The content of this evidence summary was up-to-date in January 2013. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information.
Glycopyrronium bromide (Seebri Breezhaler) is an inhaled long-acting muscarinic antagonist (LAMA) for maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). It received a European marketing authorisation in September 2012 and was launched in the UK in November 2012.
In people with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators as needed, the NICE guideline on Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update) (NICE clinical guideline 101) advises that maintenance therapy can be provided by the following (alone or in combination, with choice depending on several factors; see guideline for details):
a long-acting beta2 agonist (LABA)
a LABA with an inhaled corticosteroid (ICS) in a combination inhaler.
Evidence from 2 phase III placebo-controlled studies (GLOW1 [n=822, 26 weeks] and GLOW2 [n=1066, 52 weeks]) in patients with moderate to severe COPD, showed a statistically significant improvement in the disease-oriented primary end point, 12-week trough FEV1 (forced expired volume in 1 second), with glycopyrronium bromide compared with placebo (least squares mean difference 108 ml and 97 ml respectively, both p<0.001). These differences are around the level considered to be clinically relevant (minimum clinically important difference 100 ml).
In both studies, a statistically significant difference was seen for the key secondary patient-oriented outcomes, breathlessness and health status. However, the effect sizes for these measures were small. The difference considered to be clinically important for health status was not reached in GLOW1 or GLOW2. For breathlessness, the difference considered to be clinically important was achieved in GLOW1 but not in GLOW2.
GLOW2 included an open-label comparison with another LAMA, tiotropium. Tiotropium was statistically significantly more effective than placebo for the primary and 2 key secondary outcomes, showing similar results to glycopyrronium bromide. No significant differences were seen between glycopyrronium bromide and tiotropium for these outcomes.
A number of anticholinergic adverse events were seen with glycopyrronium bromide, particularly dry mouth, but generally the excess numbers compared with placebo were low.
More robust evidence comparing patient-orientated outcomes for glycopyrronium bromide with other active treatments for COPD would enable its place in therapy to be more clearly established. Local decision makers will need to consider the evidence for glycopyrronium bromide alongside that for the other treatments for COPD. Individual patient factors and the costs and safety profile of each treatment will need to be taken into account.
D'Urzo A, Ferguson GT, van Noord JA et al. (2011) Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respiratory Research 12: 156
Kerwin E, Hébert J, Gallagher N et al. (2012) Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. European Respiratory Journal 40: 1106–14
'Evidence summaries: new medicines' provide summaries of key evidence for selected new medicines, or for existing medicines with new indications or formulations, that are considered to be of significance to the NHS. The strengths and weaknesses of the relevant evidence are critically reviewed within this summary to provide useful information for those working on the managed entry of new medicines for the NHS, but this summary is not NICE guidance.