05.03.2014 New asthma combination inhaler scrutinised by NICE.

The strength of the inhaled corticosteroid (ICS) in the combination inhaler Relvar Ellipta has been highlighted in an evidence summary on the medicine’s use in asthma, produced by the National Institute for Health and Care Excellence. Concerns about the dosing of the product and also the colour and name, were previously raised by a group of respiratory pharmacists in a letter to The Journal.

Relvar Ellipta is licensed for the treatment of asthma in adults and adolescents 12 years of age and older where use of a combination product is appropriate and patients are not adequately controlled with an ICS and “as needed” inhaled short-acting beta2-agonists. It is a combination of the ICS fluticasone furoate and the long-acting beta2-agonist (LABA) vilanterol and it is available in two strengths of ICS: 92µg and 184µg, combined with 22µg of vilanterol.

The 92µg/22 µg strength is licensed for asthma patients requiring a low to mid dose of inhaled corticosteroid. NICE points out that Relvar Ellipta is not licensed for use in patients who are already adequately controlled on both an ICS and a LABA, unlike the other four ICS/LABA combination inhalers licensed in the UK (Seretide, Flutiform, Symbicort and Fostair).

NICE also highlights the fact that the equivalent daily doses of fluticasone furoate 92µg and 184µg to the commonly used fluticasone propionate are 500mg and 1,000mg, respectively.

In turn, these daily doses of fluticasone proprionate are equivalent to 1,000mg beclometasone and 2,000mg beclometasone, respectively, according to the guideline on asthma management from the British Thoracic Society and Scottish Intercollegiate Guidelines Network, which is NICE-accredited.

The evidence summary also emphasises advice from the BTS/SIGN guideline that recommends that before going up to an ICS dose above 400mg beclometasone, or a maximum of 800mg beclometasone, an add-on LABA should be considered. The evidence summary also concludes that because a lower strength of Relvar Ellipta is not available, the ability to step down treatment is limited.

In relation to the inhaler’s efficacy compared with other products, NICE notes that Relvar Ellipta was not found to be statistically different from fluticasone propionate combined with salmeterol (Seretide) in a study designed to show superiority. It adds that most of the patients in the study were at step 3 or 4 of the BTS/SIGN guidelines and that caution is needed in extrapolating the results of this study to people with less severe asthma.

However, NICE does concede that a trial of fluticasone furoate/vilanterol, compared with fluticasone furoate alone, showed a significant reduction in severe asthma exacerbations. But again NICE adds that most participants in the study were at step 3 or 4 of the BTS/SIGN asthma guidelines. In addition, both of the described trials assessed the lower strength of Relvar Ellipta, and the evidence summary says there are “limited” efficacy data for the higher strength.

Another key point raised in the evidence summary is that there are no published studies comparing “patient-oriented” outcomes, such as exacerbation rates, of the new inhaler with already existing inhalers.

Source: http://www.pharmaceutical-journal.com/

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