Association between the introduction of a new cystic fibrosis inhaled antibiotic class and change in prevalence of patients receiving multiple inhaled antibiotic classes

Dasenbrook, Elliott C.; Konstan, Michael W.; VanDevanter, Donald R.

doi:10.1016/j.jcf.2014.11.005

Cited by 26 publications

(26 citation statements)

References 11 publications

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“…Therapeutic inertia refers to the under‐prescription of efficacious treatments . In CF, the prescription of inhaled therapies have increased since mid 1990s . Adherence rates to international prescribing guidelines now exceed 90% for some specialist CF centres .…”

Section: Discussionmentioning

confidence: 99%

Rescue therapy within the UK Cystic Fibrosis Registry: An exploration of predictors of intravenous antibiotic use amongst adults with CF

et al. 2017

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Background and objectiveIntravenous (i.v.) antibiotics are needed for rescue when preventative therapy fails to achieve stability among adults with cystic fibrosis (CF). Understanding the distribution of i.v. days can provide insight into the care that adults with CF need. We aim to determine the baseline characteristics that are associated with higher i.v. use, in particular to test the hypothesis that prior‐year i.v. use is associated with future‐year i.v. use.MethodsThis is a cross‐sectional analysis of the 2013–2014 UK CF registry data. Stepwise logistic regression was performed using current‐year i.v. days as the dependent variable, and demographic variables including prior‐year i.v. days as the covariates. Based on these results, study sample was divided into clinically meaningful subgroups using analysis similar to tree‐based method.ResultsData were available for 4269 adults in 2013 and 4644 adults in 2014. Prior‐year i.v. use was the strongest predictor for current‐year i.v. use followed by forced expiratory volume in 1 s (FEV1). Adults with high prior‐year i.v. use (>14 days) continued to require high levels of i.v., regardless of FEV1. Those with high prior‐year i.v. use and FEV1 ≥70% had higher current‐year i.v. days compared to adults with low prior‐year i.v. use and FEV1 <40% (28 days, interquartile range (IQR): 11–41 days vs 14 days, IQR: 0–28 days; Mann–Whitney P‐value <0.001 in 2013).Conclusion CF people with prior high levels of rescue often continue to need high levels of rescue even if they have good FEV1. The reasons for this require further investigations.

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Section: Discussionmentioning

confidence: 99%

Rescue therapy within the UK Cystic Fibrosis Registry: An exploration of predictors of intravenous antibiotic use amongst adults with CF

et al. 2017

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“…Unfortunately, while randomized controlled CF inhaled antibiotic study designs were balkanizing the 28-day off-drug period, North American standards of CF care for patients with more advanced disease were evolving to be much closer to the older European model of continuous treatment originated with inhaled colistimethate [16,22,23]. Today, most US CF patients with measurable lung disease who receive inhaled antibiotics are treated continuously, with either monotherapy or regular rotation of multiple inhaled antibiotic classes [23].…”

Section: Efficacy Of Chronic Inhaled Antibiotic Treatmentsmentioning

confidence: 99%

“…Today, most US CF patients with measurable lung disease who receive inhaled antibiotics are treated continuously, with either monotherapy or regular rotation of multiple inhaled antibiotic classes [23]. This shift in North American practice has now made both placebo-controlled studies and 28-day on/off studies of inhaled antibiotics less feasible in those patients with the greatest potential to benefit from new classes of inhaled antibiotics.…”

Section: Efficacy Of Chronic Inhaled Antibiotic Treatmentsmentioning

confidence: 99%

“…In contrast to estimation of lung function benefit, which can be readily demonstrated within weeks, demonstration of a reduced exacerbation incidence or risk requires substantially longer studies [22]. Given that patients with the greatest medical need are apparently receiving (extemporaneous) continuous inhaled antibiotic therapy [23], it is not clear how to choose a valid/acceptable active inhaled antibiotic comparator for extended studies.…”

Section: Efficacy Of Chronic Inhaled Antibiotic Treatmentsmentioning

confidence: 99%

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Innovating cystic fibrosis clinical trial designs in an era of successful standard of care therapies

VanDevanter

Mayer-Hamblett

2017

Current Opinion in Pulmonary Medicine

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Purpose of review Evolving cystic fibrosis (CF) ‘standards of care’ have influenced recent CF clinical trial designs for new therapies; care additions/improvements will require innovative trial designs to maximize feasibility and efficacy detection. Recent findings Three CF therapeutic areas (pulmonary exacerbations, Pseudomonas aeruginosa airway infections, and reduced CF Transmembrane Conductance Regulator [CFTR] protein function) differ with respect to the duration for which recognized ‘standards of care’ have been available. However, developers of new therapies in all three areas are affected by similar challenge: standards of care have become so strongly entrenched that traditional placebo-controlled studies in CF populations likely to benefit from newer therapies have become less and less feasible. Today, patients/clinicians are more likely to entertain participation in active comparator trial designs, which have substantial challenges of their own. Foremost among these are the selection of ‘valid’ active comparator(s), estimation of a comparator’s current clinical efficacy (required for testing non-inferiority hypotheses), and effective blinding of commercially available comparators. Summary Recent and future CF clinical trial designs will have to creatively address this collateral result of successful past development of effective CF therapies: patients and clinicians are much less likely to accept simple, placebo-controlled studies to evaluate future therapies.

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“…However, evidence from clinical trials shows that during the "off" periods, patients lose lung function that was gained during "on" treatment periods and experience a worsened quality of life [4][5][6]. As a result, many CF physicians have moved to using continuous inhaled antibiotic therapy in their patients, either as monotherapy with a single agent used every month or as continuous alternating therapy (CAT) with 2 or more agents [7]. This practice has led to a need for randomized, prospective clinical trial data to determine whether a continuous antibiotic regimen offers further improvement in pulmonary outcomes compared with an intermittent strategy.…”

Section: Introductionmentioning

confidence: 99%

Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis

Flume

Clancy

Retsch‐Bogart

et al. 2016

Journal of Cystic Fibrosis

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Association between the introduction of a new cystic fibrosis inhaled antibiotic class and change in prevalence of patients receiving multiple inhaled antibiotic classes

Cited by 26 publications

References 11 publications

Rescue therapy within the UK Cystic Fibrosis Registry: An exploration of predictors of intravenous antibiotic use amongst adults with CF

Rescue therapy within the UK Cystic Fibrosis Registry: An exploration of predictors of intravenous antibiotic use amongst adults with CF

Innovating cystic fibrosis clinical trial designs in an era of successful standard of care therapies

Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis

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