Abstract
To assess the safety and adverse effect profile of continued use of intermittent subcutaneous apomorphine to treat "off" episodes in subjects with advanced Parkinson disease. The study enrolled subjects with Hoehn and Yahr stage II-V Parkinson disease who were experiencing "off" events despite an optimized oral medication regimen. After baseline assessment and subcutaneous apomorphine dose titration (2-10mg/dose), subjects received > or =12 months of open-label treatment, as needed, for "off" episodes. Of the 546 subjects in the study population, the majority used apomorphine on a daily basis; the average dose was 4.0 mg. A total of 187 subjects discontinued treatment because of adverse events (AEs). Most AEs were mild to moderate and expected with apomorphine. The AEs most commonly classified as definitely, probably, or possibly treatment related were nausea and vomiting, dyskinesia, dizziness, somnolence, hallucination, yawning, and injection site bruising. Serious AEs occurred in 199 subjects, but only 27 were considered to be probably or possibly treatment related. None of the 45 deaths recorded in the study were attributed to apomorphine. Long-term use of intermittent apomorphine dosing for treatment of "off" episodes was generally associated with mild-to-moderate AEs.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.