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CPD ACTIVITY 61 inhaler devices should be avoided if possible. Please note that a new version of the Australian Asthma Handbook figure: `Selecting and adjusting medication for adults and adolescents’ by the National Asthma Council Australia will be available in September this year. Open link to the preview of the new figure here: https:// www.nationalasthma.org.au/news/2020/ australian-asthma-handbook-2-1-update Clinical evidence Evidence from large 52-week randomised controlled trials shows as-needed budesonide/formoterol controls mild asthma symptoms better than as- needed SABAs, substantially reduces exposure to ICS compared with low-dose maintenance ICS, and reduces the risk of severe exacerbations.19,20,21,22 However, regular daily budesonide treatment produces greater benefits than as-needed budesonide/formoterol on symptom control, lung function and asthma-related quality of life.19,20 The SYGMA 1 trial showed that as- needed budesonide/formoterol is more effective than SABA alone in patients with mild asthma for symptom control and for prevention of moderate-to-severe exacerbations.19 While the actual number of severe exacerbations in this cohort was small, as-needed budesonide/ formoterol resulted in a 64 per cent lower rate of severe exacerbations compared with as-needed terbutaline.19 As-needed budesonide/formoterol was equally effective to budesonide maintenance therapy in preventing moderate-to-severe exacerbations, but inferior to budesonide maintenance therapy in achieving well- controlled asthma.19 Severe exacerbation was defined as worsening asthma leading to the use of oral corticosteroids (prednisone, prednisolone) for three or more days, hospitalisation or an emergency department visit leading to the use of oral corticosteroids. SYGMA 2 trial showed that as-needed budesonide/formoterol is non-inferior to budesonide maintenance therapy in preventing severe exacerbations, with no clinically significant difference in symptom control.20 Across both SYGMA trials, the median daily ICS dose was substantially reduced, with an 83 per cent reduction in SYGMA 1 and 75 per cent reduction in SYGMA 2 (Figure 2).19,20 The open-label trial, Novel Symbicort Turbuhaler Asthma reliever Therapy (Novel START), was designed to better reflect clinical practice.21 It involved 668 patients with a diagnosis of mild asthma from a doctor. Patients had less severe asthma than those in the SYGMA trials as they were using SABA as sole therapy in the previous three months and had used SABA on two or more occasions in the previous four weeks. About half of the patients used a SABA on two or fewer occasions per week in the four weeks before enrolment. Over 52 weeks, the rate of exacerbations per patient per year was reduced by 51 per cent with budesonide/formoterol as needed, compared with salbutamol as needed, with no difference when compared with budesonide maintenance therapy (Figure 3). In contrast to the SYGMA trials, the number of severe exacerbations was lower in the budesonide/formoterol as-needed group than in the other two arms of the trial. This could be explained by reduced adherence to regular maintenance therapy in those with mild asthma in the real-world setting. Overall mean adherence to twice- daily dose of budesonide maintenance was 56 per cent. Results of the Novel START trial confirmed that budesonide/formoterol is an alternative to regular ICS in patients with mild asthma and clearly superior to SABA as needed. The PRACTICAL trial was conducted in New Zealand as a pragmatic open label randomised controlled trial of adults with mild to moderate asthma.22 Patients were included if they had used low or moderate doses of ICS in the previous 12 weeks with partly or well-controlled asthma, or were not using an ICS in the previous 12 weeks and had experienced asthma symptoms or the need for SABA on two or more occasions in the last four weeks. Budesonide/formoterol used as needed for symptom relief was more effective at preventing severe exacerbations than maintenance low-dose budesonide plus as-needed terbutaline. The combined rate of moderate and severe asthma exacerbation rate was also lower. Participants who were taking as-needed budesonide/formoterol used 60 per cent less ICS, compared with the ICS and SABA participants. Summay of clinical evidence • Compared with as-needed SABA only, as-needed budesonide/formoterol:19,21 TO PAGE 62 Medication Management Review accreditation The Australian College of Pharmacy MMR Stage One course benefits: Student College member Non-member $258.60 $399.00 $844.90 • Complete online delivery - no face-to-face training • Complete the course in your own time from anywhere • Contains practice case studies • Bonus module “Building your MMR service” • Comprehensive feedback on your case studies from an experienced stage 2 assessor • Great value for money www.acp.edu.au info@acp.edu.au 07 3144 3680 RETAIL PHARMACY • AUG 2020