Page 289 - Drug Class Review

Drug Effectiveness Review Project
Patients assigned to either placebo or TAC, with weekly to biweekly measurement of serum hepatic
ALT levels elevated by more than three times normal limit observed in 25% of patients
ALT levels elevated above normal limit at least once in 49% of patients taking TAC
ALT levels greater than twenty times normal limit observed in 2% of patients
Serum AST changes generally mirrored ALT elevations
reversed elevations in ALT Elevations appeared to occur abruptly (i.e., within 50 days) and discontinuation of TAC completely Elevated ALT levels were associated with increased eosinophilia, fever, and rash No; review focused on five specific studies Page 175 of 205

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Final Report Update 1 Authors: Watkins et al. Year: 1994 CHARACTERISTICS OF INTERVENTIONS: MAIN RESULTS: ADVERSE EVENTS: COMPREHENSIVE LITERATURE SEARCH STRATEGY: STANDARD METHOD OF APPRAISAL OF STUDIES: QUALITY RATING: Alzheimer's Drugs