The efficacy and safety of dual blockage of the renin-angiotensin-aldosterone system in patients with type 2 diabetes, hypertension and obesity without renal dysfunction

Abstract

The purpose of the study was to evaluate the clinical efficacy and safety of dual RAAS blockage during treatment with angiotensin-converting enzyme (ACE) inhibitors in combination with a direct renin inhibitor (PIR) aliskiren versus combination therapy with ACE inhibitors and angiotensin receptor blocker II (ARB) valsartan in patients with type 2 diabetes mellitus (T2DM), arterial hypertension (AH) and obesity, without renal dysfunction. Materials and methods. The study included 26 patients with T2DM (10 men and 16 women, mean age 59,0±6,2 years) with inadequate control of blood pressure (over 130 and/or 80 mm Hg) on prior antihypertensive therapy and without renal dysfunctions (glomerular filtration rate (GFR) 60 ml/min/1, 73 m2 and the of albumin/creatinine (A/C) ratio in the morning urine sample 10 mg/mol). After screening with the continuation of the initial therapy, including ACE inhibitors, 14 patients were added aliskiren 150–300 mg/day, 12 patients – valsartan 80–160 mg/day. Evaluation of the treatment effectiveness in terms of blood pressure (mean of three consecutive measurements in the sitting position) and the parameters of renal function (serum creatinine and potassium, GFR, A/C ratio in the urine) was performed at 4, 12 and 24 weeks of therapy. Results. In the group of patients treated with aliskiren, after 4 weeks of treatment a significant decrease in systolic and diastolic blood pressure (SBP and DBP, respectively) was noted as compared to baseline: 146,1 and 138,9 mm Hg, p0,05, 87,1 and 81,1 mm Hg, p 0,05, respectively; with systolic BP after 24 weeks of treatment decreased to 127,8 (-18,2 mm Hg), p0,05, diastolic BP to 75,0 (-12, 1 mm Hg), p0,05, the target blood pressure (≤130/80 mm Hg) was achieved in 83% of patients. The group of patients treated with valsartan, after 4 weeks of therapy showed a significant reduction in systolic BP 148 and 141,6 mm Hg, p 0,05, diastolic BP - to 85,8 and 81,7 mm Hg, p=0,059; after 24 weeks systolic BP decreased to 128,7 (-19,3 mm Hg), p=0,05, diastolic BP – to 77,5 (-8,3 mm Hg), p=0,07, the target blood pressure was achieved in 78% of patients. When monitoring the safety of therapy in terms of potassium, serum creatinine, GFR, and A/C urine ratio statistically significant differences between the groups at 4, 12, 24 weeks of treatment were observed. Conclusion. Results of the study demonstrate the efficacy and safety of dual RAAS blockage in patients with T2DM and obesity with no prior renal impairment.