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BTS Guideline for Long Term Macrolide BTS Guideline Thorax: first published as 10.1136/thoraxjnl-2019-213929 on 17 April 2020. Downloaded from British Thoracic Society guideline for the use of long- term macrolides in adults with respiratory disease David Smith,1 Ingrid Du Rand,2 Charlotte Louise Addy,3 Timothy Collyns,4 Simon Paul Hart ,5 Philip J Mitchelmore ,6,7 Najib M Rahman,8 Ravijyot Saggu9 ► Additional material is SUMMARY OF RECOMMENDATIONS AND GOOD resource implications of this approach have not published online only. To view PRACTICE POINTS been assessed. please visit the journal online (http:// dx. doi. org/ 10. 1136/ Asthma ✓ If oral macrolide therapy is considered, justifi- thoraxjnl- 2019- 213929). Recommendations cation for ongoing treatment should be guided Oral macrolide therapy could be considered by clinical response based on specific outcome 1 ► North Bristol Lung Centre, to reduce exacerbation frequency in adults measures including exacerbation frequency, Southmead Hospital, Bristol, UK 2 symptoms and quality of life assessed at Respiratory, Wye Valley NHS (50–70 years), with ongoing symptoms despite Trust, Hereford, UK >80% adherence to high-dose inhaled steroids baseline. 3Centre for Medical Education, (>800 µg/day) and at least one exacerbation ✓ A risk:benefit profile should be considered in Queens University Belfast, requiring oral steroids in the past year. This each individual if significant side effects from Regional Respiratory Centre, oral macrolide therapy develop. If gastroin- Belfast City Hospital, Belfast, UK recommendation reflects the population within 4Medical Microbiology, Leeds the AMAZES RCT which represents the highest testinal side effects occur at the higher dose of Teaching Hospitals NHS Trust, quality evidence of macrolide therapy leading azithromycin (500 mg thrice weekly), a dose Leeds, UK reduction to azithromycin 250 mg thrice weekly 5 to a significant reduction in exacerbations. Cardiovascular and Respiratory (Conditional) could be considered if macrolide therapy has Studies, Hull York Medical School/University of Hull, Hull, ► Treatment with azithromycin should be consid- been of clinical benefit. UK ered for a minimum of 6–12 months to assess ✓ Liver function tests should be checked 1 month 6Institute of Biomedical and evidence of efficacy in reducing exacerbations. after starting treatment and then every 6 Clinical Science, College of (Conditional) months. An ECG should be performed 1 month Medicine & Health, University of Exeter, Exeter, UK ► Oral macrolide therapy should not be offered after starting treatment to check for new QTc 7Department of Respiratory as a way to reduce oral steroid dose; in some prolongation. If present, treatment should be Medicine, Royal Devon and individuals, this may result as a consequence stopped. Exeter Hospital, Exeter, UK 8 of a reduction in exacerbations or symptoms. ✓ Symptom improvement with macrolide treat- Oxford Respiratory Trials Unit (Strong) http://thorax.bmj.com/ and Oxford NIHR Biomedical ment may be minimal and not consistent across Research Centre, University of all people with asthma. If macrolide therapy is Oxford, Oxford, UK Good practice points considered for symptom reduction, this should 9Pharmacy, University College ✓ Optimisation of other asthma therapies be for a defined period (6–12 months) and London Hospitals NHS Foundation Trust, London, UK including establishing good adherence to stopped if no symptomatic improvement is inhaled therapies should be performed before seen. Use of a validated symptom score, such Correspondence to considering a trial of oral macrolide therapy. as the ACQ, may be useful to help make this Dr David Smith, Southmead ✓ Referral to a respiratory specialist or specialist assessment less subjective. on April 17, 2020 at Sheila Edwards. Protected by copyright. Hospital, North Bristol Lung asthma service should be considered prior ✓ If the desired clinical outcome is achieved, the Centre, Bristol BS10 5NB, UK; to initiation of macrolide therapy aimed at possibility of breaks in therapy may be consid- david. smith@ nbt. nhs. uk reducing exacerbation frequency. ered to reduce treatment burden for patients. It ✓ For safety purposes, an ECG should be is unclear whether this may also reduce antimi- performed prior to initiation of macrolide crobial resistance rates. therapy to assess QTc interval. If QTc is >450 Please see quick reference guide in online supple- ms for men and >470 ms for women, this is mentary file 1. considered a contraindication to initiating ► http:// dx. doi. org/ 10.1136/ macrolide therapy. Baseline liver function tests thoraxjnl- 2019- 214039 should also be measured. Bronchiectasis ✓ Patients should be counselled about potential Recommendations adverse effects before starting therapy including ► Long- term macrolide treatment could be © Author(s) (or their gastrointestinal upset, hearing and balance offered to reduce exacerbations in those with employer(s)) 2020. No disturbance, cardiac effects and microbiological high exacerbation rates (ie, 3 or more per year). commercial re-use . See rights (Strong) and permissions. Published resistance. by BMJ. ✓ Microbiological screening of sputum before ► The dosing regimens with the greatest and during macrolide therapy may be clinically supportive evidence, when using macrolides To cite: Smith D, Du Rand I, helpful in patients who are able to expecto- to reduce exacerbation rates, are azithromycin Addy CL, et al. Thorax Epub ahead of print: [please rate sputum. This would allow monitoring for 500 mg three times a week, azithromycin 250 include Day Month Year]. development of resistance and detect changes mg daily and erythromycin ethylsuccinate 400 doi:10.1136/ in microbial growth to direct appropriate mg twice a day. A starting dose of azithromycin thoraxjnl-2019-213929 antibiotic therapy if required. However, the 250 mg three times a week could be used to Smith D, et al. Thorax 2020;0:1–35. doi:10.1136/thoraxjnl-2019-213929 1 BTS Guideline Thorax: first published as 10.1136/thoraxjnl-2019-213929 on 17 April 2020. Downloaded from minimise side effect risk with subsequent titration according clearance techniques and attendance at pulmonary rehabili- to clinical response. (Conditional) tation courses. ► When using macrolides to reduce exacerbation rates, therapy ✓ Macrolides should only be started following discussion and should be offered for a minimum of 6 months. (Strong) shared decision- making between the patient and a respira- ► Macrolides can be considered with the aim of improving tory specialist. quality of life but may require a long period of therapy (eg, ✓ For safety purposes, an ECG should be performed prior to 1 year) for significant effects. (Conditional) initiation of macrolide therapy to assess QTc interval. If QTc is >450 ms for men and >470 ms for women, this is consid- Good practice points ered a contraindication to initiating macrolide therapy. Base- ✓ Therapies should be optimised in accordance with BTS line liver function tests should also be measured. Bronchiectasis Guidelines before considering long- term ✓ Patients should be counselled about potential adverse effects macrolide therapy (eg, airway clearance techniques and before starting therapy including gastrointestinal upset, attendance at pulmonary rehabilitation courses). hearing and balance disturbance, cardiac effects and micro- ✓ Macrolides should only be started following discussion and biological resistance. shared decision- making between the patient and a respira- ✓ Microbiological assessment of sputum should be performed tory specialist. before therapy, including investigation for NTM. Macrolide ✓ For safety purposes, an ECG should be performed prior to monotherapy should be avoided if an NTM is identified. initiation of macrolide therapy to assess QTc interval. If QTc Repeat assessments are recommended with clinical decline is >450 ms for men and >470 ms for women, this is consid- or during exacerbations to monitor resistance patterns. ered a contraindication to initiating macrolide therapy. Base- ✓ Accurate assessment of baseline exacerbation rate should be line liver function tests should also be measured. determined before starting long-term macrolides for patients ✓ Patients should be counselled about potential adverse effects with COPD and a CT scan should be considered to exclude before starting therapy including gastrointestinal upset, a possible diagnosis of bronchiectasis. hearing and balance disturbance, cardiac effects and micro- ✓ A risk:benefit profile should be considered in each indi- biological resistance. Microbiological assessment of sputum vidual if significant side effects from oral macrolide therapy should be performed before therapy, including investigation develop. If gastrointestinal side effects occur at the higher for NTM. Macrolide monotherapy should be avoided if an dose of azithromycin (500 mg thrice weekly), a dose reduc- NTM is identified. When evaluating for NTM infection, tion to azithromycin 250 mg thrice weekly could be consid- macrolides should not be used for 2 weeks before microbi- ered if macrolide therapy has been of clinical benefit. ological testing. ✓ Liver function tests should be checked 1 month after starting ✓ Accurate assessment of baseline exacerbation rate should treatment and then every 6 months. An ECG should be be determined before starting long-term macrolides for performed 1 month after starting treatment to check for new bronchiectasis. QTc prolongation. If present, treatment should be stopped. ✓ Liver function tests should
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