| Literature DB >> 31601711 |
Sergey Borisov1,2, Edvardas Danila3, Andrei Maryandyshev4, Margareth Dalcolmo5, Skaidrius Miliauskas6, Liga Kuksa7, Selene Manga8, Alena Skrahina9, Saulius Diktanas10, Luigi Ruffo Codecasa11, Alena Aleksa12, Judith Bruchfeld13,14,2, Antoniya Koleva15, Alberto Piubello16,17,2, Zarir Farokh Udwadia18, Onno W Akkerman19,20,2, Evgeny Belilovski1, Enrique Bernal21, Martin J Boeree22, Julen Cadiñanos Loidi23, Qingshan Cai24, Jose Joaquín Cebrian Gallardo25, Masoud Dara26, Edita Davidavičienė27,28, Lina Davies Forsman13,14, Jorge De Los Rios29, Justin Denholm30,31,2, Jacinta Drakšienė10, Raquel Duarte32, Seifeldin Eltaeb Elamin33, Nadia Escobar Salinas34, Maurizio Ferrarese11, Alexey Filippov1, Ana Garcia35, José-María García-García36, Ieva Gaudiesiute6, Blagovesta Gavazova37, Regina Gayoso5, Roscio Gomez Rosso38, Vygantas Gruslys3, Gina Gualano39, Wouter Hoefsloot22, Jerker Jonsson40, Elena Khimova4, Heinke Kunst41, Rafael Laniado-Laborín42,2, Yang Li43, Cecile Magis-Escurra22, Vinicio Manfrin44, Valentina Marchese45, Elena Martínez Robles46, Alberto Matteelli45, Jesica Mazza-Stalder47,2, Charalampos Moschos48, Marcela Muñoz-Torrico49,2, Hamdan Mustafa Hamdan33, Birutė Nakčerienė27,28, Laurent Nicod47, Magnolia Nieto Marcos50, Domingo Juan Palmero35, Fabrizio Palmieri39, Apostolos Papavasileiou48, Marie-Christine Payen51, Agostina Pontarelli52, Sarai Quirós53, Adrian Rendon54, Laura Saderi55,2, Agnese Šmite7, Ivan Solovic56, Mahamadou Bassirou Souleymane17, Marina Tadolini57, Martin van den Boom26,2, Marisa Vescovo35, Pietro Viggiani52, Askar Yedilbayev26, Rolandas Zablockis3, Dmitry Zhurkin9, Matteo Zignol58, Dina Visca59,60,2, Antonio Spanevello59,60, José A Caminero61,62,2, Jan-Willem Alffenaar63,64,65,2, Simon Tiberi41,66,2, Rosella Centis67,2, Lia D'Ambrosio68,2, Emanuele Pontali69,2, Giovanni Sotgiu55,2, Giovanni Battista Migliori70,2.
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.Entities:
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Year: 2019 PMID： 31601711 DOI： 10.1183/13993003.01522-2019
Source DB: PubMed Journal: Eur Respir J ISSN： 0903-1936 Impact factor: 16.671