Treatment of end-of-dose wearing-off in parkinson's disease: stalevo (levodopa/carbidopa/entacapone) and levodopa/DDCI given in combination with Comtess/Comtan (entacapone) provide equivalent improvements in symptom control superior to that of traditional levodopa/DDCI treatment.
The aim of this study was to evaluate the efficacy of the new optimised levodopa, Stalevo (levodopa, carbidopa and entacapone) in patients with Parkinson's disease experiencing end-of-dose wearing-off. Treatment with Stalevo was compared to treatment with traditional immediate-release levodopa and dopa-decarboxylase inhibitor (DDCI) formulations along with adjunct entacapone (Comtess/Comtan). A European, open, parallel-group, active treatment-controlled phase IIIb study evaluating 176 patients randomised to switch from their current regimen of levodopa/DDCI to either an equivalent dose of Stalevo or levodopa/DDCI plus entacapone. After 6 weeks, treatments were assessed using the Clinical Global Impression of Change, the Unified Parkinson's Disease Rating Scale and a Motor Fluctuations Questionnaire. Over 70% of patients in both the Stalevo and adjunct entacapone arms felt that they were clinically improved and over 80% experienced a reduction in fluctuations. Although there was no significant difference between Stalevo and levodopa/DDCI plus entacapone with regard to motor improvement and side effects, 81% of patients stated that they preferred treatment with Stalevo compared with taking two separate tablets (i.e. levodopa/DDCI and entacapone). Stalevo was well tolerated and safe when substituted for levodopa DDCI preparations.
Brooks
D J
DJ
MRC Clinical Sciences Centre and Division of Neuroscience, Faculty of Medicine, Imperial College, Hammersmith Hospital, London, UK. david.brooks@csc.mrc.ac.uk
Agid
Y
Y
Eggert
K
K
Widner
H
H
Ostergaard
K
K
Holopainen
A
A
D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D002230:Carbidopa / Q000627:therapeutic use*; D002396:Catechols / Q000627:therapeutic use*; D004185:Disability Evaluation; D004338:Drug Combinations; D004341:Drug Evaluation / Q000379:methods; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007980:Levodopa / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000187:drug effects; D009570:Nitriles; D010147:Pain Measurement; D010300:Parkinson Disease / Q000188:drug therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D002396:Catechols; D004338:Drug Combinations; D004791:Enzyme Inhibitors; D009570:Nitriles; C481098:Stalevo; D007980:Levodopa; C071192:entacapone; D002230:Carbidopa