Kyong Hye Joung , Tae Nyun Kim , Eu Jeong Ku , Seong Su Lee , Won Sang Yoo , Kang Seo Park , Su Kyoung Kwon , Bon Jeong Ku
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Primary efficacy endpoint was the change in visual analogue scale (VAS) scores after 8 weeks of treatment compared to baseline in both SR and IR pregabalin groups.</p></div><div><h3>Results</h3><p>Among 130 randomized subjects, 125 patients were included in full analysis set. For the change in VAS pain score, the least squares (LS) mean were −17.95 (SR pregabalin) and −18.74 (IR pregabalin) and the LS mean difference between both groups was 0.79, with the upper limit of the 95 % confidence interval [−5.99, 7.58] below the pre-specified non-inferiority margin of 9.2 mm.</p></div><div><h3>Conclusions</h3><p>This study demonstrates that the new once-daily SR pregabalin formulation is not different to the twice-daily IR pregabalin in alleviating DPN pain, indicating its potential as a promising treatment for DPN pain with a comparable safety profile.</p></div><div><h3>Trial registration</h3><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT05624853</span><svg><path></path></svg></span>.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 8","pages":"Article 108809"},"PeriodicalIF":2.9000,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release pregabalin with immediate-release pregabalin in type 2 diabetic patients with peripheral neuropathic pain\",\"authors\":\"Kyong Hye Joung , Tae Nyun Kim , Eu Jeong Ku , Seong Su Lee , Won Sang Yoo , Kang Seo Park , Su Kyoung Kwon , Bon Jeong Ku\",\"doi\":\"10.1016/j.jdiacomp.2024.108809\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Aims</h3><p>The objective of this study was to demonstrate that sustained-release (SR) pregabalin is non-inferior to immediate-release (IR) pregabalin in attenuating diabetic peripheral neuropathic (DPN) pain along with patient satisfaction and compliance.</p></div><div><h3>Methods</h3><p>This was an 8-week, randomized, active-controlled, open-label, phase 4 study. 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引用次数: 0
摘要
目的本研究旨在证明缓释（SR）普瑞巴林在减轻糖尿病周围神经病理性（DPN）疼痛以及患者满意度和依从性方面不劣于速释（IR）普瑞巴林。符合条件的受试者已服用红外普瑞巴林 4 周，按照 1:1 的比例随机分配，要么继续服用每日两次的红外普瑞巴林（75 毫克），要么改用每日一次的 SR 普瑞巴林（150 毫克）。主要疗效终点是SR组和IR普瑞巴林组治疗8周后视觉模拟量表（VAS）评分与基线相比的变化。VAS疼痛评分变化的最小二乘法（LS）均值分别为-17.95（SR普瑞巴林）和-18.74（IR普瑞巴林），两组间的LS均值差为0.79，95%置信区间的上限[-5.99, 7.58]低于9.2毫米的预设非劣效边距。结论本研究表明，每日一次的SR普瑞巴林新制剂在缓解DPN疼痛方面与每日两次的IR普瑞巴林没有差异，这表明它有可能成为一种治疗DPN疼痛的有前途的药物，且安全性相当。试验注册ClinicalTrials.gov，NCT05624853。
A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release pregabalin with immediate-release pregabalin in type 2 diabetic patients with peripheral neuropathic pain
Aims
The objective of this study was to demonstrate that sustained-release (SR) pregabalin is non-inferior to immediate-release (IR) pregabalin in attenuating diabetic peripheral neuropathic (DPN) pain along with patient satisfaction and compliance.
Methods
This was an 8-week, randomized, active-controlled, open-label, phase 4 study. Eligible subjects who had been on IR pregabalin for 4 weeks were randomized to 1:1 ratio to either continue with twice-daily IR pregabalin (75 mg), or to switch to once-daily SR pregabalin (150 mg). Primary efficacy endpoint was the change in visual analogue scale (VAS) scores after 8 weeks of treatment compared to baseline in both SR and IR pregabalin groups.
Results
Among 130 randomized subjects, 125 patients were included in full analysis set. For the change in VAS pain score, the least squares (LS) mean were −17.95 (SR pregabalin) and −18.74 (IR pregabalin) and the LS mean difference between both groups was 0.79, with the upper limit of the 95 % confidence interval [−5.99, 7.58] below the pre-specified non-inferiority margin of 9.2 mm.
Conclusions
This study demonstrates that the new once-daily SR pregabalin formulation is not different to the twice-daily IR pregabalin in alleviating DPN pain, indicating its potential as a promising treatment for DPN pain with a comparable safety profile.
期刊介绍：
Journal of Diabetes and Its Complications (JDC) is a journal for health care practitioners and researchers, that publishes original research about the pathogenesis, diagnosis and management of diabetes mellitus and its complications. JDC also publishes articles on physiological and molecular aspects of glucose homeostasis.
The primary purpose of JDC is to act as a source of information usable by diabetes practitioners and researchers to increase their knowledge about mechanisms of diabetes and complications development, and promote better management of people with diabetes who are at risk for those complications.
Manuscripts submitted to JDC can report any aspect of basic, translational or clinical research as well as epidemiology. Topics can range broadly from early prediabetes to late-stage complicated diabetes. Topics relevant to basic/translational reports include pancreatic islet dysfunction and insulin resistance, altered adipose tissue function in diabetes, altered neuronal control of glucose homeostasis and mechanisms of drug action. Topics relevant to diabetic complications include diabetic retinopathy, neuropathy and nephropathy; peripheral vascular disease and coronary heart disease; gastrointestinal disorders, renal failure and impotence; and hypertension and hyperlipidemia.
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