Trenkwalder, Claudia

[["dc.bibliographiccitation.artnumber","42"],["dc.bibliographiccitation.journal","BMC Neurology"],["dc.bibliographiccitation.volume","14"],["dc.contributor.author","Kassubek, Jan"],["dc.contributor.author","Chaudhuri, Kallol Ray"],["dc.contributor.author","Zesiewicz, Theresa"],["dc.contributor.author","Surmann, Erwin"],["dc.contributor.author","Boroojerdi, Babak"],["dc.contributor.author","Moran, Kimberly"],["dc.contributor.author","Ghys, Liesbet"],["dc.contributor.author","Trenkwalder, Claudia"],["dc.date.accessioned","2018-11-07T09:42:40Z"],["dc.date.available","2018-11-07T09:42:40Z"],["dc.date.issued","2014"],["dc.description.abstract","Background: Pain is a troublesome non-motor symptom of Parkinson's disease (PD). The RECOVER (Randomized Evaluation of the 24-hour Coverage: Efficacy of Rotigotine; Clintrials.gov: NCT00474058) study demonstrated significant improvements in early-morning motor function (UPDRS III) and sleep disturbances (PDSS-2) with rotigotine transdermal system. Improvements were also reported on a Likert pain scale (measuring any type of pain). This post hoc analysis of RECOVER further evaluates the effect of rotigotine on pain, and whether improvements in pain may be attributable to benefits in motor function or sleep disturbance. Methods: PD patients with unsatisfactory early-morning motor impairment were randomized to optimal-dose (up to 16 mg/24 h) rotigotine or placebo, maintained for 4 weeks. Pain was assessed in the early-morning using an 11-point Likert pain scale (rated average severity of pain (of any type) over the preceding 12 hours from 0 [no pain] to 10 [worst pain ever experienced]). Post hoc analyses for patients reporting 'any' pain (pain score = 1) at baseline, and subgroups reporting 'mild' (score 1-3), and 'moderate-to-severe' pain (score = 4) were performed. Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS-2 responder analysis (a responder defined as showing a = 30% reduction in early morning UPDRS III total score or PDSS-2 total score). As post hoc analyses, all p values presented are exploratory. Results: Of 267 patients with Likert pain data (178 rotigotine, 89 placebo), 187 (70%) reported 'any' pain; of these 87 (33%) reported 'mild', and 100 (37%) 'moderate-to-severe' pain. Change from baseline pain scores decreased with rotigotine compared with placebo in patients with 'any' pain (-0.88 [95% CI: -1.56, -0.19], p = 0.013), and in the subgroup with 'moderate-to-severe' pain (-1.38 [-2.44, -0.31], p = 0.012). UPDRS III or PDSS-2 responders showed greater improvement in pain than non-responders. Conclusions: The results from this post hoc analysis of the RECOVER study suggest that pain was improved in patients with PD treated with rotigotine; this may be partly attributable to benefits in motor function and sleep disturbances. Prospective studies are warranted to investigate this potential benefit and the clinical relevance of these findings."],["dc.description.sponsorship","UCB Pharma, Brussels, Belgium"],["dc.identifier.doi","10.1186/1471-2377-14-42"],["dc.identifier.fs","611732"],["dc.identifier.isi","000332639900002"],["dc.identifier.pmid","24602411"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/11924"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/34008"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","Biomed Central Ltd"],["dc.relation.issn","1471-2377"],["dc.rights.access","openAccess"],["dc.subject.mesh","Administration, Cutaneous"],["dc.subject.mesh","Adult"],["dc.subject.mesh","Aged"],["dc.subject.mesh","Aged, 80 and over"],["dc.subject.mesh","Dopamine Agonists"],["dc.subject.mesh","Female"],["dc.subject.mesh","Humans"],["dc.subject.mesh","Male"],["dc.subject.mesh","Middle Aged"],["dc.subject.mesh","Pain"],["dc.subject.mesh","Pain Measurement"],["dc.subject.mesh","Parkinson Disease"],["dc.subject.mesh","Prospective Studies"],["dc.subject.mesh","Tetrahydronaphthalenes"],["dc.subject.mesh","Thiophenes"],["dc.title","Rotigotine transdermal system and evaluation of pain in patients with Parkinson's disease: a post hoc analysis of the RECOVER study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","140"],["dc.bibliographiccitation.issue","3-4"],["dc.bibliographiccitation.journal","European Neurology"],["dc.bibliographiccitation.lastpage","147"],["dc.bibliographiccitation.volume","71"],["dc.contributor.author","Swick, Todd J."],["dc.contributor.author","Friedman, Joseph H."],["dc.contributor.author","Chaudhuri, Kallol Ray"],["dc.contributor.author","Surmann, Erwin"],["dc.contributor.author","Boroojerdi, Babak"],["dc.contributor.author","Moran, Kimberly"],["dc.contributor.author","Ghys, Liesbet"],["dc.contributor.author","Trenkwalder, Claudia"],["dc.date.accessioned","2018-11-07T09:46:20Z"],["dc.date.available","2018-11-07T09:46:20Z"],["dc.date.issued","2014"],["dc.description.abstract","Background: RECOVER (NCT00474058), a double-blind, placebo-controlled trial in patients with Parkinson's disease (PD) and unsatisfactory early-morning motor symptom control, demonstrated significant improvements with rotigotine in early-morning motor function (Unified Parkinson's Disease Rating Scale [UPDRS] III), and nocturnal sleep disturbances (modified Parkinson's Disease Sleep Scale [PDSS-2]), and improvements in nonmotor symptoms (NMS; Non-Motor Symptom Scale [NMSS]). Methods: Post hoc analyses investigated the correlation between motor symptom and NMS severity in PD by evaluating associations between UPDRS Ill and both NMSS and PDSS-2 scores. Categories were defined for UPDRS Ill, NMSS, and PDSS-2 total scores; analyses were conducted for the full analysis set (n = 267). Results: There was a trend toward increasing PDSS-2 and NMSS total and domain scores with increasing UPDRS Ill category at baseline and end of maintenance (EoM). Pearson correlation coefficients between UPDRS III and both NMSS and PDSS-2 total and domain scores were r=0.12-0.44 (r(2)=0.01-0.19) at baseline, r = 0.05-0.38 (r(2) = 0.00-0.14) at EoM, and r = -0.02-0.36 (r(2) = 0.00-0.13) for change from baseline to EoM. Conclusion: There was only a small correlation between severity of early-morning motor symptoms and overall burden of NMS and nocturnal sleep disturbances in RECOVER, suggesting that motor symptoms and NMS originate, at least partly, from distinct pathophysiological pathways. (C) 2014 S. Karger AG, Basel"],["dc.description.sponsorship","UCB Pharma, Smyrna, Ga., USA"],["dc.identifier.doi","10.1159/000355019"],["dc.identifier.isi","000333866400007"],["dc.identifier.pmid","24457253"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/34848"],["dc.language.iso","en"],["dc.notes.intern","DeepGreen Import"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","S. Karger AG"],["dc.relation.eissn","1421-9913"],["dc.relation.issn","1421-9913"],["dc.relation.issn","0014-3022"],["dc.rights","https://www.karger.com/Services/SiteLicenses"],["dc.title","Associations between Severity of Motor Function and Nonmotor Symptoms in Parkinson's Disease: A Post Hoc Analysis of the RECOVER Study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","1785"],["dc.bibliographiccitation.issue","19"],["dc.bibliographiccitation.journal","Neurology"],["dc.bibliographiccitation.lastpage","1793"],["dc.bibliographiccitation.volume","86"],["dc.contributor.author","Bauer, Axel"],["dc.contributor.author","Cassel, Werner"],["dc.contributor.author","Benes, Heike"],["dc.contributor.author","Kesper, Karl"],["dc.contributor.author","Rye, David"],["dc.contributor.author","Sica, Domenic"],["dc.contributor.author","Winkelman, John W."],["dc.contributor.author","Bauer, Lars"],["dc.contributor.author","Grieger, Frank"],["dc.contributor.author","Joeres, Lars"],["dc.contributor.author","Moran, Kimberly"],["dc.contributor.author","Schollmayer, Erwin"],["dc.contributor.author","Whitesides, John"],["dc.contributor.author","Carney, Hannah C."],["dc.contributor.author","Walters, Arthur S."],["dc.contributor.author","Oertel, Wolfgang"],["dc.contributor.author","Trenkwalder, Claudia"],["dc.date.accessioned","2018-11-07T10:14:18Z"],["dc.date.available","2018-11-07T10:14:18Z"],["dc.date.issued","2016"],["dc.description.abstract","Objective: This double-blind, placebo-controlled, interventional trial was conducted to investigate the effects of rotigotine patch on periodic limb movement (PLM)-associated nocturnal systolic blood pressure (SBP) elevations. Methods: Patients with moderate to severe restless legs syndrome (RLS) were randomized to rotigotine (optimal dose [1-3 mg/24 h]) or placebo. Continuous beat-to-beat blood pressure (BP) assessments were performed during polysomnography at baseline and at the end of 4-week maintenance. Primary outcome was change in number of PLM-associated SBP elevations (defined as slope of linear regression >= 2.5 mm Hg/beat-to-beat interval over 5 consecutive heartbeats [>= 10 mm Hg]). Additional outcomes were total SBP elevations, PLM-associated and total diastolic BP (DBP) elevations, periodic limb movements index (PLMI), and PLM in sleep arousal index (PLMSAI). Results: Of 81 randomized patients, 66 (37 rotigotine, 29 placebo) were included in efficacy assessments. PLM-associated SBP elevations were significantly reduced with rotigotine vs placebo (least squares mean treatment difference [95% confidence interval (CI)] -160.34 [-213.23 to -107.45]; p < 0.0001). Rotigotine-treated patients also had greater reduction vs placebo in total SBP elevations (-161.13 [-264.47 to -57.79]; p = 0.0028), PLM-associated elevations (-88.45 [-126.12 to -50.78]; p < 0.0001), and total DBP elevations (-93.81 [-168.45 to -19.16]; p = 0.0146), PLMI (-32.77 [-44.73 to -20.80]; p < 0.0001), and PLMSAI (-7.10 [-11.93 to -2.26]; p = 0.0047). Adverse events included nausea (rotigotine 23%; placebo 8%), headache (18% each), nasopharyngitis (18%; 8%), and fatigue (13%; 15%). Conclusions: Further investigation is required to determine whether reductions in nocturnal BP elevations observed with rotigotine might modify cardiovascular risk. Classification of evidence: This study provides Class I evidence that for patients with moderate to severe RLS, rotigotine at optimal dose (1-3 mg/24 h) reduced PLM-associated nocturnal SBP elevations."],["dc.description.sponsorship","UCB, Monheim am Rhein, Germany"],["dc.identifier.isi","000382000000010"],["dc.identifier.pmid","27164714"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/40596"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","Lippincott Williams & Wilkins"],["dc.relation.issn","1526-632X"],["dc.relation.issn","0028-3878"],["dc.title","Rotigotine's effect on PLM-associated blood pressure elevations in restless legs syndrome An RCT"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dspace.entity.type","Publication"]]