Molecula Nueva Para Epoc

Safety Profile of Indacaterol: Results of an Early Experience Program
G.A. Barrera
Background: Indacaterol is a novel, inhaled, ultra long-acting beta
2-agonist (LABA) available in EU and othercountries included
Mexico, it is approved for the maintenance treatment of airflow obstruction
in patients with chronic obstructive pulmonary disease
(COPD) in doses of 150 and 300 mcg once daily.[1]Objective: To describe the safety profile of indacaterol in an early experience
program through spontaneous adverse events reporting by
patients directly to a call center.
Methods: This programconsisted of inviting patients with COPD and
gave them Indacaterol through a physician prescription in a real life
setting.
Results: 107 patients reported adverse events (AEs) in this period, 60%were female and 40% were male. The average age was 69.1 years (range
26–98). The indication of Indacaterol was COPD in 90% of these
patients. The dose used was 150 mcg in 98% of these patients. Thereports corresponded to 151 non serious AEs and 66 serious AEs. The
most frequent non serious AEs were cough (17%), difficult for breathing
(14%), reactions in throat like throat irritation andthroat sore, dry
throat, burning throat or burning (12%), most of them were experienced
just after the administration of Indacaterol on in the next first
days of the therapy. Approximately the half ofthese cases got recovered
after the withdrawal of Indacaterol. Regarding the serious AEs, most of
them were complications of underlying respiratory conditions included
20 fatal cases. In none ofthe cases was pneumonia or COPD progression
related to indacaterol therapy. None of the prescribing physicians
suspected that indacaterol was related to these serious AEs.
Conclusions: The earlyexperienced programs are a useful strategy to
monitor the AEs in a real life setting during the first/early postmarketing
period. The profile of AE’s found for Indacaterol corresponded
to described...