Clinical safety and tolerability of tedizolid phosphate in the treatment of acute bacterial skin and skin structure infections.
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Issue Date
2018-04
Authors
Hardalo, Cathy
Lodise, Thomas P
Bidell, Monique R
Flanagan, Shawn D
De Anda, Carisa
Anuskiewicz, Steven
Prokocimer, Philippe
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Abstract
BACKGROUND: We evaluated safety and tolerability of tedizolid phosphate at the 200-mg once-daily dose approved for 6-day treatment of skin and skin-structure infections.
RESEARCH DESIGN AND METHODS: Clinical adverse event (AE) and laboratory data were pooled across completed clinical studies (13 phase 1, two phase 2, and two phase 3), for all participants who received >/=1 dose of tedizolid 200 mg, linezolid 600 mg (phase 3 only), or placebo (phase 1 only).
RESULTS: 1280 participants received tedizolid (phase 1: n = 355; phase 2/3: n = 925). In total, 13% received >6 doses of tedizolid (range: 7-21); in phase 2/3, 94% of participants received >/=5 doses (range: 5-10). Drug-related AEs occurred in 27% of participants (most commonly gastrointestinal reactions in 13% of participants and headache in 4%). Most AEs were mild-moderate in severity; <1% of participants discontinued treatment due to AEs. Tedizolid and linezolid had similar frequency, severity, and types of drug-related AEs. Tolerability in clinically important subpopulations (obese, n = 346; elderly, n = 99; renal impairment, n = 40; hepatic disease/impairment, n = 294) appeared comparable to the overall population.
CONCLUSIONS: Tedizolid, given orally or intravenously at 200 mg, has a favorable safety profile. Clinical trial and postmarketing experience with treatment >/=7 days is limited.
Citation
Hardalo C, Lodise TP, Bidell M, Flanagan S, De Anda C, Anuskiewicz S, Prokocimer P. Clinical safety and tolerability of tedizolid phosphate in the treatment of acute bacterial skin and skin structure infections. Expert Opin Drug Saf. 2018 Apr;17(4):359-367. doi: 10.1080/14740338.2018.1446939. Epub 2018 Mar 12. PMID: 29528251.
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