EFFICACY, SAFETY AND TOLERABILITY OF ROTIGOTINE TRANSDERMAL PATCHES FOR TREATING EARLY PARKINSON’S DISEASE: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS

Yajun Chang^#, Na Li^#, Wei Jin, Junshu Gao, Zhe Li, Tianjun Wang^* 

Department of Internal Medicine-Neurology, Hebei General Hospital, Shijiazhuang, 050000, Hebei Province, China 

Objective: Systematically evaluate the clinical efficacy, safety and tolerance of rotigotine transdermal patch in the treatment of patients with early Parkinson's Disease (PD). 

Methods: The literature of randomized controlled trial  (RCT) of the clinical efficacy, safety and tolerance of rotigotine transdermal patch in the treatment of patients with early PD were searched using “Rotigotine;Parkinson Disease”,“Neupro;Parkinson Disease”,“Rotigotine;Parkinson Disease(in Chinese)”as keywords in pubmed, FMRS database, CNKI database, wanfang database, weipu database. The references of the selected literature were also screened. The publication time of the literature was from the establishment of the above mentioned database to December 2019. Two researchers independently screened the literature, extracted the data and evaluated the quality. Rev Man 5.3 software was used for m eta analysis. Outcome indicators included unified Parkinson’s Disease rating scale (UPDRS) Part II and III scores, rate of adverse events (AEs), number of people who completed the experiment. 

Results: A total of 880 early PD patients of six studies were included. Compared with placebo group, the total scores of UPDRS part II and III (WMD: -4.72, 95%CI:-6.01, -3.44), the UPDRS part II scores (WMD:-1.31, 95%CI:-1.39, -1.23) and the UPDRS part III scores (WMD: -3.35, 95%CI:-4.48, -2.22) of rotigotine transdermal patch group were decreased. There was no statistically significant difference of the incidence of at least one adverse drug event and serious AEs (RR:1.13, 95%CI:0.99,1.28; RR:1.35, 95%CI:0.74, 2.47). There was also no statistically significant difference of the incidence in the number of people who completed the experiment (RR:0.96,95%CI: 0.91,1.01). 

Conclusion: Our studies have shown that rotigotine transdermal patches can improve motor and nonmotor symptoms in patients with early PD. Safety and tolerability are acceptable. The optimal formulation and dosage still need to be further confirmed.