Journal
ACTA NEUROLOGICA SCANDINAVICA
Volume 126, Issue 1, Pages 37-44Publisher
WILEY
DOI: 10.1111/j.1600-0404.2011.01594.x
Keywords
Alzheimer's disease; drug switching; donepezil; galantamine; randomized controlled trial
Categories
Funding
- Janssen-Cilag EMEA
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Engedal K, Davis B, Richarz U, Han J, Schauble B, Andreasen N. Two galantamine titration regimens in patients switched from donepezil.?Acta Neurol Scand: 2012: 126: 3744.?(c) 2011 John Wiley & Sons A/S. Objectives In addition to inhibiting acetylcholinesterase, galantamine has allosteric-modulating activity at nicotinic receptors. This may make galantamine an attractive option for patients starting treatment for Alzheimers disease (AD), but also for those who have not benefited from their current therapy. This study explored outcomes in subjects with AD transitioning from donepezil because of insufficient tolerability or efficacy. Materials and methods Subjects previously receiving donepezil for mild-to-moderate AD were enrolled in a 12-week randomized, open-label study. After screening and a 7-day washout, subjects were randomly allocated to galantamine fast (8 mg/week increments) or slow (8 mg/4 week) titration to 1624 mg. Efficacy outcomes included the Alzheimers Disease Assessment Scale cognitive subscale (ADAS-cog/11), Mini-Mental State Examination (MMSE), Clinicians Interview-Based Impression of Change Plus Caregivers Input (CIBIC-plus) and Alzheimers Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL). Results Eighty-six of 89 patients (fast titration, n = 44; slow titration, n = 45) completed the study. At week 12, ADAS-cog/11 score improved from screening by 2.6 and 0.6 in the fast- and slow-titration arms, respectively (overall, -1.6; P = 0.002). MMSE scores improved slightly in both arms (overall, +0.9; P = 0.002). Two-thirds of patients had improvement or no change on the CIBIC-plus at week 12. ADCS-ADL scores did not change significantly from screening in either treatment arm. Galantamine was generally well tolerated; nausea (5.6%) and bradycardia (4.5%) were the most commonly reported adverse events. Conclusions Patients in whom donepezil is ineffective or poorly tolerated may benefit from a switch to galantamine.
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