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Cardiovascular safety of indakaterol in the treatment of COPD

Publication at Third Faculty of Medicine |
2013

Abstract

COPD, although incurable, it is a preventable and treatable illness that not only affects the lungs, but other parts of the body, as well. These "extrapulmonary effects" as they are referred to by medical experts, are thought to contribute to the severity of COPD in people who are diagnosed with the disease.Clinical studies with indacaterol have reported 24-hour bronchodilator efficacy and improved clinical outcomes in the form of reduced symptoms and better health status.

These studies also reported reassuring safety and tolerability data with doses up to and including 600 jig once daily, double the highest licensed dose, given for up to 1 year. As the first once-daily inhaled beta2-agonist licensed for the treatment of COPD, it is relevant to scrutinize the safety of indacaterol, especially when many patients with COPD are elderly and comorbid conditions are common.

Here, an analysis of pooled safety data from recent clinical trials with indacaterol, providing a large patient population in which potential safety signals can be more robustly and comprehensively assessed compared with single studies, is reported. This pooled data set allows the safety of indacaterol to be compared with placebo and with data from formoterol, salmeterol. and tiotropium treatment groups