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- Title
Pooled analysis of phase III with entacapone in Parkinson's disease.
- Authors
Kuoppamäki, M.; Vahteristo, M.; Ellmén, J.; Kieburtz, K.
- Abstract
Objectives To investigate efficacy and safety of entacapone across phase III studies in Parkinson's disease ( PD) with wearing-off symptoms. Methods Retrospective, pooled analysis of four phase 3 randomized, double-blind, placebo-controlled studies with entacapone. Results 475 of 808 patients with PD received entacapone and 333 received placebo. Entacapone improved daily OFF- and ON-times (change from baseline) by 0.8 h compared with placebo ( P < 0.0001 for both variables). Entacapone was also better in UPDRS II ( P < 0.01) and III ( P < 0.01) scores and global evaluation ( P < 0.05). Similar benefits were seen in subgroups of patients with and without dopamine agonist ( DA) or selegiline, but the subgroup results should be regarded as exploratory. Entacapone was generally well tolerated. Dyskinesia and nausea were more frequently reported by patients on entacapone (25.7% and 14.5% of patients, respectively) than those receiving placebo (15.6% and 6.0%, respectively). However, there was no difference in reports of hallucinations between entacapone (4.8%) and placebo (4.8%). Conclusions Entacapone improved daily OFF- and ON-times by a mean of 0.8 h compared with placebo across the four pooled efficacy studies and was generally well tolerated. The results of this pooled analysis potentially serve as a useful benchmarking data for new therapies (especially levodopa products) in advanced patients with PD.
- Subjects
ENTACAPONE; PARKINSON'S disease treatment; DRUG efficacy; DOPAMINE agonists; SELEGILINE; PLACEBOS; RANDOMIZED controlled trials
- Publication
Acta Neurologica Scandinavica, 2014, Vol 130, Issue 4, p239
- ISSN
0001-6314
- Publication type
Article
- DOI
10.1111/ane.12278