Page 286 - Drug Class Review

Page 173 of 205
Drug Effectiveness Review Project
Patients randomly assigned to either placebo or RIV for 26 weeks; dosage could be fixed, partially flexible,
or fully flexible; standard 12-lead ECG performed at screening, baseline, and weeks 2, 4, 8, 12, 16, 18, 22
and 26, or early termination; ECG abnormalities characterized as “new or worsened”, “no change”, or

uncorrected QT intervals “improved”; ECG variables included heart rate, PQ or PR interval, QRS interval, and corrected and No clinically meaningful differences were apparent between RIV and placebo-treated patients with regard to mean change from baseline in heart rate, PQ or PR interval, QRS interval, QT interval uncorrected, or QT interval corrected No clinically meaningful differences in treatment-emergent ECG abnormalities, bradycardia, or tachycardia were observed between groups No; review focused on four specific studies

NR Fair

Final Report Update 1 Authors: Morganroth et al. Year: 2002 CHARACTERISTICS OF INTERVENTIONS: MAIN RESULTS: ADVERSE EVENTS: COMPREHENSIVE LITERATURE SEARCH STRATEGY: STANDARD METHOD OF APPRAISAL OF STUDIES: QUALITY RATING: Alzheimer's Drugs