The specific problem in the real clinical practice of treatment of hypertension in Russia is the availability of numerous generic drugs – are not original and reproduced medicines. They often transfer the results obtained during clinical research and innovative medicine held in accordance with the requirements of evidence-based medicine.
Many patients initially in treatment cheaper drugs. The problem is particularly acute when the original drug is much more expensive. Justified but whether such an approach when it comes to health?
The advantages of the use of diuretics in hypertension
Diuretics are one of the main drugs to effectively reduce and control blood pressure. They are suitable for initial and maintenance therapy. Medicine is prescribed alone or in combination with other means of reducing the pressure.
Indapamide is a diuretic with the first tiazidopodobnye action, specifically designed for the treatment of high blood pressure. Substance is designed taking into account the risk factors associated with pathology in a therapeutic dose of 1.5 mg per day the drug has a direct effect on the vessels, while its diuretic (diuretic) effect of secondary.
Medications based on indapamide enhance the protective function of the layer lining the inner surface of blood and lymphatic vessels (endothelium), prevent platelets from sticking together, ensure the protection and recovery of the blood vessels – provide vasoprotection. The drug reduces the reverse absorption of sodium (renal saluretikami effect), that allows to resolve overloading in the vascular wall.
Substance indapamide compares favorably with traditional diuretics that does not reduce glucose tolerance in patients with hypertension with diabetes. High activity to reduce the pressure combined with the safety of the treatment drug.
Drugs indapamide presented in the pharmaceutical market of Russia
Pharmeuticals on the Russian market at the price can be divided into three groups drugs indapamide:
- Original meds with the high cost of Arifon retard and Arifon (Servier, France).
- Drugs with an average cost of Indapamide (Hemofarm, Serbia) and Indap (Promed, Czech Republic).
- Cheap drugs Akripamid (Akrihin, Russia).
Original drug Arifon known in Russia for a long time and has a reputation as a good antihypertensive agents. A few years ago, a new dosage form indapamide – Arifon retard. It sustained release indapamide, allows to maintain a relatively stable concentration of the drug in the blood that provides a uniform therapeutic effect during the day.
Clinical studies high levels of evidence – a retrospective meta-analysis of data 10 80 818 patients from the randomized studies revealed that Arifon retard has a pronounced effect on systolic blood pressure among other antihypertensive drugs of different classes minus 22,2 mm Hg. article from baseline.
However, the widespread use of Arifona and reagirovanie form inhibits the high cost of the drug. A significant portion of patients receiving generic medicines. In this regard, of particular importance is the assessment of their clinical match the original drug, as despite the proven bioequivalence of generic and innovative drug, its clinical efficacy, they do not always coincide with the original.
To conclude what is best: or Indapamid Arifon, the results of clinical studies are presented below.
Comparative characteristics of Arifona and Indapamide: which is better
Over the last few years, published the results of comparative studies of the clinical efficacy, tolerability, influence on blood pressure during the day, some generic indapamide. However, the differences in strength of pressure reduction are interpreted ambiguously:
- or in favor of the original drug – “effect of pressure reduction is more pronounced”;
- or in favor of the generic – “there are differences, but they are not significant, and therefore therapeutically equivalent drugs”.
The practice of comparison of different generics of the same drug according to the degree and speed of absorption, time to achieve the greatest concentration in the blood and its significance, the nature of the distribution in tissues and body fluids, type and rate of excretion products (bioequivalence) does not give a definitive answer about their equivalent therapeutic effect. It is necessary to search other objective indicators to compare the original and generic drugs in order to get closer to the answer to the question about transfer of data to clinical trials high levels of evidence, performed with the use of original medicines, generics.
Study No. 1
A group of researchers under the guidance of renowned scientist, doctor of Sciences, Professor of Nedogoda S. V., conducted a comparative study of the therapeutic efficacy of Arifona retard and three generic: Indapamide, Indaba and Akripamid.
In the experiment, we evaluated not only the clinical efficacy, tolerability, effects on blood pressure during the day and the level of potassium (K+) drugs indapamide, but also other indicators that harakterizuyut the efficacy of antihypertensive drugs, such as:
- the rate of residual activity (index T/P) – how much of a reduced blood pressure at the end of the dosing interval, before taking the next dose;
- the magnitude and pulse blood pressure;
- hypertrophy (thickening of walls) of the left ventricle;
- the velocity of propagation of pulse wave.
The results of the study are as follows: all study drugs significantly reduce the pressure, but the severity of pressure reduction systolic and diastolic blood different. Were obtained the following results:
- Arifon retard compared to Indapamide reduces the pressure better by 9 mm Hg. St..
- Arifon retard is able to reduce the amount of pulse blood pressure and 33.3 %, Indapamide – 12.7 %.
- Arifon retard due to the unique matrix provides the optimal daily control of blood pressure, therefore, on such important indicator, as the degree of decrease of mass index of left ventricle myocardium, Arifon retard Indapamide replay more than 3 times.
- The best indicator T/P among the studied drugs was Arifona retard.
- In the group of patients receiving Arifon retard, there were no adverse effect on potassium, and in the Indapamide group noted the increasing excretion of potassium by 16 %.
Analysis of the impact of drugs on blood lipids and glucose levels revealed that in the treatment of Arifona retard improvement of lipid and carbohydrate metabolism. Other drugs actually turned out to be metabolically neutral.
Treatment of the original and generic means in General well tolerated by elderly patients with high systolic (upper) pressure. None of the patients was noted to have significant side effects.
Study No. 2
In 2010 has completed its work program ORIGINAL assessment of the efficiency of translation from Indapamide Generics On Arifon retard in patients with arterial hypertension. The program included patients with varying degrees of severity of arterial hypertension treated before participation treatment generic indapamide in mono – or combination therapy.
The study involved 309 doctors and 1319 patients from 73 Russian cities and towns. It included patients with different degrees of hypertension, different ages and different risk factors (increased total cholesterol, Smoking and others) and associated conditions – coronary heart disease, myocardial infarction, cerebral stroke, congestive heart failure, and concomitant diseases – chronic obstructive pulmonary disease, diseases of the joints.
Despite the fact that patients with high blood pressure last three months took generic indapamide (single or in combination with other drugs that lower blood pressure) stabilization pressure (systolic less than 140 m Hg. art., diastolic less than 90 mm Hg. calendar) didn’t happen.
Then patients were treated with Arifona retard. In the dose of 1.5 mg was observed a rapid and marked reduction in both systolic – 29 mm Hg.St., and diastolic blood pressure by 15 mm Hg.St. Replacement generic indapamide on Arifon retard has led to the fact that the target figures pressure (less than 140/90 mm Hg.St.) was achieved in 70% of cases.
In patients under 40 years patients with arterial hypertension 1 degree, in all patients treated with single antihypertensive drug in the form of generic indapamide, desired performance was achieved in 100% of cases.
Conclusion: between the original drug Arifon Indapamide generic and there are significant differences not only in strength antihypertensive effect, but also to influence the indicators that reflect the direct and indirect clinical effects, lipid, carbohydrate and electrolyte metabolism. The best influence on them has Arifon retard.
It is impossible to speak about the equivalence of treatment with Arifona retard and generic indapamide. The duration of the hypotensive effect up to 32 hours and a low dose of active principle (1.5 mg) of Arifona actually condemn other forms of indapamide on the role of “catching up”.
Persistent increase in blood pressure is one of the leading factors of risk of development of stroke, coronary heart disease, congestive heart failure, myocardial infarction. The results of the study a high level of evidence has demonstrated that lowering the top pressure by 2 mm Hg. art reduces the risk of death from stroke by 10 %, from coronary heart disease by 7 %.
Additional reduction of systolic blood pressure in the program the ORIGINAL was 29 mm Hg. St.. This figure makes it possible to assume the prevention of death from ischemia and stroke, respectively, to 101.5 and 145 %.
Is it better to lower your blood pressure at a higher cost of treatment or to save on health to solve the patient. But the difference in price, reaching up to 94% thought-provoking: how and by what has been achieved such savings in the production of generics.
|International nonproprietary name||The trade name of the drug||Price||Release form||Manufacturer|
|indapamide||Arifon||341 RUB.||Tablets 2.5 mg, 30 pieces||France|
|Arifon retard||279 RUB.||Tablets 1.5 mg, 30 pieces|
|Indapamide||109 RUB||Tablets 1.5 mg, 30 pieces||Serbia|
|Indapamid||93 RUB||Tablets 2.5 mg, 30 pieces|