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Levofloxacin linked to tenosynovitis in patients awaiting liver transplantation
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The administration of levofloxacin as tuberculosis prophylaxis in liver transplant candidates was associated with a high incidence of tenosynovitis, according to recent findings.
“The use of quinolones for prophylaxis of latent tuberculosis infection could be a good alternative [to isoniazid prophylaxis] but there is insufficient evidence of their efficacy and safety in liver transplant candidates or recipients,” the researchers wrote in Clinical Infectious Diseases.
In the open-label, prospective, multicenter randomized clinical trial, researchers from Spain evaluated 64 liver transplant candidates, aged 18 and older, without evidence of active TB.
The researchers compared the efficacy and safety of levofloxacin (500 mg every 24 hours for 9 months) initiated in 33 waiting list candidates vs. isoniazid (300 mg every 24 hours for 9 months), starting at 3 to 6 months after transplant, in 31 control patients.
During therapy, patients were seen for monthly follow-ups to evaluate drug effectiveness and safety. Patients then were followed at least every 3 months until months 6 or later, and then every 6 months until beyond month 18. Patients also were examined in the event of clinical suspicion of adverse events or TB.
At the time of the safety analysis, researchers suspended the study due to unanticipated incidence of severe tenosynovitis among six patients (18.2%) in the levofloxacin arm. While the outcome was favorable in all cases, some patients continued to have tenosynovitis for up to 7 weeks. None of the patients in the control arm developed tenosynovitis. The course of prophylaxis was completed in only 32.2% of patients assigned isoniazid, and in 54.5% of those assigned levofloxacin (P = .094). No patients developed TB during the median 270-day follow-up.
The researchers said more studies are needed to better understand the association between levofloxacin and tenosynovitis in liver transplant patients.
“Whether tolerance and safety could be improved using lower doses of levofloxacin or other quinolones prior to transplantation or full-dose after transplantation are issues that should be clarified in future studies,” the researchers wrote. – by Jen Byrne
Disclosure: The researchers report no relevant financial disclosures.
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