Wirksamkeit und Sicherheit von Rivastigmin bei Patienten mit Demenz unter Praxisbedingungen

ZusammenfassungDas Ziel dieser offenen, prospektiven Beobachtungsstudie war es, den klinischen Verlauf von Patienten mit Demenz unter der Therapie mit Rivastigmin, einem Azetylcholinund Butyrylcholinesterasehemmstoff, unter Praxisbedingungen zu untersuchen.867 Ärzte in Arztpraxen, Ambulanzen und Memory-Kliniken rekrutierten 1 214 Demenzpatienten, von denen 75% leicht bis mittelgradig (Mini-Mental-State-Test ≥ 10) und 25% schwergradig ausgeprägte Symptome aufwiesen. Die Patienten erhielten Rivastigminlösung peroral in einer durchschnittlichen Tagesdosierung von 6,7 mg über4 Monate.Unter Rivastigmin besserten sich die Patienten in allen untersuchten Symptombereichen (Gedächtnis-, Sprach-, Orientierungs-, Verhaltensund Alltagskompentenzstörungen) signifikant (p &lt; 0,05). Bei Patienten mit schwergradiger Demenz war der therapeutische Effekt von Rivastigmin am stärksten ausgeprägt. Die Verträglichkeit von Rivastigmin wurde von 93,2% der behandelnden Ärzte als gut oder sehr gut beurteilt.Rivastigmin zeigte bei Patienten mit leicht bis schwergradiger Demenz unter Praxisbedingungen eine klinisch relevante Wirksamkeit und gute Verträglichkeit.</jats:p

Effectiveness and tolerability of transdermal rivastigmine in the treatment of Alzheimer&amp;rsquo;s disease in daily practice

Johannes Seibert1, Ferenc Tracik2,3, Konstantin Articus2, Stefan Spittler41Outpatient Clinic, Heidelberg, Germany; 2Novartis Pharma, N&amp;uuml;rnberg, Germany; 3Department of Neurology, Heinrich-Heine University, D&amp;uuml;sseldorf, Germany; 4Alexianer Krefeld, Maria Hilf Clinic, Krefeld, GermanyBackground: Oral cholinesterase inhibitors at doses efficacious for the treatment of Alzheimer&amp;rsquo;s disease (AD) are often prematurely discontinued due to gastrointestinal side effects. In controlled clinical trials, transdermal rivastigmine demonstrated less such effects at similar efficacy. The current study aimed to verify the validity of this data in daily practice.Methods: This was a prospective, multicenter, observational study on transdermal rivastigmine in Germany. Eligible patients were those with AD who had not yet been treated with rivastigmine. Outcome measures were changes in clock-drawing test, Mini-Mental State Examination (MMSE), Caregiver Burden Scale, Clinical Global Impression (CGI), physicians&amp;rsquo; assessments of tolerability, and the incidence of adverse events (AEs) over 4 months of treatment.Results: In 257 centers 1113 patients were enrolled; 614 women and 499 men, mean age 76.5 years. In 58% of patients AD was treated for the first time and in 42% therapy was switched to transdermal rivastigmine, mostly due to lack of tolerability (13.6%) or effectiveness (26.9%). After 4 months, 67.4% of patients were on the target dose of 9.5 mg/day and 21.8% were still on 4.6 mg/day. MMSE significantly improved in patients with and without pretreatment (&amp;Delta;MMSE, 0.9 &amp;plusmn; 3.4 and 0.8 &amp;plusmn; 3.4, respectively, both P &amp;lt; 0.001); the CGI score improved in 60.9% and 61.3% of patients, respectively. Overall 11.7% of patients had AEs, mainly affecting the skin or the gastrointestinal tract; in 1.1% of cases AEs were serious; 14.7% of patients discontinued therapy, 6.0% due to AEs. With rivastigmine treatment the percentage of patients taking psychotropic comedication decreased, particularly in first-time treated rivastigmine patients (from 27.1% to 22.6%; P &amp;lt; 0.001).Conclusion: Results were in line with data from controlled clinical trials. Switching from any other oral acetylcholinesterase inhibitor to transdermal rivastigmine may improve cognition.Keywords: rivastigmine patch, Alzheimer&amp;rsquo;s disease, treatment practic

Physiol. Behav.

Introduction: According to its guidelines, the Multiple Sleep Latency Test (MSLT) should be performed following an all-night polysomnography (PSG). However, the sleep quality and consequently the MSLT results may be affected by PSG and by the fact that a subject sleeps under unfamiliar conditions. The aim of this study was to examine whether PSG performed in a sleep laboratory has any influence on the MSLT and other measures of daytime sleepiness. Methods: Twenty healthy subjects with a mean age of 35.9 +/- 10.1 years underwent two MSLT examinations, and the 2 examination days were at least 4 weeks apart. In addition, on each occasion a monotonous vigilance task (VT) was performed and the subjects were asked to fill out the Epworth Sleepiness (ESS) and Visual Analogue Scales (VAS). In a cross-over design, a group of 10 subjects underwent a MSLT (MSLT-P) following a PSG and, on a second occasion, a MSLT (MSLT-N) was performed without a prior PSG. Vice versa, a second group of 10 subjects underwent first MSLT-N and then MSLT-P. Results: None of the MSLT parameters differed significantly between MSLT-P and MSLT-N. The other measures of daytime sleepiness (VT, ESS, VAS) also showed no evidence of significant differences between days with and without a prior PSG. Conclusions: The results of MSLT and other measures of daytime sleepiness in healthy subjects are not influenced by the fact whether or not the subjects had a PSG the night prior to MSLT. (C) 2002 Elsevier Science Inc. All rights reserv