Page 104 - Drug Class Review

Drug Effectiveness Review Project

rivastigmine (high) NR 10% 10% 24% 9% 48% 27% 20% 14% 20% 16% rivastigmine (high) 35.5% 29% Page 82 of 205

rivastigmine (low) NR 5% 2% 15% 7% 14% 7% 8% 8% 8% 5% Titration Phase: sweating, fatigue, asthenia, weight decrease, malaise, dizziness, somnolence, nausea, Maintenance Phase: dizziness, nausea, vomiting, dyspepsia, sinusitis (P < 0.05) Yes (independent firm cited, along with voice responses system for randomization code assignment) rivastigmine (low) 14.6% 8.2%

placebo NR 4% 2% 13% 2% 11% 3% 4% 3% 2% vomiting, anorexia, flatulence (P < 0.05) Post randomization exclusions: No Overall loss to follow-up: 22% Loss to follow-up differential high: Yes placebo 16.6% 7.2%

ITT: Yes Yes Yes Fair

Final Report Update 1 Authors: Corey-Bloom et al. Year: 1998 ADVERSE EVENTS: Overall adverse effects reported: Titration Phase Fatigue • Asthenia • Dizziness • Somnolence • Nausea • Vomiting • Anorexia • Maintenance Phase Dizziness • Nausea • Vomiting • 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 out