Maintenance plus reliever budesonide/formoterol compared with a higher maintenance dose of budesonide/formoterol plus formoterol as reliever in asthma:an efficacy and cost-effectiveness study

Lundborg, Mikael; Wille, S; Bjermer, Leif; Tilling, Björn; Lundgren, Michael; Telg, Gunilla; Ekström, Thommy; Selroos, Olof

doi:10.1185/030079906x100212

Cited by 58 publications

(47 citation statements)

References 25 publications

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“…However, changes in maintenance treatment in the Budesonide/formoterol SMART arm or addition of other controller therapy were not allowed. The lack of significant differences between Budesonide/formoterol SMART and CBP with respect to time to severe exacerbation and exacerbation rates in this study and in other real-life studies (16,17) is therefore likely to reflect a lack of statistical power. This is linked to the low incidence of events in the CBP arm because of the inclusion of well-controlled patients and the added flexibility of treatment with a free choice of multiple maintenance therapies or the addition of formoterol as reliever therapy to the CBP arm, which is also effective in reducing exacerbation risk (18).…”

Section: Discussioncontrasting

confidence: 58%

A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management

Louis¹,

Joos²,

Michils³

et al. 2009

International Journal of Clinical Practice

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Objective:To study the effectiveness and safety of budesonide/formoterol (Symbicort®) Maintenance And Reliever Therapy (Symbicort SMART®, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma.Design:Open-label randomised controlled parallel group trial, 6-month treatment.Participants:A total of 908 patients ≥ 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting β2-agonist.Main outcome measures:Time to first severe asthma exacerbation and number of severe asthma exacerbations.Results:No difference between groups was seen in time to first severe exacerbation (p = 0.75). Exacerbation rates were low in both groups. A total of 12 patients in the Symbicort SMART® group experienced a total of 14 severe asthma exacerbations, and 19 patients in the CBP group experienced a total of 25 severe asthma exacerbations (annual rate 0.07 vs. 0.13 p = 0.09). The mean daily dose of ICS expressed in BDP equivalent was significantly lower in the Symbicort SMART® group (including as-needed use) vs. in the CBP group (749 μg vs. 1059 μg; p < 0.0001). Mean scores in Asthma Control Questionnaire, 5 question version improved significantly in the SMART group compared with the CBP group (p = 0.0026). Symbicort SMART and CBP were equally well tolerated.The mean drug cost/patient/month was significantly lower for the patients in the Symbicort SMART group compared with patients receiving CBP (51.3 € vs. 66.5 €; p < 0.0001).Conclusions:In Belgian patients, a simplified regimen using budesonide/formoterol maintenance and reliever therapy was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and significantly lower drug costs.

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Section: Discussioncontrasting

confidence: 58%

A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management

Louis¹,

Joos²,

Michils³

et al. 2009

International Journal of Clinical Practice

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“…The difference between the single combination inhaler and SABA as relievers is the simultaneous administration of a corticosteroid in the combination, suggesting that the relief corticosteroid may play a key role in reducing exacerbations. A recent open study showed that single inhaler therapy with the combination inhaler as rescue therapy was similar to using the same fixed-dose combination therapy with formoterol alone as rescue therapy in terms of the number of additional puffs needed to control symptoms [28]. In a recent large double-blind study which compared formoterol to budesonide/formoterol as reliever therapy [29], the combination inhaler was significantly better than using formoterol alone as reliever in reducing exacerbations, providing strong support for the idea that the ''as required'' additional use of corticosteroid plays a critical role in reducing asthma exacerbations and improving asthma control.…”

Section: Safety Of Labamentioning

confidence: 99%

Scientific rationale for using a single inhaler for asthma control

Barnes¹

2007

European Respiratory Journal

138

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Clinical trials have recently demonstrated that using a budesonide/formoterol combination inhaler as regular maintenance treatment twice daily but also as a rescue therapy for breakthrough symptoms can provide more effective control of asthma, particularly in reducing exacerbations, than using a short-acting b 2 -agonist or formoterol as rescue therapy. This suggests that the corticosteroid component of the combination therapy plays an important role in rescue therapy.Formoterol as a rescue therapy is effective in relieving symptoms by relaxing airway smooth muscle but is also likely to have important inhibitory effects on mast cells, plasma exudation and neutrophilic inflammation.Inhaled corticosteroids have much more rapid suppressing effects on airway inflammation than previously recognised and the increased dose used as rescue therapy may prevent the increase in airway inflammation that occurs during the evolution of an exacerbation, thus preventing its development.It is likely that the molecular interactions between b 2 -agonists and corticosteroids also enhance the effect of the combination therapy as rescue therapy. There is now a strong scientific rationale for single inhaler therapy in asthma, but more research is now needed to better understand the mechanisms involved.

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“…To date, this approach has reduced exacerbations when compared with a higher dose of inhaled corticosteroid, [14][15][16] or an equivalent or higher dose of a combined long-acting β 2 -agonist and corticosteroid used for maintenance treatment only. [16][17][18][19] As in most studies, patients known to have poor adherence to inhaled corticosteroid treatment were excluded from participating in these studies, and reported adherence rates during the studies were high, ranging from 85-99%.…”

Section: Comparison With Existing Literaturementioning

confidence: 99%

Poor adherence with inhaled corticosteroids for asthma: can using a single inhaler containing budesonide and formoterol help?

Sovani¹,

Whale²,

Oborne³

et al. 2008

Br J Gen Pract

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BackgroundPoor adherence with inhaled corticosteroids is an important problem in asthma management. Previous approaches to improving adherence have had limited success. AimTo determine whether treatment with a single inhaler containing a long-acting β 2 -agonist and a corticosteroid for maintenance treatment and symptom relief can overcome the problem of poor adherence with inhaled corticosteroids. Design of studyRandomised, parallel group, open-label trial. SettingForty-four general practices in Nottinghamshire. MethodParticipants who used less than 70% of their prescribed dose of inhaled corticosteroid and had poorly controlled asthma were randomised to budesonide 200 µg one puff twice daily plus their own short-acting β 2 -agonist as required (control group), or budesonide/formoterol 200/6 µg one puff once daily and as required (active group) for 6 months. The primary outcome was inhaled corticosteroid dose. ResultsSeventy-one participants (35 control, 36 active group) were randomised. Adherence with budesonide in the control group was approximately 60% of the prescribed dose. Participants in the active group used approximately 80% more budesonide than participants in the control group (448 versus 252 µg/day, mean difference 196 µg, 95% confidence interval 113 to 279; P<0.001) and were less likely to withdraw from the study (3 versus 13; P<0.01). No safety issues were identified. ConclusionUsing a single inhaler for both maintenance treatment and symptom relief approximately doubled the dose of inhaled corticosteroid taken, suggesting this could be a useful strategy to overcome the problems related to poor adherence with inhaled corticosteroids.

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Maintenance plus reliever budesonide/formoterol compared with a higher maintenance dose of budesonide/formoterol plus formoterol as reliever in asthma:an efficacy and cost-effectiveness study

Cited by 58 publications

References 25 publications

A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management

A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management

Scientific rationale for using a single inhaler for asthma control

Poor adherence with inhaled corticosteroids for asthma: can using a single inhaler containing budesonide and formoterol help?

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