Page 325 - Drug Class Review
P. 325
Drug Effectiveness Review Project
rivastigmine MHIS = 0 rivastigmine MHIS > 0 NR NR 54% 67% 25% 41% 16% 16% 17% 23% 12% 15% 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 ITT: No; observed cases used for this analysis 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) Overall loss to follow-up: 22% Loss to follow-up differentia
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
