Page 72 - Drug Class Review
P. 72
Page 66 of 205
Drug Effectiveness Review Project
placebo NR 6% 3% 2% 7% 6% placebo 6% 4%
rivastigmine 6 mg/d NR 31% 18% 12% 20% 13% Significantly more patients suffered from nausea, vomiting, diarrhea, dizziness, and headache in RIV rivastigmine 6 mg/d 15% 12%
rivastigmine 4 mg/d NR 17% 10% 7% 6% 4% groups especially at higher doses; P = NR Post randomization exclusions: NR Overall loss to follow-up: 11.2% Loss to follow-up differential high: No rivastigmine 4 mg/d 12.5% 10%
ITT: No NR Yes Yes Fair
Final Report Update 1 Authors: Agid et al. Year: 1998 ADVERSE EVENTS: Overall adverse effects reported: Nausea • Vomiting • Diarrhea • Dizziness • Headache • 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
