Document Detail

Safety and tolerability of rivastigmine transdermal patch compared with rivastigmine capsules in patients switched from donepezil: data from three clinical trials.
MedLine Citation:
PMID:  20089009     Owner:  NLM     Status:  In-Process    
OBJECTIVES: To compare the safety and tolerability of switching patients with mild-to-moderate Alzheimer's disease from donepezil to either rivastigmine capsule or transdermal patch.
METHODS: Three studies investigated the switch from donepezil to rivastigmine; study US13 was a 26-week, single-arm, immediate-switch study; US18 was a 26-week, sequential cohort study (both studies evaluated rivastigmine capsules 3-12 mg/day); study US38 was a 25-week, randomised, parallel-group, open-label study which investigated switch (immediate or after 7 days' withdrawal) from donepezil to rivastigmine transdermal patch (4.6 mg/24 hr). Safety outcomes included adverse events (AEs), discontinuations caused by AEs and serious AEs (SAEs).
RESULTS: Patient groups receiving rivastigmine patch (n = 261) or capsules (n = 331) had mean +/- SD ages of 77.3 +/- 8.0 and 78.1 +/- 7.8 years, dementia durations of 3.9 +/- 2.6 and 3.6 +/- 2.2 years and Mini-Mental State Examination scores of 18.3 +/- 4.00 and 17.9 +/- 4.4 respectively. Overall, 184 (70.5%) and 276 (83.4%) patients experienced at least one AE, and 23 (8.8%) and 55 (16.6%) patients experienced an SAE with the rivastigmine patch and capsules respectively. Of the patients who experienced an AE, 10 (3.8%) and 109 (32.9%) experienced nausea, and 11 (4.2%) and 80 (24.1%) experienced vomiting with the rivastigmine patch and capsules respectively. Discontinuations because of AEs occurred in 64 (19.3%) patients receiving capsules and 38 (14.6%) patients in the transdermal patch group. The most common reasons for discontinuation with the transdermal patch were application site reaction and disease progression, and nausea and vomiting with the capsules.
CONCLUSIONS: The rivastigmine transdermal patch appears to have better tolerability than rivastigmine capsules, with fewer gastrointestinal AEs and discontinuations because of these AEs. Simple daily rotation of patch location will likely reduce the frequency of skin reactions. This post hoc analysis was carried out by Novartis Pharmaceuticals Corporation. Data for the analysis were collected from the US13 study (CENA713B US13), the US18 study (CENA713B US18) and the US38 study (CENA713D US38).
C H Sadowsky; M R Farlow; X Meng; J T Olin
Related Documents :
12031749 - Prophylactic ondansetron is effective in the treatment of nausea and vomiting but not o...
9800929 - Uterine exteriorisation at caesarean section: influence on maternal morbidity.
23588029 - Ablation of paroxysmal and persistent atrial fibrillation with multielectrode phased ra...
8347909 - Ondansetron in the treatment of intractable nausea associated with theophylline toxicity.
17704869 - The effects of preoperative rofecoxib, metoclopramide, dexamethasone, and ondansetron o...
16885729 - Coblation versus unipolar electrocautery tonsillectomy: a prospective, randomized, sing...
8485269 - A randomized controlled study of evening primrose oil and fish oil in ulcerative colitis.
19588529 - Clinical evaluation of a single-wavelength fractional laser and a novel multi-wavelengt...
17576909 - Treatment of sudden sensorineural hearing loss: ii. a meta-analysis.
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  International journal of clinical practice     Volume:  64     ISSN:  1742-1241     ISO Abbreviation:  Int. J. Clin. Pract.     Publication Date:  2010 Jan 
Date Detail:
Created Date:  2010-01-21     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9712381     Medline TA:  Int J Clin Pract     Country:  England    
Other Details:
Languages:  eng     Pagination:  188-93     Citation Subset:  IM    
Nova SE University, Fort Lauderdale, FL, USA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Patent foramen ovale closure in post-CVA/TIA patients: psychological distress, quality of life and o...
Next Document:  Otosclerosis 2: the medical management of otosclerosis.