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Efficacy and Safety of a New Sustained-release Pregabalin Formulation Compared With Immediate-release Pregabalin in Patients With Peripheral Neuropathic Pain: A Randomized Noninferiority Phase 3 Trial
DC Field | Value | Language |
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dc.contributor.author | 이용호 | - |
dc.date.accessioned | 2023-06-02T00:51:39Z | - |
dc.date.available | 2023-06-02T00:51:39Z | - |
dc.date.issued | 2022-05 | - |
dc.identifier.issn | 0749-8047 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/194476 | - |
dc.description.abstract | Objective: This study investigated whether a new sustained-release (SR) pregabalin formulation is noninferior to immediate-release (IR) pregabalin in alleviating peripheral neuropathic pain in Korean patients. Materials and methods: This was a randomized, double-blind, active-controlled phase 3 study of patients with diabetic peripheral neuropathy or postherpetic neuralgia from 41 sites in South Korea in 2017-2018. Eligible patients were randomized (1:1) to receive once-daily SR pregabalin or twice-daily IR pregabalin (150 to 600 mg/d) in a double-dummy manner for 12 weeks according to a stratified permuted block randomization scheme. The primary endpoint was the Daily Pain Rating Scale score at the end of treatment, averaged from the last 7 available scores. Results: A total of 319 of 371 (86.0%) randomized patients completed the 12-week treatment (SR pregabalin: n=154; IR pregabalin: n=165; per-protocol set: n=296). The least square mean difference between both groups for the primary endpoint was 0.06 (SE 0.19); (95% confidence interval -0.31 to 0.42), with the lower limit of the confidence interval above the pre-specified margin (-0.78; Pnoninferiority<0.0001). Drug-related treatment-emergent adverse events (TEAEs) were comparable between both groups. The incidence of drug-related TEAEs leading to treatment discontinuation was low (SR pregabalin: 2.7%; IR pregabalin: 1.1%). No serious drug-related TEAEs or deaths occurred. Discussion: The results demonstrate that the new once-daily SR pregabalin formulation is noninferior to twice-daily IR pregabalin in reducing peripheral neuropathic pain and is well tolerated in Korean patients with diabetic peripheral neuropathy or postherpetic neuralgia after 12 weeks of treatment. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Lippincott Williams & Wilkins | - |
dc.relation.isPartOf | CLINICAL JOURNAL OF PAIN | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Analgesics | - |
dc.subject.MESH | Delayed-Action Preparations / therapeutic use | - |
dc.subject.MESH | Diabetic Neuropathies* / drug therapy | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Neuralgia* / chemically induced | - |
dc.subject.MESH | Neuralgia* / drug therapy | - |
dc.subject.MESH | Neuralgia, Postherpetic* / drug therapy | - |
dc.subject.MESH | Pain Measurement | - |
dc.subject.MESH | Pregabalin | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Efficacy and Safety of a New Sustained-release Pregabalin Formulation Compared With Immediate-release Pregabalin in Patients With Peripheral Neuropathic Pain: A Randomized Noninferiority Phase 3 Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Kyung Ah Han | - |
dc.contributor.googleauthor | Yong-Ho Lee | - |
dc.contributor.googleauthor | Hyun-Shik Son | - |
dc.contributor.googleauthor | Ki-Ho Song | - |
dc.contributor.googleauthor | Sang Yong Kim | - |
dc.contributor.googleauthor | Choon Hee Chung | - |
dc.contributor.googleauthor | Hak Chul Jang | - |
dc.contributor.googleauthor | Kwan-Woo Lee | - |
dc.contributor.googleauthor | Bong Yun Cha | - |
dc.contributor.googleauthor | Kee-Ho Song | - |
dc.contributor.googleauthor | Young Kwon Ko | - |
dc.contributor.googleauthor | Pyung-Bok Lee | - |
dc.contributor.googleauthor | Beom Joon Kim | - |
dc.contributor.googleauthor | Sohee Kim | - |
dc.contributor.googleauthor | Taewon An | - |
dc.contributor.googleauthor | Yong-Chul Kim | - |
dc.identifier.doi | 10.1097/AJP.0000000000001028 | - |
dc.contributor.localId | A02989 | - |
dc.relation.journalcode | J00583 | - |
dc.identifier.eissn | 1536-5409 | - |
dc.identifier.pmid | 35220330 | - |
dc.contributor.alternativeName | Lee, Yong Ho | - |
dc.contributor.affiliatedAuthor | 이용호 | - |
dc.citation.volume | 38 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 343 | - |
dc.citation.endPage | 350 | - |
dc.identifier.bibliographicCitation | CLINICAL JOURNAL OF PAIN, Vol.38(5) : 343-350, 2022-05 | - |
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