Page 71 - Drug Class Review
P. 71
Drug Effectiveness Review Project
rivastigmine 4 mg/d placebo rivastigmine 6 mg/d NR NR NR 6% 31% 17% 3% 18% 10% 2% 12% 7% 7% 20% 6% 6% 13% 4% Significantly more patients suffered from nausea, vomiting, diarrhea, dizziness, and headache in RIV 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 placebo rivastigmine 6 mg/d rivastigmine 4 mg/d 6% 15% 12.5% 4% 12% 10% Page 66 of 205
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
