Первые результаты международного клинического исследования VICTORY: эффективность и безопасность антигипертензивной монотерапии валсартаном и его фиксированной комбинации с гидрохлоротиазидом в разных дозовых режимах у пациентов с артериальной гипертонией 1–2-й степени

Abstract

On behalf of the group of russian researchers. The aim of the VICTORY study was to estimate the efficacy and safety of valsartan monotherapy using different dose regimes (Valsacor® 80, 160, 320 mg) and its fixed combination with hydrochlorothiazide (HCTZ) using different dosage regimens [Valsacor® H160 (valsartan 160 mg + HCTZ12.5 mg), Valsacor® H320 (valsartan 320 mg + HCTZ 12.5 mg) Valsacor® HD320 (valsartan 320 mg + HCTZ 25 mg)] in reaching the target level of blood pressure (BP) in patients with 1-2 degree arterial hypertension (AH).Materials and methods. There are 130 patients with 1-2 degree AH were enrolled in the open international multicenter prospective randomized study from 7 cities in 8 Russian Clinical Centers in Russia. The starting dose of valsartan depended upon the previous antihypertensive treatment: for previously untreated patients - 80 mg (Valsacor® 80 mg, KRKA, Slovenia) with randomization into 4 parallel groups (n=108) for the patients receiving antihypertensive therapy during the screening, after washout 7-day period of Valsacor® 160 mg application with randomization into 8 parallel groups (n=22). Besides the dynamics of clinical BP, we evaluated the impact of therapy on pulse ware velocity, erectile function (in men) and the quality of life. Results. The clinical BP in 130 patients with AH with age of 55.6±11.5 years (65% women) at the moment of inclusion into the study was 157.6/95.1 mm Hg. The BP was reduced to 140.9/85.3 mm Hg on the 4-week of valsartan 80 or 160 mg application. Valsartan titration or the combination of valsartan and HCTZ on the 8-week helped to reduce BP to 135.2/83.5 mm Hg. The 16-week treatment showed the BP reduced to 129.2/79.4 mm Hg. ( p <0.000001). The therapy was statistically significant reducing the level of heart rate and did not affect aortic augmentation index and the condition of erectile function. The percentage of patients who had the departure from normal blood glucose levels, creatinine and potassium, did not increase since the beginning of the study till the 16-week of treatment. Adverse effects were observed in 9.2% of patients, the connection with the drugs was assessed as improbable and in one case as possible, the severity - was moderate or slight.Conclusions:Valsartan monotherapy and the combination of valsartan and HCTZ significantly reduce the systolic BP and diastolic BP to normal levels in patients with 1-2 degree arterial hypertension.As a result of valsartan therapy and the combination with HCTZ the target BP values were achieved at 91% of all patients involved in the study.Valsartan monotherapy and the combination of valsartan and HCTZ led to heart rate reduction and did not affect aortic augmentation index.Therapeutic effect was very good in 89.1% of the patients and good - in 7.0%.The overall clinical efficiency was measured as extremely high in 73.4% of patients, very high - in 15.6% and high - in 6.3%.On assessing the impact of the therapy on the quality of life of patients we noted that 78.7% of patients were in good health, and in 18.1% of cases the treatment did not worsen the general well-being of the patient.