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What is MART?
Maintenance And Reliever Therapy (MART)

Product info | 22/04/2020

Prescribing information available here

 

WHAT IS MART?
MART treatment regimes are those where both the Inhaled Corticosteroid (ICS) and the beta2 agonist are combined into a single inhaler and are used for both maintenance therapy and during acute exacerbations. The use of a MART regime is only available for ICS/LABA combinations where the LABA has a fast-acting component.1

 

HOW DOES MART WORK?
MART regimes have two primary purposes. The steroid used in the combination, i.e. Budesonide, is used to prevent asthma exacerbations. The Long Acting Beta2 Agonist (LABA) i.e. Formoterol, is used to relieve symptoms during mild exacerbations. Due to the combination of ICS/LABA medicines, patients are not necessarily required to have an additional SABA as they can get fast acting relief with just the single combination inhaler.1

Preventer (ICS)
Budesonide is a glucocorticosteroid that when inhaled has a dose-dependent anti-inflammatory action in the airways, resulting in reduced symptoms and fewer asthma exacerbations.2


Reliever (LABA)
Formoterol when inhaled results in rapid and long-acting relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilating effect is dose-dependant, with an onset of effect within 1-3 minutes. The rapid onset of effect induced by formoterol means patients can calm their symptoms quickly should they become wheezy or breathless. The duration of effect is at least 12 hours after a single dose.3

 


WHAT DIFFERENCE WILL A MART REGIME MAKE TO MY INHALER PRESCRIBING?
A MART regime should only be used with adult patients over the aged of 18. For most patients, you will only need to prescribe one inhaler. This is because the reliever part of the medicine is covered with the use of formoterol as a LABA meaning that should an asthma exacerbation occur, patients can use their budesonide/formoterol combination to help alleviate their symptoms.4

 

WHAT DOES A MART DOSING REGUME LOOK LIKE WITH FOBUMIX EASYHALER? (BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE)

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Dose Indication
80/4.5 2 inhalations per day, given as a single or divided dose + as needed inhalations
160/4.5 2 inhalations per day, given as a single or divided dose. + as needed inhalations
320/9 This strength is not indicated for MART therapy

A maximum 6 inhalations on any single occasion may be taken.

A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period

 

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WHAT EVIDENCE IS AVAILABLE FOR MART AS AN EFFECTIVE TREATMENT FOR ASTHMA?
A study by Kuna et al., (2007) looked to see whether Budesonide/formoterol used as a Maintenance& Reliever Therapy (MART) could be as effective at reducing severe exacerbations as high dose fixed dose combination inhalers.5

The randomised, double blind 6 month study with 3335 symptomatic adults and adolescents split the trial into three arms to compare the efficacy of MART:

A) FIXED DOSE THERAPY - Salmeterol/fluticasone combo + SABA (terbutaline) – 25/125 two inhalations bid + as needed SABA
B) FIXED DOSE THERAPY - Budesonide/formoterol combo + SABA (terbutaline) – 320/9 one inhalation bid + as needed SABA
C) MART - Budesonide/formoterol for MART – 160/4.5 – One inhalation bid + as needed inhalations


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Figure 1: Adapted from Kuna et al., 2007. The results showed the number of severe asthma exacerbations was reduced by 39% (p < 0.001) in the MART group compared with fixed-dose salmeterol/fluticasone and by 28% (p= 0.0048) compared with fixed-dose budesonide/formoterol. The total number of exacerbations was similar in the two fixed-dose groups.

Furthermore budesonide/formoterol as a MART regime prolonged the time it took for patients to
experience their first exacerbation requiring hospitalisation, emergency room treatment or oral
steroid treatment, as demonstrated in Figure 1.5

 

WHAT IMPACT DOES A MART REGIME HAVE ON OVERALL TREATMENT LOAD OF AN ASTHMA PATIENT?
The NRAD report highlighted the need for prevention of asthma using ICS.6 However, it is well known that there are associated risks with the overuse of steroid derived medications including immune and renal supression.8

Different inhaled cortocisteroids require varied levels of potency in order to have equal efficacy therefore, in order to compare the treatment groups, all ICS doses used across the three treatment groups were converted to the equivalent ICS dose of beclomethasone dipropionate (BDP).5

The mean doses of ICS for the three groups is demonstrated below:

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Figure 2: Mean ICS doses converted to BDP equivalents based on GINA guidelines across the three
treatment groups used in Kuna et al., 2007.6

The study demonstrated that using budesonide/formoterol in a MART regime reduced the risk and rate of severe exacerbations compared with higher maintenance dose of fixed dose budesonide/formoterol. It achieves this improvement at average daily drug load with the level of ICS recorded reducing by 25% vs fixed dose budesonide/formoterol.6

 

SUMMARY
By using a budesonide/formoterol combination as part of a MART regime, your patients may be able to:

  • Experience less asthma exacerbations that require hospital treatment vs fixed dose combination
    budesonide/formoterol + SABA (terbutaline)6
  • Reduce the level of steroid patients are administering on a daily basis vs fixed dose combination
    inhaler of budesonide/formoterol + SABA (terbutaline)6
  • Achieve better adherence by having a single inhaler as both their preventer and reliever vs fixed
    dose budesonide/formoterol + SABA (terbutaline)6

Fobumix Easyhaler 80/4.5 & 160/4.5 are indicated for MART therapy for adult patients with:

  • inadequate asthma control and in frequent need of reliever medication
  • prior asthma exacerbations requiring medical intervention.4

 

Further information on Fobumix Easyhaler can be found here.


References:

  1. Di Marco F. (2020). Today’s improvement in asthma treatment: role of MART and Easyhaler. Multidisciplinary Respiratory Medicine, 15(1), 649. https://doi.org/10.4081/mrm.2020.649
  2. Easyhaler Budesonide 100, 200, and 400 mcg. SmPC. Orion Pharma.
  3. Formoterol Easyhaler 12 mcg. SmPC. Orion Pharma.
  4. Fobumix Easyhaler 80/4.5, 160/4.5, and 320/9 mcg. SmPC. Orion Pharma.
  5. Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract, May 2007, 61, 5, 725–736.
  6. RCP. Why asthma still kills. National Review of Asthma Deaths (NRAD). May 2014. accessed 10th June 2020 from: https://www.rcplondon.ac.uk/projects/outputs/why-asthma-still-kills
  7. Geddes, D. M. (1992). Inhaled corticosteroids: benefits and risks. Thorax, 47(6), 404.

 

October 2020/RESP-330bbe

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Orion Pharma (UK) Ltd on 01635 520300.

ORIONPHARMA.CO.UK

 

Full prescribing information available here

 

MAY 2021 / RESP-330b(3)

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Orion Pharma (UK) Ltd on 01635 520300.

Orion Pharma (UK) Ltd, Abbey Gardens, 4 Abbey Street, Reading, RG1 3BA, UK | Tel: +44 1635 520 300 | February 2021 / RESP-330(1)
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