Safety and Tolerability of More than Six Days of Tedizolid Treatment
| Autor: | Miguel Salavert Lletí, Mireia Mensa Vendrell, Laura Ruiz, Ester López Suñé, Josep Mensa Pueyo, Sergio Sequera Arquelladas, Maria Rosa Oltra Sempere, José Ramón Yuste Ara, Juan Pasquau Liaño, Valentina Isernia, Leonor Moreno Nuñez, Eva Calabuig Muñoz, Alex Soriano Viladomiu, María Tasias Pitarch, Maria-Luisa Pedro-Botet Montoya, Genís Castells Lao, Esteban Alberto Reynaga Sosa |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
safety
tedizolid medicine.medical_specialty Anemia Tetrazoles Clinical Therapeutics 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Interquartile range Internal medicine medicine Humans Pharmacology (medical) 030212 general & internal medicine tolerability Adverse effect Oxazoles Oxazolidinones Retrospective Studies Pharmacology 0303 health sciences 030306 microbiology business.industry Retrospective cohort study Skin Diseases Bacterial medicine.disease adverse events Organophosphates Anti-Bacterial Agents Clinical trial Infectious Diseases chemistry Tolerability Linezolid Tedizolid business |
| Zdroj: | Antimicrob Agents Chemother |
| Popis: | Tedizolid has demonstrated its efficacy and safety in clinical trials; however, data concerning its tolerability in long-term treatments are 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 that were probably associated with tedizolid. Eighty-one patients, treated with tedizolid 200 mg once daily for a median (interquartile range [IQR]) duration of 28 (14 to 59) days, were included; 36 (44.4%) had previously received linezolid. The 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%). The 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%) developed anemia, and 6 developed thrombocytopenia (7.4%) after a median (IQR) duration of treatment of 26.5 (17 to 58.5) days. Four (5%) patients discontinued tedizolid due to AEs. Among 23 patients with chronic renal failure (CRF), the rate of myelotoxicity was 17.4%, and only 8.7% had to stop tedizolid; 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 history of linezolid-associated toxicity. |
| Databáze: | OpenAIRE |
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