氟伐他汀治疗日本高胆固醇血症患者的长期事件监测研究：老年患者（≥65 岁）的疗效和心脏及其他事件的发生率。

Long-term event monitoring study of fluvastatin in Japanese patients with hypercholesterolemia: Efficacy and incidence of cardiac and other events in elderly patients (≥ 65 years old).

机构信息

Division of Health and Nutrition, College of Life Sciences, Ibaraki Christian University, Ibaraki, Japan.

出版信息

J Cardiol. 2011 Jan;57(1):77-88. doi: 10.1016/j.jjcc.2010.09.003. Epub 2010 Nov 9.

DOI:10.1016/j.jjcc.2010.09.003

PMID:21067897

Abstract

OBJECTIVE

This long-term event monitoring (LEM) study was designed to evaluate the long-term lipid-lowering efficacy and safety of fluvastatin (Lochol®, Novartis A.G.) along with the incidence of cardiac and other events, and safety of fluvastatin in Japanese patients with hypercholesterolemia.

METHODS

Patients (n = 21,139) who started fluvastatin between April 1, 2000 and March 31, 2002, across 2563 centers in Japan were prospectively registered and followed up for 3 years (secondary prevention cohort) or 5 years (primary prevention cohort).

RESULTS

Of the patients registered, 19,084 were included in this analysis. Levels of low-density lipoprotein-cholesterol (LDL-C) and total cholesterol (TC) decreased significantly in the primary (-27.1% and -18.8%) and secondary (-25.3% and -18.4%) prevention cohorts. Reductions in LDL-C (-22.1 vs. -18.2%, p < 0.0001) and TC (-16.1 vs. -13.1%, p < 0.0001) levels were significantly greater among patients aged ≥ 65 than < 65 years old. Overall, 1.7% (146/8563) and 1.1% (93/8563) of patients aged ≥ 65 years old experienced confirmed cardiac and cerebral events, compared with 1.1% (112/10,517) and 0.3% (28/10,517) of patients aged < 65 years old (p = 0.0002 and < 0.0001, respectively). Incidence of cardiac and cerebral events was lowest in patients aged < 65 years old in the primary prevention cohort and highest among patients aged ≥ 65 years old in the secondary prevention cohort. Adverse events were reported in 7.9% (1501/19,084) of patients.

CONCLUSION

This large-scale, prospective, uncontrolled study confirmed the lipid-lowering efficacy and safety of long-term fluvastatin treatment for hypercholesterolemia in Japanese patients aged ≥ 65 years old. The higher incidence of cardiac and cerebral events in patients aged ≥ 65 years old in the secondary prevention cohort reflects a high-risk clinical profile with multiple classic risk factors warranting multifactorial interventions.

摘要

目的

本项长期事件监测（LEM）研究旨在评估氟伐他汀（罗氏，诺华制药）的长期降脂疗效和安全性，以及在日本高胆固醇血症患者中的心脏和其他事件发生率和安全性。

方法

2000 年 4 月 1 日至 2002 年 3 月 31 日期间，在日本 2563 个中心开始使用氟伐他汀的 21139 例患者被前瞻性注册并随访 3 年（二级预防队列）或 5 年（一级预防队列）。

结果

在注册的患者中，19084 例患者纳入本分析。一级预防（-27.1%和-18.8%）和二级预防（-25.3%和-18.4%）队列中，低密度脂蛋白胆固醇（LDL-C）和总胆固醇（TC）水平显著降低。≥65 岁患者的 LDL-C（-22.1%比-18.2%，p<0.0001）和 TC（-16.1%比-13.1%，p<0.0001）降低更为显著。≥65 岁的患者中，分别有 1.7%（146/8563）和 1.1%（93/8563）的患者发生了确诊的心脏和脑部事件，而<65 岁的患者中分别为 1.1%（112/10517）和 0.3%（28/10517）（p=0.0002 和<0.0001）。一级预防队列中，年龄<65 岁的患者心脏和脑部事件发生率最低，二级预防队列中，年龄≥65 岁的患者发生率最高。19084 例患者中有 7.9%（1501/19084）报告了不良事件。