Levodopa/carbidopa/entacapone versus levodopa/benserazide plus pramipexole in Chinese patients with Parkinson’s disease experiencing wearing off

Cuiyu Yu¹Weiguo Liu^1*Aiping Gong²Min Ye³Hui Huang⁴Yang Zhao⁵Chun-Feng Liu⁶Yijing Guo⁷Juping Chen⁸Xueling Zhang⁹Xianwen Chen¹⁰Lihua Shen¹¹Dan Li¹²

• ¹Nanjing Brain Hospital Affiliated to Nanjing Medical University, Nanjing, China
• ²The Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
• ³Nanjing BenQ Medical Center, Nanjing, China
• ⁴Huaibei People's Hospital, Huaibei, China
• ⁵Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, China
• ⁶Second Affiliated Hospital of Soochow University, Suzhou, China
• ⁷Affiliated ZhongDa Hospital of Southeast University, Nanjing, China
• ⁸Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, China
• ⁹The Affiliated Suqian Hospital of Xuzhou Medical University, Suqian, China
• ¹⁰The First Affiliated Hospital of Anhui Medical University, Hefei, China
• ¹¹Affiliated Hospital of Nantong University, Nantong, China
• ¹²Jiangsu Province (Suqian) Hospital, Suqian, China

Objective: To compare the efficacy and safety of direct switch from levodopa/benserazide (LB) to levodopa/carbidopa/entacapone (LCE) versus LB plus pramipexole (PPX) in Chinese patients with Parkinson's disease (PD) experiencing wearing off (WO). Methods: In this multicenter, prospective, randomized, open-label, observational study, 140 patients with PD experiencing WO who had been on stable LB treatment were enrolled and randomized 3:2 to receive LCE (84) or LB+PPX (56) treatment for 8 weeks. The primary endpoint was change in the daily "OFF" time from baseline. Change in the daily "ON" time was also assessed. Treatment-emergent adverse events (TEAEs) were recorded. Results: Seventy-nine patients in the LCE group and 49 patients in the PPX group completed the study. Both LCE and PPX shortened the patients' daily OFF time significantly after 8 weeks (- 1.76±1.70 hours, p<0.001 and -1.51±1.60, p<0.001, respectively), and the shortenings were comparable between the two groups (p=0.414). Correspondingly, both the LCE group and the PPX group had significantly increased daily ON time (1.62±1.59 hours, p<0.001 and 1.38±1.65, p<0.001, respectively), and the increases were comparable between the two groups (p=0.412). Both treatments improved the patients' WO symptoms, sleep quality, depression and quality of life. Six (7.59%) patients in the LCE group and 7 (14.29%) patients in the PPX group reported TEAEs, all of which were mild and tolerable. One patient in the LCE group and 2 patients in the PPX group experienced mild dyskinesia. Conclusion: LCE and LB+PPX were both effective, safe and tolerable in treating patients with PD who experienced WO.