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Abstract

Coronary artery disease (CAD) is a leading cause of morbidity and mortality worldwide and is commonly associated with dyslipidemia. Statins, particularly atorvastatin and rosuvastatin, are the cornerstone of lipid-lowering therapy and play a vital role in reducing cardiovascular events. However, concerns remain regarding their effects on glycemic control and liver function during long-term treatment. A comparative retrospective and prospective study was conducted in the Department of Cardiology at Durgabai Deshmukh Hospital and Research Centre, Hyderabad, after obtaining institutional ethical approval. A total of 200 adult patients with CAD were included, with 100 patients receiving atorvastatin and 100 receiving rosuvastatin. Demographic details, HbA1c, liver function tests (bilirubin, ALT, AST, and ALP), and lipid profile parameters (total cholesterol, triglycerides, HDL, LDL, and VLDL) were collected before and after treatment and analyzed using appropriate statistical methods. The results demonstrated that both atorvastatin and rosuvastatin significantly improved lipid profiles by reducing total cholesterol, LDL, VLDL, and triglyceride levels, while rosuvastatin showed superior efficacy in lowering LDL cholesterol and triglycerides. Both statins were associated with a statistically significant increase in HbA1c levels, suggesting a mild impact on glycemic control. Liver enzyme changes were minimal in both treatment groups, although rosuvastatin produced a greater increase in total and indirect bilirubin, which remained within the normal clinical range. Overall, both atorvastatin and rosuvastatin were effective and well tolerated in patients with CAD, with rosuvastatin providing greater lipid-lowering efficacy. Regular monitoring of blood glucose and liver function is recommended during long-term statin therapy to ensure safe and effective patient management.

Keywords

Coronary artery disease (CAD), Very-Low-Density Lipoprotein (VLDL), Intermediate-Density Lipoprotein (IDL), Low-Density Lipoprotein (LDL), Atherosclerotic Cardiovascular Disease (ASCVD), 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA), Creatine Kinase (CK), Cytochrome P450 3A4 (CYP3A4)

Introduction

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Hyperlipidemia is a common metabolic disorder characterized by elevated levels of cholesterol, triglycerides, or both, significantly increasing the risk of atherosclerotic cardiovascular disease (ASCVD). It is broadly classified into hypercholesterolemia and hypertriglyceridemia. Hypercholesterolemia may result from polygenic, familial, or combined genetic disorders, whereas hypertriglyceridemia is frequently associated with obesity, diabetes mellitus, and increased very-low-density lipoprotein (VLDL) levels. Plasma lipids are transported by lipoproteins, including chylomicrons, VLDL, intermediate-density lipoprotein (IDL), low-density lipoprotein (LDL), and high-density lipoprotein (HDL).

Chylomicrons transport dietary triglycerides, while VLDL carries endogenously synthesized triglycerides from the liver. LDL is the primary carrier of cholesterol and is the major contributor to atherosclerosis, whereas HDL facilitates reverse cholesterol transport and offers cardiovascular protection. Lipoprotein metabolism occurs through exogenous (dietary) and endogenous (hepatic) pathways, regulated by various apolipoproteins such as Apo B-100, Apo A-I, Apo C-II, and Apo E.

Atherosclerosis develops through the accumulation of LDL cholesterol within the arterial wall, leading to macrophage uptake, foam cell formation, fatty streaks, and ultimately fibrous plaque formation. Elevated LDL cholesterol is one of the strongest risk factors for cardiovascular diseases, including myocardial infarction and stroke.

Cholesterol is an essential component of cell membranes and serves as the precursor for bile acids, vitamin D, and steroid hormones. Cholesterol homeostasis depends on dietary intake, endogenous synthesis (primarily in the liver), intestinal absorption, biliary excretion, and enterohepatic circulation. Bile acids facilitate fat digestion, while cholesterol also serves as the substrate for steroid hormone synthesis in adrenal glands and gonads.

Statins are first-line lipid-lowering agents that inhibit HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis. By reducing hepatic cholesterol production, statins increase LDL receptor expression, enhance LDL clearance, lower triglyceride production, stabilize atherosclerotic plaques, reduce inflammation, and decrease cardiovascular morbidity and mortality. Common statins include atorvastatin, rosuvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, and pita vastatin. Based on LDL reduction, statins are classified into low-, moderate-, and high-intensity therapy, with atorvastatin and rosuvastatin being the most potent agents.

Statins are recommended for both primary prevention in individuals with elevated ASCVD risk and secondary prevention in patients with established cardiovascular disease. Baseline assessment should include a lipid profile, liver function tests, creatine kinase (CK), and thyroid function. Lipid levels should be reassessed approximately 6–8 weeks after initiation and periodically thereafter. Although generally safe and well tolerated, statins may cause adverse effects such as myalgia, elevated liver enzymes, gastrointestinal disturbances, headache, sleep disorders, and, less commonly, rhabdomyolysis, hepatotoxicity, renal dysfunction, and a slight increase in the risk of type 2 diabetes. Drug interactions involving CYP3A4 inhibitors, fibrates (especially gemfibrozil), calcium channel blockers, bile acid sequestrants, and antacids may alter statin concentrations and increase toxicity or reduce efficacy. Overall, statins remain the cornerstone of hyperlipidemia management because of their proven ability to reduce LDL cholesterol, prevent atherosclerotic plaque progression, lower cardiovascular events, and improve long-term survival when combined with lifestyle modification and appropriate monitoring.

Aim and Objectives

The primary aim of this study is to evaluate the impact of statin therapy on liver function and glycemic parameters in patients with coronary artery disease (CAD). The specific objectives are: 1. To assess the effect of different statin dosages on liver function tests (LFTs) and HbA1c levels in patients with CAD. 2. To compare the effects of rosuvastatin and atorvastatin on lipid profile, glycemic status (predisposition to diabetes and glucose intolerance), and liver function tests in adult patients with CAD.

Methodology

This study will be conducted in the Department of Cardiology, Durgabai Deshmukh Hospital and Research Centre, Vidya Nagar, Hyderabad, over a period of six months. A retrospective and prospective observational study design will be employed, with an estimated sample size of approximately 200 patients. Data will be collected from patient case records and laboratory investigation reports, including lipid profile, liver function tests, and HbA1c values. Ethical approval will be obtained from the Institutional Ethics Committee before commencement of the study, and the study will be conducted in accordance with institutional ethical guidelines. The comparison between two drugs will be done Chi-square test / Fischer exact test for categorical data.

Statistical Analysis

 

Table 1. Distribution of Subjects According to Age Group Drug Mean Age (Years) Standard Deviation

P Value Atorvastatin 55.14  12.765        0.453

Rosuvastatin 56.41  11.072

 

 

 

 

The mean age of patients receiving atorvastatin was 55.14 ± 12.77 years, while that of the rosuvastatin

group was 56.41 ± 11.07 years. There was no statistically significant difference in age between the two

groups (p = 0.453), indicating that both groups were comparable at baseline with a similar age distribution

. TABLE 2:

 

 

 

 

 

DISTRIBUTION OF SUBJECTS ACCORDING TO THE GENDER.

 

Gender

Drug

Total No. (%)

P value

Atorvastatin No. (%)

Rosuvastatin No. (%)

Female

29 (29)

38 (38)

67 (33.5)

0.178

Male

71 (71)

62 (62)

133 (66.5)

Total

100

100

200

 

 

 

 

FIGURE 2:

Table 2 indicates the distribution of genders among the atorvastatin and rosuvastatin groups was not notably different. This indicates that gender did not significantly influence the selection between

atorvastatin and rosuvastatin in the population studied. Additional research might be necessary to examine other elements affecting the prescribing of these drugs.

TABLE 3:

The table assessed the effects of atorvastatin and rosuvastatin on hbA1c levels before and after treatment.

 

Paired Samples Statistics

Drugs

Mean

Std. Deviation

P value

Atorvastatin

Pair

HbA1C_Before

5.965

0.4272

<0.001

HbA1C_After

6.355

0.2231

Rosuvastatin

Pair

HbA1C_Before

6.061

0.3703

<0.001

HbA1C_After

6.395

0.1987

 

 

 

 

FIGURE 3

shows that both Atorvastatin and Rosuvastatin significantly increased HbA1C levels, indicating a possible mild impact on glucose control. However, the cardiovascular benefits of statins should be considered, especially in patients with diabetes or prediabet

TABLE 4:

The table assessed the effects of atorvastatin and rosuvastatin on total, direct, and indirect serum bilirubin levels before and after treatment.

 

Paired Samples Statistics

Drugs

Mean

Std. Deviation

P

value

Atorvastatin

Pair 1

S.BILIRUBIN_B

.6549

.32162

0.066

 

 

S.BILIRUBIN_A

.6778

.36285

 

 

Pair 2

S.BILIRUBIN (DIRECT)_B

.1606

.08587

0.121

 

 

S.BILIRUBIN (DIRECT)_A

.1666

.09415

 

 

Pair 3

S.BILIRUBIN (INDIRECT)_B

.4943

.33368

0.067

 

 

S.BILIRUBIN (INDIRECT)_A

.5218

.34150

 

Rosuvastatin

Pair 1

S.BILIRUBIN_B

.6597

.30611

0.003

 

 

S.BILIRUBIN_A

.7052

.34075

 

 

Pair 2

S.BILIRUBIN (DIRECT)_B

.1453

.08307

0.061

 

 

S.BILIRUBIN (DIRECT)_A

.1524

.08561

 

 

Pair 3

S.BILIRUBIN (INDIRECT)_B

.5144

.31546

0.006

 

 

S.BILIRUBIN (INDIRECT)_A

.5526

.32448

 

 

 

 

 

FIGURE 4:

Atorvastatin showed minor, non-significant bilirubin changes, while Rosuvastatin caused a greater increase in total and indirect bilirubin. However, all changes remained within the normal range.

TABLE 5:

The table examined the impact of atorvastatin and rosuvastatin on liver enzymes (ALT, AST, and ALP) before and after treatment.

 

Paired Samples Statistics

Drugs

Mean

Std. Deviation

P value

Atorvastatin

Pair 4

ALT_B

42.8650

15.36460

0.031

 

 

ALT_A

43.0404

15.48272

 

 

Pair 5

AST_B

38.0441

10.66280

<0.001

 

 

AST_A

40.5510

8.84032

 

 

Pair 6

ALP_B

93.2380

24.28237

0.017

 

 

 

ALP_A

95.5636

24.74273

 

Rosuvastatin

Pair 4

ALT_B

42.6310

13.71178

0.006

 

 

ALT_A

43.0541

13.58644

 

 

Pair 5

AST_B

38.3716

10.24745

<0.001

 

 

AST_A

41.2062

7.46823

 

 

Pair 6

ALP_B

80.6853

21.40628

0.018

 

 

ALP_A

83.5962

23.47719

 

 

 

 

 

FIGURE 5: Both Atorvastatin and Rosuvastatin increased liver enzymes, with significant changes in AST and ALP. Rosuvastatin showed a slightly greater effect on ALT and AST, while Atorvastatin had a similar impact on ALP. These changes suggest a possible effect on liver function, though values remained mostly within normal limits.

TABLE 6:

The table and graph analyzed the effects of atorvastatin and rosuvastatin on lipid profile parameters before and after treatment.

 

Paired Samples Statistics

Drugs

Mean

Std. Deviation

P value

Atorvastatin

Pair 1

T.CHOLESTEROL_B

214.9366

39.22313

<0.001

T.CHOLESTERO_A

159.8383

31.13555

Pair 2

TRIGLYCERIDES_B

160.0318

64.20041

<0.001

TRIGLYCERIDES_A

118.5365

58.25433

Pair 3

HDL_B

73.4743

33.94415

0.008

HDL_A

70.0373

29.56822

Pair 4

LDL_B

126.5059

27.66492

0.010

LDL_A

100.6175

17.24133

Pair 5

VLDL_B

56.536

16.2626

<0.001

VLDL_A

37.436

5.6772

Rosuvastatin

Pair 1

T.CHOLESTEROL_B

212.1554

42.13876

<0.001

T.CHOLESTERO_A

161.2732

32.65787

Pair 2

TRIGLYCERIDES_B

159.4539

75.96202

<0.001

TRIGLYCERIDES_A

107.3943

52.14012

Pair 3

HDL_B

73.9261

35.45160

0.251

HDL_A

72.3921

33.93451

Pair 4

LDL_B

123.1041

33.07844

<0.001

LDL_A

96.1651

19.28898

Pair 5

VLDL_B

51.838

17.4673

<0.001

 

 

VLDL_A

36.206

5.3820

 

 

RESULTS

Both Atorvastatin and Rosuvastatin effectively improved lipid profiles by reducing total cholesterol, LDL, VLDL, and triglycerides. Rosuvastatin showed greater lipid-lowering efficacy with stable HDL levels, making it preferable for patients requiring intensive lipid management.

CONCLUSION

Both Atorvastatin and Rosuvastatin effectively improved lipid profiles, with Rosuvastatin showing greater reduction in LDL and triglycerides while maintaining HDL levels. Both caused minor changes in liver function and a slight increase in HbA1C, suggesting a possible mild effect on glucose metabolism. Rosuvastatin may be preferred for intensive lipid management with careful monitoring of liver parameters.

CONFLICT OF INTEREST

The authors have no conflicts of interest regarding this investigation.

 

REFERENCES

  1. Atorvastatin in the Prevention of Coronary Heart Disease A study on atorvastatin's effectiveness in reducing cardiovascular events. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa020728
  2. Effect of Statins on Lipid Levels A comprehensive review on the efficacy of statins in lowering cholesterol. Available at: https://www.ahajournals.org/doi/full/10.1161/01.CIR.0000097334.64606.11
  3. Rosuvastatin and Atorvastatin: Effects on Lipid Profiles Comparative study examining both statins in patients with dyslipidemia. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0735109706002261
  4. Statins and Diabetes Risk This meta-analysis discusses the association between statin use and diabetes incidence. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3857564/
  5. Impact of Rosuvastatin on Glycemic Control A study focusing on rosuvastatin's effect on HbA1c levels in diabetic patients. Available at: https://www.ahajournals.org/doi/full/10.1161/CIRCHEARTFAILURE.113.000550
  6. Comparative Effectiveness of Statins on Cardiovascular Outcomes A systematic review of high-intensity statin therapies and their outcomes. Available at:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4825171/
  7. Statin Therapy in Patients with Atherosclerosis Review of the impact of statins on cardiovascular events in patients with atherosclerosis . Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00780-6/fulltext
  8. Efficacy of Rosuvastatin vs. Atorvastatin in Clinical Practice This study compares the two statins regarding safety and lipid-lowering efficacy. Available at: https://www.jamanetwork.com/journals/jama/fullarticle/2642832
  9. Safety and Efficacy of High-Dose Statins A review analyzing the adverse effects and effectiveness of high-dose statin regimens. Available at: https://www.jacc.org/doi/full/10.1016/j.jacc.2020.07.034
  10. Statins and Cardiovascular Disease: A Meta-Analysis This meta-analysis examines the impact of statins on cardiovascular mortality and morbidity. Available at: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.049418
  11. Rosuvastatin vs. Atorvastatin in Real-World Practice A study on the real-world effectiveness of rosuvastatin compared to atorvastatin. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8431472/
  12. Long-Term Effects of Statin Therapy on Liver Function [47] A study focusing on the impact of prolonged statin use on liver function tests. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0009915021004162
  13. Statins in the Management of Dyslipidemia Overview of current guidelines on the use of statins in dyslipidemia management. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01412-6/fulltext
  14. Assessing the Risk of Diabetes with Statin Use A critical review assessing the relationship between statins and diabetes risk. Available at: https://www.jamanetwork.com/journals/jama/fullarticle/2780865
  15. Statins and Their Role in Cardiovascular Risk Reduction This article reviews the cardiovascular benefits of statin therapy in various populations. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10240584/
  16. https://www.sciencedirect.com/topics/agricultural-and-biological-sciences/cholesterol-metabolism
  17. Cholesterol Metabolism Lipid and lipoprotein Metabolism (Rosensen,2009) https://www.utmb.edu/pedi_ed/Obesity/page_19.htm
  18. Introduction to lipids and lipoproteins https://www.ncbi.nlm.nih.gov/books/NBK305896/
  19. Cholesterol, triglycerides, and associated lipoproteins https://www.ncbi.nlm.nih.gov/books/NBK351/
  20. Human cholesterol mechanism and therapeutic molecules https://physoc.onlinelibrary.wiley.com/doi/full/10.1113/expphysiol.2006.035147
  21. Cellular cholesterol delivery, intracellular processing and utilization for biosynthesis of steroid hormones https://nutritionandmetabolism.biomedcentral.com/articles/10.1186/1743-7075-7-47
  22. Statin medications https://www.ncbi.nlm.nih.gov/books/NBK430940/ 23. HMG-CoA Reductase Inhibitors https://www.ncbi.nlm.nih.gov/books/NBK542212/

Reference

  1. Atorvastatin in the Prevention of Coronary Heart Disease A study on atorvastatin's effectiveness in reducing cardiovascular events. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa020728
  2. Effect of Statins on Lipid Levels A comprehensive review on the efficacy of statins in lowering cholesterol. Available at: https://www.ahajournals.org/doi/full/10.1161/01.CIR.0000097334.64606.11
  3. Rosuvastatin and Atorvastatin: Effects on Lipid Profiles Comparative study examining both statins in patients with dyslipidemia. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0735109706002261
  4. Statins and Diabetes Risk This meta-analysis discusses the association between statin use and diabetes incidence. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3857564/
  5. Impact of Rosuvastatin on Glycemic Control A study focusing on rosuvastatin's effect on HbA1c levels in diabetic patients. Available at: https://www.ahajournals.org/doi/full/10.1161/CIRCHEARTFAILURE.113.000550
  6. Comparative Effectiveness of Statins on Cardiovascular Outcomes A systematic review of high-intensity statin therapies and their outcomes. Available at:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4825171/
  7. Statin Therapy in Patients with Atherosclerosis Review of the impact of statins on cardiovascular events in patients with atherosclerosis . Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00780-6/fulltext
  8. Efficacy of Rosuvastatin vs. Atorvastatin in Clinical Practice This study compares the two statins regarding safety and lipid-lowering efficacy. Available at: https://www.jamanetwork.com/journals/jama/fullarticle/2642832
  9. Safety and Efficacy of High-Dose Statins A review analyzing the adverse effects and effectiveness of high-dose statin regimens. Available at: https://www.jacc.org/doi/full/10.1016/j.jacc.2020.07.034
  10. Statins and Cardiovascular Disease: A Meta-Analysis This meta-analysis examines the impact of statins on cardiovascular mortality and morbidity. Available at: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.049418
  11. Rosuvastatin vs. Atorvastatin in Real-World Practice A study on the real-world effectiveness of rosuvastatin compared to atorvastatin. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8431472/
  12. Long-Term Effects of Statin Therapy on Liver Function [47] A study focusing on the impact of prolonged statin use on liver function tests. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0009915021004162
  13. Statins in the Management of Dyslipidemia Overview of current guidelines on the use of statins in dyslipidemia management. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01412-6/fulltext
  14. Assessing the Risk of Diabetes with Statin Use A critical review assessing the relationship between statins and diabetes risk. Available at: https://www.jamanetwork.com/journals/jama/fullarticle/2780865
  15. Statins and Their Role in Cardiovascular Risk Reduction This article reviews the cardiovascular benefits of statin therapy in various populations. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10240584/
  16. https://www.sciencedirect.com/topics/agricultural-and-biological-sciences/cholesterol-metabolism
  17. Cholesterol Metabolism Lipid and lipoprotein Metabolism (Rosensen,2009) https://www.utmb.edu/pedi_ed/Obesity/page_19.htm
  18. Introduction to lipids and lipoproteins https://www.ncbi.nlm.nih.gov/books/NBK305896/
  19. Cholesterol, triglycerides, and associated lipoproteins https://www.ncbi.nlm.nih.gov/books/NBK351/
  20. Human cholesterol mechanism and therapeutic molecules https://physoc.onlinelibrary.wiley.com/doi/full/10.1113/expphysiol.2006.035147
  21. Cellular cholesterol delivery, intracellular processing and utilization for biosynthesis of steroid hormones https://nutritionandmetabolism.biomedcentral.com/articles/10.1186/1743-7075-7-47
  22. Statin medications https://www.ncbi.nlm.nih.gov/books/NBK430940/ 23. HMG-CoA Reductase Inhibitors https://www.ncbi.nlm.nih.gov/books/NBK542212/

Photo
Rudhra Sandhya
Corresponding author

Department of Pharmaceutics, Bharat School of Pharmacy ,Rangareddy , Telangana,India.

Photo
Mohd Shahnawaz
Co-author

Bharat school of Pharmacy, JNTUH, , Telangana, India.

Photo
Dr. Haritha. P
Co-author

Bharat school of Pharmacy, JNTUH, , Telangana, India.

Photo
Dr. Swathi Boddupally
Co-author

Bharat school of Pharmacy, JNTUH, , Telangana, India.

Photo
Deepika Pallati
Co-author

Bharat school of Pharmacy, JNTUH, , Telangana, India.

Photo
P. S. V. Sandeep
Co-author

Bharat school of Pharmacy, JNTUH, , Telangana, India.

Mohd Shahnawaz, Dr. Haritha. P, Dr. Swathi Boddupally, Deepika Pallati, P. S. V. Sandeep, Rudra Sandhya, The Comparision Between Rosuvastatin And Atorvastatin On Lipid Profile, Predisposition To Diabetes & Glucose Intolerance & Liver Function Test In Adult Patient’s, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 8, 2549-2558, https://doi.org/10.5281/zenodo.21948651

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