To evaluate the effects of valsartan/amlodipine (V/A) fixed combination for standard therapy of arterial hypertension (AH) and coronary heart disease (CHD) in smokers with chronic obstructive pulmonary disease (COPD)Design and method:
36 smoker male with AH (DBP 90–110 mmHg and/or SBP 140 −180 mmHg), CHD and COPD were randomized into 2 groups (gr): I gr (n = 18, 55,8 ± 5,9 yrs) which received angiotensin-converting enzyme inhibitor and II gr (n = 18, 58,0 ± 4,9 yrs) which treated with the fixed combination V/A (160 mg/5–10 mg). All pts received selective beta-blockers, 16.7% of pts I and II grs - diuretics. The duration of the study was 4 months. The trail includes bicycle exercise stress test (PE); echocardiography; spirometry (forced vital capacity, FVC; forced expiratory volume in 1 second, FEV1); 24-hour ambulatory BP monitoring; questionnaires as SGRQ and Quality of Life SF-36.Results:
Treatment with V/A significant (p < 0.001) decreased of office SBP (−39.2 ± 9.7 mmHg), DBP (−16.9 ± 5,7 mmHg), pulse BP (−22.2 ± 5.9 mmHg) vs the absence of such dynamics in pts of I gr. Also the average 24 h SBP/DBP was reduced by −10.6/9.3% (p < 0.001), daytime SBP/DBP by −11.6/9.8% (p < 0.01), nighttime SBP/DBP by −9.6/8.4% (p < 0.01). After V/A therapy there was observed increasing of the duration of the PE (22.2%, p < 0.01), threshold power (23.6%, p < 0.01), time before the development of angina pectoris (8.6%, p < 0.05) and myocardial ischemia (8.3%, p < 0.05). In pts of I gr there was a decrease of the duration of the PE (−10.2%, p < 0.05) and time to the development of angina pectoris (−29%, p < 0.05). In II gr we have found positive changes in structural parameters of the heart and decrease of mean pulmonary artery pressure. After V/A therapy there was increase of FVC (by 14.8%, p < 0.05), prebronchodilator FEV1 (by 11.7%, p < 0.05) and FEV1 after administration of salbutamol (by 12.5%, p < 0.05). After V/A therapy there was the improvement of psychological status and quality of life.Conclusions:
Combination therapy with V/A have complementary mechanisms of action, effectively decreases the levels of office and ambulatory BP, mean pulmonary artery pressure, respiratory symptoms, improves exercise tolerance, and health-related quality of life in smokers with co-morbidities.