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Long-term safety of rivastigmine in parkinson disease dementia: an open-label, randomized study


Emre, Murat, Poewe, Werner, De Deyn, Peter Paul, Barone, Paolo, Kulisevsky, Jaime, Pourcher, Emmanuelle, van Laar, Teus, Storch, Alexander, Micheli, Federico, Burn, David, Durif, Frank, Pahwa, Rajesh, Callegari, Francesca, Tenenbaum, Nadia, Strohmaier, Christine


Clinical Neuropharmacology, Volume: 37, No.: 1, Pages.: 9-16

Year of Publication



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.;

Bibtex Citation

@article{Emre_2014, doi = {10.1097/wnf.0000000000000010}, url = {}, year = 2014, month = {jan}, publisher = {Ovid Technologies (Wolters Kluwer Health)}, pages = {1}, author = {Murat Emre and Werner Poewe and Peter Paul De Deyn and Paolo Barone and Jaime Kulisevsky and Emmanuelle Pourcher and Teus van Laar and Alexander Storch and Federico Micheli and David Burn and Frank Durif and Rajesh Pahwa and Francesca Callegari and Nadia Tenenbaum and Christine Strohmaier}, title = {Long-term Safety of Rivastigmine in Parkinson Disease Dementia}, journal = {Clinical Neuropharmacology} }


adverse, aged, aged, 80 and over, analysis of variance, complications, dementia, drug carriers, drug delivery systems, drug therapy, etiology, events, female, humans, international cooperation, longitudinal studies, male, middle aged, neuroprotective agents, outcome assessment (health care), parkinson disease, patient compliance, phenylcarbamates, psychology, quality of life, rivastigmine, therapeutic use, time factors, transdermal patch, treatment outcome

Countries of Study

Argentina, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, Turkey, UK, USA

Types of Dementia

Parkinson’s Dementia

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Behaviour, Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime