期刊
RESPIRATORY MEDICINE
卷 113, 期 -, 页码 74-79出版社
W B SAUNDERS CO LTD
DOI: 10.1016/j.rmed.2016.02.001
关键词
Forced vital capacity; Acute exacerbations; Disease progression; Quality of life; Mortality
资金
- Boehringer Ingelheim by Julie Fleming and Wendy Morris of Fleishman-Hillard Group, Ltd, London, UK
Background and purpose: The Phase II TOMORROW trial and two Phase III INPULSIS (R) trials investigated the efficacy and safety of nintedanib versus placebo in patients with idiopathic pulmonary fibrosis (IPF). To obtain an overall estimate of the treatment effect of nintedanib 150 mg twice daily (bid), pooled and meta-analyses of data from these three trials were conducted. Methods: Pooled and meta-analyses were conducted for annual rate of decline in forced vital capacity (FVC), time to first acute exacerbation, change from baseline in St George's Respiratory Questionnaire (SGRQ) total score and mortality over 52 weeks. Results: 1231 patients (nintedanib n = 723, placebo n = 508) were included in the pooled analysis. Adjusted annual rate of decline in FVC was -112.4 mL/year with nintedanib and -223.3 mL/year with placebo (difference: 110.9 mL/year [95% CI: 78.5, 143.3]; p < 0.0001). The hazard ratio for time to first acute exacerbation was 0.53 (95% CI: 0.34, 0.83; p = 0.0047). Adjusted mean change from baseline in SGRQ score at week 52 was 2.92 with nintedanib and 4.97 with placebo (difference: -2.05 [95% CI: -3.59, -0.50]; p = 0.0095). Hazard ratios for time to all-cause and on-treatment mortality were 0.70 (95% CI: 0.46, 1.08; p = 0.0954) and 0.57 (95% CI: 0.34, 0.97; p = 0.0274), respectively, in favour of nintedanib. The meta-analysis was generally consistent with the pooled analysis. Diarrhoea was the most frequent adverse event in the nintedanib group (61.5% of patients treated with nintedanib versus 17.9% of patients treated with placebo). Conclusion: Nintedanib has a beneficial effect on slowing disease progression in patients with IPF. (C) 2016 The Authors. Published by Elsevier Ltd.
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