作者: Sebastian Majewski , Sebastian Slomka , Ewa Zielinska-Wyderkiewicz , Maciej Ciebiada , Pawel Gorski
DOI: 10.2165/11597400-000000000-00000
关键词: Ivabradine 、 COPD 、 Randomized controlled trial 、 Placebo 、 Anesthesia 、 Crossover study 、 Medicine 、 Adverse effect 、 Asthma 、 Respiratory function
摘要: There is substantial evidence that heart rate (HR) a powerful predictor of mortality in both normal individuals and patients with cardiovascular disease. The use b-adrenoceptor antagonists (β-blockers) has confirmed the importance lowering elevated HR patient’s prognosis. However, these agents can have undesirable adverse effects (AEs) due to risk bronchoconstriction are contraindicated obstructive airway A selective bradycardic agent, without such effects, could be therapeutic interest. Ivabradine, new I f inhibitor acts specifically on sino-atrial node, pure HR-lowering agent. objective this study was assess efficacy respiratory safety ivabradine asthma chronic pulmonary disease (COPD). This randomized, single-center, double-blind, placebo-controlled, crossover trial. Enrolment began May 2009, last patient completed January 2011. conducted an ambulatory setting. total 40 (20 asthmatic 20 COPD patients). Inclusion criteria were: documented diagnosis or according international guidelines, age 18–75 years, mean Holter ECG recording ≥60 beats/min. Exclusion included exacerbation previous month inability understand instructions procedures. All received 7.5 mg twice daily for 5 days placebo manner, one two arms study, at least 2 washout between treatments. main outcome measures difference treatment change comparison baseline. Other evaluated outcomes were differences peak expiratory flow (PEFR), symptom score, rescue medication consumption, AEs. Results: Ivabradine produced significantly lower than groups patients: 67.4 ± 8.38 versus 82.85±11.19 beats/min (p 0.05). Both treatments well tolerated. incidence AEs low generally similar periods treatment, except visual symptoms during ivabradine, which reported by 5% patients. Our demonstrated reduction effective COPD, no alteration function over duration study. offers interesting alternative, as contraindications β-blockers. Registered www.clinicaltrials.gov (NCT01365286).