Simvor in the Treatment of Hyperlipoproteinaemia
Češka R.1, Kvasnička T.1, Bláha V.2, Piťha J.3, Soška V.4 za skupinu spolupracujících center
1III. interní klinika 1. lékařské fakulty UK a VFN, Praha, přednosta doc. MUDr. Š. Svačina, DrSc. 2Klinika gerontologická a metabolická FN, Hradec Králové, přednosta prof. MUDr. Z. Zadák, CSc. 3Klinika kardiologie IKEM, Praha, přednosta doc. MUDr. J. Kautzner, CSc. 4Oddělení klinické biochemie FN u sv. Anny, Brno, přednosta prim. RNDr. P. Breinek |
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Summary:
Background: Treatment of hyperlipoproteinaemias (HLP) is a basic step in prevention and treatment
of atherosclerosis and its complications. Simvastatin is among hypolipidaemic agents a preparation
for which at present there is most evidence from intervention trials. On the Czech
market are at present in addition to the original one also some other preparations of simvastatin.
In the submitted paper the authors present results achieved with the preparation Simvor® (Rambaxy,
distribution in CR Interchemia), tablets containing 20 mg simvastatin. Characteristic of
group and methods: In 15 departments in the CR a total of 185 patients with HLP were examined,
98 men and 87 women, mean age 55.8 years. The patients were treated after a minimal 4-week
period of non-pharmacological treatment with simvastatin 20 mg for a period of 6 weeks. The
patients were subjected at the onset and end of treatment to a complete medical examination,
basic parameters of lipid metabolism were assessed and a safety laboratory was involved. Facultatively
in some departments additional examinations were made. Results: The total cholesterol
level 7.26 ± 1.01 mmol/l declined on average by 1.64 mmol/l i.e. to 5.62 mmol/l, LDL-cholesterol
declined from the original value of almost 5 mmol/l to 3.55 mmol/l. The baseline triglyceride
concentration 3.07 declined by 1 mmol/l to 2.09 mmol/l, and HDL-cholesterol which was in a normal
range already at the onset of treatment did not change significantly, i.e. its slight increase did
not reach statistical significance. Treatment was well tolerated and in the safety laboratory no
significant deviations from normal were recorded. Discussion: The results achieved in our patients
are as far as the investigated parameters are concerned, comparable with or even better than
the results presented in the ample literature. The safety and tolerance of treatment of the investigated
preparation is also very good. Unfortunately we did not have an opportunity during our
short-term follow up to evaluate the influence of the investigated preparation on the incidence of
cardiovascular diseases or mortality. In this respect we can only refer to positive results assembled
with simvastatin in large statin intervention "megatrials". Conclusion: Treatment with the
preparation Simvor, simvastatin, tabl. 20 mg led in 185 patients with HLP to a significant decline of total and LDL-cholesterol and triglycerides. Treatment was well tolerated by the patients, in
the safety laboratory no significant deviations were detected.
Key words:
Hypercholesterolaemia - Hypolipidaemic agents - Statins - Simvastatin - Safety of
hypolipidaemic treatment
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