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

J Neural Transm (Vienna). 2015 Dec;122(12):1709-14. doi: 10.1007/s00702-015-1449-6. Epub 2015 Sep 7.

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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiparkinson Agents / adverse effects
  • Antiparkinson Agents / therapeutic use*
  • Benserazide / adverse effects
  • Benserazide / therapeutic use*
  • Carbidopa / adverse effects
  • Carbidopa / therapeutic use*
  • Catechol O-Methyltransferase Inhibitors / adverse effects
  • Catechol O-Methyltransferase Inhibitors / therapeutic use*
  • Catechols / adverse effects
  • Catechols / therapeutic use*
  • Data Interpretation, Statistical
  • Double-Blind Method
  • Drug Combinations
  • Drug Therapy, Combination / adverse effects
  • Female
  • Humans
  • Levodopa / adverse effects
  • Levodopa / therapeutic use*
  • Male
  • Middle Aged
  • Nitriles / adverse effects
  • Nitriles / therapeutic use*
  • Parkinson Disease / drug therapy*
  • Parkinson Disease / physiopathology
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Antiparkinson Agents
  • Catechol O-Methyltransferase Inhibitors
  • Catechols
  • Drug Combinations
  • Nitriles
  • benserazide, levodopa drug combination
  • carbidopa, levodopa drug combination
  • Levodopa
  • entacapone
  • Benserazide
  • Carbidopa