Treatment of End-of-Dose Wearing-Off in Parkinson’s Disease: Stalevo<sup>®</sup> (Levodopa/Carbidopa/Entacapone) and Levodopa/DDCI Given in Combination with Comtess<sup>®</sup>/Comtan<sup>®</sup> (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.