Asthma management guidelines have changed

Asthma management guidelines have changed

Supplied by Teva Pharma New Zealand Ltd
Asthma

The guidelines for managing asthma in adolescents and adults have changed. The new guidelines were published in June this year. 1 The same month we moved to COVID-19 Level 1. The previous Best Practice Evidence Guidelines for Adult Asthma dated back to the early 2000s. 2

The main changes in the 2020 update are: 1-3

  • combining the recommendations for both adolescents and adults in a single document,
  • the recommendation to avoid SABA-only treatment in the long-term management of asthma,
  • the use of budesonide/formoterol (dry powder inhaler-DPI)reliever, with or without maintenance budesonide/formoterol, is preferred to SABA reliever, with or without maintenance ICS or ICS/LABA, across the spectrum of chronic asthma severity,
  • introduction of the terminology ‘anti-inflammatory reliever (AIR)’ therapy to describe the use of budesonide/formoterol as a reliever medication, with or without maintenance budesonide/ formoterol therapy. This approach encompasses and extends the ‘Single combination ICS/LABA inhaler Maintenance And Reliever Therapy’ (MART) approach recommended in the previous guideline,
  • the inclusion of two stepwise management algorithms,
  • a clinical allergy section,
  • the role of LAMA therapy in severe asthma,
  • the role of omalizumab in severe allergic asthma and mepolizumab in severe eosinophilic asthma,
  • an appendix detailing educational materials.

The major change is the recommendation to use a single 2-in-1 inhaler, containing both a preventer and a reliever medicine, to treat asthma symptoms. This is based on clinical trials, which showed that a budesonide/formoterol (DPI) inhaler, taken as needed, reduces the risk of a severe asthma attack by between 30 and 60% compared to usual reliever inhalers. 1-3

Professor Beasley has been quoted as saying that “It is important that asthma management in New Zealand is based on this evidence to ensure that patients receive the best possible care. Recalling patients who just use a blue reliever inhaler and replacing it with a combination inhaler should be the immediate priority for health professionals in New Zealand." 3

Why have the recommendations changed? 1-3

We now know that inflammation of the airways is found in most people with asthma, even if they only have symptoms intermittently.
Clinical studies have shown that treatment with an ICS significantly reduces the frequency and severity of asthma symptoms, and markedly reduces the risk of experiencing, or even dying from, an asthma attack. 3

There is strong evidence that, although short-term relief of asthma is achieved with short-acting beta2 agonist (SABA)-only treatment, this does not protect from severe exacerbations. In fact, regular or frequent use of SABA treatment actually increases the risk of exacerbations, worsening airway inflammation and lung function, and increasing allergic reaction. 3

The GINA report states that overuse of SABA treatment (eg, three or more canisters per year) is associated with an increased risk of severe exacerbations, and 12 or more canisters per year is associated with increased risk of asthma-related death. 3

The new recommendations aim to:

  • reduce the risk of serious exacerbations 1-3
  • reduce the pattern of people depending on SABA-only treatment to manage their asthma 1-3
  • provide consistent treatment plans across the whole range of asthma severity. 1-3

What has changed for treatment of adults and adolescents? 1-3

Starting asthma treatment with a SABA (ie, salbutamol or terbutaline) alone is no longer recommended. Instead, it is recommended that an ICS should be initiated from first diagnosis. This can be done either by introducing AIR treatment or by using traditional ICS/SABA therapy.

One of the risks of traditional ICS/SABA therapy is that people do not use the ICS and rely solely on the SABA. AIR therapy removes this risk as the ICS is included in the reliever treatment as well as maintenance treatment.

In adults and adolescents taking maintenance ICS/LABA therapy, budesonide/formoterol used as a reliever reduces the risk of a severe asthma exacerbation by about one-third compared with using a SABA reliever. Thus, budesonide/formoterol used both as a reliever plus regularly as maintenance therapy is the preferred treatment for patients with moderate to severe asthma.

Stepwise AIR-based algorithm using budesonide/formoterol 200micro g/6micro g

AIR therapy? 1-3

Anti-inflammatory reliever (AIR) therapy is the use of a combination budesonide/formoterol dry powder inhaler as a reliever medication. It can be used either only as needed or regularly plus as needed. This approach includes and extends the “single combination ICS/LABA inhaler maintenance and reliever therapy” (SMART) approach previously recommended.

  • AIR therapy requires an ICS in combination with a fast-onset beta2-agonist in dry powder inhaler – the only such combination currently available in New Zealand is budesonide/formoterol
  • Remember, formoterol and eformoterol are alternative names for the same medication
  • Other combinations of ICS/LABA should not be used in this way.
  • When using budesonide/formoterol as maintenance and reliever therapy, a SABA reliever should not be prescribed.
  • For people using a combination ICS/LABA maintenance inhaler that is not budesonide/formoterol, a SABA reliever should still be used.
  • The budesonide/formoterol DPI reliever combination should not be prescribed in addition to other ICS/LABA preparations.
  • A LABA should not be prescribed without an ICS for people with asthma.
  • Note that the budesonide/formoterol 400µg/12µg formulation should not be used as a reliever.

There are now two budesonide/formoterol inhalers available in New Zealand

DUORESP® SPIROMAX® (budesonide/formoterol) dry powder inhaler is a fully funded, substitutable alternative for Symbicort® Turbuhaler®. 4,#

DUORESP® SPIROMAX® has been shown to deliver significantly better clinical outcomes for asthma patients when switched from Symbicort® Turbuhaler®, with 44% more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). 5

DUORESP® SPIROMAX® dry powder inhalers comes in two strengths 6

  • 400 mcg budesonide/ 12 mcg formoterol dihydrate dry powder inhaler containing 60 doses and
  • 200 mcg budesonide/ 6 mcg formoterol dihydrate dry powder inhaler containing 120 doses.

Symbicort and Turbuhaler are registered trademarks of the AstraZeneca group of companies. # DuoResp Spiromax is indicated for adults (18 years and over).

References
  1. Beasley R et al NZMJ 2020; 133 (1517): 73-99
  2. The pharmacological management of asthma in adolescents and adults has changed. https://bpac.org.nz/2020/docs/asthma.pdf
  3. Cant H. Clinical Update New Zealand Doctor 12 August 2020; 35-36
  4. Pharmaceutical Schedule www.pharmac.govt.nz
  5. Voorham J et al. BMJ Open 2018; 8:e022051. doi:10.1136/bmjopen-2018-022051
  6. DuoResp Spiromax New Zealand Data Sheet www.medsafe.govt.nz

DUORESP® SPIROMAX® (Budesonide/formoterol fumarate dihydrate). Important note: DUORESP SPIROMAX (400 mcg budesonide/ 12 mcg formoterol dihydrate and 200 mcg budesonide/ 6 mcg formoterol dihydrate) dry powder inhaler is a fully funded prescription medicine. Please review approved Data Sheet before prescribing, available at www.medsafe.govt.nz
Indication: The treatment of asthma to achieve overall asthma control, including the prevention and relief of symptoms as well as the reduction of the risk of exacerbations.
Dosage: Anti-inflammatory reliever therapy (patients with mild disease): Adults (18 years and older): Patients should take 1 inhalation of DUORESP SPIROMAX 200/6 as needed in response to symptoms. Anti-inflammatory reliever plus maintenance therapy: Adults (18 years and older): Patients should take 1 inhalation of DUORESP SPIROMAX 200/6 as needed in response to symptoms to control asthma. Not more than 6 inhalations should be taken on any single occasion. Patients using more than 8 inhalations daily should be reassessed for alternative explanations of persisting symptoms. DUORESP SPIROMAX 400/12 should not be used for the anti-inflammatory reliever plus maintenance therapy regimen. Maintenance therapy (fixed dose): Adults (18 years and older): DUORESP SPIROMAX 200/6: 1-2 inhalations once or twice daily. Maximum daily maintenance dose: 4 inhalations. (2 inhalations twice daily). DUORESP SPIROMAX 400/12: 1 inhalation once or twice daily. Maximum daily maintenance dose: 2 inhalations (1 inhalation twice daily).
Contraindication: Hypersensitivity to budesonide, formoterol or to lactose.
Precautions: The lowest effective dose of DUORESP SPIROMAX should be used. Patients should be reminded to take their DUORESP SPIROMAX maintenance dose as prescribed, even when asymptomatic. Particular care is needed in patients transferring from oral steroids. Caution is needed in patients with phaeochromocytoma, with diabetes mellitus, with active or quiescent pulmonary tuberculosis or fungal, bacterial or viral infections of the respiratory system, with increased susceptibility to sympathomimetic amines (e.g. inadequately controlled hyperthyroidism), with thyrotoxicosis, with severe cardiovascular disorders such as ischaemic heart disease, tachyarrhythmias hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or severe heart failure, and in patients predisposed to low levels of serum potassium. DUORESP SPIROMAX should only be used in pregnancy or when breastfeeding if the expected benefit to the mother is greater than any possible risk to the child. DUORESP SPIROMAX contains lactose. Interactions: Concomitant treatment with potent CYP3A4 inhibitors should be avoided, such as HIV protease inhibitors, itraconazole, ketoconazole, voriconazole, posaconazole, clarithromycin, telithromycin, and non-selective Beta-receptor blocking agents. Other sympathomimetic agents due to potential cumulative bronchodilating effects. Xanthine derivatives, mineralcorticosteroids and diuretics due to potentiating risk of hypokalaemia. Monoamine oxidase inhibitors, tricyclic antidepressants, quinidine, disopyramide, procainamide, phenothiazines and antihistamines may precipitate hypertensive reactions. L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta-2 sympathomimetics.
Adverse effects: Since DUORESP SPIROMAX contains both budesonide and formoterol, the same pattern of undesirable effects as reported for these substances may occur. Common (1-10%): Palpitations, candida infections in the oropharynx, headache, tremor, mild irritation in the throat, coughing, hoarseness. Uncommon (0.1-1%): Dizziness, bad taste, thirst, tiredness, agitation, restlessness, nervousness, anxiety, sleep disturbances, nausea, diarrhoea, tachycardia, blurred vision, weight gain, muscle cramps, bruises.
Overdose: Supportive and symptomatic treatment may be indicated. For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
Packs: DUORESP SPIROMAX is available as a multidose inspiratory flow driven, metered dose dry powder inhaler (SPIROMAX). DUORESP SPIROMAX 200/6 is registered as a 120-dose inhaler in packs of 1. DUORESP SPIROMAX 400/12 is registered as a 60-dose inhaler in packs of 2.
Teva Pharma (New Zealand) Limited PO Box 128 244, Remuera Auckland 1541 Telephone: 0800 800 097. DuoResp and Spiromax are registered trademarks of the Teva group of companies.
NZ-00015 October 2020, TAPS MR7081 BGA201050