Sunovion Pharmaceuticals has announced the results of a post-hoc analysis of a long-term safety study evaluating Brovana (arformoterol tartrate) Inhalation Solution in people with moderate-to-severe chronic obstructive pulmonary disease (COPD). Results from this analysis reinforce the use of Brovana in COPD, as measured by COPD exacerbation-related hospitalizations compared to those treated with placebo.
Brovana is a twice-daily nebulized long-acting beta2-agonist (LABA) approved by the FDA for the long-term maintenance treatment of bronchoconstriction in people with COPD, including chronic bronchitis and emphysema.
“Reducing exacerbations is a key goal for health care providers treating people with COPD,” said Krithika Rajagopalan, vice president, head of Global Health Economics and Outcomes Research, Sunovion. “Sunovion is committed to understanding and sharing critical health outcomes information that may improve current treatment for people with COPD.”
Data for this post hoc analysis came from a multicenter, randomized, double-blind, 52-week safety trial evaluating Brovana versus placebo in patients with moderate-to-severe COPD. Data on COPD exacerbation and associated hospitalization events were collected in the study. Post-hoc analyses of these data demonstrated that patients receiving Brovana exhibited lower annualized COPD exacerbation-related hospitalization rates compared with patients receiving placebo. The Brovana group also reported a greater reduction in hospitalization risk relative to placebo, and these results were more pronounced in a subset of patients who were responders on the St. George’s Respiratory Questionnaire (SGRQ) (i.e., patients who achieved a minimum 4-point improvement in SGRQ total score at study end).
The SGRQ is an index designed to measure and quantify health-related health status in patients with chronic airflow limitation that has been shown to correlate well with established measures of symptom level, disease activity and disability.1 For the intent-to-treat population, the adjusted annualized hospitalization rate was significantly reduced with BROVANA compared with placebo (relative risk=0.60 [95% confidence interval (CI)=0.41, 0.87; p=0.007]). For those patients who were SGRQ responders, the adjusted relative risk was the lowest at 0.34 (95% CI=0.12, 0.99; p=0.048); SGRQ non-responders had an adjusted relative risk of 0.81 (95% CI=0.39, 1.67; p=0.573).