Abstract

THE SAFETY AND EFFICACY OF ATROVASTATIN IN EARLY CLINICAL TRIALS

Jyoti B. Salgar, Sanjay K. Bais and *Balaji Vyankatesh Yeldi

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Abstract

Atorvastatin, a novel 3-hydroxy-3-methylglutaryl coenzyme A (HMGCoA) reductase inhibitor, has demonstrated enhanced efficacy in managing various dyslipidemic conditions characterized by increases in triglycerides and/or low-density lipoprotein cholesterol (LDL-C). Both preclinical and clinical research produced these data. The following results were observed in patients assigned to the recent safety and efficacy research, This study included 231 patients on atorvastatin, including 131 with hypercholesterolemia (HC), 63 with combined hyperlipidemia (CH), 36 with hypertriglyceridemia (HTG), and 1 with hyperchylomicronemia (Fredrickson Type V). Patients were treated with a cholesterol-lowering diet (either the more restrictive National Institutes of Health National Cholesterol Education Program Step 1 diet or another diet) plus either 2.5, 5, 10, 20, 40, or 80 mg/day of atorvastatin or a placebo. The efficacy was assessed by calculating the percentage change from baseline in the following parameters: total cholesterol, total triglycerides, LDL-C, HDL-C, VLDL-C, apo B, non-HDL-C/HDL-C, and cholesterol from very low-density lipoproteins (VLDL-C). The preferred course of treatment at this time is surgery, but there is a significant risk of death and recurrence. The range and efficacy of nonsurgical treatments are still limited. According to our most recent research, atorvastatin helps patients with CSDH have better clinical outcomes and fewer hematomas.

Keywords: Both preclinical and clinical research produced these data.