GlaxoSmithKline (GSK) and Innoviva recently presented positive results of a study showing that Anoro Ellipta is more effective than Stiolto Respimat in symptomatic patients with chronic obstructive pulmonary disease (COPD).
The results were presented at the 2017 CHEST Annual Meeting of the American College of Chest Physicians in Toronto, Canada, and are now available in the journal Advances in Therapy. The study is titled, “Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study.”
Anoro Ellipta, marketed by GSK, is an approved combination inhaler containing umeclidinium bromide (a long-acting muscarinic antagonist, LAMA) and vilanterol (a long-acting beta 2 agonist, LABA) for COPD treatment. Stiolto Respimat (tiotropium and olodaterol), marketed by Boehringer Ingelheim, is also a LAMA/LABA inhalation spray approved as a COPD therapy.
The effectiveness of these two LAMA/LABA combination therapies was compared in COPD patients: Anoro Ellipta (UMEC/VI at 62.5 mcg/25 mcg, respectively) versus Stiolto Respimat (TIO/OLO 5 mcg/5 mcg, respectively).
The study (NCT02799784) was an open-label, cross-over trial for eight weeks that enrolled 236 COPD patients.
Reported results showed that Anoro Ellipta’s effectiveness in improving lung function — measured using the Forced Expiratory Volume in 1 second (FEV1) test at week eight — was not inferior to that of Stiolto Respimat.
FEV1 is a measure of lung function that evaluates how much air a person can exhale during a forced breath.
Anoro Ellipta also was seen to be more effective when compared to Stiolto Respimat, with a difference in the treatment’s effect of 52 mL in FEV1 at week eight (180 mL versus 128 mL, respectively).
Both treatments showed similar tolerability and safety. The overall incidence of on-treatment adverse events was comparable — 25% in the Anoro Ellipta group versus 31% in the Stiolto Respimat group. Upper respiratory tract infections, cough, and diarrhea were the most common adverse events reported by patients.
“Improving lung function is a clear goal in patients with COPD. The challenge for healthcare professionals to date has been the lack of differentiation within the LAMA/LABA class. That is why we have conducted this study, as the first in-class head-to-head comparison of two fixed-dose once-daily LAMA/LABAs. These data demonstrate that UMEC/VI (Anoro) provides superior lung function improvements to the comparator TIO/OLO,” Eric Dube, senior vice president and head of global respiratory at GSK, said in a press release.
Boehringer Ingelheim responded to these findings, noting the study was open-label and conducted in a “limited population,” and did not believe its findings could “be translated into clinically meaningful outcomes,” suggesting that additional studies would needed to confirm the benefits reported.