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Aim. To study the therapeutic equivalence of original and generic fosinopril in patients with arterial hypertension (HT) of 1-2 degrees, and to evaluate the cost effectiveness of original drug substitution with generic. Material and methods. Patients (n=36) with HT of 1-2 degree aged 41-82 years and disease duration up 3 to 22 years included in an open, crossover , randomized trial. All patients had two courses of treatment: with generic (Fosicard) and the original drug (Monopril); sequence of courses was determined by randomization. Wash-out period (10-14 days) preceded each course. Treatment duration was 6 weeks; drugs were administered QD; initial dose - 10 mg/day. Blood pressure (BP) and heart rate (HR) were evaluated at the end of the wash-out period, and in 2, 4 and 6 weeks of therapy. In case of ineffective BP control (>140/90 mm Hg) hydrochlorothiazide 12.5 mg was added initially and dose fosinopril was increased up to 20 mg/day next. Results. Patients in groups were comparable by basic clinical parameters. Both fosinopril based drugs have comparable antihypertensive effect. Differences between their effect on systolic and diastolic BP as well as HR at all steps of treatment were not significant. The individual analysis revealed a tendency to more pronounced Monopril antihypertensive effect compared with Fosicard, but the differences were not significant. An average dose of Monopril was 11.8±3.9 mg/day , and Fosicard — 13.2±4.7 mg/day (p=0.13); the rate of monotherapy with both drugs of fosinopril at dose of 10 mg/day was similar (in 41% and 44% of patients, respectively); the rate of combined therapies with various composition differed insignificantly. Reduction in BP <140/90 mmHg was recorded at the end of the study in 29 (85.3%) patients treated with Monorpil and in 27 (79.4%) — Fosicard (p=0.52). Both drugs showed a good safety profile. Conclusion. Fosicard or its combination with hydrochlorothiazide is therapeutically equivalent to original drug (Monopril) or its combination with hydrochlorothiazide.

About the Authors

N. P. Kutishenko
State Research Center for Preventive Medicine
Russian Federation

S. Yu. Martsevich
State Research Center for Preventive Medicine I.M. Setchenov First Moscow State Medical University
Russian Federation

Zh. D. Kobalava
Peoples’ Friendship University of Russia
Russian Federation

E. K. Shavarova
Peoples’ Friendship University of Russia
Russian Federation


1. Wolf-Maier K., Cooper R.S., Benegas J.R. at al Hypertension and blood pressure levels in 6 European countries, Canada, and the USA. JAMA 2003; 289: 2363-2369.

2. Duh M.S., Andermann F., Paradis P.E. et al. The economic consequences of generic substitution for antiepilep-tic drugs in 1 public payer setting: the case of lamotrigine. Dis Manag 2007; 10: 216-225.

3. Hellström J., Rudholm N. Side effects of generic competition? Eur J Health Econ 2004; 5: 203-208.

4. Registry of clinical controlled randomized study performed with generics in Russia. Available on: Russian (Реестр клинических контролируемых рандомизированных исследований, выполненных с дженериками в России. Доступно на:

5. Federal Law of 12.04.2010 № 61-FZ "On circulation of drugs". Russian (ФЗ РФ от 12.04.2010г. №61-ФЗ «Об обращении лекарственных средств»).

6. Fernandez M., Madero R., Gonzalez D. et al. Combined versus single effect of fosinopril and hydrochlorothiazide in hypertensive patients. Hypertension. 1994; 23(1 Suppl): 1207-1210.

7. Pool J.L., Cushman W.C., Saini R.K. et al. Use of factorial design and quadratic response surface models to evaluate the fosinopril and hydrochlorothiazide combination therapy in hypertension. Am J Hypertens 1997; 10(1): 117-123.

8. Guthrie R., Reggi D.R., Plesher M.M. at al. Efficacy and safety of fisinopril/hydrochlorithiazide combination on ambulatory blood pressure profiles in hypertension. Fosinopril/Hydrochlorothizide Investigators. Am J Hypertens 1996; 9(4): 306-311.

9. Zanchetti A., Hansson L. The role of combination therapy in mordern antihypertensive therapy. J Car-diovasc pharmacol 2000; 35: 1-3.

10. Mancia G., De Backer G., Dominiczak A. et al. 2007 ESH-ESC Practice guidelines for the management of arterial hypertension: ESH-ESC Task Force on the Management of Arterial Hypertension. J Hyper-tens 2007; 25(9): 1751-1762.

11. Wagstaff A.J., Davies R., McTavish D. Fosinopril. A reappraisal of its pharmacology and therapeutic efficacy in essential hypertension. Drugs 1996;51(5):777-91

12. Karpov Yu.A. Fosinopril in the treatment of hypertension (FLAG): The Russian program isassessing the attainability of the target levels of blood pressure. Russkiy meditsinskiy zhurnal 2001; 10:406-410. Russian (Карпов Ю.А. Фозиноприл при лечении артериальной гипертонии (ФЛАГ): российская программа оценки практической достижимости целевых уровней артериального давления. РМЖ 2001; 10:406-410).

13. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Available on: Rx.

14. Yagudina R.I., Kulikov A.Yu. Pharmacoeconomics: general information, research methods. Novaya apteka 2007; 9: 73-78. Russian (Ягудина Р.И., Куликов А.Ю. Фармакоэкономика: общие сведения, методы исследования. Новая аптека 2007; 9: 73-78).

For citation:

Kutishenko N.P., Martsevich S.Yu., Kobalava Z.D., Shavarova E.K. VALUE OF THERAPEUTIC EQUIVALENCE IN SUBSTITUTION OF ORIGINAL DRUG WITH GENERIC BY EXAMPLE OF FOSINIPRIL. Rational Pharmacotherapy in Cardiology. 2011;7(4):431-436. (In Russ.)

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