Michael Kreuter, R Matthew Kottmann, Fengming Luo, Carl Coeck, Madhu Kanakapura, Christina Schlecker, Ivana Ritter, Tomohiro Handa
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引用次数: 0
Abstract
Introduction: Weight loss and malnutrition are poor prognostic factors in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). In this review, the effect of weight loss and body mass index (BMI) on the decline in forced vital capacity (FVC) was assessed using published secondary analyses of the placebo arms of clinical trials of nintedanib in IPF and PPF, as well as previously unpublished analyses of the INPULSIS trials in IPF.
Methods: Published secondary analyses of placebo arms from clinical trials of nintedanib in IPF and PPF were reviewed. In addition, previously unpublished analyses of pooled INPULSIS trial data in IPF were conducted to evaluate the relationship between baseline BMI, weight loss, and FVC decline.
Results: In published analyses, both low BMI at baseline and weight loss during treatment were associated with greater decline in FVC. New analyses of INPULSIS data indicated that the effect of weight loss on FVC decline was most pronounced in patients with lower BMI (< 25 kg/m2) at baseline. In those with mid-range BMI (25 to < 30 kg/m2), patients with weight loss > 5% also had a greater decline in FVC than those who lost ≤ 5% body weight. An adverse effect of weight loss was not observed in patients with high baseline BMI (≥ 30 kg/m2). While gastrointestinal events and weight loss are recognised side effects for nintedanib, patients treated with nintedanib had lower FVC decline than those given placebo in all subgroups, regardless of weight loss or baseline BMI.
Conclusion: Increased attention to nutrition and management of gastrointestinal side effects to help patients adhere to treatment can improve outcome of treatment for IPF and PPF.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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