Prevalence of nausea and vomiting and anti-emetic use in the tinding the optimal regimen for Mycobacterium abscessus treatment (Format) trial

Abstract

Objectives: Nausea and vomiting are common, treatment-limiting side effects of drugs for Mycobacterium abscessus pulmonary disease (MABSC-PD). No evidence-based guidelines exist for managing these symptoms in MABSC-PD. The FORMaT trial includes an intensive phase (IP) with intravenous and oral therapy, and a consolidation phase with oral and inhaled therapy, based on current guidelines. We report the prevalence of nausea, vomiting, and antiemetic use in FORMaT subjects. Methods: Adverse events coded with Common Terminology Criteria for Adverse Events (CTCAE) terms “Nausea” and “Vomiting” that were “possibly”, “probably” or “definitely” related to study medications were reviewed. Concomitant medication data were analysed for prescribing frequency of antiemetics for nausea and vomiting. Results: FORMaT has recruited 37 intervention subjects; 76% (n=28) reported nausea, 30% (n=11) vomiting and 22% (n=9) had no such symptoms. Antiemetic prescribing varied from when required (n=5) to more than 3 regular antiemetics (n=4). The most common treatment for nausea and/or vomiting was one regular antiemetic ± when required antiemetics (n=12). Antibiotic prescribing frequency from 146 prescriptions was: ondansetron 43% metoclopramide 21%, cyclizine 12%, lorazepam 8%, aprepitant 6%, palonosetron 5% and other (domperidone, olanzapine, haloperidol) 5%. 4 participants withdrew from one or more study drugs in IP due to nausea despite antiemetic therapy. Conclusion: The high prevalence of nausea and vomiting and antiemetic use in the MABSC-PD cohort requires further evaluation. Optimised antiemetic protocols in patients receiving MABS-PD treatment are required to tolerate therapy