Page 110 - Drug Class Review

Page 85 of 205
Drug Effectiveness Review Project

placebo 34% (treatment-related) 1.9% 3.2% 3.2% Significance NR, although clearly significant differences in adverse events noted above ITT: No; ITT results available upon request and “generally” consistent Unable to assess method of randomization; groups adequately balanced placebo NR 7%

tacrine 20, 40, 80 mg/d 51% (mean treatment-related) 19.8%; 19.8%; 11.7% 4.7%; 5.9%; 11.7% 3.4%; 3.2%; 10% Post randomization exclusions: Yes Overall loss to follow-up: 41.7% (not included in analysis) Loss to follow-up differential high: NR tacrine NR 25%

Yes Yes Fair

Final Report Update 1 Authors: Farlow et al. Year: 1992 ADVERSE EVENTS: Overall adverse effects reported: Elevated transaminases • Nausea/Vomiting • Diarrhea • 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