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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
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 patien...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8994039/ https://www.ncbi.nlm.nih.gov/pubmed/35220330 http://dx.doi.org/10.1097/AJP.0000000000001028 |
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author | 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 |
author_facet | 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 |
author_sort | Han, Kyung Ah |
collection | PubMed |
description | 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; P (noninferiority)<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. |
format | Online Article Text |
id | pubmed-8994039 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-89940392022-04-13 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 Clin J Pain Original Articles 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; P (noninferiority)<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. Lippincott Williams & Wilkins 2022-02-28 /pmc/articles/PMC8994039/ /pubmed/35220330 http://dx.doi.org/10.1097/AJP.0000000000001028 Text en Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) |
spellingShingle | Original Articles 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 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8994039/ https://www.ncbi.nlm.nih.gov/pubmed/35220330 http://dx.doi.org/10.1097/AJP.0000000000001028 |
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