Page 281 - Drug Class Review

Drug Effectiveness Review Project
29% of TAC treated patients had three times the upper limit of normal (120 U/L)
Significantly higher rate of ALT elevations in TAC group
54% of TAC treated patients had elevated ALT levels
90% of elevations occurred within the first 12 weeks
Post randomization exclusions:
Overall loss to follow-up: 58%

tacrine Loss to follow-up differential high: placebo 11% 55% Primary reason: ALT elevations; also gastrointestinal symptoms (16%) Page 171 of 205

ITT: Yes Poor

Yes NR Yes

Final Report Update 1 Authors: Knapp et al. Year: 1994 ADVERSE EVENTS: Significant differences in adverse events: ANALYSIS: ADEQUATE RANDOMIZATION: ADEQUATE ALLOCATION CONCEALMENT: BLINDING OF OUTCOME ASSESSORS: ATTRITION (overall): ATTRITION (treatment specific): Loss to follow-up: Withdrawals due to adverse events: QUALITY RATING: *primary outcome measures Alzheimer's Drugs