Back to Search
Start Over
Safety and tolerability of rivastigmine capsule with memantine in patients with probable Alzheimer's disease: a 26-week, open-label, prospective trial (Study ENA713B US32)
- Source :
- International journal of geriatric psychiatry. 25(4)
- Publication Year :
- 2009
-
Abstract
- Objective Rivastigmine, a dual cholinesterase inhibitor (ChEI), is widely approved for the symptomatic treatment of both mild-to-moderate Alzheimer's disease (AD) and Parkinson's disease dementia. Orally administered ChEIs may be associated with gastrointestinal (GI) side effects and add-on therapy with memantine, an N-methyl-d-aspartate receptor antagonist, approved for moderate-to-severe AD, may ameliorate such side effects. This was a 26-week, prospective, multicenter, single-arm, open-label pilot study to assess the safety and tolerability of rivastigmine capsules plus memantine in patients with moderate AD. Methods The primary objective was to assess the safety and tolerability of rivastigmine capsules 6–12 mg/day plus memantine (5–20 mg/day) as measured by the incidences of vomiting and nausea compared with those reported in the rivastigmine United States Prescribing Information (US PI). A total of 117 patients were enrolled with 116 receiving at least one dose of study medication. Results The incidences of nausea and vomiting (30% and 13%, respectively) observed in patients who received 6–12 mg/day rivastigmine plus memantine were lower than those stated in the US PI for rivastigmine monotherapy 6–12 mg/day (47% and 31%, respectively). The most common adverse events were nausea, vomiting, and dizziness. Conclusion Results from this study suggest the combination of rivastigmine capsule and memantine in patients with moderate AD is safe and tolerable. A greater reduction in the GI tolerability of rivastigmine has been established with rivastigmine transdermal patch. Copyright © 2009 John Wiley & Sons, Ltd.
- Subjects :
- Male
medicine.medical_specialty
Nausea
Transdermal patch
Vomiting
Phenylcarbamates
Administration, Oral
Blood Pressure
Capsules
Pilot Projects
Rivastigmine
Dizziness
Antiparkinson Agents
Cognition
Alzheimer Disease
Memantine
Internal medicine
Activities of Daily Living
medicine
Humans
Prospective Studies
Adverse effect
Aged
Aged, 80 and over
business.industry
Incidence
Middle Aged
Clinical trial
Psychiatry and Mental health
Tolerability
Anesthesia
Drug Therapy, Combination
Female
Cholinesterase Inhibitors
Geriatrics and Gerontology
medicine.symptom
business
Excitatory Amino Acid Antagonists
medicine.drug
Subjects
Details
- ISSN :
- 10991166
- Volume :
- 25
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- International journal of geriatric psychiatry
- Accession number :
- edsair.doi.dedup.....1f28b105d4becc47902a847e1383a0f2