Atorvastatin 10 mg tablet
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Atorvastatin 10 mg Tablet: Pharmacokinetics, Efficacy, and Safety
Pharmacokinetics and Bioequivalence in Chinese Population
Atorvastatin calcium, a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor, is widely used for preventing cardiovascular disease and treating dyslipidemia. A study conducted on healthy fasted Chinese male volunteers assessed the pharmacokinetics and bioequivalence of a test and branded reference formulation of atorvastatin calcium 10-mg tablets. The study found that both formulations were bioequivalent, with no significant differences in pharmacokinetic parameters such as C_max, AUC_0-t, and AUC_0-∞ for atorvastatin and its primary active metabolite, ortho-hydroxy-atorvastatin. Both formulations were well tolerated, with only mild adverse events reported.
Efficacy and Safety in High-Risk Asian Patients
A Phase IV randomized controlled trial compared the efficacy and safety of atorvastatin 10 mg and 20 mg in high-risk Asian patients with hypercholesterolemia. The study revealed that atorvastatin 20 mg significantly reduced LDL-C levels more than the 10 mg dose (42.4% vs. 33.5%). Additionally, more patients achieved target LDL-C levels with the higher dose. Both doses were well tolerated, with similar safety profiles.
Bioequivalence of Fixed Dose Combination with Aspirin
A study evaluated the bioavailability and bioequivalence of a fixed-dose combination of atorvastatin 10 mg and aspirin 150 mg capsules compared to their respective marketed formulations. The pharmacokinetic parameters for atorvastatin and aspirin were comparable between the test and reference formulations, confirming bioequivalence under fasting conditions. This combination was also well tolerated among the study participants.
Comparative Safety of Atorvastatin 80 mg vs. 10 mg
A retrospective analysis of pooled data from 49 clinical trials involving 14,236 patients compared the safety of atorvastatin 10 mg and 80 mg. The incidence of treatment-associated adverse events was similar across both doses and placebo. Serious adverse events were rare, and no cases of rhabdomyolysis were reported. The study concluded that atorvastatin 80 mg has a safety profile comparable to the 10 mg dose.
Efficacy in Pediatric Hypercholesterolemia
A multicenter, randomized, placebo-controlled trial assessed the efficacy and safety of atorvastatin (10 to 20 mg) in children and adolescents with familial hypercholesterolemia or severe hypercholesterolemia. The study found that atorvastatin significantly reduced LDL-C, total cholesterol, triglycerides, and apolipoprotein B levels compared to placebo. The treatment was well tolerated over a 12-month period .
Conclusion
Atorvastatin 10 mg tablets have been extensively studied for their pharmacokinetics, efficacy, and safety across various populations. The drug is bioequivalent to its branded formulations, effective in reducing LDL-C levels, and well tolerated in both adult and pediatric patients. Higher doses, such as 20 mg and 80 mg, offer greater efficacy in lipid reduction with a comparable safety profile. These findings support the use of atorvastatin 10 mg as a reliable option for managing hypercholesterolemia and preventing cardiovascular diseases.
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