Safety and tolerability of more than 6 days of tedizolid treatment
Mensa Vendrell M (1), Tasias Pitarch M (2), Salavert Lletí M (2), Calabuig Muñoz E (2), Morata Ruiz L (3), Castells Lao G (4), López Suñé E (4), Mensa Pueyo J (3), Oltra Sempere MR (5), Pedro-Botet Montoya ML (6), Isernia V (6), Reynaga Sosa EA (6), Moreno Nuñez L (7), Pasquau Liaño J (8), Sequera Arquelladas S (8), Yuste Ara JR (9), Soriano Viladomiu A (10).
(1) Pharmacy Department, Hospital Plató, Barcelona, Spain.
(2) Department of Infectious Diseases, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
(3) Department of Infectious Diseases, Hospital Clinic, University of Barcelona, Barcelona, Spain.
(4) Pharmacy Department, Hospital Clinic, Barcelona, Spain.
(5) Department of Infectious Diseases, Hospital Clínico Universitario de València, Valencia, Spain.
(6) Department of Infectious Diseases, Hospital Germans Trias i Pujol, Barcelona, Spain.
(7) Department of Infectious Diseases, Hospital Universitario Fundación Alcorcón, Madrid, Spain.
(8) Department of Infectious Diseases, Hospital Universitario Virgen de las Nieves de Granada, Granada, Spain.
(9) Department of Infectious Diseases, Clínica Universidad de Navarra, Navarra, Spain.
(10) Department of Infectious Diseases, Hospital Clinic, University of Barcelona, Barcelona, Spain.
Tedizolid has demonstrated its efficacy and safety in clinical trials, however, data concerning its tolerability in long-term treatments is scarce. The aim of the study was to assess the indications and to describe the long-term safety profile of tedizolid.
A multicentric, retrospective study of patients who received tedizolid for more than 6-days was conducted. Adverse events (AEs) were identified from patients' medical records and laboratory data.
The World Health Organization causality categories were used to discern AEs probably associated with tedizolid.Eighty-one patients, treated with tedizolid 200mg once-daily for a median (IQR) duration of 28 (14-59) days, were included, 36 (44.4%) had previously received linezolid. Most common reasons for selecting tedizolid were to avoid linezolid potential toxicities or interactions (53.1%) or due to previous linezolid-related toxicities (27.2%).
Most common indications were off-label, including prosthetic joint infections, osteomyelitis and respiratory infections (77.8%). Overall, 9/81 patients (11.1%) experienced a probably associated AE. Two patients (2.5%) developed gastrointestinal disorders, 1 (1.2%) anemia and 6 thrombocytopenia (7.4%) after a median (IQR) duration of treatment of 26.5 (17-58.5) days. Four (5%) patients discontinued tedizolid due to AEs.
Among 23 patients with chronic renal failure (CRF) the rate of mielotoxicity was 17.4% and only 8.7% had to stop tedizolid and 20 out of 22 with previous linezolid-associated toxicity had no AE.
Long-term tedizolid treatments had good tolerance with rates of gastrointestinal AE and hematological toxicity lower than those reported with linezolid, particularly in patients with CRF and in those with a previous history of linezolid-associated toxicity.
CITA DEL ARTÍCULO Antimicrob Agents Chemother. 2020 Apr 20. pii: AAC.00356-20. doi: 10.1128/AAC.00356-20