PMID- 25437301 OWN - NLM STAT- MEDLINE DCOM- 20160208 LR - 20150519 IS - 1546-4156 (Electronic) IS - 0893-0341 (Linking) VI - 29 IP - 2 DP - 2015 Apr-Jun TI - 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. PG - 110-6 LID - 10.1097/WAD.0000000000000073 [doi] AB - 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. FAU - Farlow, Martin R AU - Farlow MR AD - *Department of Neurology, Indiana University School of Medicine, Indianapolis, IN daggerDepartment of Neurology and Psychiatry, St Louis University School of Medicine, St Louis, MO double daggerDivision of Neurology, Nova Southeastern University, Fort Lauderdale, FL section signNovartis Pharmaceuticals Corporation, East Hanover, NJ. FAU - Grossberg, George T AU - Grossberg GT FAU - Sadowsky, Carl H AU - Sadowsky CH FAU - Meng, Xiangyi AU - Meng X FAU - Velting, Drew M AU - Velting DM LA - eng PT - Clinical Study PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - Alzheimer Dis Assoc Disord JT - Alzheimer disease and associated disorders JID - 8704771 RN - 0 (Cholinesterase Inhibitors) RN - PKI06M3IW0 (Rivastigmine) SB - IM MH - Accidental Falls MH - Activities of Daily Living MH - Aged MH - Aged, 80 and over MH - Alzheimer Disease/*drug therapy MH - Cholinesterase Inhibitors/*administration & dosage/therapeutic use MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Longitudinal Studies MH - Male MH - Neuropsychological Tests MH - Prospective Studies MH - Rivastigmine/*administration & dosage/therapeutic use MH - Severity of Illness Index MH - Transdermal Patch MH - Treatment Outcome MH - Urinary Tract Infections/chemically induced MH - Weight Loss EDAT- 2014/12/02 06:00 MHDA- 2016/02/09 06:00 CRDT- 2014/12/02 06:00 PHST- 2014/12/02 06:00 [entrez] PHST- 2014/12/02 06:00 [pubmed] PHST- 2016/02/09 06:00 [medline] AID - 10.1097/WAD.0000000000000073 [doi] PST - ppublish SO - Alzheimer Dis Assoc Disord. 2015 Apr-Jun;29(2):110-6. doi: 10.1097/WAD.0000000000000073.