Potentials for the use of azilsartan and spironolactone in patients with arterial hypertension and diabetes mellitus

Background. Arterial hypertension (AH) and type 2 diabetes mellitus (DM2) are often combined and mutually enhance the adverse effect on vascular and renal prognosis. In patients with such comorbidity, a comparative assessment of the capabilities of individual representatives of the basic classes of antihypertensive drugs seems important, which can increase the effectiveness of treatment programs.

Objective. Prospective study of tolerability, hypotensive and organoprotective effects of the combination of azilsartan and spironolactone in patients with AH and DM2.

Methods. A randomized comparative prospective study of the tolerability and safety of two antihypertensive therapy regimens in patients with AH and DM2 was conducted for 12 months. The planned follow-up period was completed by 71 patients (38 men and 33 women), mean age – 65.6 ± 11.8 years. Randomization was carried out by the envelope method: group A (azilsartan at doses of 40–80 mg/day in combination with spironolactone 25–50 mg/day) and group B (ramipril 5–10 mg/day with indapamide 1.5–2.5 mg/day). Diagnosis of AH and DM2, as well as their complications, was based on the relevant domestic and international recommendations. Based on generally accepted approaches, general clinical and biochemical studies were performed, blood pressure (BP) was assessed in the doctor’s office and using ambulatory BP monitoring (ABPM); the left ventricular myocardial mass index and the common carotid artery intima-media thickness were determined.

Results. Treatment in both groups was associated with a statistically significant decrease in systolic and diastolic BP (SBP and DBP, respectively). In group A, compared with group B, the hypotensive effect was more significant and developed faster. The degree of decrease in office SBP in group A over this period was 42.3 ± 8.4 mm Hg (25.0 ± 5.0% of the initial value), in group B – 29.3 ± 6.2 mm Hg (17.6 ± 4.1%), respectively. For DBP, similar values were 23.1 ± 5.6 mm Hg in group A (23.5 ± 4.3%), in group B – 12.6 ± 2.8 mmHg (13.0 ± 2.4%), all P < 0.05. A more pronounced hypotensive effect of treatment in group A compared to group B was also noted according to ABPM data. During treatment, favorable changes in cardiovascular remodeling were recorded in both groups, they were more significant in group A.

Conclusion. In patients with a combination of arterial hypertension and type 2 diabetes mellitus, a wider use of azilsartan, which has high hypotensive efficacy and additional favorable properties, in combination with the mineralocorticoid receptor antagonist spironolactone is justified.