Universität zu Köln

Timmermann, Lars, Asgharnejad, Mahnaz, Boroojerdi, Babak, Dohin, Elisabeth, Woltering, Franz and Elmer, Lawrence W. (2015). 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. Expert Opin. Pharmacother., 16 (10). S. 1423 - 1434. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1744-7666

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Abstract

Objective: Investigate impact of 6-month earlier versus postponed initiation of rotigotine in patients with early Parkinson's disease (PD) with mild symptom severity. Background: 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 similar to 2 years (513702) and similar to 4 years (SP716). Methods: Post hoc 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). Results: 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 similar to 45 months for mean scores to cross baseline in 'Rotigotine-Rotigotine', and similar to 21 months in 'Placebo-Rotigotine.' At the time mean UPDRS II + III had crossed baseline in 'Placebo-Rotigotine' (open-label week 84; similar to 21 months), treatment difference (LS-mean) to 'Rotigotine-Rotigotine' change from baseline was -3.89 (95% CI -6.94, -0.84); p = 0.013. Conclusions: In this post hoc 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Timmermann, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Asgharnejad, Mahnaz UNSPECIFIED UNSPECIFIED UNSPECIFIED Boroojerdi, Babak UNSPECIFIED UNSPECIFIED UNSPECIFIED Dohin, Elisabeth UNSPECIFIED UNSPECIFIED UNSPECIFIED Woltering, Franz UNSPECIFIED UNSPECIFIED UNSPECIFIED Elmer, Lawrence W. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-399543
DOI:	10.1517/14656566.2015.1049597
Journal or Publication Title:	Expert Opin. Pharmacother.
Volume:	16
Number:	10
Page Range:	S. 1423 - 1434
Date:	2015
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1744-7666
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DELAYED-START TRIAL; DOUBLE-BLIND; TRANSDERMAL ROTIGOTINE; OPEN-LABEL; PLACEBO; SYSTEM; TOLERABILITY; RASAGILINE; PROFILE; SAFETY Multiple languages Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/39954