Body composition and weight changes after ivacaftor treatment in adults with cystic fibrosis carrying the G551 D cystic fibrosis transmembrane conductance regulator mutation: A double-blind, placebo-controlled, randomized, crossover study with open-label extension

Nutrition - Tập 85 - Trang 111124 - 2021
Susannah J. King1,2,3, Audrey C. Tierney1,2,3,4, Deirdre Edgeworth2,5, Dominic Keating2,6, Elyssa Williams2, Tom Kotsimbos2,6, Brenda M. Button2,6,7, John W. Wilson2,6
1Nutrition Department, Alfred Hospital, Melbourne, Victoria, Australia
2Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia
3Department of Dietetics, Nutrition and Sport, LaTrobe University, Victoria, Australia
4School of Allied Health, University of Limerick, Limerick, Ireland
5Department of Anesthesia and Intensive Care Medicine, St James’ Hospital, Dublin, Ireland
6Department of Medicine, Monash University, Melbourne, Victoria, Australia
7Physiotherapy Department, Alfred Hospital, Melbourne, Victoria, Australia

Tài liệu tham khảo

Barry, 2014, Effects of ivacaftor in patients with cystic fibrosis who carry the G551D mutation and have severe lung disease, Chest, 146, 152, 10.1378/chest.13-2397 Davies, 2013, Efficacy and safety of ivacaftor in patients aged 6 to 11 years with cystic fibrosis with a G551D mutation, Am J Respir Crit Care Med, 187, 1219, 10.1164/rccm.201301-0153OC McKone, 2014, Long-term safety and efficacy of ivacaftor in patients with cystic fibrosis who have the Gly551Asp-CFTR mutation: A phase 3, open-label extension study (PERSIST), Lancet Respir Med, 2, 902, 10.1016/S2213-2600(14)70218-8 Ramsey, 2011, A CFTR potentiator in patients with cystic fibrosis and the G551D mutation, N Engl J Med, 365, 1663, 10.1056/NEJMoa1105185 Edgeworth, 2017, Improvement in exercise duration, lung function and well-being in G551D-cystic fibrosis patients: a double-blind, placebo-controlled, randomized, cross-over study with ivacaftor treatment, Clin Sci (Lond), 131, 2037, 10.1042/CS20170995 Flume, 2018, Recovery of lung function following a pulmonary exacerbation in patients with cystic fibrosis and the G551D-CFTR mutation treated with ivacaftor, J Cyst Fibros, 17, 83, 10.1016/j.jcf.2017.06.002 Rowe, 2014, Clinical mechanism of the cystic fibrosis transmembrane conductance regulator potentiator ivacaftor in G551D-mediated cystic fibrosis, Am J Respir Crit Care Med, 190, 175, 10.1164/rccm.201404-0703OC Yen, 2013, Better nutritional status in early childhood is associated with improved clinical outcomes and survival in patients with cystic fibrosis, J Pediatr, 162, 530, 10.1016/j.jpeds.2012.08.040 Sainath, 2019, Italian and North American dietary intake after ivacaftor treatment for Cystic Fibrosis Gating Mutations, J Cyst Fibros, 18, 135, 10.1016/j.jcf.2018.06.004 Stallings, 2018, Energy balance and mechanisms of weight gain with ivacaftor treatment of cystic fibrosis gating mutations, J Pediatr, 201, 229, 10.1016/j.jpeds.2018.05.018 King, 2014, Loss of fat-free mass over four years in adult cystic fibrosis is associated with high serum interleukin-6 levels but not tumour necrosis factor-alpha, Clin Nutr, 33, 150, 10.1016/j.clnu.2013.04.012 Sermet-Gaudelus, 2003, Insulin-like growth factor I correlates with lean body mass in cystic fibrosis patients, Arch Dis Child, 88, 956, 10.1136/adc.88.11.956 Bailey, 2020, Effect of CFTR modulators on anthropometric parameters in individuals with cystic fibrosis: An evidence analysis center systematic review, J Acad Nutr Diet, 10.1016/j.jand.2020.03.014 Alvarez, 2016, Body composition and lung function in cystic fibrosis and their association with adiposity and normal-weight obesity, Nutrition, 32, 447, 10.1016/j.nut.2015.10.012 Ionescu, 2003, Hidden depletion of fat-free mass and bone mineral density in adults with cystic fibrosis, Chest, 124, 2220, 10.1378/chest.124.6.2220 King, 2010, Fat-free mass depletion in cystic fibrosis: Associated with lung disease severity but poorly detected by body mass index, Nutrition, 26, 753, 10.1016/j.nut.2009.06.026 Earthman, 2015, Body composition tools for assessment of adult malnutrition at the bedside: A tutorial on research considerations and clinical applications, JPEN J Parenter Enteral Nutr, 39, 787, 10.1177/0148607115595227 Peleg, 2018, Antibiotic exposure and interpersonal variance mask the effect of ivacaftor on respiratory microbiota composition, J Cyst Fibros, 17, 50, 10.1016/j.jcf.2017.08.002 Bosy-Westphal, 2013, What makes a BIA equation unique? Validity of eight-electrode multifrequency BIA to estimate body composition in a healthy adult population, Eur J Clin Nutr, 67, S14, 10.1038/ejcn.2012.160 Madeira, 2013, Normal weight obesity is associated with metabolic syndrome and insulin resistance in young adults from a middle-income country, PloS One, 8, e60673, 10.1371/journal.pone.0060673 Narayanan, 2017, Adherence to therapies in cystic fibrosis: A targeted literature review, Expert Rev Respir Med, 11, 129, 10.1080/17476348.2017.1280399 Hubert, 2018, Retrospective observational study of French patients with cystic fibrosis and a Gly551Asp-CFTR mutation after 1 and 2 years of treatment with ivacaftor in a real-world setting, J Cyst Fibros, 17, 89, 10.1016/j.jcf.2017.07.001 Turck, 2016, ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis, Clin Nutr, 35, 557, 10.1016/j.clnu.2016.03.004 van der Haak, 2020, Highlights from the nutrition guidelines for cystic fibrosis in Australia and New Zealand, J Cyst Fibros, 19, 16, 10.1016/j.jcf.2019.05.007 McDonald, 2020, Academy of Nutrition and Dietetics: 2020 Cystic Fibrosis Evidence Analysis Center Evidence-based Nutrition Practice Guideline, J Acad Nutr Diet, 10.1016/j.jand.2020.03.015 Harindhanavudhi, 2020, Prevalence and factors associated with overweight and obesity in adults with cystic fibrosis: A single-center analysis, J Cyst Fibros, 19, 139, 10.1016/j.jcf.2019.10.004 Franssen, 2008, Obesity and the lung: 5. Obesity and COPD, Thorax, 63, 1110, 10.1136/thx.2007.086827 Wilson, 2017, The effect of ivacaftor CFTR gene-potentiating therapy on cytokine levels in CF patients with the G551D mutation, J Cyst Fibros, 16, S83, 10.1016/S1569-1993(17)30437-X Cheah, 2015, Cessation of pancreatic enzyme replacement therapy (PERT) after initiation of therapy wtih ivacaftor - A case series, J Cyst Fibros, 14, S51, 10.1016/S1569-1993(15)30165-X Heijerman, 2019, Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: A double-blind, randomised, phase 3 trial, Lancet, 394, 1940, 10.1016/S0140-6736(19)32597-8 Middleton, 2019, Elexacaftor–tezacaftor–ivacaftor for cystic fibrosis with a single Phe508del Allele, N Engl J Med, 381, 1809, 10.1056/NEJMoa1908639 Beaumesnil, 2011, Ginies JL Body composition analysis in patients with cystic fibrosis. Comparison of 3 methods: Dual energy x-ray absorptiometry, bioelectrical impedance analysis, and skinfold measurements, Arch Pediatr, 18, 370, 10.1016/j.arcped.2011.01.008 Charatsi, 2016, Bioelectrical impedance in young patients with cystic fibrosis: Validation of a specific equation and clinical relevance, J Cyst Fibros, 15, 825, 10.1016/j.jcf.2016.05.004 Alicandro, 2015, Estimating body composition from skinfold thicknesses and bioelectrical impedance analysis in cystic fibrosis patients, J Cyst Fibros, 14, 784, 10.1016/j.jcf.2015.07.011 King, 2005, Body composition assessment in adults with cystic fibrosis: Comparison of dual-energy x-ray absorptiometry with skinfolds and bioelectrical impedance analysis, Nutrition, 21, 1087, 10.1016/j.nut.2005.04.005 Ziai, 2014, Agreement of bioelectric impedance analysis and dual-energy X-ray absorptiometry for body composition evaluation in adults with cystic fibrosis, J Cyst Fibros, 13, 585, 10.1016/j.jcf.2014.01.006