Skin Reactions At The Application Site Of Rivastigmine Patch (4.6 Mg/24 H, 9.5 Mg/24 H Or 13.3 Mg/24 H): A Qualitative Analysis Of Clinical Studies In Patients With Alzheimer'S Disease

Background and objectivesRivastigmine patch is approved for the treatment of all stages of Alzheimer's disease (AD). Application site reactions may be a concern to clinicians and we used two large clinical trial databases to investigate the incidence of skin reactions in patients receiving rivastigmine patch.MethodsData from a 24-week, randomised, double-blind (DB) evaluation of 13.3 vs. 4.6mg/24h rivastigmine patch in severe AD (ACTION) and a 72- to 96-week study comprising an initial open-label (IOL) phase followed by a 48-week randomised, DB phase (13.3 vs. 9.5mg/24h rivastigmine patch) in declining patients with mild-to-moderate AD (OPTIMA) were analyzed. The incidence, frequency, severity, management and predictors of application site reactions were assessed.ResultsApplication site reactions were mostly mild or moderate in severity and reported by similar proportions in each treatment group (ACTION: 13.3mg/24h, 24.5% and 4.6mg/24h, 24.2%; OPTIMA: IOL 9.5mg/24h, 22.9%; DB 13.3mg/24h, 11.4% and 9.5mg/24h, 12.0%); none were rated serious. In both studies, <9% of patients required treatment for application site reactions. Application site reactions led to discontinuation of 1.7% and 2.5% of the 13.3mg/24h and 4.6mg/24h groups, respectively, in ACTION, 8.7% in OPTIMA IOL and 1.8% and 3.5% of the 13.3mg/24h and 9.5mg/24h groups, respectively, in OPTIMA DB.ConclusionsApplication site reactions were experienced by <25% of patients in both studies, with no notable effect of dose. No reactions qualified as serious and skin reactions were uncommon as a reason for study discontinuation.