What question did this study set out to answer?

To evaluate the efficacy and safety of four oral doses of the tyrosine kinase inhibitor BIBF 1120 compared with placebo in patients with idiopathic pulmonary fibrosis.

September 21, 2011New England Journal of MedicineOpen Access

Efficacy of a Tyrosine Kinase Inhibitor in Idiopathic Pulmonary Fibrosis

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Authors

LRLuca RicheldiUniversità Cattolica del Sacro Cuore UCUlrich CostabelCedars-Sinai Medical Center MSMoisés SelmanInstituto Nacional de Enfermedades Respiratorias

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Implication

Randomized trial demonstrates that BIBF 1120 slows lung function decline in idiopathic pulmonary fibrosis, suggesting potential therapeutic benefit.

Key Points

To evaluate the efficacy and safety of four oral doses of the tyrosine kinase inhibitor BIBF 1120 compared with placebo in patients with idiopathic pulmonary fibrosis.
In a 12-month, phase 2 trial (ClinicalTrials.gov number, NCT00514683), 432 patients were randomized to receive placebo or BIBF 1120 at doses of 50 mg once daily, 50 mg twice daily, 100 mg twice daily, or 150 mg twice daily.
The primary end point was the annual rate of decline in forced vital capacity (FVC); secondary end points included acute exacerbations, St. George's Respiratory Questionnaire (SGRQ) scores, and total lung capacity.
In the group receiving 150 mg twice daily, FVC declined by 0.06 liters per year compared with 0.19 liters per year with placebo, representing a 68.4% reduction in the rate of loss (P=0.06 with closed testing; P=0.01 with hierarchical testing).
The 150 mg twice-daily dose resulted in a significantly lower incidence of acute exacerbations (2.4 vs. 15.7 per 100 patient-years, P=0.02) and improved SGRQ scores compared with placebo (-0.66 vs. 5.46, P=0.007).
Gastrointestinal symptoms leading to study discontinuations and elevated liver aminotransferase levels were more common in the 150 mg twice-daily group than in the placebo group.

Cite This Study

Richeldi et al. (2011) studied this question.

synapsesocial.com/papers/6a7cebe9c25c3f1308a1e560 https://doi.org/10.1056/nejmoa1103690

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Implication

Randomized trial demonstrates that BIBF 1120 slows lung function decline in idiopathic pulmonary fibrosis, suggesting potential therapeutic benefit.

Efficacy of a Tyrosine Kinase Inhibitor in Idiopathic Pulmonary Fibrosis

Discussion

Member takes

Implication

Key Points

Cite This Study

Efficacy of a Tyrosine Kinase Inhibitor in Idiopathic Pulmonary Fibrosis

Discussion

Member takes

Implication

Key Points

Cite This Study

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