Efficacy and safety of rotigotine in elderly patients with Parkinson's disease in comparison with the non-elderly: a post hoc analysis of randomized, double-blind, placebo-controlled trials.
Masahiro NomotoHirotaka IwakiHiroyuki KondoMasaya SakuraiPublished in: Journal of neurology (2017)
Rotigotine-a non-ergot dopamine agonist-has two advantages; it can stimulate all dopamine receptors (D1-D5) like innate dopamine, and its transdermal administration provides continuous dopaminergic stimulation. The age of the patient impacts the effect and adverse events of anti-parkinsonian treatment. We conducted a post hoc analysis on three randomized, double-blind, placebo-controlled trials performed in Japan to clarify the difference of anti-parkinsonian treatment in elderly and non-elderly patients. Data from two combination therapy trials (with levodopa) in advanced stage Parkinson's disease patients and one monotherapy trial in early stage patients were pooled and grouped by age (non-elderly aged < 70, elderly aged 70 +). In each age group, efficacy of rotigotine was compared to placebo. In the combination therapy, total Unified Parkinson's Disease Rating Scale Part III scores and some subtotal scores, including those for tremor, akinesia and gait disturbance, significantly improved in both elderly and non-elderly patients. Regarding safety, the incidence of total adverse event tended to be lower in elderly patients than non-elderly patients, although it was not significant. No difference was observed in maintenance dosage of rotigotine between the two groups. In conclusion, the improvement in motor symptoms and frequency of adverse events were shown to be similar in elderly and non-elderly patients with rotigotine-levodopa combination therapy. Further, there was no major difference in maintenance dosage of rotigotine between the age groups. These results suggest good tolerability of rotigotine among elderly patients.
Keyphrases
- combination therapy
- placebo controlled
- double blind
- phase iii
- middle aged
- phase ii
- community dwelling
- clinical trial
- open label
- early stage
- study protocol
- end stage renal disease
- phase ii study
- ejection fraction
- newly diagnosed
- parkinson disease
- immune response
- chronic kidney disease
- emergency department
- prognostic factors
- case report
- deep learning
- patient reported outcomes
- squamous cell carcinoma
- depressive symptoms
- physical activity
- adverse drug
- radiation therapy
- sentinel lymph node