SAFETY AND EFFICACY OF PITAVASTATIN IN DYSLIPDEMIC/HYPERLIPIDEMIC PATIENTS

Abstract

Background: Dyslipidemia and hyperlipidemia are prevalent conditions worldwide, characterized by abnormal lipid levels such as elevated LDL cholesterol, total cholesterol, or triglycerides, which increase the risk of cardiovascular diseases. Statins are widely used for lipid management, with pitavastatin emerging as a promising option due to its potent lipid-lowering effects and favorable safety profile. This study evaluates the safety and efficacy of pitavastatin in dyslipidemic and hyperlipidemic patients.

Objective: To assess the safety and efficacy of pitavastatin in reducing LDL cholesterol, total cholesterol, and triglycerides in dyslipidemic and hyperlipidemic patients.

Methods: A randomized controlled trial (RCT) was conducted, enrolling 200 participants aged ≥18 years with dyslipidemia or hyperlipidemia. Participants were randomized in a 1:1 ratio to receive either pitavastatin 4 mg or placebo once daily for 12 weeks. Randomization was performed using a computer-generated sequence, with blinding maintained for participants, investigators, and staff. The primary endpoint was the percent change in LDL cholesterol levels from baseline to week 12. Secondary endpoints included changes in total cholesterol, triglycerides, HDL cholesterol, and adverse events. Laboratory evaluations were performed at baseline and at weeks 4, 8, and 12.

Results: Of the 200 participants, 52% were male, with a mean age of 55 years. The pitavastatin group achieved a significant 29.6% reduction in LDL cholesterol levels compared to 1.2% in the placebo group (p<0.001). Total cholesterol levels decreased by 22.4% in the pitavastatin group versus 1.6% in the placebo group (p<0.001). Triglycerides were reduced by 12.9% in the pitavastatin group compared to 0.9% in the placebo group (p=0.01). HDL cholesterol levels showed no significant difference between groups (-1.5% vs. -0.8%, p=0.36). Adverse events were reported by 16% of participants in the pitavastatin group and 12% in the placebo group, with no statistically significant difference (p=0.36).

Conclusion; Pitavastatin demonstrated significant efficacy in reducing LDL cholesterol, total cholesterol, and triglycerides in dyslipidemic and hyperlipidemic patients, with a safety profile comparable to placebo. These findings support its role as an effective therapeutic option for managing dyslipidemia and hyperlipidemia.