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Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report.
Journal article

Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report.

  • Borisov S Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation.
  • Danila E Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
  • Maryandyshev A Northern State Medical University, Arkhangelsk, Russian Federation.
  • Dalcolmo M Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil.
  • Miliauskas S Dept of Pulmonology, Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • Kuksa L MDR-TB Dept, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia.
  • Manga S Dept of Infectious Diseases, University National San Antonio Abad Cusco, Cusco, Peru.
  • Skrahina A Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus.
  • Diktanas S Tuberculosis Dept, 3rd Tuberculosis Unit, Republican Klaipėda Hospital, Klaipėda, Lithuania.
  • Codecasa LR TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy.
  • Aleksa A Dept of Phthisiology and Pulmonology, Grodno State Medical University, Grodno, Belarus.
  • Bruchfeld J Division of Infectious Diseases, Dept of Medicine, Karolinska Institute, Solna, Sweden.
  • Koleva A Pulmonology and Physiotherapy Dept, Gabrovo Lung Diseases Hospital, Gabrovo, Bulgaria.
  • Piubello A Tuberculosis Division, International Union against Tuberculosis and Lung Disease (The Union), Paris, France.
  • Udwadia ZF Dept of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India.
  • Akkerman OW University of Groningen, University Medical Center Groningen, Dept of Pulmonary Diseases and Tuberculosis, Groningen, The Netherlands.
  • Belilovski E Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation.
  • Bernal E Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofia, Murcia, Spain.
  • Boeree MJ Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands.
  • Cadiñanos Loidi J Internal Medicine Dept, Hospital General de Villalba, Collado Villalba, Spain.
  • Cai Q Zhejiang Integrated Traditional and Western Medicine Hospital, Hangzhou, China.
  • Cebrian Gallardo JJ Unidad de Neumología, Agencia Sanitaria Costa del Sol, Marbella, Spain.
  • Dara M World Health Organization Regional Office for Europe, Copenhagen, Denmark.
  • Davidavičienė E National TB Registry, Public Health Dept, Ministry of Health, Vilnius, Lithuania.
  • Forsman LD Division of Infectious Diseases, Dept of Medicine, Karolinska Institute, Solna, Sweden.
  • De Los Rios J Centro de Excelencia de TB "Niño Jesus", Servicio de Neumologia, Hospital Maria Auxiliadora, Lima, Peru.
  • Denholm J Victorian Tuberculosis Program, Melbourne Health, Melbourne, Australia.
  • Drakšienė J Tuberculosis Dept, 3rd Tuberculosis Unit, Republican Klaipėda Hospital, Klaipėda, Lithuania.
  • Duarte R National Reference Centre for MDR-TB, Hospital Centre Vila Nova de Gaia, Dept of Pneumology, Public Health Science and Medical Education Dept, Faculty of Medicine, University of Porto, Porto, Portugal.
  • Elamin SE MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan.
  • Escobar Salinas N Division of Disease Prevention and Control, Dept of Communicable Diseases, National Tuberculosis Control and Elimination Programme, Ministry of Health, Santiago, Chile.
  • Ferrarese M TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy.
  • Filippov A Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation.
  • Garcia A Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina.
  • García-García JM Tuberculosis Research Programme, SEPAR, Barcelona, Spain.
  • Gaudiesiute I Dept of Pulmonology, Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • Gavazova B "Improve the Sustainability of the National TB Programme", Sofia, Bulgaria.
  • Gayoso R Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil.
  • Gomez Rosso R National Institute of Respiratory and Environmental Diseases "Prof. Dr. Juan Max Boettner" Asunción, Paraguay.
  • Gruslys V Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
  • Gualano G Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases "L. Spallanzani", IRCCS, Rome, Italy.
  • Hoefsloot W Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands.
  • Jonsson J Dept of Public Health Analysis and Data Management, Public Health Agency of Sweden, Solna, Sweden.
  • Khimova E Northern State Medical University, Arkhangelsk, Russian Federation.
  • Kunst H Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
  • Laniado-Laborín R Universidad Autónoma de Baja California, Baja California, Mexico; Clínica de Tuberculosis del Hospital General de Tijuana, Tijuana, Mexico.
  • Li Y Dept of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.
  • Magis-Escurra C Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands.
  • Manfrin V S. Bortolo Hospital, Vicenza, Italy.
  • Marchese V Clinic of Infectious and Tropical Diseases, WHO Collaborating Centre for TB elimination and TB/HIV co-infection, University of Brescia, Brescia, Italy.
  • Martínez Robles E Internal Medicine Dept, Tuberculosis Unit, Hospital de Cantoblanco - Hospital General Universitario La Paz, Madrid, Spain.
  • Matteelli A Clinic of Infectious and Tropical Diseases, WHO Collaborating Centre for TB elimination and TB/HIV co-infection, University of Brescia, Brescia, Italy.
  • Mazza-Stalder J Division of Pulmonary Medicine, University Hospital of Lausanne CHUV, Lausanne, Switzerland.
  • Moschos C Dept of Tuberculosis, Sotiria Athens Hospital of Chest Diseases, Athens, Greece.
  • Muñoz-Torrico M Clínica de Tuberculosis, Instituto Nacional De Enfermedades Respiratorias Ismael Cosio Villegas, Ciudad De Mexico, Mexico.
  • Mustafa Hamdan H MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan.
  • Nakčerienė B National TB Registry, Public Health Dept, Ministry of Health, Vilnius, Lithuania.
  • Nicod L Division of Pulmonary Medicine, University Hospital of Lausanne CHUV, Lausanne, Switzerland.
  • Nieto Marcos M Internal Medicine Dept, Hospital Doctor Moliner, Valencia, Spain.
  • Palmero DJ Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina.
  • Palmieri F Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases "L. Spallanzani", IRCCS, Rome, Italy.
  • Papavasileiou A Dept of Tuberculosis, Sotiria Athens Hospital of Chest Diseases, Athens, Greece.
  • Payen MC Division of Infectious Diseases, CHU Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium.
  • Pontarelli A Reference Center for MDR-TB and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy.
  • Quirós S Pneumology Dept, Tuberculosis Unit, Hospital de Cantoblanco - Hospital General Universitario La Paz, Madrid, Spain.
  • Rendon A Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias CIPTIR, University Hospital of Monterrey UANL (Universidad Autonoma de Nuevo Leon), Monterrey, Mexico.
  • Saderi L Clinical Epidemiology and Medical Statistics Unit, Dept of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
  • Šmite A MDR-TB Dept, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia.
  • Solovic I National Institute for TB, Lung Diseases and Thoracic Surgery, Vysne Hagy, Catholic University Ruzomberok, Ruzomberok, Slovakia.
  • Souleymane MB Tuberculosis Division, Damien Foundation, Niamey, Niger.
  • Tadolini M Unit of Infectious Diseases, Dept of Medical and Surgical Sciences Alma Mater Studiorum University of Bologna, Bologna, Italy.
  • van den Boom M World Health Organization Regional Office for Europe, Copenhagen, Denmark.
  • Vescovo M Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina.
  • Viggiani P Reference Center for MDR-TB and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy.
  • Yedilbayev A World Health Organization Regional Office for Europe, Copenhagen, Denmark.
  • Zablockis R Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
  • Zhurkin D Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus.
  • Zignol M Global Tuberculosis Programme, World Health Organization, Geneva, Switzerland.
  • Visca D Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy.
  • Spanevello A Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy.
  • Caminero JA Pneumology Dept, Hospital General de Gran Canaria "Dr. Negrin", Las Palmas de Gran Canaria, Spain.
  • Alffenaar JW University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, Australia.
  • Tiberi S Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
  • Centis R Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy.
  • D'Ambrosio L Public Health Consulting Group, Lugano, Switzerland.
  • Pontali E Dept of Infectious Diseases, Galliera Hospital, Genova, Italy.
  • Sotgiu G Clinical Epidemiology and Medical Statistics Unit, Dept of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
  • Migliori GB Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy giovannibattista.migliori@icsmaugeri.it.
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  • 2019-10-12
Published in:
  • The European respiratory journal. - 2019
Adult
Aged
Antitubercular Agents
Drug-Related Side Effects and Adverse Reactions
Female
Humans
Male
Middle Aged
Pharmacovigilance
Prospective Studies
Tuberculosis, Multidrug-Resistant
English 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.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://folia.unifr.ch/global/documents/44628
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