PMID- 24434526
OWN - NLM
STAT- MEDLINE
DCOM- 20140911
LR  - 20191210
IS  - 1537-162X (Electronic)
IS  - 0362-5664 (Linking)
VI  - 37
IP  - 1
DP  - 2014 Jan-Feb
TI  - Long-term safety of rivastigmine in parkinson disease dementia: an open-label, 
      randomized study.
PG  - 9-16
LID - 10.1097/WNF.0000000000000010 [doi]
AB  - OBJECTIVE: This study investigated the long-term safety of rivastigmine (12 mg/d 
      capsules, 9.5 mg/24 h patch) and effects on motor symptoms in patients with 
      mild-to-moderately severe Parkinson disease dementia. METHODS: This was a 
      76-week, prospective, open-label, randomized study in patients aged 50 to 85 
      years. Primary outcomes included incidence of, and discontinuation due to, 
      predefined adverse events (AEs) potentially arising from worsening of Parkinson 
      disease motor symptoms with capsules. Secondary outcomes included frequency of 
      AEs/serious AEs. Efficacy outcomes included Alzheimer's Disease Cooperative 
      Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI-10), 
      and Mattis Dementia Rating Scale (MDRS). RESULTS: Five hundred eighty-three 
      patients were randomized to rivastigmine capsules (n = 295) or patch (n = 288). 
      Incidence of predefined AEs was 36.1% for capsules, 31.9% for patch; 
      discontinuation due to worsening of motor symptoms was 4.4% and 2.4%, 
      respectively. Most common AEs were nausea (capsules, 40.5%; patch, 8.3%), tremor 
      (24.5%; 9.7%), fall (17.0%; 20.1%), vomiting (15.3%; 2.8%), and application site 
      erythema (0%; 13.9%). Significant efficacy in favor of capsules was observed at 
      weeks 24 to 76 on MDRS; 24 and 76 on NPI-10; weeks 52 and 76 on ADCS-ADL. In 
      patients with Mini-Mental State Examination (MMSE) greater than 21, no 
      differences in efficacy on MDRS and ADCS-ADL were observed at any time point; 
      significant differences in favor of capsules were maintained in patients with 
      MMSE less than or equal to 21. CONCLUSIONS: This study supports the long-term 
      safety of rivastigmine in Parkinson disease dementia. The rate of worsening of 
      motor symptoms was in the range expected due to the natural progression of 
      Parkinson disease, no new or unexpected safety issues emerged in the long-term.
FAU - Emre, Murat
AU  - Emre M
AD  - *Department of Neurology, Behavioural Neurology and Movement Disorders Unit, 
      Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey; daggerDepartment 
      of Neurology, Medical University Innsbruck, Innsbruck, Austria; double daggerMiddelheim 
      Hospital, Institute Born-Bunge, University of Antwerp, Antwerp, Belgium; 
       section signDepartment of Neurology, University Medical Center Groningen, University of 
      Groningen, Groningen, Netherlands;  vertical lineNeurodegenerative Diseases Centre, Department 
      of Medicine, University of Salerno, Italy;  paragraph signDepartment of Neurology, Movement 
      Disorders Unit, Hospital de Sant Pau (IIB-Sant Pau) and CIBERNED, Universitat 
      Autonoma de Barcelona, Barcelona, Spain; #Quebec Memory and Motor Skills 
      Disorders Research Center, Clinique Sainte Anne, Quebec, Canada; **Division of 
      Neurodegenerative Diseases, Department of Neurology, Dresden University of 
      Technology, Dresden, Germany; daggerdaggerDepartment of Neurology, Hospital de Clinicas, 
      University of Buenos Aires, Argentina; double daggerdouble daggerInstitute for Ageing and Health, 
      Newcastle University, Newcastle upon Tyne, United Kingdom;  section sign section signService De 
      Neurologie CHU, Clermont-Ferrand, France;  vertical line vertical lineParkinson's Disease and Movement 
      Disorder Center, University of Kansas Medical Center, Kansas City, KS;  paragraph sign paragraph signNovartis 
      Pharma AG, Basel, Switzerland; and ##Novartis Pharmaceuticals Corporation, East 
      Hanover, NJ.
FAU - Poewe, Werner
AU  - Poewe W
FAU - De Deyn, Peter Paul
AU  - De Deyn PP
FAU - Barone, Paolo
AU  - Barone P
FAU - Kulisevsky, Jaime
AU  - Kulisevsky J
FAU - Pourcher, Emmanuelle
AU  - Pourcher E
FAU - van Laar, Teus
AU  - van Laar T
FAU - Storch, Alexander
AU  - Storch A
FAU - Micheli, Federico
AU  - Micheli F
FAU - Burn, David
AU  - Burn D
FAU - Durif, Frank
AU  - Durif F
FAU - Pahwa, Rajesh
AU  - Pahwa R
FAU - Callegari, Francesca
AU  - Callegari F
FAU - Tenenbaum, Nadia
AU  - Tenenbaum N
FAU - Strohmaier, Christine
AU  - Strohmaier C
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Neuropharmacol
JT  - Clinical neuropharmacology
JID - 7607910
RN  - 0 (Drug Carriers)
RN  - 0 (Neuroprotective Agents)
RN  - 0 (Phenylcarbamates)
RN  - PKI06M3IW0 (Rivastigmine)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Analysis of Variance
MH  - Dementia/*drug therapy/etiology
MH  - Drug Carriers
MH  - Drug Delivery Systems
MH  - Female
MH  - Humans
MH  - International Cooperation
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Neuroprotective Agents/*therapeutic use
MH  - Outcome Assessment, Health Care
MH  - Parkinson Disease/complications/*drug therapy/psychology
MH  - Patient Compliance
MH  - Phenylcarbamates/*therapeutic use
MH  - Quality of Life
MH  - Rivastigmine
MH  - Time Factors
MH  - Transdermal Patch
MH  - Treatment Outcome
EDAT- 2014/01/18 06:00
MHDA- 2014/09/12 06:00
CRDT- 2014/01/18 06:00
PHST- 2014/01/18 06:00 [entrez]
PHST- 2014/01/18 06:00 [pubmed]
PHST- 2014/09/12 06:00 [medline]
AID - 00002826-201401000-00003 [pii]
AID - 10.1097/WNF.0000000000000010 [doi]
PST - ppublish
SO  - Clin Neuropharmacol. 2014 Jan-Feb;37(1):9-16. doi: 10.1097/WNF.0000000000000010.