Jeong In-Kyung, Kwon Hyuk-Sang, Kim Dae Jung, Kim Sin Gon
Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Endocrinol Metab (Seoul). 2025 Aug;40(4):598-609. doi: 10.3803/EnM.2024.2200. Epub 2025 Apr 15.
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.
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.
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.
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.
尽管他汀类药物具有疗效，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出现不良后果。在本研究中，我们评估了普伐他汀在韩国的安全性和有效性。
汇总了2011年至2020年在韩国进行的四项多中心前瞻性观察性研究的数据。最后，分别有7334名和2022名参与者纳入安全性和有效性分析。分析了总体安全性，尤其是与肌肉相关的安全性、新发糖尿病（DM）的发生率、空腹血糖和糖化血红蛋白水平的变化、目标低密度脂蛋白胆固醇（LDL-C）水平的达标情况以及LDL-C水平的变化。
在第24周，接受20毫克或40毫克普伐他汀治疗后，安全性结果显示，不良事件（AE）和药物不良反应（ADR）的发生率分别为8.7%和1.3%，与肌肉相关的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无统计学显著差异。在研究期间，没有患者发生DM。此外，在第24周时，低、中、高和极高风险组的目标LDL-C水平达标率分别为87.9%、78.4%、57.8%和11.6%。
本研究发现，20毫克或40毫克普伐他汀的副作用极小，在韩国的实际临床环境中使用是安全的。具体而言，这些剂量有效地使动脉粥样硬化性心血管疾病（ASCVD）低、中、高风险组的血脂异常患者达到了目标LDL-C水平。这些结果表明，在实际临床环境中，普伐他汀可以安全地持续用于低、中、高风险的ASCVD患者。
