Page 233 - Drug Class Review
P. 233
Drug Effectiveness Review Project
galantamine 24mg placebo galantamine 32mg 77% 89% 83% 12% 40% 37% 4% 17% 20% 7% 13% 7% 5% 12% 11% 3% 11% 10% 0% 11% 10% Nausea (P = NR); vomiting (P = NR); dizziness (P = NR); headache (P = NR); anorexia (P < 0.001) Post randomization exclusions: Yes Overall loss to follow-up: 19.6 % Loss to follow-up differential high: No (< 15 percentage points difference) placebo galantamine 32mg galantamine 24mg 13.5% 25.2% 20% 9% 22% 14% Page 147 of 205
ITT: Yes Yes Yes Yes Good
Final Report Update 1 Authors: Wilcock et al. Year: 2000 ADVERSE EVENTS Overall adverse effects reported: Nausea • Vomiting • Diarrhea • Dizziness • Headache • Anorexia • 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
