Double-blind, placebo-controlled study of entacapone in levodopa-treated patients with stable Parkinson disease.
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.


METHODS
Prospective, double-blind, placebo-controlled trial.


METHODS
Outpatient multicenter study.


METHODS
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.


METHODS
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.
Olanow
C W
CW
Department of Neurology, Mount Sinai School of Medicine, New York, NY 10029, USA. warren.olanow@MSSM.edu
Kieburtz
K
K
Stern
M
M
Watts
R
R
Langston
J W
JW
Guarnieri
M
M
Hubble
J
J
D000368:Aged; D000704:Analysis of Variance; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D065098:Catechol O-Methyltransferase Inhibitors; D002396:Catechols / Q000627:therapeutic use*; D004311:Double-Blind Method; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007980:Levodopa / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000187:drug effects; D009570:Nitriles; D010300:Parkinson Disease / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D065098:Catechol O-Methyltransferase Inhibitors; D002396:Catechols; D009570:Nitriles; D007980:Levodopa; C071192:entacapone