Leukotriene Antagonists as First-Line or Add-on Asthma-Controller Therapy

Price, David; Musgrave, Stanley D.; Shepstone, Lee; Hillyer, Elizabeth V.; Sims, Erika J.; Gilbert, R.F.T.; Juniper, Elizabeth F.; Ayres, Jon G.; Kemp, Linda; Blyth, Andrew; Wilson, Ed; Wolfe, Stephanie; Freeman, Daryl; Mugford, H. Miranda; Murdoch, Jamie; Harvey, Ian

doi:10.1056/nejmoa1010846

Cited by 220 publications

(126 citation statements)

References 35 publications

Supporting

Mentioning

118

Contrasting

Unclassified

Order By: Relevance

“…Moreover, this study included non-adherent patients in the final analysis, thus providing valuable information for real life practice [94]. Evidence of how real life variables can subvert the ideal conclusions from RCTs was provided in a study on the efficacy of leukotriene receptor antagonists (LTRAs), a second line treatment for asthma in adults in RCT settings [95]. This study was a multicenter pragmatic trial that compared the real world effectiveness of 1) LTRA with low dose inhaled glucocorticoid as first-line asthma-controller therapy, and of 2) LTRA with LABA as add-on therapy in patients not controlled by low dose ICS [95].…”

Section: Real Life Studies: Advantagesmentioning

confidence: 99%

“…Evidence of how real life variables can subvert the ideal conclusions from RCTs was provided in a study on the efficacy of leukotriene receptor antagonists (LTRAs), a second line treatment for asthma in adults in RCT settings [95]. This study was a multicenter pragmatic trial that compared the real world effectiveness of 1) LTRA with low dose inhaled glucocorticoid as first-line asthma-controller therapy, and of 2) LTRA with LABA as add-on therapy in patients not controlled by low dose ICS [95]. The treatments were proven to be equivalent for asthma control, with a greater compliance to oral treatment compared to inhaled treatment, which contribute to make a second line oral treatment (LTRA) appear as effective as first choice inhaled treatment [95].…”

Section: Real Life Studies: Advantagesmentioning

confidence: 99%

“…This study was a multicenter pragmatic trial that compared the real world effectiveness of 1) LTRA with low dose inhaled glucocorticoid as first-line asthma-controller therapy, and of 2) LTRA with LABA as add-on therapy in patients not controlled by low dose ICS [95]. The treatments were proven to be equivalent for asthma control, with a greater compliance to oral treatment compared to inhaled treatment, which contribute to make a second line oral treatment (LTRA) appear as effective as first choice inhaled treatment [95]. This was confirmed in children, where adherence to monotherapy with LTRA was better than to that of ICS [96].…”

Section: Real Life Studies: Advantagesmentioning

confidence: 99%

See 2 more Smart Citations

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

Saturni¹,

Bellini²,

Braido³

et al. 2014

Pulmonary Pharmacology & Therapeutics

189

155

View full text Add to dashboard Cite

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.

show abstract

Section: Real Life Studies: Advantagesmentioning

confidence: 99%

Section: Real Life Studies: Advantagesmentioning

confidence: 99%

Section: Real Life Studies: Advantagesmentioning

confidence: 99%

See 1 more Smart Citation

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

Saturni¹,

Bellini²,

Braido³

et al. 2014

Pulmonary Pharmacology & Therapeutics

189

155

View full text Add to dashboard Cite

show abstract

“…These findings are contrary to guideline recommendations, 15 possibly due to the recruitment of patients such as the elderly, the obese or cigarette smokers 4 who are often excluded from clinical trials.…”

Section: Real-life Studiesmentioning

confidence: 75%

Developments in the diagnosis and management of asthma

Thomson¹

2013

Prescriber

View full text Add to dashboard Cite

show abstract

“…The qualitative study described was undertaken in East anglia, England, as part of a large randomized controlled trial called ELEVatE (Price et al 2011), 1 which compared the clinical and cost effectiveness of different asthma medications. Qualitative study participants were recruited from those taking part in the ELEVatE study who were previously known to have been (or labelled as) non-adherent to prophylactic asthma treatment (n=54).…”

Section: The Studymentioning

confidence: 99%