Page 196 - Drug Class Review
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Page 128 of 205
Drug Effectiveness Review Project
placebo 72% 10% 6% 7% 8% 9% 2% 3% 3% 2% placebo 13% 7%
rivastigmine 6-12 mg/d 91% 50% 34% 20% 19% 17% 14% 12% 10% 10% 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) rivastigmine 6-12 mg/d 33% 23%
rivastigmine 1-4 mg/d 71% 17% 8% 10% 7% 10% 3% 5% 2% 1% 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 rivastigmine 1-4 mg/d 14% 7% Fair
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
