Efficacy and safety of azilsartan medoxomil in various doses in patients with metabolic disorders

Abstract

Background. Obesity is an independent risk factor of the cardiovascular complications in patients with arterial hypertension (HTN). It can directly contribute to an increase in blood pressure (BP). Thus, the treatment of patients with HTN and obesity becomes a complex clinical problem, which requires new highly effective antihypertensive drugs. Aim. To assess the effectiveness and safety of novel angiotensin II receptor blocker azilsartan medoxomil (AZL-M) as monotherapy and in free combinations with diuretics and/or calcium antagonists in obese or overweight patients with HTN in real clinical practice. Materials and methods. An international multicenter observational non-interventional prospective study of the efficacy and safety of AZL-M in patients with hypertension and overweight or obesity was performed in the Russian Federation and the Republic of Kazakhstan. Patients took the drug for 6 months in accordance with the approved local instructions for use. All examinations were performed in accordance with routine clinical practice on the basis of a physicians decision. Results. In patients prescribed AZL-M as monotherapy (without dosage changes during the study) a significant decrease in systolic and diastolic blood pressure (systolic BP and diastolic BP, respectively) was observed (p0.001, compared to baseline); the average decrease in systolic BP and diastolic BP was 30.5012.67 and 14.478.65 mmHg, respectively (n=865). Target BP (140/90 mmHg or 140/85 mmHg in patients with diabetes mellitus) was achieved in 112 (94.12%), 547 (92.24%) and 135 (88.24%) of patients who were prescribed AZL-M at doses of 20, 40, or 80 mg/day, correspondingly. In patients receiving AZL-M in combination with a diuretic or calcium antagonist, the rate of achievement of ad blood pressure targets was 78.887.5% and 81.385.5%, respectively, and the frequency of response to therapy was 68.892.9% and 81.393.9%, respectively. During the entire observation period, 43 adverse events (AEs) were recorded, the most common of which were arterial hypotension (14 cases). All AEs associated with the study drug were of mild or moderate intensity. Conclusion. AEs administered as monotherapy and as part of combination therapy provided a statistically and clinically significant decrease in BP and a high frequency of target BP achievement in patients with HTN and metabolic disorders associated with overweight or obesity. Given the high efficacy and good tolerance of the drug, AEs can be considered as the drug of choice for the treatment of HTN in patients with overweight or obesity.