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
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