Page 41 - Drug Class Review

Final Report Update 1 Drug Effectiveness Review Project

Table 6: Summary of trials assessing adverse events
Author, Year N Study design Results Quality
Rating

Hepatotoxicity
80
Watkins et al., 1994 2446 secondary data 49% of tacrine-treated patients presented N/A
review ALT elevations

58
Farlow et al., 1992 468 RCT 25% of tacrine-treated patients had Fair
elevated ALT levels
*Knapp et al., 1994 68, 86-88 663 RCT 54% of tacrine-treated patients had Poor
elevated ALT levels
67
*Wong et al ., 1999 100 RCT 51% of tacrine-treated patients had Poor
elevated ALT levels
69
*Wood et al.,1994 154 RCT 44% of tacrine-treated patients had Poor
elevated ALT levels

Gastrointestinal adverse events
Grimley Evans et al., NR pooled analysis Nausea, vomiting, and diarrhea 3 to 5 N/A
14
2004 times more likely for donepezil,
galantamine, and rivastigmine than for
placebo
Cutler et al., 1994 81 3350 pooled data Tacrine had a higher rate of adverse N/A
analysis events than donepezil and rivastigmine
Gauthier et al. 2001 82 NR Retrospective dose dependent rates of gastrointestinal N/A
data review adverse events for ChEIs
*Gillette-Guyonnet et al. 486 Cohort study Similar incidence of weight loss for Poor
83
2005 patients taking ChEIs compared to
patients not taking ChEIs
Cardiovascular adverse events
Dunn et al., 2000 84 1762 Prescription- No cardiac arrhythmias were reported for N/A
event monitoring donepezil
Morganroth et al. 2002 85 2791 Pooled analysis No effect on heart rate for rivastigmine Fair
of RCTs
*Poor quality rating for efficacy but included for adverse events

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