Aspects of efficacy, safety and adherence to antihypertensive therapy with single pill combinations of valsartan, amlodipine and hydrochlorothiazide (Vamloset® and Co-Vamloset) in patients with 2 and 3 grade of arterial hypertension in the Russian clinical study VICTORY II

Abstract

Aim. To assess the efficacy and safety of Vamloset (amlodipine/valsartan 5/80, 5/160, 10/160 mg) and Co-Vamloset (amlodipine/valsartan/hydrochlorothiazide 10/160/12.5, 10/160/25 mg) in achieving the target levels of blood pressure (BP) in patients with stage 23 arterial hypertension (AH). The article discusses indicators affecting adherence to antihypertensive therapy (AHT).
 Material and methods. The VICTORY II Russian study in 8 clinical centers of the Russian Federation included 103 patients over 18 years of age with stage 23 essential AH (who havent been previously treated and have office systolic BP160 mm Hg and/or diastolic BP100 mm Hg or who havent reached the target office blood pressure with mono- or double AHT). The Full Analysis Set (FAS) for efficacy analysis included 99 patients, a FAS population with the restoration of data missed using Last Observation Carried Forward. The SF-36 questionnaire for assessing the quality of life, the effect on erectile function in men, the convenience of current therapy from the point of view of patients were analyzed after 16 weeks of treatment. The Per Protocol (PP) population included 80 patients completing the study without major protocol deviations to assess the primary parameters of efficacy. All patients with stage 2 hypertension were prescribed Vamloset (amlodipine/valsartan 5/80 mg), with stage 3 hypertension amlodipine/valsartan 5/160 mg. Dose titration of Vamloset and Co-Vamloset (LLC Krka-RUS) was carried out every 4 weeks according to the AHT schemes.
 Results. The studys active phase included 100 patients aged 59.510.9 years (women 59%) with AH duration of 83.48.4 months; 83% of patients received AHT prior inclusion in the study. In the PP population, 16 week- AHT with Vamloset or Co-Vamloset allowed reaching the target BP in 90.0% of patients (95% confidence interval [CI] 81.295.6). Overall clinical efficacy was achieved in 98.8% of patients (95% CI 93.2100.0). All treatment regimens were characterized by high patient compliance. In the total group, 50% of patients rated their AHT as more convenient than they had previously used; of them, in the stage 2 AH group 47.8%, in the stage 3 AH group 53.3%. Metabolic neutrality with regard to at least one indicator was observed in 100% of patients, with regard to 6 indicators in 43.9% [33.9; 54.9]. For all 98 patients included in the analysis, changes in all SF-36 scales, except for physical functioning (p=0.339), were statistically significant (p0.05). The effect of AHT on erectile function was rated as positive in 51.3% of men. Good tolerance data are consistent with the established drug safety profile.
 Conclusion. In the VICTORY II study, high antihypertensive efficacy and an improvement in a set of indicators of optimal adherence to AHT by Vamloset and Co-Vamloset within 16 weeks were proved in patients with stage 23 AH. Patients high rating for quality improvement in the quality of life, safety of therapy and ease of use ensured optimal compliance of Vamloset and Co-Vamloset therapy throughout the study.