Brazilian Journal of Pulmonology

ISSN (on-line): 1806-3756 | ISSN (printed): 1806-3713

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Recommendations for the pharmacological treatment of COPD: questions and answers

Recomendações para o tratamento farmacológico da DPOC: perguntas e respostas

Frederico Leon Arrabal Fernandes1, Alberto Cukier1, Aquiles Assunção Camelier2,3, Carlos Cezar Fritscher4, Cláudia Henrique da Costa5, Eanes Delgado Barros Pereira6, Irma Godoy7, José Eduardo Delfini Cançado8, José Gustavo Romaldini8, Jose Miguel Chatkin4, José Roberto Jardim9, Marcelo Fouad Rabahi10, Maria Cecília Nieves Maiorano de Nucci11, Maria da Penha Uchoa Sales12, Maria Vera Cruz de Oliveira Castellano13, Miguel Abidon Aidé14, Paulo José Zimermann Teixeira15,16, Renato Maciel17, Ricardo de Amorim Corrêa18, Roberto Stirbulov8, Rodrigo Abensur Athanazio1, Rodrigo Russo19, Suzana Tanni Minamoto7, Fernando Luiz Cavalcanti Lundgren20

J Bras Pneumol.2017;43(4):290-301

Abstract PDF PT PDF EN Portuguese Text

The treatment of COPD has become increasingly effective. Measures that range from behavioral changes, reduction in exposure to risk factors, education about the disease and its course, rehabilitation, oxygen therapy, management of comorbidities, and surgical and pharmacological treatments to end-of-life care allow health professionals to provide a personalized and effective therapy. The pharmacological treatment of COPD is one of the cornerstones of COPD management, and there have been many advances in this area in recent years. Given the greater availability of drugs and therapeutic combinations, it has become increasingly challenging to know the indications for, limitations of, and potential risks and benefits of each treatment modality. In order to critically evaluate recent evidence and systematize the major questions regarding the pharmacological treatment of COPD, 24 specialists from all over Brazil gathered to develop the present recommendations. A visual guide was developed for the classification and treatment of COPD, both of which were adapted to fit the situation in Brazil. Ten questions were selected on the basis of their relevance in clinical practice. They address the classification, definitions, treatment, and evidence available for each drug or drug combination. Each question was answered by two specialists, and then the answers were consolidated in two phases: review and consensus by all participants. The questions answered are practical questions and help select from among the many options the best treatment for each patient and his/her peculiarities.

 


Keywords: Pulmonary disease, chronic obstructive/drug therapy; pulmonary disease, chronic obstructive/prevention & control; pulmonary disease, chronic obstructive/therapy.

 


Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis in Brazil

Segurança e tolerabilidade de Nintedanibe em pacientes com fibrose pulmonar idiopática no Brasil

Carlos Alberto de Castro Pereira1,a, José Antonio Baddini-Martinez2,b, Bruno Guedes Baldi3,c, Sérgio Fernandes de Oliveira Jezler4,d, Adalberto Sperb Rubin5,e, Rogerio Lopes Rufino Alves6,f, Gilmar Alves Zonzin7,g, Manuel Quaresma8,h, Matthias Trampisch9,i, Marcelo Fouad Rabahi10,j

J Bras Pneumol.2019;45(5):e20180414-e20180414

Abstract PDF PT PDF EN Portuguese Text

Objective: Clinical trials have shown that nintedanib 150 mg twice daily (bid) reduces disease progression in patients with idiopathic pulmonary fibrosis (IPF), with an adverse event profile that is manageable for most patients. Prior to the approval of nintedanib as a treatment for IPF in Brazil, an expanded access program (EAP) was initiated to provide early access to treatment and to evaluate the safety and tolerability of nintedanib in this patient population. Methods: Patients with a diagnosis of IPF within the previous five years, forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity of the lungs for carbon monoxide (DLco) 30% to 79% predicted were eligible to participate in the EAP. Patients received nintedanib 150 mg bid open-label. Safety assessments included adverse events leading to permanent discontinuation of nintedanib and serious adverse events. Results: The EAP involved 57 patients at eight centers. Most patients were male (77.2%) and white (87.7%). At baseline, mean (SD) age was 70.7 (7.5) years and FVC was 70.7 (12.5) % predicted. Mean (SD) exposure to nintedanib was 14.4 (6.2) months; maximum exposure was 22.0 months. The most frequently reported adverse events considered by the investigator to be related to nintedanib treatment were diarrhea (45 patients, 78.9%) and nausea (25 patients, 43.9%). Adverse events led to permanent discontinuation of nintedanib in 16 patients (28.1%). Sixteen patients (28.1%) had a serious adverse event. Conclusion: In the Brazilian EAP, nintedanib had an acceptable safety and tolerability profile in patients with IPF, consistent with data from clinical trials.

 


Keywords: Drug tolerance; Expanded access program; Interstitial lung disease; Tyrosine kinase inhibitor.

 


 

 


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