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Background : Information is lacking on the relative effectiveness and cost effectiveness — in a real-life primary-care setting — of leukotriene receptor antagonists (LTRAs) and long-acting β2 adrenergic receptor agonists (β2 agonists) as add-on therapy for patients whose asthma symptoms are not controlled on low-dose inhaled corticosteroids (ICS). Objective : To estimate the cost effectiveness of LTRAs compared with longacting β2 agonists as add-on therapy for patients whose asthma symptoms are not controlled on low-dose ICS. Methods : An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 1280 years with asthma insufficiently controlled with ICS (n = 361) were randomly assigned to add-on LTRAs (n = 176) or long-acting β2 agonists (n = 185). The main outcome measures were the incremental cost per point improvement in the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), per point improvement in the Asthma Control Questionnaire (ACQ) and per QALY gained from perspectives of the UK NHS and society. Results : Over 2 years, the societal cost per patient receiving LTRAs was £1157 versus £952 for long-acting b2 agonists, a (significant, adjusted) increase of d214 (95%CI 2, 411) [year 2005 values]. Patients receiving LTRAs experienced a non-significant incremental gain of 0.009 QALYs (95% CI −0.077, 0.103). The incremental cost per QALY gained from the societal (NHS) perspective was £22 589 (£11 919). Uncertainty around this point estimate suggested that, given a maximum willingness to pay of £30 000 per QALY gained, the probability that LTRAs are a cost-effective alternative to long-acting β2 agonists as add-on therapy was approximately 52% from both societal and NHS perspectives. Conclusions : On balance, these results marginally favour the repositioning of LTRAs as a cost-effective alternative to long-acting β2 agonists as add-on therapy to ICS for asthma. However, there is much uncertainty surrounding the incremental cost effectiveness because of similarity of clinical benefit and broad confidence intervals for differences in healthcare costs. Trial registration : UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.

In this pragmatic trial, patients with asthma who required first-line controller therapy or were already using an inhaled glucocorticoid and needed additional therapy received a leukotriene-receptor antagonist (LTRA) or an inhaled glucocorticoid as first-line treatment or an LTRA or a long-acting beta 2 -agonist as an add-on. Results of double-blind, randomized, controlled trials provide, appropriately, the bedrock of evidence in determining the efficacy of therapeutic interventions. Proof of efficacy in the trial setting of optimized adherence and follow-up for selective patient populations does not, however, guarantee that a particular therapy will be effective in the diverse patient populations seen in clinical practice. 1 – 3 In the case of asthma, for example, the eligibility criteria in most such trials exclude an estimated 95% of patients with a current diagnosis of asthma, including smokers and those who have “insufficient” bronchodilator reversibility or impaired pulmonary function. 4 , 5 Moreover, the design of . . .

Background : Information is lacking on the relative effectiveness and cost effectiveness — in a primary-care setting — of leukotriene receptor antagonists (LTRAs) as an alternative to inhaled corticosteroids (ICS) for initial asthma controller therapy. Objective : To compare the cost effectiveness of LTRAs versus ICS for patients initiating asthma controller therapy. Methods : An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 1280 years with asthma and symptoms requiring regular antiinflammatory therapy (n = 326) were randomly assigned to LTRAs (n = 162) or ICS (n = 164). The main outcome measures were the incremental costs per point improvement in the Mini Asthma Quality of Life Questionnaire, per point improvement in the Asthma Control Questionnaire and per QALY gained from the UK NHS and societal perspectives. Results : Over 2 years, resource use was similar between the two treatment groups, but the cost to society per patient was significantly higher for the LTRA group, at £711 versus £433 for the ICS group (adjusted difference £204; 95% CI 74, 308) [year 2005 values]. Cost differences were driven primarily by differences in prescription drug costs, particularly study drug costs. There was a nonsignificant (imputed, adjusted) difference between treatment groups, favouring ICS, in QALYs gained at 2 years of −0.073 (95% CI −0.143, 0.010). Therapy with LTRAs was, on average, a dominated strategy, and, at a threshold for willingness to pay of £30 000 per QALY gained, the probability of LTRAs being cost effective compared with ICS was approximately 3% from both societal and NHS perspectives. Conclusions : There is a very low probability of LTRAs being cost effective in the UK, at 2005 values, compared with ICS for initial asthma controller therapy. Trial registration : UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.