Switching from oral donepezil to rivastigmine transdermal patch in Alzheimer's disease: 20-week extension phase results.

OBJECTIVE: To evaluate the long-term safety, tolerability, and efficacy of 2 strategies for switching from donepezil to rivastigmine transdermal patches in patients with mild to moderate Alzheimer's disease. METHOD: This was a prospective, 25-week, randomized, open-label, parallel-group study to evaluate an immediate or delayed switch (7-day withdrawal) from donepezil (5 to 10 mg/d) to rivastigmine transdermal patches (4.6 mg/24 h). Participants included male and female patients, aged ≥ 50 years, with a DSM-IV-TR diagnosis of mild to moderate dementia of the Alzheimer's type, defined as a Mini-Mental State Examination score of 10-24, inclusive. Patients were enrolled between February 2007 and February 2008. The study was split into a 5-week core phase and a 20-week extension phase. Safety and efficacy results from the extension phase are presented. RESULTS: Both switching strategies were well tolerated. Rates of discontinuation for any reason were similar between the groups. Discontinuations due to adverse events were also similar, and the incidence of gastrointestinal adverse events was low. Apart from Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale scores, at the end of the study, there was no statistically significant change from baseline in cognitive, behavioral, or global outcomes. Over half of the patients preferred rivastigmine transdermal patches to a tablet. CONCLUSIONS: This study suggests that the majority of patients receiving donepezil tablets can be safely switched to rivastigmine transdermal patches without significant deterioration in cognition, behavior, and global functioning. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00305903.

Switching from donepezil tablets to rivastigmine transdermal patch in Alzheimer's disease.

OBJECTIVE: Evaluate safety and tolerability of switching from donepezil to rivastigmine transdermal patch in patients with mild to moderate Alzheimer's disease. METHODS: Prospective, parallel-group, open-label study to evaluate immediate or delayed switch from 5-10 mg/day donepezil to 4.6 mg/24 h rivastigmine following a 4-week treatment period. RESULTS: Rates of discontinuation due to any reason or adverse events were similar between groups. Incidences of gastrointestinal adverse events were 3.8% in the immediate and 0.8% in the delayed switch group. No patients discontinued secondary to nausea and vomiting. Discontinuations due to application site reactions were low (2.3%). Asymptomatic bradycardia was more common following the immediate switch (2.3% vs 0%); however, these patients had coexisting cardiac comorbidities. CONCLUSION: Both switch strategies were safe and well tolerated. The majority of patients may be able to switch directly to rivastigmine patches without a withdrawal period. Appropriate clinical judgment should be used for patients with existing bradycardia or receiving beta blockers.

The clinical efficacy and safety of galantamine in the treatment of Alzheimer's disease.

Alzheimer's disease is a progressive, neurodegenerative condition characterized by deficits in cognition, inability to perform activities of daily living, and alterations in behavior. Galantamine hydrobromide is the newest acetylcholinesterase inhibitor (AChEI) approved in the United States for the treatment of mild-to-moderate AD. The safety and efficacy of galantamine has been demonstrated in multiple randomized, Phase III trials of >2,600 patients with mild-to-moderate AD. Studies have found that galantamine improved or maintained performance in all domains of AD (cognition, function, behavior, and caregiver burden) in the short term and slowed the decline in performance or maintained baseline performance through 12 months. The dual mechanism of action may make galantamine a reasonable treatment option for both newly diagnosed patients and patients who have not benefitted from or have poorly tolerated current therapy.