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One‐week dose titration of extended release galantamine in patients with Alzheimer's disease
Author(s) -
Scharre Douglas W.,
Shiovitz Thomas,
Zhu Young,
Amatniek Joan
Publication year - 2008
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2007.10.013
Subject(s) - tolerability , galantamine , medicine , placebo , adverse effect , titration , dosing , anesthesia , disease , dementia , donepezil , chemistry , pathology , inorganic chemistry , alternative medicine
Background Our purpose was to assess the safety and tolerability of extended‐release galantamine (GAL‐ER), using a 1‐week dose titration in Alzheimer's patients. Methods An open‐label, 12‐week, multicenter study was performed (n = 82). Results were compared with findings from a placebo‐controlled trial using a 4‐week titration of GAL‐ER and immediate‐release galantamine. The primary analysis compared incidences of adverse events (AEs). Results Although not statistically significant, more patients in the 1‐week titration study experienced an AE. More patients with a 1‐week titration had at least one prespecified gastrointestinal (GI) AE. These findings correlated with a higher baseline incidence of GI disturbances. Four patients experienced serious AEs; no deaths occurred. Mean Mini‐Mental State Examination scores improved by 1.8 and 1.9 points at weeks 4 and 12, respectively. Conclusions A 1‐week titration of GAL‐ER was generally safe and well tolerated, with a potential risk of more GI side effects. A 1‐week titration may permit dosing flexibility and promote increased adherence to medication regimens.