Page 195 - Drug Class Review
P. 195

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
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