Safety and tolerability of indacaterol in asthma: A randomized, placebo-controlled 28-day study
2007; Elsevier BV; Volume: 101; Issue: 10 Linguagem: Inglês
10.1016/j.rmed.2007.06.002
ISSN1532-3064
AutoresА. Г. Чучалин, A N Tsoĭ, Kai Richter, Norbert Krug, Ronald Dahl, P.B. Luursema, Ray Cameron, Weibin Bao, Mark Higgins, Ralph Woessner, Andre van As,
Tópico(s)Respiratory and Cough-Related Research
ResumoThe safety and tolerability of indacaterol, a novel once-daily β2-agonist bronchodilator with a fast onset of action, were assessed in 156 asthma patients in a multicentre, randomized, double-blind, placebo-controlled study. Patients received indacaterol 200, 400 or 600μg or placebo once daily for 28 days. Adverse events (AEs), laboratory assessments, vital signs, electrocardiograms, spirometry and physical examinations were monitored. Indacaterol pharmacokinetics were assessed.There was no evidence of dose-related increases in AE incidence or clinically significant hypokalaemia or hyperglycaemia in indacaterol-treated patients. Mean pulse rate changes were minor in any group, with maximum 1-h post-dose changes from baseline of −3.7, −3.3 and −2.2bpm for indacaterol 200, 400 and 600μg, respectively, and −2.9bpm for placebo. Mean QTc interval was similar between groups; change from baseline >60ms occurred in only two patients. Mean FEV1 increased after the first indacaterol dose; baseline-adjusted pre-dose (trough) values remained ⩾166mL higher than placebo at all subsequent visits, supporting a 24-h bronchodilator effect. Pre-dose (but not post-dose) serum indacaterol concentrations indicated a slight trend for accumulation.Once-daily indacaterol 200–600μg has a favourable therapeutic index. It is well tolerated, and is not associated with any adverse cardiac or metabolic effects, while providing effective 24-h bronchodilation.
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