2016


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2016/№5

Efficacy and safety of a combination of Fosinopril and hydrochlorothiazide for microAlbuminUria in patients with cardiovaScular condiTions (FAUST). Design and results of a study in subgroups of patients with and without concomitant type 2 DM

Mareev V. Yu.1, Minina Yu. V.2, Begrambekova Yu. L.1
1 – Federal State Budgetary Educational Institution of Higher Professional Education, "M. V. Lomonosov Moscow State University", Leninskie Gory 1, GSP-1, Moscow 119991
2 – All-Russian Public Organization, "Society of experts in heart failure", Moscow, info@ossn.ru

Keywords: arterial hypertension, type 2 diabetes mellitus, CHF, microalbuminuria, Fosinopril, hydrochlorothiazide, treatment, safety, efficacy

DOI: 10.18087/rhfj.2016.5.2258

Background. The combination of AH and DM increases the risk for development of cardiovascular events. Impaired kidney function plays an important role in worsening prognosis for such patients. Searching for combinations of antihypertensive drugs that would improve the kidney function (GFR and degree of MAU) in AH patients both with and without diabetes is relevant. Aim. To study incidence of MAU and/or type 2 DM in a Russian cohort of patients with grade 1–2 AH and to evaluate the efficacy and safety of a combination of fosinopril and hydrochlorothiazide (HCTZ) in patients with complicated AH in a multicenter, open, prospective study. Materials and methods. The study included 1012 patients aged 18 to 80 with grade 1 or 2 essential AH from 74 investigational sites in 41 cities of the Russian Federation. Patients were divided into two groups, with (545 patients) and without (467 patients) MAU. Each group contained subgroups with or without type 2 DM. All patients received starting doses of fosinopril (10–20 mg/day) in combination with HCTZ (6.25–12.5 mg/day). Doses of the drugs were adjusted based on the control of BP. The follow-up period lasted for 16 weeks. Clinical status, changes in AH, MAU, calculated GFR , quality of life by the SF-36 questionnaire, changes in cardiovascular risk (CVR), incidence of metabolic syndrome (MS) and its components, indexes of carbohydrate metabolism (fasting glucose and HbA1C) and lipid metabolism were evaluated. Safety was assesses based on records of adverse events (AEs). Results. The incidence of MAU in the Russian cohort of AH patients was 53.9% and the presence of concomitant type 2 DM was 47.5%, which was considerably higher than in real-life clinical practice. Fosinopril and HCTZ demonstrated high hypotensive efficacy: 91.5% (without MAU) and 90.5% (with MAU) of patients without type 2 DM achieved the BP goal (BP <140/90 mm Hg). In subgroups with AH and type 2 DM, BP was under control in 54.6% (without MAU) and 51.2% (with MAU) of patients using the criterion of BP <130/80 mm Hg and in 84 and 81% of patients without MAU and with MAU, respectively, using the current criterion of BP<140/90 mm Hg. In the group of patients with MAU, MAU disappeared under the treatment in 48.6% of patients without diabetes and in 63.6% of patients with the combination of AH and type 2 DM. In 23 patients, emergence of MAU was detected (4.0% in the group without DM and 5.9% in the group with concomitant type 2 DM). In two more AH patients without type 2 DM, MAU transformed into macroalbuminuria. In total, impairment of kidney function was observed in 25 (2.5%) of 1012 patients. GFR significantly increased only in AH patients with type 2 DM, by 3.4 ml/min (p=0.017) with original MAU and by 2.3 ml/min (p=0.02) without MAU. The treatment resulted in good glycemic control and decreased the number of patients with MS. The decrease in CVR was more pronounced among non-diabetic patients; however, among diabetic patients also the number of patients with moderate CVR increased while the number of patients with high and very high CVR decreased. Analysis of all AEs distributed by severity and relationship with the treatment showed good tolerability of the study combination in all groups. Conclusion. The data obtained favor the use of the ACEI fosinopril and its combination with HCTZ in patients with grades 1 and 2 AH and type 2 DM and MAU as well as the high nephroprotective capacity and beneficial metabolic effects of these drugs.
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Mareev V.Yu., Minina Yu.V., Begrambekova Yu.L.Efficacy and safety of a combination of Fosinopril and hydrochlorothiazide for microAlbuminUria in patients with cardiovaScular condiTions (FAUST). Design and results of a study in subgroups of patients with and without concomitant type 2 DM. Russian Heart Failure Journal. 2016;17 (5):312–332

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