Tuberculosis prophylaxis with levofloxacin in liver transplant patients is associated with a high incidence of tenosynovitis: safety analysis of a multicenter randomized trial
Metadatos
Mostrar el registro completo del ítemAutor
Torre Cisneros, Julián; San Juan, Rafael; Rosso Fernández, Clara; Tiago Silva, J; Muñoz Sanz, Agustín; Muñoz, Patricia; Miguez, Enrique; Martín-Dávila, Pilar; López Ruz, Miguel Ángel; Vidal, Elisa; Cordero, Elisa; Montejo, Miguel; Blanes, Marino; Fariñas, Carmen; Herrero, José Ignacio; Rodrigo, Juan; Aguado, Jose MaríaEditorial
Oxford University Press
Materia
Tuberculosis Levofloxacin Tenosynovitis Investigator-driven clinical trial
Fecha
2015-02-25Referencia bibliográfica
Torre-Cisneros, J. et al. Tuberculosis Prophylaxis With Levofloxacin in Liver Transplant Patients Is Associated With a High Incidence of Tenosynovitis: Safety Analysis of a Multicenter Randomized Trial, Clinical Infectious Diseases, Volume 60, Issue 11, 1 June 2015, Pages 1642–1649, https://doi.org/10.1093/cid/civ156
Patrocinador
Ayudas para el fomento de la investigación clínica independiente [EC 10-120]; Programa Intramural Consorcio de Apoyo a la Investigación Biomédica en Red 2010; National R&D&I Plan 2008–2011; Instituto de Salud Carlos III (ISCIII); Ministerio de Economía y Competitividad RD06/0008, RD12/0015; European Development Regional FundResumen
Background: It is necessary to develop a safe alternative to isoniazid for tuberculosis prophylaxis in liver transplant recipients. This study was designed to investigate the efficacy and safety of levofloxacin.
Methods: An open-label, prospective, multicenter, randomized study was conducted to compare the efficacy and safety of levofloxacin (500 mg q24h for 9 months) initiated in patients awaiting liver transplantation and isoniazid (300 mg q24h for 9 months) initiated post-transplant when liver function was stabilized. Efficacy was measured by tuberculosis incidence at 18 months after transplantation. All adverse events related to the medication were recorded.
Results: CONSORT guidelines were followed in order to present the results. The safety committee suspended the study through a safety analysis when 64 patients had been included (31 in the isoniazid arm and 33 in the levofloxacin arm). The reason for suspension was an unexpected incidence of severe tenosynovitis in the levofloxacin arm (18.2%). Although the clinical course was favorable in all cases, tenosynovitis persisted for 7 weeks in some patients. No patients treated with isoniazid, developed tenosynovitis. Only 32.2% of patients randomized to isoniazid (10/31) and 54.5% of patients randomized to levofloxacin (18/33, P = .094) completed prophylaxis. No patient developed tuberculosis during the study follow-up (median 270 days).
Conclusions: Levofloxacin prophylaxis of tuberculosis in liver transplant candidates is associated with a high incidence of tenosynovitis that limits its potential utility.