J Lipid Atheroscler.  2020 Jan;9(1):162-171. 10.12997/jla.2020.9.1.162.

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

• Moon J
• Yoo S
• Koh G
• Min KW
• Shin HH

• KMID: 2470808
• DOI: http://doi.org/10.12997/jla.2020.9.1.162

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.

Keyword

Postmenopause; Koreans; Dyslipidemia; Atorvastatin

MeSH Terms

Apolipoproteins
Asian Continental Ancestry Group
Atherosclerosis
Atorvastatin Calcium*
Blood Glucose
Cholesterol
Diabetes Mellitus
Dyslipidemias*
Female
Hospitals, Teaching
Humans
Korea
Lipoproteins
Liver
Postmenopause
Prospective Studies
Triglycerides
Apolipoproteins
Atorvastatin Calcium
Blood Glucose
Cholesterol
Lipoproteins

Figure

• 

  Fig. 1 Patient disposition. FA, full analysis; PP, per protocol.

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