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Efficacy and tolerability of entacapone in patients with Parkinson's disease treated with levodopa plus a dopamine agonist and experiencing wearing-off motor fluctuations. A randomized, double-blind, multicentre study.
J Neural Transm (Vienna). 2003 Mar; 110(3):239-51.JN

Abstract

The efficacy and tolerability of entacapone was investigated in a randomized, double-blind, placebo-controlled, 3-month study of 162 patients with Parkinson's disease (PD) treated with levodopa and a dopamine agonist and experiencing wearing-off motor fluctuations. Patients were randomized in a 3 : 2 ratio to entacapone 200 mg or placebo, administered with each dose of levodopa. Efficacy was judged on the improvement of "on" and "off" time while awake (Patient Diary and UPDRS part IV Item 39), Investigators' Global Assessment, the SF-36 Health Survey, and changes in levodopa dosages. Patients were monitored for adverse events, laboratory safety and vital signs throughout the study. Improvements in "on" time as assessed using patient diary data showed a trend in favour of entacapone, however these did not reach statistical significance. "Off" time while awake (UPDRS part IV Item 39) showed an improvement of at least one category in 36% of entacapone-treated patients, compared with 22% in the control group (p = 0.0038). The proportion of patients showing an improvement at the Investigators' Global Assessment was significantly higher (p = 0.0006) in the entacapone-treated group of patients. Also, the proportion of patients with a reduction in their daily levodopa dose was significantly higher (p = 0.02) in the entacapone group (28%) compared with placebo (13%). As expected, the most frequent adverse events were dopamine-mediated (dyskinesia: entacapone 31% versus placebo 13%), and harmless urinary discoloration. The modest increase in dyskinesias could be readily managed by levodopa down-adjustment, and, at study end there was no significant difference for the UPDRS "overall dyskinesia score" between entacapone and placebo. In conclusion, although the primary efficacy variable did not reach statistical significance, the present results demonstrate that entacapone provides additional antiparkinsonian benefits to levodopa therapy and is well tolerated in levodopa-treated PD patients experiencing wearing-off motor fluctuations despite adjunct dopamine agonist therapy.

Authors+Show Affiliations

Hôpital Henri Mondor, Paris, Créteil, France. gfenelon@wanadoo.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12658373

Citation

Fénelon, G, et al. "Efficacy and Tolerability of Entacapone in Patients With Parkinson's Disease Treated With Levodopa Plus a Dopamine Agonist and Experiencing Wearing-off Motor Fluctuations. a Randomized, Double-blind, Multicentre Study." Journal of Neural Transmission (Vienna, Austria : 1996), vol. 110, no. 3, 2003, pp. 239-51.
Fénelon G, Giménez-Roldán S, Montastruc JL, et al. Efficacy and tolerability of entacapone in patients with Parkinson's disease treated with levodopa plus a dopamine agonist and experiencing wearing-off motor fluctuations. A randomized, double-blind, multicentre study. J Neural Transm (Vienna). 2003;110(3):239-51.
Fénelon, G., Giménez-Roldán, S., Montastruc, J. L., Bermejo, F., Durif, F., Bourdeix, I., Péré, J. J., Galiano, L., & Schadrack, J. (2003). Efficacy and tolerability of entacapone in patients with Parkinson's disease treated with levodopa plus a dopamine agonist and experiencing wearing-off motor fluctuations. A randomized, double-blind, multicentre study. Journal of Neural Transmission (Vienna, Austria : 1996), 110(3), 239-51.
Fénelon G, et al. Efficacy and Tolerability of Entacapone in Patients With Parkinson's Disease Treated With Levodopa Plus a Dopamine Agonist and Experiencing Wearing-off Motor Fluctuations. a Randomized, Double-blind, Multicentre Study. J Neural Transm (Vienna). 2003;110(3):239-51. PubMed PMID: 12658373.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of entacapone in patients with Parkinson's disease treated with levodopa plus a dopamine agonist and experiencing wearing-off motor fluctuations. A randomized, double-blind, multicentre study. AU - Fénelon,G, AU - Giménez-Roldán,S, AU - Montastruc,J L, AU - Bermejo,F, AU - Durif,F, AU - Bourdeix,I, AU - Péré,J-J, AU - Galiano,L, AU - Schadrack,J, PY - 2003/3/27/pubmed PY - 2003/8/9/medline PY - 2003/3/27/entrez SP - 239 EP - 51 JF - Journal of neural transmission (Vienna, Austria : 1996) JO - J Neural Transm (Vienna) VL - 110 IS - 3 N2 - The efficacy and tolerability of entacapone was investigated in a randomized, double-blind, placebo-controlled, 3-month study of 162 patients with Parkinson's disease (PD) treated with levodopa and a dopamine agonist and experiencing wearing-off motor fluctuations. Patients were randomized in a 3 : 2 ratio to entacapone 200 mg or placebo, administered with each dose of levodopa. Efficacy was judged on the improvement of "on" and "off" time while awake (Patient Diary and UPDRS part IV Item 39), Investigators' Global Assessment, the SF-36 Health Survey, and changes in levodopa dosages. Patients were monitored for adverse events, laboratory safety and vital signs throughout the study. Improvements in "on" time as assessed using patient diary data showed a trend in favour of entacapone, however these did not reach statistical significance. "Off" time while awake (UPDRS part IV Item 39) showed an improvement of at least one category in 36% of entacapone-treated patients, compared with 22% in the control group (p = 0.0038). The proportion of patients showing an improvement at the Investigators' Global Assessment was significantly higher (p = 0.0006) in the entacapone-treated group of patients. Also, the proportion of patients with a reduction in their daily levodopa dose was significantly higher (p = 0.02) in the entacapone group (28%) compared with placebo (13%). As expected, the most frequent adverse events were dopamine-mediated (dyskinesia: entacapone 31% versus placebo 13%), and harmless urinary discoloration. The modest increase in dyskinesias could be readily managed by levodopa down-adjustment, and, at study end there was no significant difference for the UPDRS "overall dyskinesia score" between entacapone and placebo. In conclusion, although the primary efficacy variable did not reach statistical significance, the present results demonstrate that entacapone provides additional antiparkinsonian benefits to levodopa therapy and is well tolerated in levodopa-treated PD patients experiencing wearing-off motor fluctuations despite adjunct dopamine agonist therapy. SN - 0300-9564 UR - https://www.unboundmedicine.com/medline/citation/12658373/Efficacy_and_tolerability_of_entacapone_in_patients_with_Parkinson's_disease_treated_with_levodopa_plus_a_dopamine_agonist_and_experiencing_wearing_off_motor_fluctuations__A_randomized_double_blind_multicentre_study_ L2 - https://doi.org/10.1007/s00702-002-0799-z DB - PRIME DP - Unbound Medicine ER -