Table of Contents
Telithromycin (Ketek™): General Safety Profile
Ketek Phase 3 safety database
Extent of exposure - phase 3
Deaths
Serious AEs - Phase 3
AEs - Phase 3
AEs by 3A4 inhibitor intake
Telithromycin (Ketek™): Cardiac Effects
Telithromycin: Cardiac Effects
QTc vs. QTn
QTc effects: in vitro and preclinical data
?QTc with telithromycin: Phase 1
?QTc in Phase 1 subjects with CV disease
?QTc vs. telithromycin concentration (Phase 1 studies)
Telithromycin vs. Cisapride
3A4 inhibitor interactions
Telithromycin: PK variability
Telithromycin pharmacokinetics in special populations
Phase 1 conclusions
Issues in ?QTc assessment
Limitations of phase 3 EKG data
Exclusion criteria for telithromycin phase 3 trials
?QTc: controlled phase 3 trials
?QTc: telithromycin vs. clarithromycin
?QTc with CYP substrates
?QTc vs. clarithromycin with CYP substrates
PPT Slide
PPT Slide
QTc: In vitro/preclinical conclusions
QTc: phase 1 conclusions
QTc: phase 3 conclusions
Telithromycin (Ketek™): Risk/benefit issues
S. pneumoniae resistance 1995-1998
Risk factors for mortality in pneumococcal pneumonia
Resistance and mortality in pneumococcal pneumonia
Assessing benefits of resistance claims
Telithromycin-ketoconazole interaction
Drugs associated with ?QTc/TdP
Telithromycin effects on co-administered drugs
Mibefradil (Posicor)
Mibefradil regulatory history
Ketek safety concerns
Ketek safety concerns (cont.)
PPT Slide
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