A group of 65 patients (22 women, 43 men) with Parkinson's disease (PD) in the advanced stage was treated between August 1999 and January 2001 by a new catechol-O-methyl-transferase inhibitor (COMT inhibitor), entacapone. The preparation Comtan©(entacapone) was administered to patients with PD in addition to L-DOPA and other antiparkinsonian therapy to trest fluctuations of the clinical status. The mean age of the group at the time when entacapone therapy was started was 66.6±8.4 years, the mean duration of the disease 9.9±5.3 years, the mean age at the time of the hrst clinical symptoms was 56.7±10.3 years, the mean grade of the disease according to Hoehn and Yahr before initiation of entacapone treatment was 3.1±0.7, the mean period of fluctuations of the clinical status was 5.4±3.7 years, the mean period of L-DOPA administration 8.3±4.6 years. Before entacapone treatment was started in every patients the UPDRS III score (motor examination), the UPDRS IV score (complications of treatment), the mean daily period of the wakeful day spent in the off-state (state of poor mobility) and on-state of mobility (state of adequate mobility) were assessed. Furthermore a blond sample was taken for laboratory analysis of liver transaminases. The mean daily dole of L-DOPA before the beginning of therapy was 1091±474 mg. The shortest follow up period for evaluation of the effect of entacapone therapy was 4 months, the longest 17 months (mean period of follow up of the group was 12.1±3.9 months). Twelve patients (18.5 %) where entacapone treatment was started had a history of previous intolerance or complications during treatment with dopaminergic agonists, in another 10 patients (15.4 %) mental complications were present (cognitive deflciency, hallucinations), which limited the administration of other antiparkinsonian therapy except L-DOPA. During subsequent check-up examinations after initiation of entacapone treatment, for evaluation of the effects of therapy scales UPDRS III (mean decline by 27.8 %),UPDRS IV (mean decline by 31.9 %) were used and the time spent in the off-state of mobility (reduction by 2.3±1.4 hours, the time spent in the on-state of mobility (increase by 1.7±1.2 hours) were assessed - all statistically signiflcant at the level of p < 0.0001 as compared with baseline values before the initiation of entacapone treatment. The mean entacapone dole was 812±197 mg. The total daily dole of L-DOPA 933±380 mg (decline by 14.5 % statistically signiflcant at the level ofp < 0.05). Side-effects (dyspepsia, diarrhoea, orthostatic hypotension, hallucinations) were recorded in 5 patients (7.7 %). Dyskinesias became more marked in 11 patients (16.9 %), they receded after reduction of the total daily L-DOPA dole. Entacapone was discontinued in 7 patients (10.8 %), usually because of an inadequate effect (3 patients), non-compliance (2 patients) or side-effects (2 patients). Two patients died during the follow up period from other intercurrent diseases (heart failure, cerebrovascular attack). In none of the patients alteration of liver transaminases was observed as compared with values before entacapone treatment. Entacapone is an effective and rafe preparation suitable for treatment of fluctuations of the clinical status of patients with the advanced stage of Parkinson's disease. Entacapone prolongs signiflcantly the time of the wakeful day spent in the on-state of mobility, it reduces the percentage of time in the off-state of mobility. Entacapone dnes not cause a change of liver transaminases. It can be successfully used also in patients with mental complications of the disease or those with a previous history of intolerance of dopaminergic agonists.

        Key words: Parkinson's disease, COMT inhibitors, entacapone, lafety, long-term evaluation