Caregiver treatment preference/satisfaction and efficacy among patients in the OPtimising Transdermal Exelon In Mild-to-moderate Alzheimer’s disease (OPTIMA) study (P7.104)

2015 
OBJECTIVE: Assess whether caregiver preference for rivastigmine transdermal patch and treatment satisfaction predict efficacy in patients with mild-to-moderate Alzheimer’s disease (AD) who previously received oral cholinesterase inhibitor treatment. BACKGROUND: Caregivers of patients with AD are often responsible for medication administration and management. Treatment preference/satisfaction could ease associated stress, which may favorably impact patient outcomes. DESIGN/METHODS: Patients meeting pre-specified decline criteria during a 24-48-week initial open-label phase (IOL) with 9.5mg/24 h patch entered a 48-week, randomized, double-blind phase (13.3 versus 9.5mg/24 h patch). Co-primary outcomes were change from double-blind baseline to Week 48 on the Instrumental domain of the AD Cooperative Study-Activities of Daily Living (ADCS-IADL) scale and the AD Assessment Scale-cognitive subscale (ADAS-cog). Caregivers of patients previously taking pills completed the Caregiver Medication Questionnaire at the beginning and end of the IOL, focused on medication administration, perceived compliance/satisfaction, and at the end of the IOL only, treatment preference (pills or patch). Primary efficacy variables were analyzed based on caregiver treatment preference. RESULTS: Of 882 caregivers of patients on prior AD treatment, 642 (72.8[percnt]; 95[percnt]CI: 69.7, 75.7) preferred patch; 77.2[percnt] (285/369) preferred patch among randomized patients. Patients of caregivers who preferred patch experienced significantly less cognitive decline on ADAS-cog at Week 24 in the 13.3 versus 9.5mg/24 h patch group (p=0.009); no significant difference was observed in patients of caregivers who preferred pills (p=0.541). Similarly, reduced functional decline on the ADCS-IADL in the 13.3 versus 9.5mg/24 h patch group was more evident at Weeks 24, 32 and 48 in patients of caregivers who preferred patch versus pills (p=0.044, 0.032 and 0.037 versus 0.783, 0.345 and 0.298, respectively). CONCLUSIONS: Caregiver treatment preference/satisfaction is associated with positive functional and cognitive outcomes in mild-to-moderate AD; this highlights the importance of easy-to-use therapies that aid effective AD management. Study Supported by: Novartis Pharmaceuticals Corporation Disclosure: Dr. Ferris has received personal compensation for activities with Accera, Inc., Baxter, Bristol-Myers Squibb, Cebria, Dart Neuroscience, Eisai Inc., Janssen Pharmaceuticals, Inc., Eli Lilly & Company, Forest Industries, Lundbeck Research USA, Inc., Lupin Dr. Meng has received personal compensation for activities with Novartis as an employee. Dr. Velting has received personal compensation for activities with Novartis as an employee.
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