Efficacy and safety of entacapone in levodopa/carbidopa versus levodopa/benserazide treated Parkinson's disease patients with wearing-off

Mikko Kuoppamäki, Mika Leinonen, Werner Poewe, Mikko Kuoppamäki, Mika Leinonen, Werner Poewe

Abstract

Entacapone is frequently used together with levodopa/carbidopa (LC) and levodopa/benserazide (LB) in the treatment of Parkinson's disease (PD) patients with wearing-off symptoms. It is generally assumed that the effects of entacapone are independent of the type of decarboxylase inhibitor used, but there is very little published data available on the efficacy of entacapone administered with LB versus LC. We have performed a pooled analysis of three randomized, double-blind, 6-month, phase III studies to compare the treatment effects of entacapone (compared to placebo) in PD patients receiving LC or LB. A total of 551 PD patients experiencing wearing-off were included in the analysis. 300 patients were on LB and 251 on LC at baseline. At 6 months, entacapone (compared to placebo) improved mean daily OFF-time in patients on LB and LC by 0.76 (p = 0.016) and 0.95 (p = 0.011) hours, respectively. The corresponding improvements in ON-time were 0.97 (p = 0.002) and 0.83 h (p = 0.022), respectively. The treatment effects of entacapone both in LB and LC users were statistically significant (p < 0.05) also in UPDRS II and III scores, except in UPDRS II scores in patients receiving LC (p = 0.20). None of the treatment effects of entacapone were statistically significantly different between patients receiving LB or LC. Reported adverse events were comparable between LB and LC users. We conclude that entacapone provided comparable benefits in PD patients with wearing-off symptoms using either LB or LC.

Keywords: Benserazide; Carbidopa; Entacapone; Levodopa; Parkinson’s disease.

Figures

Fig. 1
Fig. 1
Changes in daily ON- and OFF-times in patients randomized to entacapone or placebo and using levodopa/benserazide (LB) or levodopa/carbidopa (LC). a ON-time and b OFF-time. Bars represent estimated mean changes with standard error of mean (SEM); ITT-OC (intent to treat observed cases). Black bars entacapone; white bars placebo
Fig. 2
Fig. 2
Changes in UPDRS II and III scores in patients randomized to entacapone or placebo and using levodopa/benserazide (LB) or levodopa/carbidopa (LC). a UPDRS II and b UPDRS III. Bars represent estimated mean changes with standard error of mean (SEM); ITT-OC (intent to treat observed cases). Black bars entacapone; white bars placebo. UPDRS Unified Parkinson’s Disease Rating Scale

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