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Comparative Study of Atorvastatin and Rosuvastatin in Combination with

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 www.ijpcs.net RESEARCH ARTICLE

Comparative Study of Atorvastatin and

Rosuvastatin in Combination with Fenofibrate in
mixed Hyperlipidemia
Rohit Dixit1 and Shankar Jagan2
1
Department of Pharmacology, Navodaya Medical College, INDIA.
2
Medical Review Safety Physician, Accenture, Chennai, INDIA.

ABSTRACT

Aim: To compare the effects of Atorvastatin and Rosuvastatin in combination with fenofibrate in patients with mixed
Hyperlipidemia. Materials and Methods: It was an open label, randomized, parallel group, comparative, prospective
clinical study. A total of 70 subjects diagnosed with mixed hyperlipidemia were screened and were randomly allocated
into two groups of thirty each. Initial readings of lipid levels like TC, TG, HDL, LDL and VLDL for both the groups
were taken as baseline values. Then, Group I received Tab Atorvastatin 10 mg + Fenofibrate 160 mg and Group II
received Tab Rosuvastatin 10 mg+ Fenofibrate 160 mg once a day at night for 12 weeks. Patients were assessed
after 12 weeks and their Lipid profile was done. Results: Patients who received a combination of atorvastatin with
fenofibrate had a reduction of Total cholesterol by 39%, Triglycerides by 47%, LDL-C by 50% and VLDL-C by 35%
respectively. In group treated with combination of rosuvastatin with fenofibrate there was a decrease in TC by 54%,
TGs by 58%, LDL-C by 52% and VLDL-C by 56% respectively. At the same time, HDL-C levels were increased by
14% in the group treated with rosuvastatin with fenofibrate as compared to atorvastatin with fenofibrate treated
group which increased the HDL-C levels by 6%. Conclusion: Both the treatment regimens significantly decreased
TC, TG, LDL‑C, VLDL‑C, but the reduction was more and statistically significant in Rosuvastatin and fenofibrate
combination group when compared with atorvastatin and fenofibrate treated group at the end of 12 weeks.

Key words: Cholesterol, Lipoprotein, Heart, Atherosclerosis, Statins.

Citation: Rohit D and Shankar J. Comparative Study of Atorvastatin and Rosuvastatin in Combination with Fenofibrate in mixed
Hyperlipidemia. Int J Pharmacol and Clin Sci. 2016;5(1):25-31.

INTRODUCTION (TGs) and decreased high-density lipoprotein cholesterol

(HDL-C) which is more common in patients with type 2
Dyslipidemia is the commonest cause of the blood vessel diabetes mellitus.[4]
diseases and their incidence has been rising all over the
world thereby increasing the morbidity and mortality due to National cholesterol education program–Adult Treatment
cardiovascular diseases.[1,2] Dyslipidemia is also one of the Panel–III (NCEP-ATP III) has set a goal to treat these
component of Metabolic syndrome along with other group
of cardiovascular risk factors such as high blood pressure
(BP), abdominal obesity, and insulin intolerance, whose Received : 05-02-2016 Revised : 23-03-2016
concurrent appearance increases the risk of atherosclerotic Accepted : 31-03-2016
cardiovascular disease.[3] *Correspondence : Rohit Dixit,
Department of Pharmacology,
Dyslipidemia occurs due to disturbance in the lipid Navodaya Medical College, INDIA.
parameters like Total Cholesterol, LDL-C, VLDL, TGs E-mail: [email protected]
and HDL-C.[1,2] Combined or mixed hyperlipidemia (CHL) Conflict of interest: Nil ; Source of support : Nil
Copyright: © 2015 Journal. All rights reserved.
is a lipid disorder characterized by increased low-density
DOI : 10.5530/ijpcs.5.1.5
lipoprotein cholesterol (LDL-C), elevated triglycerides

International Journal of Pharmacology and Clinical Sciences | Mar 2016 | Vol 5 | Issue 1 | 25-31 25
 Dixit et al.: Statins, fibrates and Hyperlipidemia

dyslipidemic patients and which canbe achieved by proper MATERIALS AND METHODS
treatment with lipid lowering drugs especially statins
(National CEP-ATP III, 2002).[5] The present study was carried out in the Department
of Pharmacology in collaboration with Department of
A number of lipid lowering drugs e.g. statins, fenofibrate, Medicine and Surgery, Mamata Medical College, Khammam.
niacin, ezetamibe, bile sequestrants etc. are being used to
treat this disorder.[2] Many studies are carried out on these Nature of the study
drugs out of which few have been made in the people of
North India especially in the Majharegion of Punjab because Open label, randomized, parallel group, comparative,
their socio-economic background and standard of living prospective clinical Study. The study was designed and
is quite different from the people of Western countries.[6] conducted in accordance with Good Clinical Practice
guidelines as per ICH-GCP.
Hypolipidemic effect of statins is due to inhibition of
hydroxymethylglutaryl-CoA reductase (HMG-CoA) and Source of patient
decrease in LDL-C is due to up regulation of LDL receptor
activity.[7] Outcome trials of statins have proved conclusively The patients attending outpatient department (O.P.D.) of
that these drugs decrease LDL-C levels, resulting in a Medicine were enrolled into the present study.
significant reduction of cardiovascular events in many high-
risk patients.[8,9] Rosuvastatin has been considered superior Study population
in achieving greater LDL-C level reductions as compared
to atorvastatin, simvastatin, or pravastatin use.[10] Statins Sample size was calculated according to the study done by
have also been reported to produce “pleiotropic” effects Athyro et al.[18] Assuming a 15% difference between two
such as vasodilatation, antioxidant, plaque stabilization, treatments, a total sample size of 70 subjects was calculated
antithrombotic and anti-inflammatory effects.[11] based on the two sided difference with the type I error α
being 0.05 and type II error β at 0.2.
Fibrates, are commonly referred to as peroxisome
proliferator activated receptor-α (PPAR-α) agonists. A total of 70 subjects diagnosed with combined
PPAR-α expression is present in liver, kidney, endothelium hyperlipidemia were screened for the entry into the study
and vascular smooth muscle. They significantly decrease and then were randomly allocated into two groups of thirty
triglycerides and increases high-density lipoprotein (HDL) each.
cholesterol without reducing LDL cholesterol, is associated
with significant decreases in coronary events.[12] Period (duration of study)

However, statins or fibrates affect different aspects Total duration of the study was 1 year i.e., from June
of lipoprotein metabolism. Hence, statin or fibrate 2013–May 2014. Each patient had 2 visits to the study site:
monotherapy becomes difficult to modify the lipid profile Screening/baseline visit and 12 weeks after the treatment
of patients with combined hyperlipidemia according with study drug.
to the recent investigations of the American Diabetes
Association.[13] Inclusion criteria

Combined therapy with statins and fibrates is more Male patients (35-55 years) and female patients (45-65
effective in controlling lipid profile in patients with mixed years) having low density lipoprotein cholesterol (LDL-C)
hyperlipidemia (CHL).[14-17] higher than 100 mg/dl and triglycerides (TG) more than
200 mg/dL were included in the study. All patients with
Hence, the present study is to compare the effects of Hypertension, Diabetes mellitus, Obesity and coronary
Atorvastatin and Rosuvastatin each in combination with artery diseasewere included in the study.
fenofibrate in patients with mixed Hyperlipidemia.
Exclusion criteria
The objective of this study was to evaluate and compare
the efficacy and safety of fixed-dose combinations of Patients with Renal and hepatic failure, Pregnancy and
Rosuvastatin 10 mg + Fenofibric acid 160 mg with lactation, Hypothyroidism, Malignancy, Myopathy,
Atorvastation 10 mg + Fenofibric acid 160 mg in patients Patients who had undergone bypass surgery and those
with mixed hyperlipidemia. with concurrent medications like warfarin, verapamil,

26 International Journal of Pharmacology and Clinical Sciences | Mar 2016 | Vol 5 | Issue 1 | 25-31
 Dixit et al.: Statins, fibrates and Hyperlipidemia

amiodarone, and beta blockers were excluded from the Similarly in Group II (Rosuvastatin and Fenofibrate
study. combination tablets), four patients were withdrawn from
the study out of which two did not take the medicines
Investigations: The following investigations were done regularly and two patients did not turned up after the
‘Before’ and ‘After’ the study. Complete blood count screening.
(CBC), Liver function tests (LFT), Renal function tests
(RFT), Random blood sugar levels (RBS) and Urine So data of 27 participants in Atorvastatin + fenofibrate
analysis. group and 26 participants in Rosuvastatin + Fenofibrate
group were used for analysis.

METHODOLOGY Initial readings of lipid levels like TC, TG, HDL, LDL
and VLDL were taken for both the groups as baseline
The total sixty (n=60) patients enrolled in the study were values before assigning the treatment. Then, Group I
randomly allocated into two groups of thirty (n=30) each, (n=27)–received Atorvastatin 10 mg + Fenofibrate 160
using a randomization chart. mg and Group II (n=26)–received Rosuvastatin 10 mg +
Fenofibrate 160 mg combination tablets for 12weeks orally
Initial readings of plasma lipid levels like TC, TG, HDL, at night time. Patients were assessed after 12 weeks and
LDL and VLDL for both the groups were taken as baseline were asked to report immediately if they developed any
values before assigning the treatment. muscle pain throughout the study. Lipid profile was done
after 12 weeks. Both the groups tolerated study medications
Then, Group I received Tab.Atorvastatin 10 mg and completed the study. No significant adverse reactions
+ Fenofibrate 160 mg and Group II received Tab. were recorded during the study. The results are shown in
Rosuvastatin 10 mg + Fenofibrate 160 mg. Both the groups Table 1.
received One tablet once a day at night for 12 weeks.
Effects of both the treatments on lipid parameters
Patients were assessed after 12 weeks and their Lipid profile
was done. As shown in Figure 1. The effect of both the treatments on lipid parameters is
shown in Table 2. Effects on Total Cholesterol Levels: In
Statistical analysis Group I, the baseline and post treatment values of total
cholesterol were found as 280 ± 59.17 mg/dL and 168.4
Mean ± SD values were calculated for each variable. ± 35 mg/dL.16 respectively. Similarly in Group II, the
Demographic details were summarized for all subjects baseline and after treatment values of total cholesterol
using descriptive statistics. Pair wise comparisons within were found as 272.7 ± 61.68 mg/dL and 124 ± 30 mg/
the groups and between the two treatments were tested dL. 8 respectively.
for statistical significance using the paired and unpaired
Student t test respectively. Statistical significance was at Effects on Triglyceride Levels: In Group I, the baseline and
P<0.05. All statistical tests were processed using graph pad post treatment values of Triglycerides were found as 291.9
prism software, Version 5. ± 14.56 mg/dL and 155.4 ± 43 mg/dL. 36 respectively.
Similarly in Group II, the baseline and after treatment
values of Triglycerides were found as 329.8 ± 87.91 mg/
RESULTS AND ANALYSIS
dL and 138 ± 32 mg/dL. 81 respectively.

A total of 70 subjects diagnosed with combined Effects on HDL Levels: In Group I, the baseline and post
hyperlipidemia were screened for the entry into the study treatment values of HDL were found as 40.56 ± 9.057
and from that pool only 60 subjects were randomised to mg/dL and 38.04 ± 9.15 mg/dL respectively. Similarly in
group I and Group II. Group II, the baseline and after treatment values of HDL
were found as 39.46 ± 3.93 mg/dL and 44.88 ± 5.39 mg/
In Group I (Atorvastatin and Fenofibrate combination dL respectively.
tablets), three patients were dropped out from the study
out of which one did not take the medications regularly, Effects on LDL Levels: In Group I, the baseline and post
one patient terminated the study due to personal reasons treatment values of LDL were found as 193.6 ± 39.06
and one withdrew consent to participate. mg/dL and 96.19 ± 20.64 mg/dL respectively. Similarly in

International Journal of Pharmacology and Clinical Sciences | Mar 2016 | Vol 5 | Issue 1 | 25-31 27
 Dixit et al.: Statins, fibrates and Hyperlipidemia

Table 1: Baseline characteristic of Patients attending OPD

Atorvastatin 10 mg + Fenofibrate 160 Rosuvastatin 10 mg + Fenofibrate 160
Characteristics
mg per day (n=27) mg per day (n=26)
Age in years 46.96 ± 10.88 46.69 ± 10.8
Male:Female 15:12 12:14
BMI Kg/m 2
27.79 ± 2.80 30.87 ± 4.79
Total Cholesterol (mg/dL) 280 ± 59.17 272.7 ± 61.68
Triglycerides (mg/dL) 291.9 ± 14.56 329.8 ± 87.91
HDL (mg/dL) 38.04 ± 9.15 39.46 ± 3.93
LDL (mg/dL) 193.6 ± 39.06 185.3 ± 46.34
VLDL (mg/dL) 53.26 ± 19.4 62.65 ± 17.73
All the values are expressed as Mean ± SD.

Table 2: Comparison of changes in the lipid profile between two treatment groups before and after 12 weeks of
treatment
Atorvastatin 10 mg + Fenofibrate 160 mg Rosuvastatin 10 mg + Fenofibrate 160 mg
Lipid profile
(n=27) (n=27)
Percentage Percentage
Baseline values 12 weeks later Baseline values 12 weeks later
change change
TC (mg/dL) 280 ± 59.17 168.4 ± 35.1 -39% 272.7 ± 61.68 124 ± 30.8 -54%#
TG (mg/dL) 291.9 ± 14.56 155.4 ± 43.3 -47% 329.8 ± 87.91 138 ± 32.81 -58%*
HDL (mg/dL) 38.04 ± 9.15 40.56 ± 9.057 +6% 39.46 ± 3.93 44.88 ± 5.39 +14%
LDL (mg/dL) 193.6 ± 39.06 96.19 ± 20.6 -50% 185.3 ± 46.3 88.73 ± 18.03 -52%*
VLDL (mg/dL) 53.26 ± 19.4 34.09 ± 12.5 -35% 62.65 ± 17.7 27.04 ± 8.79 -56.83%#
All the values are expressed as Mean ± SD, *P<0.05, #P<0.01.

Group II, the baseline and post treatment values of LDL fibrates is more effective in controlling lipid profile in
were found as 185.3 ± 46.34 mg/dL and 88.73 ± 18.03 patients with combined hyperlipidemia (CHL).[22,23]
mg/dL respectively.
Studies evaluating the combination of atorvastatin
Effects on VLDL Levels: In Group I, the baseline and
post treatment values of VLDL were found as 53.26 ± 19.4 In one study, Atorvastatin (20 mg/day) alone was compared
mg/dL and 34.09 ± 12.57 mg/dL respectively. Similarly with micronized fenofibrate (200 mg/day) monotherapy
in Group II, the baseline and after treatment values of and in combination with fenofibrate in type 2 diabetes
VLDL were found as 62.65 ± 17.73 mg/dL and 27.04 ± mellitus patients with CHL in the patients with age group
8.79 mg/dL respectively. of 44‑69 years.[24] The combination treatment had reduced
LDL‑C by 46%, TGs by 50%, TC by 37% and increased
HDL‑C by 46% and the changes are better than compared
DISCUSSION with monotherapy.

Dyslipidemia is the commonest cause of the blood vessel Studies evaluating the combination of rosuvastatin
diseases and their incidence has been rising all over the
world thereby increasing the morbidity and mortality due One study done by Durrington et al studied the effect of
to cardiovascular diseases. Statins are the mainstay in the fenofibrate alone or in combination with rosuvastatin in
management of dyslipidemia. Outcome trials of statins type 2 diabetics with elevated TG and TC.[25] At week 24,
have proved conclusively that these drugs decrease LDL-C the percentage of patients achieving the LDL-C goal of
levels, resulting in a significant reduction of cardiovascular <100 mg/dL was 86% with rosuvastatin 40 mg (n=50),
events in many high-risk patients.[19,20] Rosuvastatin has 4.1% with fenofibrate 67 mg 3 times a day (n=49) whereas
been considered superior in achieving greater LDL-C 75.5% is seen with rosuvastatin 10 mg plus fenofibrate 67
level reductions as compared to atorvastatin, simvastatin, mg 3 times a day (n=53) and 75% with rosuvastatin 5 mg
or pravastatin use.[21] Combined therapy with statins and plus fenofibrate 67 mg 3 times a day (n=60).

28 International Journal of Pharmacology and Clinical Sciences | Mar 2016 | Vol 5 | Issue 1 | 25-31
 Dixit et al.: Statins, fibrates and Hyperlipidemia

Figure 1: Study design

In one more study with 760 patients, efficacy and safety of also shows that Rosuvastatin + Fenofibrate combination
fenofibric acid with rosuvastatin were evaluated in patients therapy is superior to monotherapy of rosuvastatin and
with mixed dyslipidemia (LDL-C≥130 mg/dL, TG≥150 fenofibrate.
mg/dL, HDL-C<40 mg/dL males, <50 mg/dL females).[26]
This 12-week study randomized individuals to rosuvastatin However, these studies also suggest that combination of
5 mg/day, fenofibric acid 135 mg/day or fenofibric acid rosuvastatin and fenofibrate was well tolerated and is as safe
135 mg/day plus rosuvastatin 5 mg/day. Statistically as therapy with the individual agents used as monotherapy.
significant results, comparing rosuvastatin to fenofibric [27]
These studies also suggest that data up to 2 years
acid with rosuvastatin, were a mean percent change from supports the safety of this combination.[28]
baseline of HDL-C (rosuvastatin 12.4%, combination
23.0%), TG (rosuvastatin -17.5%, combination -40.3%), Other treatment strategies for normalizing multiple lipid
VLDL-C (rosuvastatin-22.2%, combination -41.3%), TC parameters in patients with mixed dyslipidemia include the
(rosuvastatin -25%, combination -28.1%). So this study addition of nicotinic acid or omega 3-fatty acids to statin

International Journal of Pharmacology and Clinical Sciences | Mar 2016 | Vol 5 | Issue 1 | 25-31 29
 Dixit et al.: Statins, fibrates and Hyperlipidemia

therapy. Both strategies have resulted in improvements of cholesteryl ester transfer from HDL to VLDL1 particles. Arterioscler
Thromb Vasc Biol. 2000;20(1):189-97.
lipid parameters other than LDL-C.[29,30]
12. Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam
MB et al. Gemfibrozil for the secondary prevention of coronary
heart disease in men with low levels of high-density lipoprotein
CONCLUSION cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol
Intervention Trial Study Group. N Engl J Med. 1999;341(6):410-18.
13. Haffner SM. Management of dyslipidemia in adults with diabetes.
Atorvastatin with fenofibrate and Rosuvastatin with
Diabetes Care. 2002;251:74-7.
fenofibrate significantly decreased Total cholesterol, 14. Vega GL, Ma PT, Cater NB, Filipchuk N, Meguro S, Garcia AB et
Triglycerides, LDL‑C, VLDL‑C, but the reduction was al. Effects of adding fenofibrate (200 mg/day) to simvastatin (10
more and statistically significant in Rosuvastatin and mg/day) in patients with combined hyperlipidemia and metabolic
syndrome. Am J Cardiol. 2003;91(8): 956-60.
fenofibrate combination group when compared with 15. Fiévet C, Staels B. Combination therapy of statins and fibrates
atorvastatin and fenofibrate group at the end of 12 weeks. in the management of cardiovascular risk. Current Opinion in
At the same time Rosuvastatin and fenofibrate combination Lipidology. 2009;20(6):505-11.
16. Athyros VG, Papageorgiou AA, Hatzikonstandinou HA, Didangelos
group showed statistically significant increase in HDL-C TP, Carina MV, Kranitsas DF et al. Safety and efficacy of long-
levels when compared with atorvastatin and fenofibrate term statin-fibrate combinations in patients with refractory familial
group. combined hyperlipidemia. Am J Cardiol. 1997;80(5):608-13.
17. Kiortisis DN, Millionis H, Bairaktari E, Elisaf MS. Efficacy of
combination of atorvastatin and micronized fenofibrate in the
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ACKNOWLDGEMENT
2000;56(9-10):631-35.
18. Athyros VG, Papageorgiou AA, Athyrou VV, Demitriadis DS,
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Diabetes Care. 2002;25(7):1198-202.
19. Bakker-Arkema RG, Davidson MH, Goldstein RJ, Davignon
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