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Efficacy
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| 1. What is the evidence for improved asthma control with Symbicort SMART®? |
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Six studies in over 14,000 patients have consistently shown that compared to higher doses of inhaled steroids and similar or higher doses of ICS/LABA therapy, all with separate SABA as needed, Symbicort SMART significantly reduces the number of severe exacerbations and also provides stable asthma control (Kuna et al 2007; O’Byrne et al 2005; Rabe et al 2006a,b; Vogelmeier et al 2005; Scicchitano et al 2004). |
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| 2. How does Symbicort SMART® compare to a higher-dose of ICS + SABA? |
In a 6-month study in patients with mild to moderate asthma Symbicort SMART was compared with double the dose of inhaled budesonide (320 µg/day) +SABA for as-needed use (Rabe et al 2006a).
Patients receiving Symbicort SMART showed greater improvements in morning PEF, had a greater reduction in the risk of having a severe exacerbation, and fewer hospitalizations/ED treatments compared with those receiving double the dose of budesonide (Rabe et al 2006a).
In a 12-month study involving 1890 patients with moderate to severe asthma, Symbicort SMART significantly (p<0.001) prolonged the time to first exacerbation compared with double the dose of budesonide + SABA as needed.
The Symbicort SMART group had 45% fewer severe exacerbations requiring medical intervention per patient compared with the budesonide group (p<0.001) and fewer hospitalisations/ER treatments (15 vs 25 events, respectively).
In addition, the mean daily ICS dose was lower in the Symbicort SMART group than in the budesonide group (466 µg/day vs. 640 µg/day, respectively) (Scicchitano et al 2004).
In 2760 patients with moderate asthma, Symbicort SMART was compared with Symbicort + SABA and four times the dose of budesonide + SABA (O’Byrne et al 2005). Symbicort SMART prolonged the time to first severe exacerbation, resulting in a 45–47% lower exacerbation risk vs. Symbicort + SABA or budesonide + SABA.
Symbicort SMART also prolonged the time to first, second, and third exacerbation requiring medical intervention (p<0.001), reduced severe exacerbation rate, and improved symptoms and lung function compared with both fixed-dosing regimens (O’Byrne et al 2005).
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| Symbicort SMART® reduces the rate of severe exacerbations requiring medical intervention |
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| 3. How does Symbicort SMART® compare to fixed combinations of ICS/LABA? |
In a large clinical study (Kuna et al 2007), the Symbicort SMART treatment approach was more effective than higher doses of fixed combination therapy with Symbicort or salmeterol/fluticasone (Seretide) + SABA.
Kuna et al (2007) was a 6-month study including 3335 asthmatic patients that compared efficacy of Symbicort SMART with higher fixed maintenance doses of Symbicort or Seretide + SABA in terms of asthma control.
Symbicort SMART reduced exacerbations more effectively. Importantly, patients had similarly good day-to-day control in all treatment groups using 25 % less ICS with Symbicort SMART compared to the other treatment groups.
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| Symbicort SMART® reduces exacerbations more effectively than higher maintenance doses of fixed ICS/LABA + SABA |
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In a study in 2143 adolescents and adults with asthma, mirroring clinical practice, Symbicort SMART was compared with Seretide for maintenance + SABA for relief (Vogelmeier et al 2005). Symbicort SMART reduced exacerbation by 22% compared to Seretide + SABA, and the use of SABA for relief of symptoms was 38% lower with Symbicort SMART than with Seretide + SABA (0.58 vs 0.93 inhalations per day (p<0.001).
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| 4. Symbicort SMART® reduces exacerbations, but what about daily asthma control? |
Two clinical studies (Rabe et al 2006a, O’Byrne et al 2005) have shown a clear benefit for Symbicort SMART in preventing daily asthma control compared with Symbicort + SABA.
With Symbicort SMART any symptoms that follow an increase in inflammation are also treated with anti-inflammatory therapy (rather than just an increase in SABA use).
The first study was a 12-month, double-blind, randomised study in 3394 patients aged 12 years and above (Rabe et al 2006a). The Symbicort SMART® approach proved more effective in reducing day-to-day asthma control than a fixed-dose Symbicort regimen with additional as needed SABA.
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| Symbicort SMART® improves day-to-day control compared to fixed-dose Symbicort + SABA |
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| Reduction in symptoms from run-in |
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In the second study, Symbicort SMART was also associated with improved day-to-day symptom control (O’Byrne et al 2005). In this randomised, double-blind study in 2760 patients (age 4–80 years) with asthma the Symbicort SMART approach was associated with significant improvements in a range of day-to-day symptoms measures, including the number of awakenings due to asthma symptoms, lung function and asthma control days.
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| 5. Current fixed-dose combination therapy is very effective. Why should I consider changing to Symbicort SMART®? |
A recent survey conducted in 8 countries in Western Europe, Canada, USA and Australia among 3415 asthma patients all of whom were prescribed regular 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. 3 canisters of salbutamol per year).
These results suggest that there remains considerable scope for improving the asthma control achieved with fixed-dose combination therapy (Partridge et al 2006).
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| Despite ICS or ICS/LABA therapy, 74% of patients used rescue therapy each day |
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