Symbicort® Indications in Asthma
Symbicort® is used in the treatment of asthma where a combination (inhaled corticosteroid [ICS] and long-acting β2-agonist [LABA]) is appropriate. Symbicort can be used as regular maintenance therapy with a separate short-acting β2-agonist (SABA) as needed to relief symptoms. A second Symbicort indication as maintenance and reliever therapy (Symbicort SMART®) received the regulatory approval and was incorporated in the 2008 Global Initiative for Asthma (GINA) guidelines [1].
Currently Symbicort is the only ICS/LABA approved for maintenance and reliever therapy in adult population.
GINA guidelines state [1]: “The use of the combination of a rapid and long-acting β2-agonist (formoterol) and an inhaled glucocorticosteroid (budesonide) in a single inhaler both as a controller and reliever is effective in maintaining a high level of asthma control and reduces exacerbations requiring systemic glucocorticosteroids and hospitalizations (Evidence A). The benefit in preventing exacerbations appears to be the consequence of early intervention at a very early stage of a threatened exacerbation.
Combination therapy with budesonide and formoterol used both as maintenance and rescue has been shown to reduce asthma exacerbations in moderate to severe asthma patients.”
The use of Symbicort SMART is also recommended in the 2009 British Thoracic Society/Scottish Intercollegiate Guidelines Network (BTS/SIGN) guidelines on the management of asthma [2], for selected adult patients who are poorly controlled at step 2 or step 3. GINA classification steps were defined according to the patient’s current asthma medication: Step 2 – low dose ICS; Step 3 – low dose ICS plus at least one of LABA, leukotriene receptor antagonist (LTRA) or xanthines, or, medium to high dose ICS without addition of any of these; Step 4 – medium to high dose ICS plus at least one of LABA, LTRA or xanthines)
BTS/SIGN guidelines state: “In selected adult patients at step 3 who are poorly controlled or in selected adult patients at step 2 (above BDP 400 mcg/day who are poorly controlled), the use of budesonide/formoterol in a single inhaler as rescue medication instead of a short-acting B2–agonist, in addition to its regular use as controller therapy has been shown to be an effective treatment regimen.”
Symbicort® Dosage in Asthma
For the treatment of asthma, three doses are approved: Symbicort Turbuhaler, 320/9 μg/inhalation and 160/4.5 μg/inhalation and 80/4.5 μg/inhalation.
The Symbicort dose 320/9 μg/inhalation should only be used as maintenance therapy.
The Symbicort doses 160/4.5 μg/inhalation and 80/4.5 μg/inhalation are indicated for both maintenance therapy and maintenance and reliever therapy.
SEE YOUR LOCAL COUNTRY SYMBICORT PRODUCT INFORMATION, AS PRESCRIBING INFORMATION MAY VARY FROM COUNTRY TO COUNTRY.
Symbicort® in Asthma – Efficacy
The primary goal of national and international asthma management guidelines is to achieve and maintain overall asthma control [1,2] – which is comprised of current asthma control and the prevention of future risk of, for example, exacerbations. Large-scale, randomised, clinical studies in patients with asthma, have consistently highlighted the benefits of Symbicort SMART [3-9] – they have shown that when used at the approved Symbicort SMART doses, this treatment approach provides superior overall asthma control to comparator therapies, achieving the same or better current control and superior reductions in exacerbations.
What is the evidence for improved current asthma control with Symbicort SMART®?
Several large-scale randomised clinical studies in over 14,000 patients have reported that Symbicort SMART, compared with higher maintenance doses of ICS and similar or higher maintenance doses of ICS/LABA, all with a separate SABA as needed, provides at least a similar level of current control, achieved at a lower total overall steroid load [3-9].
Compared with 2–4 times higher maintenance dose ICS (budesonide) plus as-needed SABA, Symbicort SMART improves current asthma control [3,4,8]:
- Greater improvements in lung function – morning peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) [3,8];
- 24–27 additional symptom-free days/patient-year [4,8];
- 28–31 additional asthma control days/patient-year [4,8];
- 8–12 fewer night-time awakenings/patient-year [4,8];
- 44–77% fewer days with oral corticosteroids [4,8].
Compared with Seretide™ (salmeterol/fluticasone) plus SABA as needed, at a higher ICS/LABA maintenance dose to Symbicort SMART, Symbicort SMART results in similar improvements in daily asthma control (lung function, asthma control days and asthma-related quality of life) but at a 25% lower total daily ICS load [5].
Symbicort SMART has also been shown to improve asthma control in a non-randomised ‘real-life’ setting [10]. In this study, in which asthma control was assessed using the validated 5-item Asthma Control Questionnaire (ACQ-5), Symbicort SMART improved the mean ACQ-5 score by more than 3-fold the defined minimal important difference [10].
What is the evidence for reduced future risk of exacerbations with Symbicort SMART®?
There is consistent evidence from these randomised clinical trials that Symbicort SMART significantly reduces the number of severe exacerbations when compared with higher maintenance doses of ICS and similar or higher maintenance doses of ICS/LABA therapy, all with separate SABA as needed [3-9].
Compared with a 2–4 times higher maintenance dose of budesonide plus SABA as needed, Symbicort SMART has been shown to significantly prolong the time to first severe exacerbation and significantly reduce the risk of having a severe exacerbation requiring medical intervention and the need for hospitalisations/emergency room treatments [3,4,8]. Read more about this data in the STEP study, the STEAM study and the STAY study.
Symbicort SMART reduces the rate of severe exacerbations requiring medical intervention [3,4,8]
Compared with Seretide plus SABA as needed, Symbicort SMART has been shown to significantly reduce the risk of severe exacerbations, resulting in:
- 21–39% reduction in severe exacerbations [5–9]
- 31–39% fewer hospitalisations/emergency room visits [5,6]
Symbicort SMART also reduces exacerbations more effectively than higher maintenance doses of fixed combination therapy with Symbicort plus SABA [5]. See the COMPASS study for more information.
Symbicort SMART reduces exacerbations more effectively than higher maintenance doses of fixed ICS/LABA plus SABA [5]
How can Symbicort SMART® improve overall asthma control and reduce the dose at the same time?
Symbicort SMART targets the underlying inflammation with every inhalation whether used for maintenance or relief, in addition to providing rapid control of symptoms [11]. This approach provides appropriate adjustments in both ICS and LABA therapy in a way not possible with separate maintenance and reliever inhalers [12]. Read more about the mechanism of action of Symbicort on the mode of action asthma page. Rather than sustaining a high dose continuously, the increased efficacy of Symbicort SMART is achieved with an increase in dose of therapy at the right time to prevent asthma worsening and exacerbations. As a result, the improvements in overall asthma control with Symbicort SMART are achieved at a lower mean overall drug load compared with alternative treatment approaches [4-7].
Results from the COMPASS study by Kuna et al., for example showed that on 56% of days, patients required no reliever therapy with Symbicort SMART; therefore on these days, patients received 50% less Symbicort than would be taken with a fixed higher maintenance dose of Symbicort plus SABA as needed [5].
No increased drug load when using Symbicort SMART [5]
Current fixed-dose combination therapy is very effective. Why should I consider changing to Symbicort SMART®?
A survey conducted in eight countries in western Europe, Canada, USA and Australia among 3415 asthma patients all of whom were prescribed regular maintenance ICS or ICS/LABA therapy found that 74% of patients reported that they required reliever therapy at least once every day in the past week (i.e. three canisters of salbutamol per year) [13]. These results suggest that there remains considerable scope for improving the asthma control achieved with fixed maintenance dose combination therapy.
Despite ICS or ICS/LABA therapy, 74% of patients used rescue therapy each day [13]
Read more about studies with Symbicort SMART in asthma
References
- Global Initiative for Asthma. Global strategy for asthma management and prevention - updated 2008. Available at: www.ginasthma.com. Last accessed 11 December 2009.
- British Thoracic Society and Scottish Intercollegiate Guidelines Network. British Guideline on the Management of Asthma: A National Clinical Guideline. 2009.
- O'Byrne PM, Bisgaard H, Godard PP, et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005;171:129-136.
- Scicchitano R, Aalbers R, Ukena D, et al. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin 2004;20:1403-1418.
- Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007;61:725-736.
- Bousquet J, Boulet LP, Peters MJ, et al. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med 2007;101:2437-2446.
- Rabe KF, Atienza T, Magyar P, et al. Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomised controlled, double-blind study. Lancet 2006;368:744-753.
- Rabe KF, Pizzichini E, Stallberg B, et al. Budesonide/formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: a randomized, double-blind trial. Chest 2006;129:246-256.
- Vogelmeier C, D'Urzo A, Pauwels R, et al. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005;26:819-828.
- Steurer-Stay C, Courteheuse C, Taegtmeyer AB, et al. "Real-life" data on asthma control using budesonide/formoterol for both maintanance and relief: the Swiss experience. Praxis (Bern 1994) 2009;98: 1335-42
- Kaplan A, Ryan D. The role of budesonide/formoterol for maintenance and relief in the management of asthma. Pulm Pharmacol Ther 2009; Epub ahead of print
- Humbert M, Andersson TL, Buhl R. Budesonide/formoterol for maintenance and reliever therapy in the management of moderate to severe asthma. Allergy 2008;63:1567-1580.
- Partridge MR, Van der MT, Myrseth SE, et al. Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study. BMC Pulm Med 2006;6:13.
