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| |  High-Dose Donepezil Tablets Offer Improvement in Patients With Moderate to Severe Alzheimer's: Presented at ICAD By Nancy A. Melville HONOLULU -- July 15, 2010 -- High-dose, extended-release donepezil tablets provide improved cognitive benefits to patients with Alzheimer's disease who are already on Alzheimer's treatment, offering the greatest improvements to patients with more advanced levels of the disease, according to a study presented here at the Alzheimer's Association's International Conference on Alzheimer's Disease 2010 (ICAD). Compared with once-daily donepezil 10 mg immediate-release tablets, a 23-mg extended-release formulation is designed to delay time to maximum plasma concentration and blunt Cmax. The study of 1,467 patients with moderate to severe Alzheimer's disease who had already been treated for 3 or more months with donepezil 10 mg, demonstrated significant cognitive and global function improvements with donepezil 23 mg, compared with patients who continued to receive 10 mg. For the study, patients were randomised in a 2:1 ratio to receive donepezil 23 or 10 mg, with the primary endpoints including the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change plus caregiver input (CIBIC+). "The objective was to determine the efficacy and safety of donepezil 23 mg/day compared with 10 mg/day in patients with moderate to severe Alzheimer's disease who had been taking donepezil 10 mg/day for at least 3 months prior to screening for the study," explained lead author Martin R. Farlow, MD, Indiana Alzheimer Disease Center, Indiana University School of Medicine, Indianapolis, Indiana, on July 7. "Donepezil once-daily 23-mg tablets are currently under evaluation by the US Food and Drug Administration for the treatment of patients with moderate to severe Alzheimer's disease," he said. After 24 weeks of treatment, patients in the 23-mg group in the intent-to-treat population last observation carried forward showed a least squares mean change from baseline of 2.6 +- 0.58, compared with 0.4 +- 0.66 for the 10-mg group, for a difference of 2.2 (P = .0001). Similar results were seen in the observed case group, with improved scores at week 24 in the overall population for CIBIC+ for 23 mg (4.23 +- 1.07), compared with 10 mg (4.29 +- 1.07 (P = .1789). Patients in the 23-mg group with less severe cases of Alzheimer's disease (Mini-Mental State Examination score 0-16) also showed significant benefits on both endpoints (SIB, P < .0001; CIBIC+, P < .03). Overall, donepezil 23 mg was well tolerated. Cholinergic-related adverse events were more common in the 23-mg group, but did not give rise to any new safety signals. Among adverse events occurring among 5% or more patients were nausea, vomiting, diarrhoea, and anorexia. In the 23-mg group, 18.6% of patients discontinued due to adverse events, compared with 7.9% in the 10-mg group, with the majority of discontinuations in the 23-mg group occurring in the first month of exposure. Funding for this study was provided by Eisai Inc. [Presentation title: Donepezil High-Dose Extended-Release Tablets Provide Greater Benefit to Moderate-to-Severe AD Patients Already Treated With Donepezil Immediate Release. Abstract O4-01-08]
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