Efficacy and Safety of High-Dose Atorvastatin in Moderate-to-High Cardiovascular Risk Postmenopausal Korean Women with Dyslipidemia

Abstract

Objective Postmenopausal women show a more atherogenic lipid profile and elevated cardiovascular risk compared to premenopausal women. The aim of this study was to investigate the efficacy and safety of high-dose atorvastatin on the improvement of the blood lipid profile of postmenopausal women in Korea. Methods This study is a prospective, open-label, single-arm clinical trial that was conducted in 3 teaching hospitals. Postmenopausal women with a moderate-to-high cardiovascular risk, according to guidelines from the Korean Society of Lipid & Atherosclerosis, were enrolled. Participants were administered 20 mg of atorvastatin daily for the first 8 weeks, and if the targeted low-density lipoprotein cholesterol (LDL-C) level was not achieved, the dose was increased to 40 mg for the second 8 weeks. The primary endpoint was percentage change of LDL-C from baseline after 16 weeks of drug administration. Results Forty-four women were enrolled, 28 of whom (75.6%) had diabetes mellitus. By the end of treatment period (16 weeks) all patients had achieved LDL-C target levels, with 33 (94.2%) of the participants achieving it after only 8 weeks of administration. After 16 weeks, LDL-C decreased by 45.8±16.7% ( p <0.001) from the baseline, and total cholesterol (33.2±10.9%; p <0.001), triglyceride (24.2±37.5%; p =0.001), and apolipoprotein B (34.9±15.6%; p <0.001) also significantly decreased. Blood glucose and liver enzyme levels slightly increased, but none of the participants developed serious adverse events that would cause them to prematurely withdraw from the clinical trial. Conclusion 20 and 40 mg atorvastatin was effective and safe for treating dyslipidemia in postmenopausal Korean women with moderate-to-high cardiovascular risk.

A randomized, open-label, parallel, multi-center Phase IV study to compare the efficacy and safety of atorvastatin 10 and 20 mg in high-risk Asian patients with hypercholesterolemia

“…Still, there were no statistically significant differences between the groups. These relatively small and nonsignificant changes in TG, HDL-C, and Apo-A1 levels were also similar to those of previous studies [ 35 , 37 , 38 ]. Atorvastatin 20 was more efficient than atorvastatin 10 mg in for the very high-risk group patients in achieving target LDL-C and non-HDL-C levels.…”

“…In the present study, treatments with atorvastatin 10 and 20 mg over a 12-week period were compared to explore the dose of atorvastatin that is more appropriate in high-risk Asian patients in terms of efficacy, safety, and cost-effectiveness. As reported by earlier studies regarding the effectiveness and safety of atorvastatin in Asian patients even at a high dose [ 35 , 36 ], the present study also demonstrated that atorvastatin effectively improved various lipid profiles without increasing the rate of ADRs. The percentage change in LDL-C levels after atorvastatin therapy was comparable to that reported by previous studies [ 35 , 37 , 38 ].…”

“…As reported by earlier studies regarding the effectiveness and safety of atorvastatin in Asian patients even at a high dose [ 35 , 36 ], the present study also demonstrated that atorvastatin effectively improved various lipid profiles without increasing the rate of ADRs. The percentage change in LDL-C levels after atorvastatin therapy was comparable to that reported by previous studies [ 35 , 37 , 38 ]. The reduction of LDL-C, non-HDL-C, TC, and Apo-B levels was significantly higher in the atorvastatin 20 mg group than in the atorvastatin 10 mg group.…”

“…As shown in our study, an increase in blood glucose level induced by a statin is not just a chronic, long-term change. Other studies on statin conducted for a relatively short period also demonstrated elevated blood glucose levels, and statin treatment for only a few days in the early phase of acute myocardial infarction also reduced insulin sensitivity [ 35 , 40 ]. Therefore, although the benefit of LDL-C reduction is known to outweigh the harm from the elevation of blood glucose [ 41 ], it is necessary to monitor blood glucose levels from the early days of the statin treatment even in patients with low risk of diabetes.…”

Exercise Training Protects against Atorvastatin-Induced Skeletal Muscle Dysfunction and Mitochondrial Dysfunction in the Skeletal Muscle of Rats

“…Statin treatment is relatively safe for patients with dyslipidemia and cardiovascular diseases [ 6 , 7 , 8 ]. Specifically, statin treatment often causes adverse skeletal muscle symptoms, including skeletal muscle pain, weakness, and fatal rhabdomyolysis [ 9 ], which are associated with major pathological changes, such as the elevation of creatine kinase (CK) levels [ 10 ], reduction of muscular strength, muscle weakness [ 11 ], induction of apoptosis [ 12 ], and mitochondrial dysfunction [ 13 ] in skeletal muscles.…”