Journal
COPD-JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Volume 7, Issue 6, Pages 418-427Publisher
TAYLOR & FRANCIS INC
DOI: 10.3109/15412555.2010.528812
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Funding
- AstraZeneca
- Boehringer Ingelheim
- Menarini
- Schering-Plough
- Chiesi Farmaceutici
- GlaxoSmithKline
- Merck Sharp
- Dohme
- Nycomed
- Union Chimique Belge
- Pfizer
- Sigma-Tau
- Italian Ministry of Health
- Italian Ministry for University and Research
- Novartis Pharma AG, Basel, Switzerland
- Medtronics
- Glaxo Smith Kline
- Astra Zeneca
- Novartis
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This study assessed the cardiovascular safety of QVA149, an inhaled, once daily, bronchodilator combination containing two 24-hour bronchodilators, the long-acting beta(2)-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237). In this randomised, double-blind, placebo-controlled, parallel-group study, 257 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) were randomised to receive QVA149 (indacaterol/NVA237) 600/100 mu g, 300/100 mu g or 150/100 mu g, indacaterol 300 mu g or placebo, once daily for 14 days. The primary endpoint was change from baseline in 24-h mean heart rate versus placebo on Day 14. 255 patients were included in the safety analysis (mean age 63.8 years, 76.5% male, post-bronchodilator forced expiratory volume in one second [FEV1] 53.2% predicted, FEV1/FVC [forced vital capacity] 50.0%, mean 24-h heart rate 79.6 bpm). There were no clinically significant differences in the 24-h mean heart rate on Day 14 between the three doses of QVA149 and placebo or indacaterol. The confidence intervals of these treatment differences (contrasts) were within the pre-specified equivalence limit (-5 to 5 bpm). No clinically relevant differences in QTc interval (Fridericia's) were observed between groups on Days 1, 7 and 14. Once-daily QVA149 was well tolerated in COPD patients with a cardiovascular safety profile and overall adverse event rates similar to placebo.
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