Page 195 - Drug Class Review

Drug Effectiveness Review Project

rivastigmine 1-4 mg/d placebo rivastigmine 6-12 mg/d 72% 91% 71% 10% 50% 17% 6% 34% 8% 7% 20% 10% 8% 19% 7% 9% 17% 10% 2% 14% 3% 3% 12% 5% 3% 10% 2% 2% 10% 1% All adverse events occurred significantly more often for high dose RIV than placebo (P < 0.05); nausea occurred significantly more often for low dose RIV than placebo (P < 0.05) ITT: Yes Post randomization exclusions: NR Yes, computer generated Yes Yes, but method not described Overall loss to follow-up: 144 (20%) Loss to follow-up differential high: Yes

Final Report Update 1 Authors: Rösler et al. Year: 1999 ADVERSE EVENTS: Overall adverse effects reported: Nausea • Vomiting • Dizziness • Headache • Diarrhea • Anorexia • Abdominal Pain • Fatigue • Malaise • 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