[Direct switch from conventional levodopa to stalevo (levodopa/carbidopa/entacapone) improves quality of life in Parkinson's disease: results of an open-label clinical study].
The most effective symptomatic treatment for Parkinson's disease (PD) is levodopa/dopa decarboxylase (DDC)-inhibitor or conventional levodopa. However, after a few years of treatment, motor complications may develop, such as <<wearing-off>> and dyskinesias. Symptoms of <<wearing-off>> can be both motor symptoms, e.g. tremor and bradykinesia, as well as non-motor symptoms (pain, mood changes and anxiety). The development of these complications may affect the patients quality of life (QOL). To investigate the efficacy and safety direct switch from conventional levodopa to stalevo(levodopa/carbidopa/entacapone) in PD patients with fluctuations and dyskinesias.


METHODS
Thirty four patients with PD were recruited in the study. The mean age (+/-SD) of the patients was 64,5+/-8,3 years, the mean duration of PD (+/-SD) was 5,9+/-3,1 years, the mean H&Y was 2,5+/-0,5. All patients experienced fluctuations and six had dyskinesias (one patient had biphasic dyskinesias with painful dystonia). The mean baseline levodopa dose was 785,8+/-150,2 mg per day taking in three to six doses. Assessments were performed before, end of 1, 4 and 12 weeks of treatment period and consisted of Hoen/Yahr stages (H&Y), II and III parts of the Unified Parkinson's Disease Rating Scale (UPDRS), patients diaries with registration <<on-off>> periods, scale EQ-5D, WOQ-9. While switching from conventional levodopa to stalevo taking single levodopa doses were equivalent or less. Maximum allowed doses of stalevo were four times per day.


RESULTS
Direct switch to stalevo results in improvement of motor and non-motor symptoms (pain and anxiety) in fluctuating patients and significant prolongation of <<on>> periods (p<0.01). We observed dramatic improvement biphasic dyskinesias with painful dystonia and reducing severity of dyskinesias in others patients. Improvement was seen in QOL by scale EQ-5D from 10,7+/-1,9 to 8,6+/-2,1 points (p<0,05). Conclusions. Switching from conventional levodopa to stalevo is efficacy and safety and can significantly improve QOL PD patients with fluctuations and dyskinesias.
Litvinenko
I V
IV
Odinak
M M
MM
Mogil'naia
V I
VI
Sologub
O S
OS
Sakharovskaia
A A
AA
D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage*; D002230:Carbidopa / Q000008:administration & dosage / Q000627:therapeutic use*; D002396:Catechols / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007980:Levodopa / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D002396:Catechols; D004338:Drug Combinations; C481098:Stalevo; D007980:Levodopa; D002230:Carbidopa