Efficacy and safety of fimasartan, a new angiotensin-receptor blocker, compared to losartan in mild-to-moderate hypertension
https://doi.org/10.18705/1607-419X-2016-22-2-204-216
Abstract
Background. A phase III multicenter open-label randomized comparative trial on antihypertensive efficacy and safety of fimasartan and losartan in parallel groups for adult outpatients with arterial hypertension (AH) 1–2 grade during 12 weeks of therapy was performed in 13 investigational sites of Russia.
Design and methods. The study included patients with mean systolic blood pressure (SBP) in the sitting position ≥ 140 mm Hg and ≤ 179 mm Hg, previously treated patients underwent a «wash-out» period. The starting therapy was fimasartan 60 mg per day or losartan 50 mg per day, in case blood pressure was maintained at the level SBP ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg at 4 and 8 weeks of therapy the doses were increased up
to 100 and 120 mg, respectively. Primary end-point was change from baseline in “office” sitting SBP at week 12 that was intended to show a “non-inferior” fimasartan efficiency (non-significant difference was set at 5,5 mm Hg).
Results. Altogether 179 patients were randomized either to fimasartan (n = 89) or losartan (n = 90) groups. There were no differences between groups by demographic data and the characteristics of hypertension. After 12 weeks of treatment, mean SBP was 127,7 ± 8,0 mm Hg (–25,2 ± 8,6 mm Hg compared with baseline) in group fimasartan and 127,6 ± 5,6 mm Hg (–24,3 ± 7,8 mm Hg compared with baseline) in losartan group. The mean change in SBP was –0,18 ± 1,00 mm Hg (p = 0,390), the upper limit of the 95 % confidence interval was equal to 1,47 mm Hg that confirms the primary criterion of effectiveness. “Non-inferior” fimasartan efficiency was confirmed by the secondary criteria — the change in SBP and DBP at follow-up visits and the response rate. Safety profiles of fimasartan and losartan were comparable.
Conclusions. Fimasartan is well tolerated, safe and provides similar to losartan BP lowering effect in outpatient population.
About the Authors
N. E. ZvartauRussian Federation
MD, PhD, Research Laboratory of Pathogenesis and Treatment of Hypertension, V. A. Almazov Federal North-West Medical
Research Centre
A. O. Konradi
Russian Federation
MD, PhD, DSc, Professor, Deputy Director General of Science, V. A. Almazov Federal North-West Medical Research Centre
E. V. Korneva
Russian Federation
MD, PhD, Scientific Adviser, JSC «R‑Pharm»
N. A. Bessonova
Russian Federation
MD, PhD, Head, Cardiovascular Care Unit, State Institution of Health «City Hospital № 28»
S. A. Boldueva
Russian Federation
MD, PhD, DSc, Professor, Head, Department of Faculty and Hospital Therapy, North-Western State Medical University named author I. I. Mechnikov
L. P. Egorova
Russian Federation
MD, PhD, Consultant Cardiologist, Department of Internal Medicine, Pavlov First State Medical University of St. Petersburg
V. V. Esip
Russian Federation
MD, Cardiologist, the 1st Consultative Unite, Diagnostic Centre № 85
B. M. Goloshchekin
Russian Federation
MD, PhD, Head, Department of Cardiology, State Institution of Health «City Hospital № 15»
S. Yu. Martsevich
Russian Federation
MD, PhD, DSc, Professor, Head, Department of Preventive Pharmacology, State Research Center for Preventive Medicine
S. S. Sayganov
Russian Federation
MD, PhD, DSc, Associate Professor, Department of Faculty and Hospital Therapy, North-Western State Medical University n. a. I. I. Mechnikov
Z. S. Shogenov
Russian Federation
MD, PhD, Head, Coronary Care Unit, Municipal Hospital № 81
Zh. D. Kobalava
Russian Federation
MD, PhD, DSc, Professor, Head, Department of Propedeutics of Internal Diseases, PFUR
A. Yu. Vishnevskiy
Russian Federation
MD, PhD, Cardiologist, Department of Cardiology, Pokrovskaya City Hospital
K. N. Zrazhevskiy
Russian Federation
MD, PhD, Head, Department of Cardiology, State Institution of Health «Hospital № 38 n. a. Semashko»
N. Yu. Khozyainova
Russian Federation
MD, PhD, DSc, Professor, Medical Adviser, Clinical Development & Medical Affairs Department, JSC «R‑Pharm»
M. Yu. Samsonov
Russian Federation
MD, PhD, Medical Director, JSC «R‑Pharm»
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Review
For citations:
Zvartau N.E., Konradi A.O., Korneva E.V., Bessonova N.A., Boldueva S.A., Egorova L.P., Esip V.V., Goloshchekin B.M., Martsevich S.Yu., Sayganov S.S., Shogenov Z.S., Kobalava Zh.D., Vishnevskiy A.Yu., Zrazhevskiy K.N., Khozyainova N.Yu., Samsonov M.Yu. Efficacy and safety of fimasartan, a new angiotensin-receptor blocker, compared to losartan in mild-to-moderate hypertension. "Arterial’naya Gipertenziya" ("Arterial Hypertension"). 2016;22(2):204-216. https://doi.org/10.18705/1607-419X-2016-22-2-204-216