BACKGROUND Statins play an important role in the care of patients with cardiovascular disease and have a good safety record in clinical practice. Hepatotoxicity is a barrier that limits the ability of primary care physicians to prescribe statins for patients with elevated liver transaminase values and/or underlying liver disease. However, limited population-based data are available on the use of statin therapy and on the hepatotoxicity of statins in very elderly patients. This prospective study evaluated the liver enzyme elevation during statin therapy in very elderly patients (≥80 years old). METHODS Patients with hypercholesterolemia (LDL-C levels ≥3.4 and < 5.7 mmol/L), atherosclerosis, coronary heart disease (CHD), or a CHD-risk equivalent were enrolled and received once-daily statin treatment. Multivariate logistic regression models were used to study the impact of age, gender, hepatitis B infection, fatty liver disease, biliary calculus, other chronic diseases, drug kinds, alcohol abuse, statin variety, and statin dose variables. RESULTS A total of 515 consecutive patients ranging from 80 to 98 years old were included in the analysis. These patients were treated with simvastatin, fluvastatin, pravastatin, rosuvastatin, or atorvastatin. Twenty-four patients (4.7, 95% CI 2.7-6.6) showed an increase in their hepatic aminotransferase levels. No significant difference of hepatic aminotransferase elevation rates was observed in different statin treatment groups. The incidence of mild, moderate, and severe elevation of aminotransferase levels was 62.5% (15/24), 29.2% (7/24), and 8.3% (2/24), respectively. None of the patients developed hepatic failure. Nine patients with moderate or severe aminotransferase elevations discontinued therapy. The time of onset of hepatic aminotransferase elevation ranged from 2 weeks to 6 months after statin treatment. The onset of hepatic aminotransferase elevation was within 1 month for 70.8% of patients. The patients took 2 weeks to 3 months to recover their liver function after statin therapy cessation. Multivariate analysis identified chronic hepatitis B infection and alcohol consumption as independent factors associated with the hepatic response to statins: OR, 12.83; 95% CI (4.36-37.759) and OR, 2.736; 95% CI (1.373-5.454), respectively. CONCLUSION The prevalence of elevated transaminases was higher than published data in very elderly patients. Overall, statin treatment is safe for patients ≥80 years old.

中文翻译：

---

他汀类药物在非常年老患者中的肝脏安全性的前瞻性研究。

背景技术他汀类药物在心血管疾病患者的护理中起着重要作用，并且在临床实践中具有良好的安全记录。肝毒性是一个障碍，限制了初级保健医生为肝转氨酶值升高和/或潜在肝病患者开具他汀类药物的能力。但是，在非常年老的患者中，关于他汀类药物治疗的使用和他汀类药物的肝毒性的基于人群的数据有限。这项前瞻性研究评估了非常年老的患者（≥80岁）在他汀类药物治疗期间肝酶的升高。方法纳入高胆固醇血症（LDL-C水平≥3.4且<5.7 mmol / L），动脉粥样硬化，冠心病（CHD）或具有CHD风险的同等患者，并接受每日一次他汀类药物治疗。使用多元逻辑回归模型研究年龄，性别，乙型肝炎感染，脂肪肝疾病，胆结石，其他慢性疾病，药物种类，酒精滥用，他汀类药物和他汀类药物剂量变量的影响。结果分析共纳入515例80至98岁的连续患者。这些患者接受辛伐他汀，氟伐他汀，普伐他汀，瑞舒伐他汀或阿托伐他汀治疗。24名患者（4.7，95％CI 2.7-6.6）显示其肝转氨酶水平升高。在不同他汀类药物治疗组中未观察到肝氨基转移酶升高率的显着差异。轻度，中度和重度转氨酶水平升高的发生率分别为62.5％（15/24），29.2％（7/24）和8.3％（2/24）。没有患者发生肝衰竭。9名中度或重度转氨酶升高的患者终止了治疗。他汀类药物治疗后2周至6个月，肝转氨酶升高的发作时间不等。肝转氨酶升高的发生率在70.8％的患者中为1个月以内。他汀类药物停止治疗后，患者花了2周至3个月的时间恢复了肝功能。多变量分析确定慢性乙型肝炎感染和饮酒是与他汀类药物的肝反应相关的独立因素：OR，12.83； OR：12。95％CI（4.36-37.759）和OR，2.736；95％CI（1.373-5.454）。结论在非常年老的患者中转氨酶升高的发生率高于已发表的数据。总体而言，他汀类药物治疗对≥80岁的患者是安全的。