European Journal of Cardiovascular Medicine

Dyslipidemia, characterized by abnormal lipid levels in the bloodstream, is a major modifiable risk factor for cardiovascular diseases (CVD), including coronary artery disease and stroke [1,2]. Elevated levels of low-density lipoprotein (LDL) cholesterol, commonly referred to as "bad cholesterol," are particularly implicated in the pathogenesis of atherosclerosis, the underlying cause of most CVD [3].

Statins, a class of medications primarily targeting LDL cholesterol, have emerged as cornerstone agents in the management of dyslipidemia and the prevention of CVD events [4]. Among statins, rosuvastatin has gained prominence due to its potent LDL-lowering effects and favorable safety profile [5]. Clinical trials have demonstrated the efficacy of rosuvastatin in reducing LDL cholesterol levels and lowering the risk of cardiovascular events [6,7]. However, real-world evidence regarding the effectiveness and safety of rosuvastatin in routine clinical practice remains limited.

Observational studies play a crucial role in providing insights into the real-world utilization and outcomes associated with pharmacotherapies. By capturing data from diverse patient populations and clinical settings, observational studies complement findings from randomized controlled trials (RCTs) and offer valuable evidence on the effectiveness and safety of medications in everyday clinical practice [8].

In this context, we conducted an observational study to assess the effectiveness and safety of rosuvastatin in reducing LDL cholesterol levels among individuals with dyslipidemia. By examining real-world data, our study aims to provide practical insights into the clinical utility of rosuvastatin and its role in managing dyslipidemia and reducing cardiovascular risk.

Through a comprehensive evaluation of baseline characteristics, treatment outcomes, safety profile, compliance, and adherence, our study seeks to contribute valuable evidence to inform clinical decision-making and optimize the management of dyslipidemia in routine practice. Ultimately, our findings may help enhance the quality of care for individuals at risk of cardiovascular events and improve long-term health outcomes in the population affected by dyslipidemia.

Aim and Objectives

To evaluate the effectiveness and safety of rosuvastatin therapy in reducing LDL cholesterol levels among individuals with dyslipidemia attending Government Medical College, Suryapet.

Assess the change in LDL cholesterol levels following 12 weeks of rosuvastatin therapy.

Investigate the incidence of adverse events associated with rosuvastatin treatment.

Evaluate compliance and adherence to the prescribed medication regimen.

Explore secondary outcomes, including changes in total cholesterol, triglycerides, and HDL cholesterol levels

Study Design: This observational study was conducted at Government Medical College, Suryapet, over a period from August 2023 to March 2024.

Study Population: The study included individuals diagnosed with dyslipidemia who sought medical care at the outpatient department of Government General Hospital/ Government Medical College, Suryapet, during the study period. Eligible participants were aged between 45 and 65 years and had baseline LDL cholesterol levels ranging from 130 to 190 mg/dL.

Data Collection: Baseline characteristics, including age, gender, and baseline LDL cholesterol levels, were recorded for all participants at the time of enrollment. Demographic data and medical history were obtained through structured interviews and review of medical records.

Intervention: Participants received rosuvastatin therapy as per standard clinical practice. The choice of rosuvastatin dosage and treatment duration was determined by the treating physician based on individual patient characteristics and clinical considerations.

Outcome Measures: The primary outcome measure was the change in LDL cholesterol levels from baseline to the end of the 12-week treatment period. Secondary outcomes included changes in total cholesterol, triglycerides, and high-density lipoprotein (HDL) cholesterol levels. Safety assessments included monitoring for adverse events, liver function tests, and creatine kinase levels.

Data Analysis: Descriptive statistics were used to summarize baseline characteristics and treatment outcomes. Continuous variables were expressed as means with standard deviations (±) or as medians with interquartile ranges, while categorical variables were presented as frequencies and percentages. Subgroup analyses were conducted based on baseline LDL cholesterol levels to evaluate treatment response across different strata. Statistical significance was assessed using appropriate parametric or non-parametric tests, as applicable.

Ethical Considerations: The study protocol was reviewed and approved by the Institutional Ethics Committee of Government Medical College, Suryapet, in accordance with ethical principles outlined in the Declaration of Helsinki. Informed consent was obtained from all participants prior to enrollment in the study

The baseline characteristics of the study cohort revealed a total of 100 participants with a mean age of 55 years (± 10 years). Gender distribution among the participants was equal, ensuring a balanced representation across sexes. Baseline LDL cholesterol levels ranged from 130 to 190 mg/dL, with a mean of 160 mg/dL (Table 1).

Following a 12-week course of rosuvastatin therapy, a significant reduction in LDL cholesterol levels was observed across the entire sample. The mean reduction in LDL cholesterol was 30 mg/dL (± 5 mg/dL), corresponding to a notable 19% decrease from baseline levels (Table 2).

Subgroup analysis based on baseline LDL cholesterol levels further elucidated the effectiveness of rosuvastatin therapy. Participants with higher baseline LDL cholesterol levels exhibited greater reductions, with mean reductions of 25 mg/dL (± 3 mg/dL), 30 mg/dL (± 4 mg/dL), and 35 mg/dL (± 5 mg/dL) for baseline ranges of 130-150 mg/dL, 151-170 mg/dL, and 171-190 mg/dL, respectively (Table 3).

In terms of safety profile, rosuvastatin therapy demonstrated a favorable tolerability profile. No serious adverse events were reported during the study period. The most commonly observed adverse effects were mild and transient, including muscle aches, gastrointestinal discomfort, and headache. Moreover, no significant abnormalities were detected in liver function tests or creatine kinase levels (Table 4).

High levels of compliance and adherence to the rosuvastatin therapy regimen were noted among the study participants. A compliance rate of 95% was observed, with the vast majority completing the 12-week treatment period. Additionally, adherence to the medication regimen exceeded 90%, as assessed through self-reporting and pill counts (Table 5).

Secondary outcomes of rosuvastatin therapy encompassed improvements in various lipid parameters. Notably, total cholesterol levels saw a mean reduction of 35 mg/dL (± 6 mg/dL), while triglyceride levels decreased by a mean of 25 mg/dL (± 4 mg/dL). Conversely, HDL cholesterol levels exhibited an increase of 5 mg/dL (± 2 mg/dL) (Table 6).

Dyslipidemia is a significant risk factor for cardiovascular diseases, and statin therapy, such as rosuvastatin, plays a crucial role in managing lipid levels and reducing cardiovascular risk. In this study conducted at Government Medical College, Suryapet, we aimed to evaluate the effectiveness and safety of rosuvastatin therapy in individuals with dyslipidemia.

Our findings demonstrate that rosuvastatin therapy led to a significant reduction in LDL cholesterol levels among participants over the 12-week treatment period. This reduction is consistent with previous clinical trials and supports the efficacy of rosuvastatin in managing dyslipidemia [9,10]. Subgroup analysis based on baseline LDL cholesterol levels revealed consistent reductions across all strata, with greater reductions observed in individuals with higher baseline LDL cholesterol levels. This underscores the dose-dependent response of rosuvastatin and its ability to achieve target LDL cholesterol levels across a spectrum of dyslipidemia severity[11].

The safety profile of rosuvastatin therapy observed in our study aligns with previous evidence, with no serious adverse events reported during the study period. Common adverse effects such as muscle aches, gastrointestinal discomfort, and headache were mild and transient, consistent with the known side effect profile of statin medications [12]. The absence of significant abnormalities in liver function tests and creatine kinase levels further supports the favorable safety profile of rosuvastatin.

Compliance and adherence to rosuvastatin therapy were high among study participants, with the majority completing the 12-week treatment period and adhering to the prescribed medication regimen. This high level of adherence is encouraging and suggests good acceptance of rosuvastatin therapy among individuals with dyslipidemia[13].

Secondary outcomes of rosuvastatin therapy revealed favorable changes in lipid parameters, including reductions in total cholesterol and triglycerides, along with an increase in HDL cholesterol levels. These improvements in lipid profiles contribute to overall cardiovascular risk reduction and highlight the multifaceted benefits of statin therapy beyond LDL cholesterol lowering [14].

Limitations of our study include its observational design, which precludes causal inference, and the single-center setting, which may limit the generalizability of the findings. Additionally, the relatively short duration of follow-up may not capture long-term effects or assess the sustainability of treatment outcomes over time.

Our study provides real-world evidence supporting the effectiveness and safety of rosuvastatin therapy in managing dyslipidemia among individuals attending Government Medical College, Suryapet. These findings reinforce the role of rosuvastatin as a cornerstone therapy for lipid management and cardiovascular risk reduction in clinical practice

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