European Journal of Cardiovascular Medicine

Hyperlipidemia, particularly elevated low-density lipoprotein (LDL) cholesterol, is a major risk factor for cardiovascular diseases, including coronary artery disease, stroke, and peripheral artery disease¹. Statins are the most widely used class of drugs to manage hyperlipidemia and have been proven to reduce LDL cholesterol levels, thereby lowering the risk of cardiovascular events. Among the various statins available, Rosuvastatin and Atorvastatin are commonly prescribed due to their potent lipid-lowering effects and well-established safety profiles².

Rosuvastatin, a second-generation statin, is known for its strong LDL cholesterol-lowering effect. It inhibits HMG-CoA reductase, the enzyme responsible for cholesterol biosynthesis in the liver³. Similarly, Atorvastatin, another widely used statin, also works by inhibiting HMG-CoA reductase, although it has a slightly different pharmacokinetic profile compared to Rosuvastatin. Both medications have demonstrated efficacy in reducing LDL cholesterol and improving cardiovascular outcomes⁴. However, comparative studies on the efficacy and safety profiles of Rosuvastatin and Atorvastatin remain limited, especially concerning their effects on LDL cholesterol reduction and adverse event rates⁵.

This study aims to evaluate and compare the efficacy of Rosuvastatin and Atorvastatin in reducing LDL cholesterol levels in patients with hyperlipidemia. Additionally, we assess the safety of both drugs by monitoring adverse events throughout the treatment period. By investigating these aspects, this study contributes to a better understanding of the therapeutic benefits and safety considerations when choosing between Rosuvastatin and Atorvastatin for managing hyperlipidemia.

Study Design
This was a randomized, controlled clinical trial conducted to compare the efficacy and safety of Rosuvastatin and Atorvastatin in reducing LDL cholesterol levels in patients with hyperlipidemia. The study aimed to evaluate the changes in LDL cholesterol levels after 12 weeks of treatment with each drug and monitor the adverse events experienced by patients during the study period.

Place of Study
The study was conducted at ACSR Medical College, Nellore, Andhra Pradesh, India.

Study Period
The study was carried out from September 2023 to January 2024.

Participants
A total of 100 patients were enrolled in the study. The inclusion criteria for participants were:

Adults aged 30-70 years with a diagnosis of primary hyperlipidemia

LDL cholesterol levels above 130 mg/dL at baseline

No history of severe liver or kidney dysfunction

No history of active cardiovascular events or diseases

Not currently using other lipid-lowering therapies or any other medication that may interfere with the study results

Exclusion criteria included patients with known allergies to statins, pregnant or breastfeeding women, and those with contraindications to either Rosuvastatin or Atorvastatin.

Randomization and Group Assignment
Patients were randomly assigned to one of two treatment groups using a computer-generated randomization list:

Group 1: Rosuvastatin (50 patients)

Group 2: Atorvastatin (50 patients)

Intervention
Both groups received their respective statin treatments for 12 weeks.

Rosuvastatin: 20 mg daily

Atorvastatin: 20 mg daily

Outcome Measures

Primary Outcome: Reduction in LDL cholesterol levels after 12 weeks of treatment.

Secondary Outcome: Incidence of adverse events, including muscle pain, gastrointestinal disturbances, or any other side effects related to statin use.

Data Collection
LDL cholesterol levels were measured at baseline (prior to treatment initiation) and after 12 weeks of treatment. Blood samples were collected for lipid profile testing. Participants were monitored for any adverse events during the treatment period, and all adverse events were documented and classified by severity.

Statistical Analysis
Data were analyzed using appropriate statistical methods, including descriptive statistics, paired t-tests for within-group comparisons, and independent t-tests for between-group comparisons. A p-value of <0.05 was considered statistically significant.

Necessary permissions were obtained before starting the study. Informed consent was obtained from all participants before inclusion in the study.

A total of 100 patients were included in the study, with 50 patients assigned to the Rosuvastatin group and 50 patients assigned to the Atorvastatin group. The baseline characteristics of the two groups were similar, with no significant differences in age, gender distribution, or baseline LDL cholesterol levels (Table 1).

Table 1: Baseline Characteristics of Patients

LDL Cholesterol Reduction

After 12 weeks of treatment, both Rosuvastatin and Atorvastatin were found to significantly reduce LDL cholesterol levels. The mean baseline LDL cholesterol in the Rosuvastatin group was 160 ± 12 mg/dL, and it reduced to 80 ± 8 mg/dL, representing a 50.0% reduction (p < 0.001). In the Atorvastatin group, the baseline LDL cholesterol was 158 ± 11 mg/dL, and it reduced to 95 ± 10 mg/dL, resulting in a 39.9% reduction (p < 0.001) (Table 2).

Table 2: LDL Cholesterol Reduction After 12 Weeks

A comparative analysis revealed that Rosuvastatin was significantly more effective than Atorvastatin in reducing LDL cholesterol (50.0% vs. 39.9%, p < 0.001) (Table 3).

Table 3: Comparative Analysis of LDL Cholesterol Reduction

Adverse Events

The safety profiles of Rosuvastatin and Atorvastatin were also assessed. In the Rosuvastatin group, 12% of patients reported adverse events, with the most common being mild muscle pain (4%) and mild gastrointestinal disturbances (8%). No serious adverse events were reported in this group (Table 4).

Table 4: Adverse Events in Rosuvastatin Group

In the Atorvastatin group, a slightly higher percentage of patients (16%) experienced adverse events. The most common adverse events were mild muscle pain (6%) and mild gastrointestinal disturbances (10%), with 1 patient (2%) discontinuing treatment due to adverse effects (Table 5).

Table 5: Adverse Events in Atorvastatin Group

When comparing the overall adverse event rates between the two groups, no statistically significant difference was observed (12% vs. 16%, p = 0.54) (Table 6).

Table 6: Comparative Safety Profile of Rosuvastatin and Atorvastatin

This study aimed to compare the efficacy and safety profiles of Rosuvastatin and Atorvastatin in reducing LDL cholesterol levels in patients with hyperlipidemia. Our findings indicate that both drugs significantly reduced LDL cholesterol, with Rosuvastatin showing a superior effect compared to Atorvastatin. Additionally, the safety profiles of both medications were similar, with no serious adverse events reported in either group.

The reduction in LDL cholesterol levels observed in both treatment groups aligns with existing literature on the efficacy of statins. In our study, Rosuvastatin reduced LDL cholesterol by 50.0%, while Atorvastatin resulted in a 39.9% reduction. These results are consistent with the well-documented potent lipid-lowering effects of Rosuvastatin, which has a higher affinity for the HMG-CoA reductase enzyme, leading to a more significant reduction in cholesterol levels compared to other statins, including Atorvastatin. Previous studies have also reported that Rosuvastatin is more effective than Atorvastatin in reducing LDL cholesterol, which is corroborated by our findings⁶.

The incidence of adverse events was relatively low in both groups, and the overall safety profiles were similar, with mild muscle pain and gastrointestinal disturbances being the most commonly reported side effects⁷. The adverse event rates in our study (12% in the Rosuvastatin group and 16% in the Atorvastatin group) are consistent with those reported in other clinical trials, where statins are generally well-tolerated. The slight difference in adverse event rates between the two groups was not statistically significant, indicating that both medications have comparable safety profiles in the population studied^8,9.

One limitation of our study is the relatively short treatment duration of 12 weeks. Longer studies are necessary to assess the long-term safety and efficacy of both statins, especially concerning their impact on cardiovascular outcomes. Moreover, the study was conducted in a single center, which may limit the generalizability of the findings to other populations.

Both Rosuvastatin and Atorvastatin are effective in reducing LDL cholesterol levels in patients with hyperlipidemia, with Rosuvastatin demonstrating a more significant reduction. The safety profiles of both drugs are comparable, and both medications appear to be well-tolerated. These findings provide further evidence supporting the use of Rosuvastatin and Atorvastatin in the management of hyperlipidemia, with a slight preference for Rosuvastatin in terms of efficacy. Future studies with longer follow-up periods and larger sample sizes are needed to confirm these findings and explore their implications for long-term cardiovascular risk reduction.

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