A 24-Week, Open-Label Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of 13.3 mg/24 h Rivastigmine Patch in Patients With Severe Alzheimer Disease.

Abstract

The long-term safety, tolerability, and efficacy of high-dose 13.3 mg/24 h rivastigmine patch in severe Alzheimer disease was evaluated in a 24-week, open-label extension to the double-blind ACTION study. Safety and tolerability, and efficacy on the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-Severe Impairment Version (ADCS-ADL-SIV), Severe Impairment Battery (SIB), and ADCS-Clinical Global Impression of Change (ADCS-CGIC) were assessed. Overall, 197 patients continued on 13.3 mg/24 h patch; 199 uptitrated from 4.6 mg/24 h to 13.3 mg/24 h patch. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar in patients who continued on, and patients who uptitrated to, 13.3 mg/24 h patch (AEs: 57.9% and 59.8%; serious AEs: 16.2% and 16.1%; discontinuations: 11.2% and 12.1%, respectively). Larger mean changes from double-blind baseline were observed in patients uptitrated on the ADCS-ADL-SIV (-4.6; SD=8.7) and SIB (-7.0; SD=16.6), than those who continued on 13.3 mg/24 h patch (-3.9; SD=8.0 and -4.7; SD=16.8, respectively). ADCS-CGIC scores were comparable. There were no clinically relevant between-group differences in safety and tolerability. Greater decline was observed in patients with delayed uptitration to high-dose 13.3 mg/24 h patch than patients who continued on high-dose patch.

• Authors: Martin R Farlow, George T Grossberg, Carl H Sadowsky, Xiangyi Meng, Drew M Velting
• Journal: Alzheimer disease and associated disorders (Alzheimer Dis Assoc Disord) 2015 Apr-Jun Vol. 29 Issue 2 Pg. 110-6 ISSN: 1546-4156 [Electronic] United States
• PMID: 25437301 (Publication Type: Clinical Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Cholinesterase Inhibitors
• Rivastigmine

Topics

• Accidental Falls
• Activities of Daily Living
• Aged
• Aged, 80 and over
• Alzheimer Disease (drug therapy)
• Cholinesterase Inhibitors (administration & dosage, therapeutic use)
• Dose-Response Relationship, Drug
• Female
• Humans
• Longitudinal Studies
• Male
• Neuropsychological Tests
• Prospective Studies
• Rivastigmine (administration & dosage, therapeutic use)
• Severity of Illness Index
• Transdermal Patch
• Treatment Outcome
• Urinary Tract Infections (chemically induced)
• Weight Loss