New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

2 nd Annual Essentials in Primary Care
Fall Conference
Friday, November 11, 2011
Indacaterol – Arcapta Neohaler
Dose-ranging in COPD
• A 2-week, randomized, double-blinded, placebo-controlled
design that enrolled 552 patients with a clinical diagnosis of
COPD, who were 40 years or older, had a smoking history of at
least 10 pack years, had a post-bronchodilator FEV1 less than
80% and at least 30% of the predicated normal value and a
post-bronchodilator ratio of FEV1 over forced vital capacity
(FEV1/FVC) of less than 70%. The trial compared doses of
18.75, 37.5, 75 and 150 mcg once daily, a salmeterol active
control group, and placebo. The trial showed that the effect
on FEV1 in patients treated with 18.75 mcg dose was lower
compared to patients treated with other indacaterol doses.
– Although a dose-response relationship was observed at Day 1, the
effect did not clearly differ among the 37.5, 75 and 150 mcg doses by
Day 15
Indacaterol – Arcapta Neohaler
Like other beta2-agonists, indacaterol can produce a clinically significant cardiovascular
effect in some patients as measured by increases in pulse rate, systolic or diastolic blood
pressure, or symptoms. In addition, beta-agonists have been reported to produce ECG
changes, such as flattening of the T wave, prolongation of the QTc interval, and ST
segment depression, although the clinical significance of these findings is unknown
Wayne Weart
New Drug Update Part I