Ator Simvas Ok
Ator Simvas Ok
Ator Simvas Ok
PMCID: PMC3326925
doi: [10.4103/0253-7613.93864: 10.4103/0253-7613.93864] PMID: 22529488
Received 2011 Apr 6; Revised 2011 Sep 28; Accepted 2011 Dec 14.
This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-
Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided
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Abstract
Objective:
The objective of the study was to evaluate the safety and efficacy of atorvastatin compared with
simvastatin and pravastatin in patients of hyperlipidemia.
Results:
The results showed that atorvastatin significantly reduced the lipid levels (LDL-C, TC, TG, VLDL) when
compared to simvastatin and pravastatin after 3rd and 5th month of treatment. Atorvastatin increased the
HDL-C levels significantly when compared to simvastatin and pravastatin after 5 months of treatment.
Atorvastatin also significantly reduced the CK levels when compared to pravastatin but no increase in liver
enzyme levels was observed.
Conclusion:
The study showed that atorvastatin is more effective when compared to simvastatin and pravastatin in
patients with hyperlipidemia.
KEY WORDS: Creatine kinase, creatine kinase - myocardial band, pravastatin, simvastatin
Introduction
Hyperlipidemia is a disorder of lipoprotein metabolism, which includes a number of abnormalities such as
hypercholesterolemia and hypertriglyceridemia.[1] Recently World Health Organization (WHO) has
declared that by 2020, 60% of cardiovascular cases will be of Indian origin.[2] Statins are the first line
therapy for lowering lipid levels.[1] Treatment of hyperlipidemia with statins has become an integral part
of management of vascular diseases.[3] Statins have become the leading prescription drug.[1] Indications
of statins have been greatly extended over the last 5 years subsequent to the publication of many
multicenter prospective trials. There are multiple statins available in the Indian market like atorvastatin,
simvastatin, pravastatin, pitavastatin, fluvastatin, cerivastatin and rosuvastatin.[4] Most of the trials
compared the fixed-dose regimens of more intensive statin therapy with less intensive statin therapy.[5]
Recent studies in patients with stable coronary disease showed greater reduction in C-reactive protein
(CRP) with higher dose than with lower dose of statins.[6] However, various studies suggest that efficacy
and safety of various statins in hyperlipidemia differs considerably.[7] It is difficult for the medical
practitioners to select suitable statins for their patients. Hence we have compared the efficacy and safety of
atorvastatin with simvastatin and pravastatin in patients of hyperlipidemia.
Study Design
The randomized, open label, parallel group study was conducted at KG hospital, Coimbatore, Tamilnadu,
India. This study was carried out from June 2009 to January 2010. The protocol was approved by
Institutional Ethics Committee (IEC). Informed consent was obtained from the patients prior to the study.
Patient Selection
Inclusion Criteria
Male patients (35 – 55 years) and female patients (45 – 65 years) having low density lipoprotein
cholesterol (LDL-C) higher than130 mg/dl and triglycerides (TG) more than 250 mg/dl were included in
the study.
Exclusion Criteria
Patients with renal and hepatic failure, diabetes mellitus (I and II), pregnancy, hypothyroidism,
uncontrolled hypertension, patients who had undergone bypass surgery, patients taking other lipid
lowering agents like fibrates, niacin and patients who were taking cardiac drugs like warfarin, verapamil
and amiodarone were excluded from the study.
Study visits and treatment schedule
The patients were randomized into three groups of 20 patients each taking 20 mg of atorvastatin,
simvastatin and pravastatin according to the treatment regimen. Initial readings of lipid levels like LDL,
TC, TG, HDL, VLDL were taken as baseline. First review values for the lipids were taken at the end of 3rd
month, and the second review values were taken at the end of 5th month. For liver enzymes and creatine
kinase (CK), creatine kinase – Myocardial Band (CK-MB) levels were taken before treatment and at the
end of 5th month. Lipid parameters, liver enzymes, CK and CK-MB were measured by using autoanalyzer
(Microlab-300X). Participants on the baseline were advised to take the medication according to treatment
schedule.
Statistics
All the values were expressed in mean±SD. The baseline, first review and second review values of
atorvastatin were compared with simvastatin and pravastatin by using one-way ANOVA followed by
Tukey multiple comparison test. P<0.05 was considered as significant.
Results
The baseline lipid profile values showed that, there was no significant difference between the groups.
Atorvastatin produced significant reduction in lipids levels in comparison with simvastatin (LDL-C
P<0.001, TC P<0.001, TG P<0.05, VLDL P<0.05) and pravastatin (LDL-C P<0.001, TC P<0.001, TG
P<0.001, VLDL P<0.001) in the first review [Table 1]. The atorvastatin also produced significant
reduction in lipid levels in comparison with simvastatin (LDL-C P<0.001, TC P<0.001, TG P<0.05,
VLDL P<0.05) and pravastatin (LDL-C P<0.001, TC P<0.001, TG P<0.001, VLDL P<0.001) in the
second review [Table 2]. Atorvastatin had increased the HDL-C levels significantly in comparison with
simvastatin (P<0.001) and pravastatin (P<0.001) at second review. None of these drugs increase the liver
enzyme levels after 5th month of treatment. But atorvastatin significantly (P<0.001) reduced CK levels
when compared to pravastatin [Table 3].
Discussion
The study was designed to evaluate the safety and efficacy of atorvastatin compared with simvastatin and
pravastatin in hyperlipidemia patients considering the previous reports of efficacy and safety of different
statins. The results revealed that all three drugs (atorvastatin, simvastatin and pravastatin) reduces the lipid
levels (LDL-C, TC, TG, VLDL) but atorvastatin produced significant reduction when compared to
simvastatin and pravastatin in both first and second review [Tables 1 and 2]. Our results were consistent
with the results of previous authors.[3,4,9] Our results also revealed that atorvastatin increases HDL-C
levels significantly when compared to simvastatin and pravastatin at second review. In this study we have
also compared the effect of atorvastatin with simvastatin and pravastatin on liver enzyme (SGOT, SGPT,
ALP), bilirubin and albumin levels. The study showed that none of these drugs increase the liver enzyme
levels significantly as compared with baseline value. None of these drugs damaged the liver in 5 months of
treatment. These results contradicted with the results of previous studies.[10] There were no serious
adverse events reported in this study. The biochemical markers that are widely used in the detection of
infarction are CK, a more sensitive and cardio specific isoform of this enzyme was CK-MB.[10] Our study
revealed that atorvastatin reduces the CK levels significantly when compared to pravastatin at second
review. The present results were consistent with the result of Pasceri et al., who reported that pretreatment
with atorvastatin decreases the incidence of myocardial injury during coronary intervention with placebo.
[11] But results of Kernsa et al., contradict our results.[12] To conclude, our study revealed that
atorvastatin is a more effective drug when compared to simvastatin and pravastatin in patients of
hyperlipidemia. None of these drugs caused hepatotoxicity after 5 months of treatment. These results
might be of value to practicing physicians while selecting suitable statins for these patients.
Footnotes
Source of Support: Nil.
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