Department of Neurology, St. Joseph Hospital Berlin-Weißensee, Gartenstr. 1, 13088, Berlin, Germany.
Movement Disorder Unit, Neurology Service, Hospital Clínic de Barcelona, Universitat de Barcelona, IDIBAPS, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Barcelona, Catalonia, Spain.
J Neural Transm (Vienna). 2018 Jun;125(6):953-963. doi: 10.1007/s00702-018-1860-x. Epub 2018 Feb 26.
Real-world data from large cohorts of patients with Parkinson's disease on the long-term effectiveness of different dopamine-substituting drug therapies are rare. The objective of this study was to obtain information on real-world management of PD with dopamine-substituting drugs. SP0854 (NCT00599339) was a prospective, multicenter, non-interventional, multiple-cohort, post-authorization safety study of rotigotine versus other dopaminergic therapies. The study was also part of a European Medicines Agency risk-management plan for the non-ergoline dopamine agonist rotigotine, focussing on cardiovalvular fibrosis. Eligible patients requiring monotherapy with a dopamine agonist, or levodopa in combination with a dopamine agonist were followed for ≤ 33 months; 1531 of 2195 patients completed the study. Mean motor scores improved for all dopamine-substituting treatments. Patients with more severe motor-symptoms/increased disability were more likely to receive levodopa alone or in combination with a DA at study onset. More patients who started on combination therapy with levodopa remained on this treatment versus those starting on dopaminergic monotherapy. This real-world study showed that the dopamine-substituting therapies were efficacious, with a safety profile consistent with that expected of dopaminergic treatments. Cardiovalvular pathology was rare and not found to be causally-related to rotigotine.
关于帕金森病患者长期使用不同多巴胺替代药物治疗的真实世界数据较为罕见。本研究旨在了解帕金森病患者使用多巴胺替代药物的真实世界管理情况。SP0854（NCT00599339）是一项关于罗替高汀与其他多巴胺能治疗药物的前瞻性、多中心、非干预性、多队列、上市后安全性研究，也是欧洲药品管理局（EMA）针对非麦角类多巴胺激动剂罗替高汀的风险管理计划的一部分，该计划重点关注心瓣膜纤维化。需要多巴胺激动剂单药治疗或左旋多巴联合多巴胺激动剂治疗的合格患者随访时间最长达 33 个月；2195 例患者中有 1531 例完成了研究。所有多巴胺替代治疗的运动评分均有改善。在研究开始时，运动症状更严重/残疾程度更高的患者更有可能单独接受左旋多巴或与 DA 联合治疗。与起始多巴胺能单药治疗的患者相比，更多起始联合左旋多巴治疗的患者继续接受该治疗。这项真实世界研究表明，多巴胺替代治疗是有效的，其安全性与预期的多巴胺能治疗一致。心瓣膜病少见，与罗替高汀无因果关系。
