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Double-blind, placebo-controlled study of entacapone in levodopa-treated patients with stable Parkinson disease.
Arch Neurol. 2004 Oct; 61(10):1563-8.AN

Abstract

BACKGROUND

The catechol O-methyltransferase inhibitor entacapone acts by extending the elimination half-life of levodopa and is currently approved as an adjunct to levodopa for the treatment of patients with Parkinson disease (PD) with motor fluctuations.

OBJECTIVE

To determine if the addition of entacapone administration provides benefit to levodopa-treated PD patients who have a stable response to levodopa and do not experience motor complications.

DESIGN

Prospective, double-blind, placebo-controlled trial.

SETTING

Outpatient multicenter study.

PATIENTS

Female and male patients 30 years or older with idiopathic PD receiving stable doses of levodopa or carbidopa with or without other dopaminergic therapies and who did not experience motor fluctuations were eligible for the study.

MAIN OUTCOME MEASURES

Parkinsonian function and quality of life.

RESULTS

The addition of entacapone did not improve motor scores on the Unified Parkinson's Disease Rating Scale in levodopa-treated PD patients who did not experience motor fluctuations. The mean +/- SE adjusted change between baseline and final treatment visit was -0.9 +/- 0.35 in the entacapone group and -0.8 +/- 0.35 in the placebo group (P = .83). Significant improvement with entacapone treatment was detected in several quality-of-life measures, including the Parkinson Disease Questionnaire 39, the 36-item Short-Form Health Survey, the Parkinson's Symptom Inventory, and investigator and subject Clinical Global Assessments. The drug was well tolerated by patients in this population.

CONCLUSIONS

The catechol O-methyltransferase inhibitor entacapone, used as an adjunct to levodopa in PD patients who do not experience motor fluctuations, does not improve Unified Parkinson's Disease Rating Scale motor scores but does improve a variety of quality-of-life measures.

Authors+Show Affiliations

Department of Neurology, Mount Sinai School of Medicine, New York, NY 10029, USA. warren.olanow@MSSM.eduNo 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
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15477510

Citation

Olanow, C W., et al. "Double-blind, Placebo-controlled Study of Entacapone in Levodopa-treated Patients With Stable Parkinson Disease." Archives of Neurology, vol. 61, no. 10, 2004, pp. 1563-8.
Olanow CW, Kieburtz K, Stern M, et al. Double-blind, placebo-controlled study of entacapone in levodopa-treated patients with stable Parkinson disease. Arch Neurol. 2004;61(10):1563-8.
Olanow, C. W., Kieburtz, K., Stern, M., Watts, R., Langston, J. W., Guarnieri, M., & Hubble, J. (2004). Double-blind, placebo-controlled study of entacapone in levodopa-treated patients with stable Parkinson disease. Archives of Neurology, 61(10), 1563-8.
Olanow CW, et al. Double-blind, Placebo-controlled Study of Entacapone in Levodopa-treated Patients With Stable Parkinson Disease. Arch Neurol. 2004;61(10):1563-8. PubMed PMID: 15477510.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind, placebo-controlled study of entacapone in levodopa-treated patients with stable Parkinson disease. AU - Olanow,C W, AU - Kieburtz,K, AU - Stern,M, AU - Watts,R, AU - Langston,J W, AU - Guarnieri,M, AU - Hubble,J, AU - ,, PY - 2004/10/13/pubmed PY - 2004/12/16/medline PY - 2004/10/13/entrez SP - 1563 EP - 8 JF - Archives of neurology JO - Arch Neurol VL - 61 IS - 10 N2 - BACKGROUND: The catechol O-methyltransferase inhibitor entacapone acts by extending the elimination half-life of levodopa and is currently approved as an adjunct to levodopa for the treatment of patients with Parkinson disease (PD) with motor fluctuations. OBJECTIVE: To determine if the addition of entacapone administration provides benefit to levodopa-treated PD patients who have a stable response to levodopa and do not experience motor complications. DESIGN: Prospective, double-blind, placebo-controlled trial. SETTING: Outpatient multicenter study. PATIENTS: Female and male patients 30 years or older with idiopathic PD receiving stable doses of levodopa or carbidopa with or without other dopaminergic therapies and who did not experience motor fluctuations were eligible for the study. MAIN OUTCOME MEASURES: Parkinsonian function and quality of life. RESULTS: The addition of entacapone did not improve motor scores on the Unified Parkinson's Disease Rating Scale in levodopa-treated PD patients who did not experience motor fluctuations. The mean +/- SE adjusted change between baseline and final treatment visit was -0.9 +/- 0.35 in the entacapone group and -0.8 +/- 0.35 in the placebo group (P = .83). Significant improvement with entacapone treatment was detected in several quality-of-life measures, including the Parkinson Disease Questionnaire 39, the 36-item Short-Form Health Survey, the Parkinson's Symptom Inventory, and investigator and subject Clinical Global Assessments. The drug was well tolerated by patients in this population. CONCLUSIONS: The catechol O-methyltransferase inhibitor entacapone, used as an adjunct to levodopa in PD patients who do not experience motor fluctuations, does not improve Unified Parkinson's Disease Rating Scale motor scores but does improve a variety of quality-of-life measures. SN - 0003-9942 UR - https://www.unboundmedicine.com/medline/citation/15477510/Double_blind_placebo_controlled_study_of_entacapone_in_levodopa_treated_patients_with_stable_Parkinson_disease_ L2 - https://jamanetwork.com/journals/jamaneurology/fullarticle/10.1001/archneur.61.10.1563 DB - PRIME DP - Unbound Medicine ER -