1. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
- Author
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José-María García-García, Jerker Jonsson, Fabrizio Palmieri, Luigi Codecasa, Matteo Zignol, Andrei Maryandyshev, Qingshan Cai, Domingo Palmero, Magnolia Nieto Marcos, Seifeldin Eltaeb Elamin, Enrique Bernal, Simon Tiberi, Alberto Matteelli, Marisa Vescovo, Judith Bruchfeld, Edita Davidavičienė, Saulius Diktanas, Skaidrius Miliauskas, Rolandas Zablockis, Raquel Duarte, R. Rosso, Martin J. Boeree, Marcela Muñoz-Torrico, Valentina Marchese, Adrian Rendon, Evgeny Belilovski, Sergey Borisov, Zarir F Udwadia, Antoniya Koleva, Jorge De Los Rios, Giovanni Battista Migliori, Ana Garcia, Elena Martínez Robles, Hamdan Mustafa Hamdan, Vygantas Gruslys, Marina Tadolini, Laurent P. Nicod, Laura Saderi, Alena Aleksa, Mahamadou Bassirou Souleymane, Rafael Laniado-Laborín, Vinicio Manfrin, Jesica Mazza-Stalder, Alberto Piubello, Charalampos Moschos, Liga Kuksa, Alexey Filippov, Giovanni Sotgiu, Lia D'Ambrosio, Agostina Pontarelli, Heinke Kunst, Pietro Viggiani, Jan-Willem C. Alffenaar, Emanuele Pontali, Maurizio Ferrarese, Regina Gayoso, Ieva Gaudiesiute, Onno W. Akkerman, Agnese Šmite, Edvardas Danila, Marie-Christine Payen, Justin T Denholm, Jacinta Drakšienė, Blagovesta Gavazova, Wouter Hoefsloot, Elena Khimova, Dina Visca, Askar Yedilbayev, Nadia Escobar Salinas, Julen Cadiñanos Loidi, Sarai Quirós, Ivan Solovic, Jose A. Caminero, Margareth Pretti Dalcolmo, Apostolos Papavasileiou, Gina Gualano, Birutė Nakčerienė, Martin van den Boom, Lina Davies Forsman, Dmitry Zhurkin, Yang Li, Alena Skrahina, Antonio Spanevello, Cecile Magis-Escurra, Masoud Dara, Selene Manga, Jose Joaquin Cebrian Gallardo, Rosella Centis, Microbes in Health and Disease (MHD), Borisov S., Danila E., Maryandyshev A., Dalcolmo M., Miliauskas S., Kuksa L., Manga S., Skrahina A., Diktanas S., Codecasa L.R., Aleksa A., Bruchfeld J., Koleva A., Piubello A., Udwadia Z.F., Akkerman O.W., Belilovski E., Bernal E., Boeree M.J., Loidi J.C., Cai Q., Gallardo J.J.C., Dara M., Davidaviciene E., Forsman L.D., de Los Rios J., Denholm J., Draksiene J., Duarte R., Elamin S.E., Salinas N.E., Ferrarese M., Filippov A., Garcia A., Garcia-Garcia J.-M., Gaudiesiute I., Gavazova B., Gayoso R., Rosso R.G., Gruslys V., Gualano G., Hoefsloot W., Jonsson J., Khimova E., Kunst H., Laniado-Laborin R., Li Y., Magis-Escurra C., Manfrin V., Marchese V., Robles E.M., Matteelli A., Mazza-Stalder J., Moschos C., Munoz-Torrico M., Hamdan H.M., Nakceriene B., Nicod L., Marcos M.N., Palmero D.J., Palmieri F., Papavasileiou A., Payen M.-C., Pontarelli A., Quiros S., Rendon A., Saderi L., Smite A., Solovic I., Souleymane M.B., Tadolini M., Boom M.V.D., Vescovo M., Viggiani P., Yedilbayev A., Zablockis R., Zhurkin D., Zignol M., Visca D., Spanevello A., Caminero J.A., Alffenaar J.-W., Tiberi S., Centis R., D'Ambrosio L., Pontali E., Sotgiu G., and Migliori G.B.
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Adult ,Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Tuberculosis ,Drug-Related Side Effects and Adverse Reactions ,Antitubercular Agents ,Terizidone ,Clofazimine ,Antitubercular Agent ,Pharmacovigilance ,chemistry.chemical_compound ,Internal medicine ,Tuberculosis, Multidrug-Resistant ,medicine ,Humans ,Prospective Studies ,Adverse effect ,Aged ,business.industry ,Middle Aged ,medicine.disease ,Prospective Studie ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,chemistry ,Tolerability ,Female ,Delamanid ,Bedaquiline ,Drug-Related Side Effects and Adverse Reaction ,business ,Human ,medicine.drug - Abstract
The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1–2) and 57 (11.3%) as serious (grade 3–5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.
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- 2019