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Continuous glucose monitoring and advanced glycation endproducts for prediction of clinical outcomes and development of cystic fibrosis-related diabetes in adults with CF.
Scully KJ, Brenner L, Martin K, Ruazol M, Sawicki GS, Uluer A, Neuringer I, Yonker LM, Sicilian L, Putman MS. Scully KJ, et al. Among authors: sawicki gs. Front Endocrinol (Lausanne). 2024 Feb 6;15:1293709. doi: 10.3389/fendo.2024.1293709. eCollection 2024. Front Endocrinol (Lausanne). 2024. PMID: 38379863 Free PMC article.
We previously reported that CGM measures of hyperglycemia and glycemic variability are superior to hemoglobin A1c (HbA1c) in distinguishing those with and without CFRD. However, little is known about the long-term predictive value of CGM measures of glycemia for both the d …
We previously reported that CGM measures of hyperglycemia and glycemic variability are superior to hemoglobin A1c (HbA1c) in distinguishing …
Real-world feasibility of short-term, unsupervised home spirometry in CF.
Davis J, Ryan M, Marchetti P, Dahlberg SE, Greenberg J, Bacon C, Kaur R, Scalia S, Sawicki GS. Davis J, et al. Among authors: sawicki gs. Pediatr Pulmonol. 2022 Dec;57(12):3129-3135. doi: 10.1002/ppul.26147. Epub 2022 Sep 27. Pediatr Pulmonol. 2022. PMID: 36124390
OBJECTIVES: The objective of this study was to study the performance of two available home spirometers used by people with Cystic Fibrosis (PwCF) over a short-term period and to assess user experience. STUDY DESIGN: This was a prospective observational study. ...
OBJECTIVES: The objective of this study was to study the performance of two available home spirometers used by people with Cystic Fibrosis ( …
A Phase 3, open-label, 96-week trial to study the safety, tolerability, and efficacy of tezacaftor/ivacaftor in children ≥ 6 years of age homozygous for F508del or heterozygous for F508del and a residual function CFTR variant.
Sawicki GS, Chilvers M, McNamara J, Naehrlich L, Saunders C, Sermet-Gaudelus I, Wainwright CE, Ahluwalia N, Campbell D, Harris RS, Paz-Diaz H, Shih JL, Davies JC. Sawicki GS, et al. J Cyst Fibros. 2022 Jul;21(4):675-683. doi: 10.1016/j.jcf.2022.02.003. Epub 2022 Feb 18. J Cyst Fibros. 2022. PMID: 35190292 Free article. Clinical Trial.
CONCLUSIONS: Tezacaftor/ivacaftor is generally safe and well tolerated, and treatment effects are maintained for up to 120 weeks. These results support long-term use of tezacaftor/ivacaftor in children 6 years of age with CF and F/F or F/RF genotypes....
CONCLUSIONS: Tezacaftor/ivacaftor is generally safe and well tolerated, and treatment effects are maintained for up to 120 weeks. These resu …
Financial impacts of the COVID-19 pandemic on cystic fibrosis care: lessons for the future.
Sawicki GS, Van Citters AD, Dieni O, Sabadosa KA, Willis A, Benitez D, Ong T, Dasenbrook EC. Sawicki GS, et al. J Cyst Fibros. 2021 Dec;20 Suppl 3:16-20. doi: 10.1016/j.jcf.2021.09.008. J Cyst Fibros. 2021. PMID: 34930535 Free PMC article.
Planning for the future of CF care model needs to address these short-term impacts, particularly to ensure a lack of interruption in high-quality multi-disciplinary care....
Planning for the future of CF care model needs to address these short-term impacts, particularly to ensure a lack of interruption in …
The effect of elexacaftor/tezacaftor/ivacaftor (ETI) on glycemia in adults with cystic fibrosis.
Scully KJ, Marchetti P, Sawicki GS, Uluer A, Cernadas M, Cagnina RE, Kennedy JC, Putman MS. Scully KJ, et al. Among authors: sawicki gs. J Cyst Fibros. 2022 Mar;21(2):258-263. doi: 10.1016/j.jcf.2021.09.001. Epub 2021 Sep 14. J Cyst Fibros. 2022. PMID: 34531155 Free PMC article.
Further studies are needed to investigate underlying etiology of these changes and the long-term impact of ETI on glycemic control in patients with CF....
Further studies are needed to investigate underlying etiology of these changes and the long-term impact of ETI on glycemic control in …
Long-term safety and efficacy of tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study.
Flume PA, Biner RF, Downey DG, Brown C, Jain M, Fischer R, De Boeck K, Sawicki GS, Chang P, Paz-Diaz H, Rubin JL, Yang Y, Hu X, Pasta DJ, Millar SJ, Campbell D, Wang X, Ahluwalia N, Owen CA, Wainwright CE; VX14-661-110 study group. Flume PA, et al. Among authors: sawicki gs. Lancet Respir Med. 2021 Jul;9(7):733-746. doi: 10.1016/S2213-2600(20)30510-5. Epub 2021 Feb 10. Lancet Respir Med. 2021. PMID: 33581080
Here, we present results of study 661-110 (EXTEND), a 96-week open-label extension study that assessed long-term safety, tolerability, and efficacy of tezacaftor-ivacaftor in participants aged 12 years or older with cystic fibrosis who were homozygous or heterozygous for t …
Here, we present results of study 661-110 (EXTEND), a 96-week open-label extension study that assessed long-term safety, tolerability …
Evaluating the Impact of Stopping Chronic Therapies after Modulator Drug Therapy in Cystic Fibrosis: The SIMPLIFY Clinical Trial Study Design.
Mayer-Hamblett N, Nichols DP, Odem-Davis K, Riekert KA, Sawicki GS, Donaldson SH, Ratjen F, Konstan MW, Simon N, Rosenbluth DB, Retsch-Bogart G, Clancy JP, VanDalfsen JM, Buckingham R, Gifford AH. Mayer-Hamblett N, et al. Among authors: sawicki gs. Ann Am Thorac Soc. 2021 Aug;18(8):1397-1405. doi: 10.1513/AnnalsATS.202010-1336SD. Ann Am Thorac Soc. 2021. PMID: 33465316 Free PMC article.
The protocol is composed of two concurrent randomized controlled trials designed to evaluate the independent short-term effects of discontinuing hypertonic saline or dornase alfa, enabling individuals on both therapies to participate in one or both trials. ...
The protocol is composed of two concurrent randomized controlled trials designed to evaluate the independent short-term effects of di …
Disease progression in patients with cystic fibrosis treated with ivacaftor: Data from national US and UK registries.
Volkova N, Moy K, Evans J, Campbell D, Tian S, Simard C, Higgins M, Konstan MW, Sawicki GS, Elbert A, Charman SC, Marshall BC, Bilton D. Volkova N, et al. Among authors: sawicki gs. J Cyst Fibros. 2020 Jan;19(1):68-79. doi: 10.1016/j.jcf.2019.05.015. Epub 2019 Jun 10. J Cyst Fibros. 2020. PMID: 31196670 Free article.
BACKGROUND: Ivacaftor is the first in a class of drugs, CFTR modulators, that target the underlying defect in cystic fibrosis (CF). This long-term observational safety study evaluated CF disease progression in patients treated with ivacaftor in a real-world setting for up …
BACKGROUND: Ivacaftor is the first in a class of drugs, CFTR modulators, that target the underlying defect in cystic fibrosis (CF). This lon …
Data from the US and UK cystic fibrosis registries support disease modification by CFTR modulation with ivacaftor.
Bessonova L, Volkova N, Higgins M, Bengtsson L, Tian S, Simard C, Konstan MW, Sawicki GS, Sewall A, Nyangoma S, Elbert A, Marshall BC, Bilton D. Bessonova L, et al. Among authors: sawicki gs. Thorax. 2018 Aug;73(8):731-740. doi: 10.1136/thoraxjnl-2017-210394. Epub 2018 May 10. Thorax. 2018. PMID: 29748252 Free PMC article.
As ivacaftor is intended for chronic, lifelong use, understanding long-term effects is important for patients and healthcare providers. ...
As ivacaftor is intended for chronic, lifelong use, understanding long-term effects is important for patients and healthcare provider …
Cystic fibrosis patient registries: A valuable source for clinical research.
Dasenbrook EC, Sawicki GS. Dasenbrook EC, et al. Among authors: sawicki gs. J Cyst Fibros. 2018 Jul;17(4):433-440. doi: 10.1016/j.jcf.2018.03.001. Epub 2018 Mar 16. J Cyst Fibros. 2018. PMID: 29555479 Free article. Review.
Cystic Fibrosis (CF) patient registries are valuable data sources for researchers studying the natural history, treatment paradigms, and long-term health outcomes of individuals with CF. In this review, we discuss the role of CF patient registries in facilitating comparati …
Cystic Fibrosis (CF) patient registries are valuable data sources for researchers studying the natural history, treatment paradigms, and lon …
17 results