查看原文本刊更多论文

每日一次缓释普瑞巴林治疗糖尿病周围神经病变的疗效和安全性：一项随机、双盲、有效、安慰剂对照试验

目的：比较普瑞巴林缓释（PR）制剂与普瑞巴林即刻释放（IR）制剂治疗糖尿病周围神经病变（DPN）的疗效和安全性。患者和方法：这是一项非劣效性、随机、双盲、双假、多剂量、多中心、活性和安慰剂对照、三组平行研究。患者按1:1:1的比例随机分配接受普瑞巴林PR片，普瑞巴林IR硬胶囊（Lyrica）或安慰剂，根据个体受试者的反应和耐受性以最佳剂量服用13周。主要疗效指标是从基线到治疗结束时平均每周疼痛评分的变化。结果：总体而言，453例患者被随机分组。在每个方案（PP）分析集中，测试组和参考组从基线到治疗结束的每周疼痛评分变化的最小二乘平均值（LSM）差异为0.06 (95% CI: -0.28, 0.41, p = 0.7121)，表明普瑞巴林PR不劣于普瑞巴林IR。在完整分析集（FAS）中，测试组、参考组和安慰剂组从基线到治疗结束的平均每周疼痛评分变化的LSM分别为-3.43、-3.49和-3.04。试验品和参比品均优于安慰剂（p分别为0.0158和0.0047）。结论：普瑞巴林PR治疗DPN患者疼痛的疗效和安全性与普瑞巴林IR相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Pain Practice ANESTHESIOLOGY-CLINICAL NEUROLOGY

CiteScore

5.60

自引率

3.80%

发文量

审稿时长

6-12 weeks

期刊介绍： Pain Practice, the official journal of the World Institute of Pain, publishes international multidisciplinary articles on pain and analgesia that provide its readership with up-to-date research, evaluation methods, and techniques for pain management. Special sections including the Consultant’s Corner, Images in Pain Practice, Case Studies from Mayo, Tutorials, and the Evidence-Based Medicine combine to give pain researchers, pain clinicians and pain fellows in training a systematic approach to continuing education in pain medicine. Prior to publication, all articles and reviews undergo peer review by at least two experts in the field.