Page 326 - Drug Class Review

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Drug Effectiveness Review Project

rivastigmine MHIS > 0 NR 54% 25% 16% 17% 12% Treatment with RIV not associated with any increase in mortality, serious adverse events, effects on laboratory measures, ECGs or cardiovascular vital signs in either MHIS category Post randomization exclusions: Yes (2 patients with no MHIS score were excluded) Yes (independent firm cited, along with voice responses system for randomization code assignment) Loss to follow-up differential high: No (between treatment groups, stratified by MHIS status) MHIS > 0 21% 17% 15% 33% NR

rivastigmine MHIS = 0 NR 67% 41% 16% 23% 15% ITT: No; observed cases used for this analysis Overall loss to follow-up: 22% MHIS = 0 22% 16% 14% 37% NR

Yes Yes Fair

Final Report Update 1 Authors: Kumar et al. Year: 2000 ADVERSE EVENTS: [See table for Corey-Bloom et al (1998)] Overall adverse effects reported: All gastrointestinal • Nausea • Vomiting • Diarrhea • Anorexia • Significant differences in adverse events: ANALYSIS: ADEQUATE RANDOMIZATION: ADEQUATE ALLOCATION CONCEALMENT: BLINDING OF OUTCOME ASSESSORS: ATTRITION (overall): ATTRITION (MHIS score-specific): Loss to follow-up: Placebo RIV (low) RIV (high) Withdrawals due to adverse events: QUALITY RATING: *primary outcome measures Alzheimer