Telithromycin (Ketekô): General Safety Profile

5/16/01


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Table of Contents

Telithromycin (Ketekô): 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 (Ketekô): 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 (Ketekô): 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

Author: CDER.USER