Page 103 - Drug Class Review

Drug Effectiveness Review Project

placebo rivastigmine (high) rivastigmine (low) NR NR NR 10% 5% 4% 10% 2% 2% 24% 15% 13% 9% 7% 2% 48% 14% 11% 27% 7% 3% 20% 8% 14% 8% 4% 20% 8% 3% 16% 5% 2% Titration Phase: sweating, fatigue, asthenia, weight decrease, malaise, dizziness, somnolence, nausea, vomiting, anorexia, flatulence (P < 0.05) Maintenance Phase: dizziness, nausea, vomiting, dyspepsia, sinusitis (P < 0.05) Post randomization exclusions: No Yes (independent firm cited, along with voice responses system for randomization code assignm

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