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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.
Han, Kyung Ah; Lee, Yong-Ho; Son, Hyun-Shik; Song, Ki-Ho; Kim, Sang Yong; Chung, Choon Hee; Jang, Hak Chul; Lee, Kwan-Woo; Cha, Bong Yun; Song, Kee-Ho; Ko, Young Kwon; Lee, Pyung-Bok; Kim, Beom Joon; Kim, Sohee; An, Taewon; Kim, Yong-Chul.
Afiliación
  • Han KA; Nowon Eulji Medical Center, Eulji University.
  • Lee YH; Yonsei University Severnace Hospital.
  • Son HS; The Catholic University of Korea Uijeongbu St. Mary's Hospital, Uijeongbu.
  • Song KH; The Catholic University of Korea Yeouido St. Mary's Hospital.
  • Kim SY; Chosun University, School of Medicine, Gwangju.
  • Chung CH; Yonsei University Wonju Severance Christian Hospital, Wonju.
  • Jang HC; Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam.
  • Lee KW; Ajou University School of Medicine, Suwon.
  • Cha BY; Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine.
  • Song KH; Konkuk University Hospital.
  • Ko YK; Chungnam National University Hospital, Daejeon, Republic of Korea.
  • Lee PB; Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam.
  • Kim BJ; Chung-Ang University Hospital.
  • Kim S; Yuhan Corporation.
  • An T; Yuhan Corporation.
  • Kim YC; Seoul National University Hospital, Seoul.
Clin J Pain ; 38(5): 343-350, 2022 02 28.
Article en En | MEDLINE | ID: mdl-35220330
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neuropatías Diabéticas / Neuralgia Posherpética / Neuralgia Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Revista: Clin J Pain Asunto de la revista: NEUROLOGIA / PSICOFISIOLOGIA Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neuropatías Diabéticas / Neuralgia Posherpética / Neuralgia Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Revista: Clin J Pain Asunto de la revista: NEUROLOGIA / PSICOFISIOLOGIA Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos