Long-term Safety of Rivastigmine in Parkinson Disease Dementia: An Open-Label, Randomized Study
Por:
Emre, M, Poewe, W, De Deyn, PP, Barone, P, Kulisevsky, J, Pourcher, E, van Laar, T, Storch, A, Micheli, F, Burn, D, Durif, F, Pahwa, R, Callegari, F, Tenenbaum, N, Strohmaier, C
Publicada:
1 ene 2014
Resumen:
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.
Filiaciones:
Emre, M:
Istanbul Univ, Dept Neurol, Behav Neurol & Movement Disorders Unit, Istanbul Fac Med, Istanbul, Turkey
Poewe, W:
Med Univ Innsbruck, Dept Neurol, A-6020 Innsbruck, Austria
De Deyn, PP:
Univ Antwerp, Middelheim Hosp, Inst Born Bunge, B-2020 Antwerp, Belgium
Univ Groningen, Univ Med Ctr Groningen, Dept Neurol, Groningen, Netherlands
Barone, P:
Univ Salerno, Neurodegenerat Dis Ctr, Dept Med, Salerno, Italy
Kulisevsky, J:
Univ Autonoma Barcelona, Dept Neurol, Movement Disorders Unit, Hosp St Pau IIB St Pau, E-08193 Barcelona, Spain
Univ Autonoma Barcelona, CIBERNED, E-08193 Barcelona, Spain
Pourcher, E:
Quebec Memory & Motor Skills Disorders Res Ctr, Clin St Anne, Quebec City, PQ, Canada
van Laar, T:
Univ Groningen, Univ Med Ctr Groningen, Dept Neurol, Groningen, Netherlands
Storch, A:
Tech Univ Dresden, Div Neurodegenerat Dis, Dept Neurol, Dresden, Germany
Micheli, F:
Univ Buenos Aires, Dept Neurol, Hosp Clin, RA-1053 Buenos Aires, DF, Argentina
Burn, D:
Newcastle Univ, Inst Ageing & Hlth, Newcastle Upon Tyne NE1 7RU, Tyne & Wear, England
Durif, F:
CHU, Serv Neurol, Clermont Ferrand, France
Pahwa, R:
Univ Kansas, Med Ctr, Parkinsons Dis & Movement Disorder Ctr, Kansas City, KS 66103 USA
Callegari, F:
Novartis Pharma AG, Basel, Switzerland
Tenenbaum, N:
Novartis Pharmaceut, E Hanover, NJ USA
Strohmaier, C:
Novartis Pharma AG, Basel, Switzerland
|