SIMVASTATIN GENERIK

Abstract

This study aims to know and determine the lipid profile in patients with hyperlipidemia who consumed Generic Simvastatin compared
with its patent product contained in the Formularium at Sanglah Hospital. The observations made, were the measurement of the total
cholesterol and low-density lipoprotein (LDL) before and after the drug administration. A total of 30 subjects who met the inclusion
criteria, were divided into two (2) groups, each group consist of 15 persons, the first group was given 20 mg generic Simvastatin
(1 tablet daily) for 15 days and Group II given 20 mg patent Simvastatin (1 tablet daily) for 15 day. After 15 days, their blood samples
were taken and examined for total cholesterol and LDL. Once the data were collected, statistical analysis was done by using the normality
test, homogeneity and t. Statistical analysis using p-value less than or equal to 0.05 was the limit of significance. The statistical analysis
showed that the data was normally distributed and homogeneous (p≥0.05). The T-test showed that there were significant differences
in the levels of total cholesterol and LDL serum samples before and after the administration of generic simvastatin and patents the
(sig.=0.000). However, there was no significant difference in decreased levels of totall cholesterol samples between the generic Simvastatin
and patent (sig=0.365 with α=0.05 level). Besides this, there was also no significant difference in the decreased levels of LDL between
generic Simvastatin and the patent one (sig=0.372 with α=0.05 level).