Effects of body weight on tolerability of rivastigmine transdermal patch: a post-hoc analysis of a double-blind trial in patients with Alzheimer disease.
The rationale for the development of the rivastigmine transdermal patch was to improve upon an efficacious therapy by mitigating certain adverse events, such as nausea and vomiting. This may be particularly important in Alzheimer disease patients with low body weights, who may be more susceptible to these adverse events. This analysis compared the effect of body weight on tolerability in Alzheimer disease patients receiving rivastigmine capsules or rivastigmine patch. Using data from a 24-week trial, adverse events and discontinuations were evaluated in patients stratified on the basis of extreme low weight (<50 kg), medium weight (50 to 80 kg), and high weight (>80 kg) at baseline. Rivastigmine patch was generally well tolerated, regardless of patient body weight. Among patients receiving rivastigmine patch, lower body weight, as stratified, was not associated with a higher adverse event rate; however, there was an association between a higher adverse event rate and low body weight among patients receiving rivastigmine capsules. Discontinuations because of adverse events were not directly related to weight. A lower incidence of adverse events was apparent with transdermal delivery of rivastigmine compared with oral administration.
Lee
Jae-Hong
JH
Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. jhlee@amc.seoul.kr
Sevigny
Jeff
J
D000284:Administration, Oral; D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D001835:Body Weight; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D018696:Neuroprotective Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D048448:Phenylcarbamates / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D000068836:Rivastigmine; D057968:Transdermal Patch
D018696:Neuroprotective Agents; D048448:Phenylcarbamates; D000068836:Rivastigmine