Indacaterol vs Tiotropium: Tie on FEV1; Spiriva wins on exacerbations

Once-daily long-acting beta agonist indacaterol (Arcapta Neohaler) went head to head against tiotropium (Spiriva) in a randomized trial among 3,444 patients with severe COPD, funded by indacaterol makers Novartis.

Indacaterol, approved in 2011 as a treatment for COPD, was deemed noninferior to tiotropium according to the prespecified criteria of the trial, bronchodilating almost identically (a least-squares mean difference between the two of only about 10 mL in trough FEV1 after 3 months).

However, indacaterol did not prevent COPD exacerbations as well as tiotropium: a 0.79 annual exacerbation rate among those taking indacaterol, vs. 0.61 COPD exacerbations yearly among those taking Spiriva. That suggests one exacerbation was prevented for every 6 people treated for a year with Spiriva compared to Arcapta. (Of course, you could also prescribe them both, since combining long-acting beta agonists, inhaled steroids and tiotropium as treatment for severe COPD seems to work well.)

Indacaterol was previously shown to work about as well or better than twice daily salmeterol. Spiriva vs indacaterol have been compared directly before, but exacerbation rates were not reported in that small study.

The new once-daily long-acting beta agonists indacaterol and vilanterol will be combined with once-daily inhaled corticosteroids to create a new class of once-daily inhaler treatments for asthma and COPD. The FDA approved Breo Ellipta, the first of these combining vilanterol and fluticasone, in 2013. A once-daily indacaterol-mometasone product is in the works, as is a once-daily combination of Spiriva (tiotropium) and a long-acting beta-agonist (olodaterol, not yet FDA approved at this writing).

Marc Decramer et al. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respiratory Medicine, pp 524 - 533, September 2013.  doi:10.1016/S0140-6736(08)61345-8.