Safety and Effectiveness of Pravastatin in Korean Patients with Dyslipidemia Based on the Cardiovascular Risk Classification: Pooled Analysis of Four Observational Studies.

IF 3.9 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM
In-Kyung Jeong, Hyuk-Sang Kwon, Dae Jung Kim, Sin Gon Kim
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Abstract

Background: Despite their efficacy, statin-related adverse events (AEs) may interfere with statin treatment and contribute to negative outcomes in patients with cardiovascular diseases. In this study, we evaluated the safety and effectiveness of pravastatin in Korea.

Methods: Pooled data were collected from four multicenter prospective observational studies conducted in Korea between 2011 and 2020. Finally, 7,334 and 2,022 participants were included in the safety and effectiveness analyses, respectively. Overall safety, particularly muscle-related, incidence of new-onset diabetes mellitus (DM), changes in fasting plasma glucose and hemoglobin A1c level, achievement of target low-density lipoprotein cholesterol (LDL-C) level, and changes in LDL-C level were analyzed.

Results: At week 24, after 20 or 40 mg pravastatin treatment, safety results showed that AEs and adverse drug reactions (ADRs) were 8.7% and 1.3%, respectively, and that muscle-related AEs and ADRs were 0.5% and 0.3%, respectively, with no statistically significant difference in risk factors for statin-associated muscle symptoms. No patients developed DM during the study period. Additionally, at week 24, the achievement rates of target LDL-C levels were 87.9%, 78.4%, 57.8%, and 11.6% in low-, moderate-, high-, and very high-risk groups, respectively.

Conclusion: This study found that 20 or 40 mg pravastatin had minimal side effects and was safe for use in real-world clinical settings in Korea. Specifically, these doses effectively achieved the target LDL-C levels in patients with dyslipidemia in low-, moderate-, and high-risk groups for atherosclerotic cardiovascular disease (ASCVD). These results demonstrate that pravastatin can be safely administered continuously to patients with low-, moderate-, and high-risk ASCVD in a real-world clinical setting.

基于心血管风险分类的普伐他汀在韩国血脂异常患者中的安全性和有效性:四项观察性研究的汇总分析
背景:尽管他汀类药物有疗效,但他汀类药物相关不良事件(ae)可能会干扰他汀类药物治疗,并导致心血管疾病患者的负面结果。在这项研究中,我们评估了普伐他汀在韩国的安全性和有效性。方法:收集2011年至2020年间在韩国进行的四项多中心前瞻性观察性研究的汇总数据。最后,7334名参与者和2022名参与者分别被纳入安全性和有效性分析。分析总体安全性,特别是肌肉相关,新发糖尿病(DM)的发生率,空腹血糖和血红蛋白A1c水平的变化,低密度脂蛋白胆固醇(LDL-C)目标水平的实现以及LDL-C水平的变化。结果:第24周,普伐他汀治疗20或40 mg后,安全性结果显示ae和adr分别为8.7%和1.3%,肌肉相关ae和adr分别为0.5%和0.3%,他汀类药物相关肌肉症状的危险因素差异无统计学意义。在研究期间没有患者发生糖尿病。此外,在第24周,低、中、高、高危组的目标LDL-C水平完成率分别为87.9%、78.4%、57.8%和11.6%。结论:本研究发现20mg或40mg普伐他汀副作用最小,在韩国临床环境中使用是安全的。具体来说,这些剂量有效地达到了动脉粥样硬化性心血管疾病(ASCVD)低、中、高风险人群血脂异常患者的LDL-C目标水平。这些结果表明,在现实世界的临床环境中,普伐他汀可以安全地连续给药于低、中、高风险ASCVD患者。
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来源期刊
Endocrinology and Metabolism
Endocrinology and Metabolism Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
6.60
自引率
5.90%
发文量
145
审稿时长
24 weeks
期刊介绍: The aim of this journal is to set high standards of medical care by providing a forum for discussion for basic, clinical, and translational researchers and clinicians on new findings in the fields of endocrinology and metabolism. Endocrinology and Metabolism reports new findings and developments in all aspects of endocrinology and metabolism. The topics covered by this journal include bone and mineral metabolism, cytokines, developmental endocrinology, diagnostic endocrinology, endocrine research, dyslipidemia, endocrine regulation, genetic endocrinology, growth factors, hormone receptors, hormone action and regulation, management of endocrine diseases, clinical trials, epidemiology, molecular endocrinology, neuroendocrinology, neuropeptides, neurotransmitters, obesity, pediatric endocrinology, reproductive endocrinology, signal transduction, the anatomy and physiology of endocrine organs (i.e., the pituitary, thyroid, parathyroid, and adrenal glands, and the gonads), and endocrine diseases (diabetes, nutrition, osteoporosis, etc.).
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