Clinical neurology and neurosurgery · 2009
A multicentre retrospective study of the clinical use of ropinirole in the treatment of Parkinson's disease: the ROPI-PARK study.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Valldeoriola F, Cobaleda S, Lahuerta J
Аннотация
OBJECTIVES: To evaluate the use of the non-ergot dopamine agonist ropinirole (RPN) in patients with Parkinson's disease in Spain, and to examine its effectiveness and tolerability in both monotherapy and combination therapy.
METHODS: Fifty-two investigators participated in this study. Patients receiving RPN under usual clinical care conditions in Spanish Neurology outpatient clinic settings were identified (n=643) out of these, a random sample of 423 clinical records of patients treated with RPN in the previous 18 months was selected. The endpoints analyzed were: percentage of patients remaining on treatment during the period of study (maintenance), reported adverse reactions and treatment withdrawal (tolerability), changes in symptoms' severity as assessed by the Clinical Global Impression-Improvement (CGI-I) scale (effectiveness), and start-to-end mean RPN dose.
RESULTS: Patients were 68.6+/-9.7 years old (mean+/-SD) and 57.6% were male. RPN was administered as monotherapy (24%) or add-on treatment (76%). The mean maintenance dose was 9.54+/-5.34mg/day. Adverse reactions were reported by 28.6% patients, the most frequent being somnolence and sedation (9.2%), gastrointestinal symptoms (6.9%), increase in dyskinesia (5.9%), and orthostatic symptoms (3.8%). Treatment was withdrawn in 14.4% of patients, because of adverse reactions (5.9%), lack of efficacy (2.1%), change in treatment or clinical trial inclusion (1.9%) or other reasons (4.5%). Neurologists considered that improvement was achieved in 81.5% of patients, according to CGI-I scale.
CONCLUSIONS: The low incidence of adverse reactions and low rate of treatment withdrawal observed in this study support the effectiveness and tolerability of RPN in the treatment of Parkinson's disease.
METHODS: Fifty-two investigators participated in this study. Patients receiving RPN under usual clinical care conditions in Spanish Neurology outpatient clinic settings were identified (n=643) out of these, a random sample of 423 clinical records of patients treated with RPN in the previous 18 months was selected. The endpoints analyzed were: percentage of patients remaining on treatment during the period of study (maintenance), reported adverse reactions and treatment withdrawal (tolerability), changes in symptoms' severity as assessed by the Clinical Global Impression-Improvement (CGI-I) scale (effectiveness), and start-to-end mean RPN dose.
RESULTS: Patients were 68.6+/-9.7 years old (mean+/-SD) and 57.6% were male. RPN was administered as monotherapy (24%) or add-on treatment (76%). The mean maintenance dose was 9.54+/-5.34mg/day. Adverse reactions were reported by 28.6% patients, the most frequent being somnolence and sedation (9.2%), gastrointestinal symptoms (6.9%), increase in dyskinesia (5.9%), and orthostatic symptoms (3.8%). Treatment was withdrawn in 14.4% of patients, because of adverse reactions (5.9%), lack of efficacy (2.1%), change in treatment or clinical trial inclusion (1.9%) or other reasons (4.5%). Neurologists considered that improvement was achieved in 81.5% of patients, according to CGI-I scale.
CONCLUSIONS: The low incidence of adverse reactions and low rate of treatment withdrawal observed in this study support the effectiveness and tolerability of RPN in the treatment of Parkinson's disease.