Quanzhong Liu1, Haibo Chen2, Liyan Xi3, Zhen Hong4, Li He5, Yi Fu6, Hong Fang7, Ningxiu Shang8, Ping Yan9, Dongsheng Fan10. 1. Dermatology Department, Tianjin Medical University General Hospital, Tianjin, China. 2. Neurology Department, Beijing Hospital, Beijing, China. 3. Dermatology Department, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guandong, China. 4. Neurology Department, Huashan Hospital, Fudan University, Shanghai, China. 5. Neurology Department, West China Hospital of Sichuan University, Sichuan, China. 6. Neurology Department, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. 7. The First Affiliated Hospital of College of Medicine, Zhejiang University, Zhejiang, China. 8. Pfizer (China) Clinical Science Department, Global Innovative Pharma Business, Beijing, China. 9. Pfizer (China) Research & Development Center, Shanghai, China. 10. Neurology Department, Peking University Third Hospital, Beijing, China.
Abstract
BACKGROUND AND PURPOSE: Currently, there are limited options for treatment of postherpetic neuralgia (PHN) patients in China. While pregabalin is an effective treatment option for PHN in several countries, there is limited information on its efficacy in Chinese patients. METHODS: This was an 8-week, double-blind, placebo-controlled trial in Chinese patients with PHN randomized (1:1) topregabalin 300 mg/day or placebo. Primary efficacy endpoint was change from baseline in mean pain score (Daily Pain Rating Scale; 0 = 'no pain' to 10 = 'worst possible pain'). Secondary efficacy endpoints included change from baseline in overall pain intensity score, by visual analog scale (VAS; 0 = 'no pain' to 100 = 'worst possible pain') and daily sleep interference score (0 = 'pain does not interfere with sleep' to 10 = 'completely interferes'). RESULTS: A total of 220 patients were randomized and received treatment (111 pregabalin and 109 placebo). Improvement in mean pain score with pregabalin was significantly greater than placebo, least squares mean difference (95% CI), -0.71 (-1.08, -0.34); P = 0.0002. Improvements in VAS and sleep interference score at endpoint were significantly greater with pregabalin than placebo, least squares mean difference (95% CI), -8.18 (-11.99, -4.37); P < 0.0001, and -0.54 (-0.93, -0.14); P = 0.0079, respectively. Adverse events were consistent with current product labeling, with dizziness the most commonly reported adverse event (24.3% of pregabalin-treated patients). CONCLUSION:Pregabalin improved measures of pain and sleep, and is well tolerated in Chinese patients with PHN. These results may inform physicians treating patients with PHN in China.
RCT Entities:
BACKGROUND AND PURPOSE: Currently, there are limited options for treatment of postherpetic neuralgia (PHN) patients in China. While pregabalin is an effective treatment option for PHN in several countries, there is limited information on its efficacy in Chinese patients. METHODS: This was an 8-week, double-blind, placebo-controlled trial in Chinese patients with PHN randomized (1:1) to pregabalin 300 mg/day or placebo. Primary efficacy endpoint was change from baseline in mean pain score (Daily Pain Rating Scale; 0 = 'no pain' to 10 = 'worst possible pain'). Secondary efficacy endpoints included change from baseline in overall pain intensity score, by visual analog scale (VAS; 0 = 'no pain' to 100 = 'worst possible pain') and daily sleep interference score (0 = 'pain does not interfere with sleep' to 10 = 'completely interferes'). RESULTS: A total of 220 patients were randomized and received treatment (111 pregabalin and 109 placebo). Improvement in mean pain score with pregabalin was significantly greater than placebo, least squares mean difference (95% CI), -0.71 (-1.08, -0.34); P = 0.0002. Improvements in VAS and sleep interference score at endpoint were significantly greater with pregabalin than placebo, least squares mean difference (95% CI), -8.18 (-11.99, -4.37); P < 0.0001, and -0.54 (-0.93, -0.14); P = 0.0079, respectively. Adverse events were consistent with current product labeling, with dizziness the most commonly reported adverse event (24.3% of pregabalin-treated patients). CONCLUSION: Pregabalin improved measures of pain and sleep, and is well tolerated in Chinese patients with PHN. These results may inform physicians treating patients with PHN in China.
Authors: Sheena Derry; Rae Frances Bell; Sebastian Straube; Philip J Wiffen; Dominic Aldington; R Andrew Moore Journal: Cochrane Database Syst Rev Date: 2019-01-23
Authors: Bruce Parsons; Rainer Freynhagen; Stephan Schug; Ed Whalen; Marie Ortiz; Pritha Bhadra Brown; Lloyd Knapp Journal: J Pain Res Date: 2019-08-22 Impact factor: 3.133
Authors: Giulia Di Stefano; Andrea Di Lionardo; Giuseppe Di Pietro; Giorgio Cruccu; Andrea Truini Journal: Pain Res Manag Date: 2021-04-26 Impact factor: 3.037