Comparative effectiveness of original and generic losartan in patients with arterial hypertension
Abstract
Aim. To compare clinical effectiveness and tolerability of original (Cozaar®) and generic (Lozap®) losartan in high and very high-risk patients with Stage I-II arterial hypertension (AH).
Material and methods. This blind, randomized (envelope method), parallel study included 40 patients, 20 subjects in each group. After 14-day wash-out period, the participants were administered Cozaar® or Lozap® (50 mg/d; 1 tablet in the morning) for 3 months.
Results. Cozaar® and Lozap® reduced systolic blood pressure (SBP) by 11,6% and 12,0% (р<0,05), respectively, diastolic BP (DBP) – by 8,3% and 8,2% (р<0,05), respectively (office measurement data). According to 24-hour BP monitoring data, T/P for SBP was 67,1% and 66,3% in Cozaar® and Lozap® groups, respectively (p<0,05). Both agents similarly reduced left ventricular posterior wall thickness, carotid-femoral and carotid-radial pulse wave rates – by 16,6%, 9,9%, 12,8% vs 16,6%, 10,1%, and 12,2%, respectively.
Conclusion. Original and generic losartan medications were similar by antihypertensive activity and effects on surrogate end-points.
About the Authors
S. V. NedogodaRussian Federation
T. A. Chalyabi
Russian Federation
V. V. Tsoma
Russian Federation
U. A. Brel
Russian Federation
G. V. Mazina
Russian Federation
References
1. Белоусов Ю.Б. Быков А.В. Фармакоэкономика: оптимальный выбор для формуляров. Фарматека 2003; 3: 10-2.
2. Кутишенко Н.П., Марцевич С.Ю., Шальнова С.А. и др. Изучение клинической эквивалентности двух препаратов эналаприла у больных артериальной гипертонией. РКЖ 2003; 5: 68-72.
3. Леонова М.В. Современный взгляд на конечные точки для оценки антигипертензивной терапии. Качеств клин практ 2002; 4: 18-22.
4. Недогода С.В, Чаляби Т.А. Сравнительная антигипертензивная эффективность генериков ангиотензин-превращающего фермента эналаприла (ренитека, энапа, эднита, инворила, энванса и энама) и стоимость лечения у больных гипертонической болезнью. Артер гиперт 2000; 1: 52-5.
5. Lindholm LH, Ibsen H, Dahlof B, et al. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoit reduction in hypertensive study (LIFE). Lancet 2002; 359: 1004-10.
6. Wilson-Davis K. Study design and the use of statistics in drug use research// McGavock H., editor. Handbook of Drug Use Research Methodology. 1st ed. - Newcastle: The United Kingdom Drug Utilization Research Group 2000; 36-55.
Review
For citations:
Nedogoda S.V., Chalyabi T.A., Tsoma V.V., Brel U.A., Mazina G.V. Comparative effectiveness of original and generic losartan in patients with arterial hypertension. Cardiovascular Therapy and Prevention. 2007;6(6):10-14. (In Russ.)