Journal Article

Five-year efficacy and safety of levodopa/DDCI and entacapone in patients with Parkinson’s disease

Kuoppamäki, Mikko, Nissinen, Helena, Brooks, David J., Leinonen, Mika

2008

Overview

This was a retrospective pooled analysis of data from four comparably designed, double-blind, placebo-controlled, Phase III studies and their long-term open-label extensions. Patients on levodopa and a dopa decarboxylase inhibitor (DDCI) were randomized to entacapone or to placebo in the 6-month, double-blind phase, with all patients subsequently receiving entacapone in the extension phase. UPDRS III motor scores improved by −2.1 points during the first 6 months of levodopa/DDCI and entacapone therapy, and remained below baseline for up to 2 years. Increased daily ‘ON’ time, together with response duration to a single morning dose of levodopa and clinical global evaluation, also supported the long-term efficacy of levodopa/DDCI and entacapone. The mean daily dose of levodopa did not increase over the 5-year follow-up period. Long-term therapy with levodopa/DDCI and entacapone was well-tolerated.

• Publisher: Springer Vienna,Springer Nature B.V
• Subject: Activities of daily living / Aged / Antiparkinson Agents - administration & dosage / Antiparkinson Agents - adverse effects / Aromatic Amino Acid Decarboxylase Inhibitors / Aromatic-L-amino-acid decarboxylase / Brain - drug effects / Brain - metabolism / Brain - physiopathology / Catechols - administration & dosage / Catechols - adverse effects / Clinical trials / Clinical Trials, Phase III as Topic - statistics & numerical data / Dopa Decarboxylase - metabolism / Dopamine / Dose-Response Relationship, Drug / Double-Blind Method / Double-blind studies / Drug Administration Schedule / Drug dosages / Drug Resistance - drug effects / Drug Resistance - physiology / Drug Synergism / Drug Therapy, Combination / Enzyme Inhibitors - administration & dosage / Enzyme Inhibitors - adverse effects / Female / Follow-Up Studies / Humans / Levodopa / Levodopa - administration & dosage / Levodopa - adverse effects / Male / Medicine / Medicine & Public Health / Middle Aged / Neurodegenerative diseases / Neurology / Neurosciences / Nitriles - administration & dosage / Nitriles - adverse effects / Parkinson Disease - drug therapy / Parkinson Disease - metabolism / Parkinson Disease - physiopathology / Parkinson's Diasease and Allied Conditions - Original Article / Parkinson's disease / Patients / Placebos / Psychiatry / Randomized Controlled Trials as Topic - statistics & numerical data / Retrospective Studies / Time / Treatment Outcome