A randomized,placebo-controlled,double-blind,parallel-group trial of entacapone in patients with fluctuating Parkinson's disease / 中华神经科杂志

ABSTRACT

Objective To study the efficacy and safety of entacapone as an adjunct to levodopa treatment in pakinsonian patients with wearing-off motor fluctuations. Methods A total 209 pakinsonian patients with end-of-dose deterioration participated in a multi-center,12-weeks randomized,placebo-controlled,double blind,parallel-group trial.The efficacy of entacapone was assessed using the patient’s diary card,the Unified Parkinson’s Disease Rating Scale (UODRS) score,the daily levodopa dosage,and the global assessment of changes.Results 96.2% of the entacapone and 92.4% of the placebo-treated patients completed the study.In 209 cases of the ITT population,in comparison to the placebo-treated patients,entacapone had increased the mean “on” time (h/d) from 7.4?1.8 in base-line to 9.1?2.5 in week 12,decreased the “fof” time (from 6.8?2.2 in base-line to 5.2?2.8 in week 12),improved the motor scores (from 36.7?11.3 in base-line to 30.0?14.4 in week 12),and reduced the levodopa dose (from 589.2?264.3 in base-line to 561.5?248.1 in week 4). The improvement was also evident on impression of successful treatment for 69.9% of neurologists through global change assessment.There was no significant difference in the frequency of dopaminergic adverse events and serious laboratory abnormalities between entacapone and placebo groups.Conclusion The results of this study demonstrate that entacapone,the COMT inhibitor is a safe and effective extender of levodopa treatment for Parkinson’s disease patients with motor flucturations.