Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis in Brazil
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.
| Errataetall: |
CommentIn: J Bras Pneumol. 2019 Oct 07;45(5):e20190303. - PMID 31596314 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:45 |
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| Enthalten in: |
Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia - 45(2019), 5 vom: 16. Sept., Seite e20180414 |
| Sprache: |
Portugiesisch |
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| Weiterer Titel: |
Segurança e tolerabilidade de Nintedanibe em pacientes com fibrose pulmonar idiopática no Brasil |
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| Beteiligte Personen: |
Pereira, Carlos Alberto de Castro [VerfasserIn] |
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| Links: |
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| Themen: |
Aspartate Aminotransferases |
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| Anmerkungen: |
Date Completed 10.04.2020 Date Revised 10.04.2022 published: Electronic CommentIn: J Bras Pneumol. 2019 Oct 07;45(5):e20190303. - PMID 31596314 Citation Status MEDLINE |
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| doi: |
10.1590/1806-3713/e20180414 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis in Brazil |
| 246 | 3 | 3 | |a Segurança e tolerabilidade de Nintedanibe em pacientes com fibrose pulmonar idiopática no Brasil |
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| 500 | |a CommentIn: J Bras Pneumol. 2019 Oct 07;45(5):e20190303. - PMID 31596314 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSION: In the Brazilian EAP, nintedanib had an acceptable safety and tolerability profile in patients with IPF, consistent with data from clinical trials | ||
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