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

被引：5

作者：

Han, Kyung Ah ^{[1
]}

Lee, Yong-Ho ^{[2
]}

Son, Hyun-Shik ^{[9
]}

Song, Ki-Ho ^{[3
]}

Kim, Sang Yong ^{[10
]}

Chung, Choon Hee ^{[11
]}

Jang, Hak Chul ^{[12
]}

Lee, Kwan-Woo ^{[13
]}

Cha, Bong Yun ^{[4
]}

Song, Kee-Ho ^{[5
]}

Ko, Young Kwon ^{[14
]}

Lee, Pyung-Bok ^{[12
]}

Kim, Beom Joon ^{[6
]}

Kim, Sohee ^{[7
]}

An, Taewon ^{[7
]}

Kim, Yong-Chul ^{[8
]}

机构：

[1] Eulji Univ, Nowon Eulji Med Ctr, Seoul, South Korea

[2] Yonsei Univ, Severnace Hosp, Seoul, South Korea

[3] Catholic Univ Korea, Yeouido St Marys Hosp, Seoul, South Korea

[4] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Seoul, South Korea

[5] Konkuk Univ Hosp, Seoul, South Korea

[6] Chung Ang Univ Hosp, Seoul, South Korea

[7] Yuhan Corp, Seoul, South Korea

[8] Seoul Natl Univ Hosp, 101 Daehak Ro, Seoul 03080, South Korea

[9] Catholic Univ Korea Uijeongbu, St Marys Hosp, Uijongbu, South Korea

[10] Chosun Univ, Sch Med, Gwangju, South Korea

[11] Yonsei Univ, Wonju Severance Christian Hosp, Wonju, South Korea

[12] Seoul Natl Univ, Coll Med, Bundang Hosp, Seongnam, South Korea

[13] Ajou Univ, Sch Med, Suwon, South Korea

[14] Chungnam Natl Univ Hosp, Daejeon, South Korea

来源：

CLINICAL JOURNAL OF PAIN | 2022年 / 38卷 / 05期

关键词：

pregabalin; sustained-release formulation; neuropathic pain; diabetic peripheral neuropathy; postherpetic neuralgia; POSTHERPETIC NEURALGIA; DOSING FREQUENCY; DOUBLE-BLIND; ADHERENCE; IMPACT; EPIDEMIOLOGY; THERAPY; SLEEP;

D O I：

10.1097/AJP.0000000000001028

中图分类号：

R614 [麻醉学];

学科分类号：

100217 ;

摘要：

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; 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.

引用

页码：343 / 350

页数：8