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Expert Opin Drug Saf ; 20(8): 959-963, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34030570

ABSTRACT

Background: Azithromycin maintenance therapy is widely used in cystic fibrosis (CF), but little is known about its long-term safety. We investigated whether chronic azithromycin use is safe regarding renal function, hepatic cell toxicity and QTc-interval prolongation.Methods: Adult CF patients (72 patients using azithromycin for a cumulative period of 364.8 years and 19 controls, 108.8 years) from two CF-centers in the Netherlands with azithromycin (non)-use for at least three uninterrupted years were studied retrospectively.Results: There was no difference in mean decline of estimated glomerular filtration rate (eGFR), nor in occurrence of eGFR-events. No drug-induced liver injury could be attributed to azithromycin. Of the 39 azithromycin users of whom an ECG was available, 4/39 (10.3%) had borderline and 4/39 (10.3%) prolonged QTc-intervals, with 7/8 patients using other QTc-prolonging medication. Of the control patients 1/6 (16.7%) had a borderline QTc-interval, without using other QTc-prolonging medication. No cardiac arrhythmias were observed.Conclusion: We observed no renal or hepatic toxicity, nor cardiac arrythmias during azithromycin use in CF patients for a mean study duration of more than 5 years. One should be aware of possible QTc-interval prolongation, in particular in patients using other QTc-interval prolonging medication.


Subject(s)
Anti-Bacterial Agents/adverse effects , Azithromycin/adverse effects , Cystic Fibrosis/drug therapy , Adult , Anti-Bacterial Agents/administration & dosage , Azithromycin/administration & dosage , Biomarkers/metabolism , Cohort Studies , Electrocardiography , Female , Humans , Kidney Function Tests , Liver Function Tests , Long QT Syndrome/chemically induced , Male , Netherlands , Retrospective Studies , Time Factors , Young Adult
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