An observational study of rotigotine transdermal patch and other currently prescribed therapies in patients with Parkinson’s disease

Abstract

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.

Rotigotine Transdermal Patch for Motor and Non-motor Parkinson’s Disease: A Review of 12 Years’ Clinical Experience

“…A novel placebo-controlled trial using NMS as a primary outcome measure also showed a significant improvement in motor function, as measured by UPDRS III, and in QoL [36]. A post hoc analysis of six placebo-controlled studies (n>2000) in early or advanced PD confirmed the efficacy of rotigotine on motor symptoms and ADL [37], a finding further supported by a recent review [38], two large metaanalyses [39,40], and a prospective, multisite real-world study in more than 2000 patients with PD of varying stages and symptom severity [41]. A few open-label extension studies have also documented motor benefits lasting up to 6 years [42][43][44][45].…”

Parkinson’s Disease in Romania: A Scoping Review

“…Twenty-nine trials were national studies. In 22 studies, the Romanian participants were part of international, multicenter studies [101][102][103][104][105][106][107]109,110,[115][116][117]119,[123][124][125][126][127]129,132,141,143]. In the last category, 11 studies were published as original articles [101,102,[115][116][117]119,124,125,129,132,141], and 11 were abstracts presented at international conferences [103][104][105][106][107]109,110,123,126,127,143].…”

“…,124,125,129,132,141], and 11 were abstracts presented at international conferences[103][104][105][106][107]109,110,123,126,127,143].…”

Moderne Parkinson-Therapie: Stellenwert von Dopaminagonisten im Verlauf der Erkrankung (Sponsor: UCB Pharma GmbH)

“…B. Neupro ® ) mind. genauso gut wirksam und verträglich ist wie die oralen Dopaminagonisten [7][8][9]. Deshalb sollte es gleichberechtigt mit diesen eingesetzt und nicht ausschließlich speziellen Situa tionen vorbehalten werden.…”