Device type and real-world effectiveness of asthma combination therapy: An observational study

Price, David; Roche, N.; Virchow, J. Christian; Burden, Annie; Ali, Muzammil; Chisholm, Alison; Lee, Dean A.; Hillyer, Elizabeth V.; Ziegenweidt, Julie von

doi:10.1016/j.rmed.2011.04.010

Cited by 64 publications

(46 citation statements)

References 36 publications

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“…Based on differences identified through exploratory analysis of baseline variables and predictive modeling of the baseline data in relation to the primary outcome variable (independent of treatment group), individual patients from the comparator and reference budesonide cohorts were matched to ensure the comparison of similar patients as in previous studies from our group 26,27. Exact matching for categorical variables and coarsened exact matching for numeric variables were used to match patients using 1:1 nearest neighbor matching, without replacement.…”

Section: Methodsmentioning

confidence: 99%

Real-life effectiveness and safety of the inhalation suspension budesonide comparator vs the originator product for the treatment of patients with asthma: a historical cohort study using a US health claims database

Price

Gefen

Gopalan

et al. 2017

POR

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Objective: The objective of this study was to determine whether the effectiveness of budesonide comparator is non-inferior to budesonide reference in the prevention of asthma exacerbations. Asthma-related hospitalizations and safety were also examined. Methods: This study used a matched, historic cohort design. Data were drawn from the Clinformatics ™ Data Mart US claims database and included a 1-year baseline, starting 1 year before the index prescription date, and a 1-year outcome period. Patients received budesonide comparator or reference treatment. The primary outcome was the rate of asthma exacerbations. Non-inferiority for budesonide comparator vs budesonide reference was established if the 95% confidence interval (CI) upper limit of mean difference in proportions between treatments was <15%. Secondary outcomes examined rate of asthma-related hospitalizations and adverse events (AEs). Results:The budesonide comparator and reference-matched cohorts each included 3109 patients. The adjusted upper 95% CI for the difference in proportions of patients experiencing asthma exacerbations was 0.035 (3.5%), demonstrating non-inferiority. Cohorts did not significantly differ in the rate of asthma exacerbations (adjusted rate ratio [RR]=1.04, 95% CI: 0.95-1.14) or rate of asthma-related hospitalizations (adjusted RR=1.10, 95% CI: 0.99-1.24) after adjusting for baseline confounders. No asthma exacerbations occurred during the outcome period in 72.9% of budesonide comparator patients and 71.8% of budesonide reference patients. No asthma-related hospitalizations occurred in 77.9% of patients in the budesonide comparator cohort and 79.0% of patients in the budesonide reference cohort. The most frequent AEs were throat irritation (≤0.4% of patients) and hoarseness/dysphonia (0.02% of patients). AEs did not significantly differ between treatment cohorts. Conclusion:In this real-life study, non-inferiority of the budesonide comparator vs reference was met for the primary end point of asthma exacerbation rates. Asthma-related hospitalization and AE rates did not differ between the two treatment cohorts. The budesonide comparator is an effective and safe treatment alternative for asthma exacerbations.

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Section: Methodsmentioning

confidence: 99%

Real-life effectiveness and safety of the inhalation suspension budesonide comparator vs the originator product for the treatment of patients with asthma: a historical cohort study using a US health claims database

Price

Gefen

Gopalan

et al. 2017

POR

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“…A cohort study demonstrated that monotherapy with inhaled corticosteroids (ICS) is more successful when patients use breathactuated pressurized metered dose inhalers (BA-pMDIs) or dry powder inhalers (DPIs) rather than pressurized metered dose inhalers (pMDIs) [90]. Interestingly, the opposite was found for combination therapy ICS þ long acting beta2 agonist (LABA), where a cohort study reported that a pMDI formulation of fluticasonee salmeterol provides greater benefits than a DPIs formulation [91]; moreover, a cross-sectional trial demonstrated that an extrafine formulation of beclomethasoneeformoterol combination pMDI leads to better asthma control than ICS/LABA formulations DPIs [92]. These apparently conflicting results require careful interpretation but they underscore the importance of device selection and show how it can potentially influence clinical outcomes in real life.…”

Section: Real Life Studies: Advantagesmentioning

confidence: 99%

Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view.

Saturni¹,

Bellini²,

Braido³

et al. 2014

Pulmonary Pharmacology & Therapeutics

194

155

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a b s t r a c tRandomized Controlled Trials (RCTs) are the "gold standard" for evaluating treatment outcomes providing information on treatments "efficacy". They are designed to test a therapeutic hypothesis under optimal setting in the absence of confounding factors. For this reason they have high internal validity. The strict and controlled conditions in which they are conducted, leads to low generalizability because they are performed in conditions very different from real life usual care. Conversely, real life studies inform on the "effectiveness" of a treatment, that is, the measure of the extent to which an intervention does what is intended to do in routine circumstances. At variance to RCTs, real life trials have high generalizability, but low internal validity. Recently the number of real life studies has been rapidly growing in different areas of respiratory medicine, particularly in asthma and COPD. The role of such studies is becoming a hot topic in respiratory medicine, attracting research interest and debate.In the first part of this review we discuss some of the advantages and disadvantages of different types of RCTs and analyze the strengths and weaknesses of real life trials, considering the recent examples of some studies conducted in COPD. We then discuss methodological approaches and options to overcome some of the limitations of real life studies.Comparing the conclusions of effectiveness and efficacy trials can provide important pieces of information. Indeed, these approaches can result complementary, and they can guide the interpretation of each other results.

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“…(22)(23)(24) The introduction of a device new to the patient may also affect disease control. (25) Similarly, problems with perceived asthma control may occur when patients are switched to generic inhaled products without their consent. (26) These problems may be related to a decline in adherence due to lack of confidence in the new product, although it is likely that the demands of becoming competent in the use of a new inhaler device (particularly if training has been inadequate) also have a negative influence.…”

Section: Impact Of Poor Inhaler Competencementioning

confidence: 99%

Emerging Technologies for Electronic Monitoring of Adherence, Inhaler Competence, and True Adherence

Pritchard

Nicholls²

2015

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Despite the availability of effective treatments for respiratory disorders, disease control is often suboptimal, due in part to the failure of patients to adhere to prescribed regimens, or to demonstrate competence with the often complex steps in the administration of inhaled medications. The cost of poor true adherence, a combined measure of adherence and inhaler competence, is considerable, both economically and in terms of health-related impact. While patient education is recognized as essential, there exist many barriers to healthcare professional-led monitoring and promotion of true adherence. Successful intervention remains a challenging task, dependent upon understanding and addressing the distinct issues associated with poor adherence and inhaler competence, and lessening the perceived burden on healthcare professionals. Electronic monitors provide an accurate and objective indication of adherence and may also be of value in assessing inhaler competence. The information provided by such devices is a helpful aid to understanding the challenging nature of true adherence, and may be crucial to the development and assessment of true adherence promoting interventions. This article provides a background to the impact of suboptimal adherence and inhaler competence, and the challenges associated with the promotion of true adherence, with an emphasis on respiratory therapies. Contemporary electronic monitors of adherence and inhaler competence are critically reviewed, and case studies of emerging technologies are provided to illustrate the use of innovative monitoring devices in the promotion of true adherence in practice. Potential future directions, including increased targeting and individualization, enhanced coordination of care, and a greater focus on inhaler competence are considered to be important additions to currently available technologies in this rapidly evolving field.

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Device type and real-world effectiveness of asthma combination therapy: An observational study

Abstract: For UK primary care patients, pMDIs appear to achieve better asthma control outcomes than DPIs for delivery of FDC fluticasone-salmeterol. Pragmatic trials are needed to further investigate real-world outcomes with different inhaler devices for combination therapy.

Cited by 64 publications

References 36 publications

Real-life effectiveness and safety of the inhalation suspension budesonide comparator vs the originator product for the treatment of patients with asthma: a historical cohort study using a US health claims database

Real-life effectiveness and safety of the inhalation suspension budesonide comparator vs the originator product for the treatment of patients with asthma: a historical cohort study using a US health claims database

Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view.

Emerging Technologies for Electronic Monitoring of Adherence, Inhaler Competence, and True Adherence

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