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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

Authors
 Kyung Ah Han  ;  Yong-Ho Lee  ;  Hyun-Shik Son  ;  Ki-Ho Song  ;  Sang Yong Kim  ;  Choon Hee Chung  ;  Hak Chul Jang  ;  Kwan-Woo Lee  ;  Bong Yun Cha  ;  Kee-Ho Song  ;  Young Kwon Ko  ;  Pyung-Bok Lee  ;  Beom Joon Kim  ;  Sohee Kim  ;  Taewon An  ;  Yong-Chul Kim 
Citation
 CLINICAL JOURNAL OF PAIN, Vol.38(5) : 343-350, 2022-05 
Journal Title
CLINICAL JOURNAL OF PAIN
ISSN
 0749-8047 
Issue Date
2022-05
MeSH
Analgesics ; Delayed-Action Preparations / therapeutic use ; Diabetic Neuropathies* / drug therapy ; Double-Blind Method ; Humans ; Neuralgia* / chemically induced ; Neuralgia* / drug therapy ; Neuralgia, Postherpetic* / drug therapy ; Pain Measurement ; Pregabalin ; Treatment Outcome
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.
Files in This Item:
T9992023134.pdf Download
DOI
10.1097/AJP.0000000000001028
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Yong Ho(이용호) ORCID logo https://orcid.org/0000-0002-6219-4942
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/194476
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