Impact of 6-month earlier versus postponed initiation of rotigotine on long-term outcome: post hoc analysis of patients with early Parkinson's disease with mild symptom severity. (July 2015)

• Record Type: Journal Article
• Authors: Timmermann, Lars; Asgharnejad, Mahnaz; Boroojerdi, Babak; Dohin, Elisabeth; Woltering, Franz; Elmer, Lawrence W
• Is Part Of: Expert opinion on pharmacotherapy. Volume 16:Number 10(2015)
• Page Start: 1423
• Page End: 1433
• Publication Date: 2015-07
• Subjects: Chemotherapy -- Periodicals; 615.5805
• DOI: 10.1517/14656566.2015.1049597
• Languages: English
• ISSNs: 1465-6566

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Objective:</italic> </bold> Investigate impact of 6-month earlier versus postponed initiation of rotigotine in patients with early Parkinson's disease (PD) with mild symptom severity.</p> <p> <bold> <italic>Background:</italic> </bold> Long-term benefit of rotigotine in early-PD has been demonstrated: SP702 (NCT00594165) and SP716 (NCT00599196) were long-term, open-label extensions of double-blind, placebo-controlled studies of 6-month maintenance; rotigotine was well tolerated for up to 6 years, and demonstrated efficacy (Unified Parkinson's Disease Rating Scale [UPDRS] II + III below baseline) for ∼ 2 years (SP702) and ∼ 4 years (SP716).</p> <p> <bold> <italic>Methods:</italic> </bold> <italic>Post hoc</italic> analysis of patients at Hoehn and Yahr 1–2; groups defined by treatment received in 6-month double-blind studies: 'Rotigotine–Rotigotine' received rotigotine (n = 221), 'Placebo–Rotigotine' received placebo (n = 125).</p> <p> <bold> <italic>Results:</italic> </bold> At the start of open-label rotigotine maintenance, UPDRS II + III mean ± SD change from double-blind baseline was: −8.5 ± 10.6 'Rotigotine–Rotigotine', −7.7 ± 9.0 'Placebo–Rotigotine.' After this initial improvement scores gradually increased: It took ∼ 45 months for mean scores to cross baseline in 'Rotigotine–Rotigotine', and ∼ 21 months in 'Placebo–Rotigotine.' At the time mean UPDRS II + III had crossed baseline in 'Placebo–Rotigotine' (open-label week 84; ∼ 21 months), treatment difference (LS-mean) to 'Rotigotine–Rotigotine' change from baseline was −3.89 (95% CI −6.94, −0.84); p = 0.013.</p> <p> <italic> <bold>Conclusions:</bold> </italic> In this <italic>post hoc</italic> analysis, 6-month earlier initiation of rotigotine resulted in slower return to baseline mean UPDRS II + III; initiation of rotigotine in patients with minimal/no functional disability or impairment may lead to an extended benefit.</p> </abstract>