The quality of evidence is downgraded by indirectness of evidence (short follow-up, surrogate outcomes).
A treatment attempt with galantamine is recommended for improving cognitive function in Alzheimer's disease as an alternative to other cholinesterase inhibitors.
The recommendation is strong because of possible positive effect on cognitive function. The cost of galantamine is low.
A Cochrane review [Abstract] 1 included 10 studies with a total of 6805 subjects. Treatment with galantamine led to a significantly greater proportion of subjects with improved or unchanged global rating scale rating (8 studies) at all dosing levels except for 8 mg/d, and to significantly greater reduction in ADAS-cog score at all dosing levels (n=8), with greater effect over six months compared to three months. Confidence intervals for the ORs overlapped across the dose range of 16 mg to 36 mg per day. For example, treatment effect for 24 mg/d over six months was 3.1 point reduction in ADAS-cog (95% CI 2.6-3.7; 4 trials, ITT). Galantamine's adverse effects appeared similar to those of other cholinesterase inhibitors and to be dose related. Prolong release / once daily formulation of galantamine at 16-24 mg/d had similar efficacy and side-effect profile as the equivalent twice-daily regime.
A NICE systematic review [PubMed] 2 included 6 published and 1 unpublished RCT studying galantamine in doses of 8−36 mg/day. The duration of the studies varied from 3 months (n = 3) and 5 months (n = 1) to 6 months (n = 2). Altogether there were 3 324 patients with mild to moderate Alzheimer's disease (1 051 in placebo and 2 273 in galantamine group), with a mean age between 70 and 80 years.
A systematic review [PubMed] 3 included 23 studies of which 4 assessed galantamine (n = 2265). Cognitive effects were significant at 24 weeks measured by the ADAS-cog using galantamine 24 mg/day (-3.03, 95% CI -3.66 to -2.41) and galantamine 32 mg/day (-3.2, 95% CI-3,28 to -3,12). No behavioral benefits were observed.
Although the clinical benefits in the included studies were small, a treatment attempt is warranted due to the debilitating nature of the disease and its impact on the patient's quality of life.
Primary/Secondary Keywords