Methods: after enrollment in this trial 98 patients (70 men and 28 women), aged 64.1 ± 4.8 years, with CHF classes II to III (New York Heart Association) combined with moderate to severe COPD (GOLD-2015) with initial ejection fraction of the left ventricle (LVEF) less than 45%, were randomized into three groups – tiotropium (18 µg daily, n=36), indacaterol (150 µg daily, n=32) and tiotropium/indacaterol group (18/150 µg daily, n=30). Patients of all groups received the complex CHF treatment comprising carvedilol, losartan, diuretics, nitrates, cardiac glycosides (if necessary) and basic COPD therapy (inhalation corticosteroids). Echocardiography, exercise tolerance, 24-hour electrocardiography, respiratory function test were assessed at baseline and after 6 months of treatment. The quality of life was evaluated by MYHFQ, SGRQ and mMRC.
Results: after 6 months of therapy the improvement of clinical condition and quality of life were marked in all groups. In 1st, 2nd and 3rd group LVEF was increased by 20.9%, 18.3% and 22.5%, pulmonary hypertension decreased by 21.2%, 22.8% and 26.7%, episodes of silent myocardial ischemia decreased by 52.3%, 47.6% and 52.4%, respectively. Towards the end of the observation period, in all groups there was a confident and authentic increase of FEV1 witch made 10.4%, 7.8%, and 11.9% accordingly. Patients showed statistically significant and clinically meaningful reduction of SGRQ, MYHFQ scores and MMRC dyspnea grade (see table 1). All treatment regimens were well tolerated.
Conclusions: the carvedilol and losartan with tiotropium and/or indacaterol administration in patients with CHF combined with COPD raises efficiency of treatment, improves quality of life, basic parameters of central hemodinamics and pulmonary function. Efficacy of long-acting inhaled anticholinergic agent (tiotropium) and long-acting ß-agonist (indacaterol) in patient with CHF due to CAD combined with COPD are similar. Combination of these drugs significantly enhances the positive effects of the therapy.