SVMPharma’s Real World Treatment Evaluator tool helped deliver the first real-world multicentre study of the use of inhaled aztreonam lysine in clinical practice for cystic fibrosis (CF) patients. Our treatment evaluator tool provided valuable insights and demonstrated significant improvement in lung function in CF patients in a real-world setting.
A treatment evaluator tool to monitor the real-world effectiveness of inhaled aztreonam lysine in cystic fibrosis
Barry J Plant, Damian G Downey, Joe A Eustace, Cedric Gunaratnam, Charles S Haworth,
Andrew M Jones, Edward F McKone, Daniel G Peckham, R. Ian Ketchell, Diana Bilton
Background: Studies are required that evaluate real-world outcomes of inhaled aztreonam lysine in patients with cystic fibrosis (CF).
Methods: Our treatment-evaluator tool assessed the effectiveness of inhaled aztreonam in routine practice in 117 CF patients across four time periods (6–12 (P2) and 0–6 months (P1) pre-initiation, and 0–6 (T1) and 6–12 months (T2) post-initiation). Outcomes were: changes in %-predicted forced expiratory volume in 1 s (FEV1), body-mass index (BMI), hospitalisation days and intravenous antibiotic usage.
Results: Median FEV1% predicted for each 6-month period was 38.9%, 34.6%, 37.1% and 36.5%; median change was −2.0% between P2 and P1, increasing to +0.6% (p b 0.001) between P1 and T1. Annualised hospital bed-days was reduced (p = 0.05) post-initiation, as was intravenous antibiotics days (p = 0.001). BMI increased over 6 months post-initiation (p ≤ 0.001).
Conclusions: In patients with CF in routine practice, inhaled aztreonam lysine is associated with improved lung function and weight, and reduced hospitalisation and intravenous antibiotic use.
© 2017 The Authors. Published by Elsevier B.V. on behalf of European Cystic Fibrosis Society.
This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Click here to read the full study
SVMPharma is an innovative strategic consultancy, specialising in Real World Evidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe through bespoke online Real World Treatment Evaluators, leading to successful health technology appraisal (HTA) submissions. Clinical trial programmes do not reflect real-world clinical practice and outcomes, RWE supplements and enhances clinical datasets. SVMPharma’s specialist teams focus on delivering the outcomes that matter to your brand.