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RESEARCH PRODUCT
The effects of transdermal rotigotine on non-motor symptoms of Parkinson's disease: a multicentre, observational, retrospective, post-marketing study
José Maria Gómez-arguellesMiguel MoyaAntonio Caridad SalvadorJosé MareyFrancesc ValldeoriolaFrancisco RamirezÁNgel Ayugasubject
MaleSleep Wake Disordersmedicine.medical_specialtyParkinson's diseaseTetrahydronaphthalenesThiophenesDiseaseAdministration CutaneousMotor symptoms03 medical and health sciences0302 clinical medicineSurveys and QuestionnairesProduct Surveillance PostmarketingmedicineHumans030212 general & internal medicineAgedRetrospective StudiesTransdermalAged 80 and overbusiness.industryGeneral NeuroscienceParkinson DiseaseRotigotineGeneral MedicineUrination Disordersmedicine.diseaseClinical PracticeTreatment OutcomeSpainDopamine AgonistsPhysical therapyNon motorFemaleObservational studyCognition Disordersbusiness030217 neurology & neurosurgerymedicine.drugdescription
This study evaluated the effect of ≥6 months of transdermal rotigotine on non-motor and motor symptoms of patients with advanced Parkinson's disease.The study was conducted in Spain between September 2011 and December 2012 (ClinicalTrials.gov: NCT01504529). The primary efficacy variable was the change from baseline in non-motor symptoms, as assessed by changes in Parkinson's Disease Non-Motor Symptoms Questionnaire total scores at 6 months. Secondary endpoints included the assessment of motor symptoms by Unified Parkinson's Disease Rating Scale III scores.Data from 378 patients (mean age: 70.2 years; 56.9% male) with Parkinson's disease receiving rotigotine from were collected. Mean disease duration was 6.1 years, and mean rotigotine treatment duration was 45.6 months. Rotigotine reduced non-motor symptoms by 14.6% (mean change from baseline in Parkinson's Disease Non-Motor Symptoms Questionnaire: -1.5 ± 3.4; p0.0001). The majority of patients (58.2%) had improved non-motor symptoms at 6 months. Comparing the baseline versus study end, fewer patients experienced events in the urinary (78.6% vs. 73.3%; p = 0.0066), sleep (82.8% vs. 72.8%; p0.0001) and mood/cognition (77.3% vs. 66.4%; p0.0001) domains of the Parkinson's Disease Non-Motor Symptoms Questionnaire. Mean motor symptoms were reduced from baseline by 8.0% (mean change from baseline in Unified Parkinson's Disease Rating Scale III: -2.6 ± 8.0; p0.0001).In clinical practice in Spain, rotigotine may be an effective treatment to reduce the non-motor and motor symptoms in patients with advanced Parkinson's disease.
year | journal | country | edition | language |
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2017-12-17 | International Journal of Neuroscience |