Low-density lipoprotein cholesterol targeting with pitavastatin + ezetimibe for patients with acute coronary syndrome and dyslipidaemia: the HIJ-PROPER study, a prospective, open-label, randomized trial.
Low-density lipoprotein cholesterol targeting with pitavastatin + ezetimibe for patients with acute coronary syndrome and dyslipidaemia: the HIJ-PROPER study, a prospective, open-label, randomized trial.
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DOI：
10.1093/eurheartj/ehx162
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发表时间：
2017-08-01
影响因子：
39.3
通讯作者：
Ogawa H
中科院分区：
文献类型：
--
作者：
Hagiwara N;Kawada-Watanabe E;Koyanagi R;Arashi H;Yamaguchi J;Nakao K;Tobaru T;Tanaka H;Oka T;Endoh Y;Saito K;Uchida T;Matsui K;Ogawa H
为阐明在血脂异常且冠心病事件高风险患者中，使用标准剂量的他汀类药物和依折麦布强化降低低密度脂蛋白胆固醇（LDL - C），将LDL - C目标值设定为低于70mg/dL（1.8mmol/L），相较于将LDL - C目标值设定为低于100mg/dL（2.6mmol/L）的标准降低LDL - C的单一脂质疗法的效果。
HIJ - PROPER研究是一项前瞻性、随机、开放标签试验，旨在评估在急性冠状动脉综合征（ACS）合并血脂异常患者中，使用标准剂量的匹伐他汀加依折麦布强化降低LDL - C是否比匹伐他汀单一疗法标准降低LDL - C更能减少心血管事件。患者被随机分配到强化降低组（目标LDL - C < 70mg/dL[1.8mmol/L]；匹伐他汀加依折麦布）或标准降低组（目标LDL - C为90mg/dL至100mg/dL[2.3 - 2.6mmol/L]；匹伐他汀单一疗法）。主要终点是全因死亡、非致命性心肌梗死、非致命性卒中、不稳定型心绞痛和缺血驱动的血运重建的复合终点。在2010年1月至2013年4月期间，日本19家医院共招募了1734名患者。患者随访至少36个月。中位随访时间为3.86年。匹伐他汀加依折麦布组随访期间平均LDL - C为65.1mg/dL（1.68mmol/L），匹伐他汀单一疗法组为84.6mg/dL（2.19mmol/L）。与标准他汀单一疗法相比，他汀加依折麦布降低LDL - C并未减少主要终点事件的发生（283/864，32.8%对316/857，36.9%；风险比0.89，95%置信区间0.76 - 1.04，P = 0.152）。在ACS患者中，以治疗前谷甾醇升高为代表的胆固醇吸收较高的患者，在他汀加依折麦布组中主要终点事件发生率显著降低（风险比0.71，95%置信区间0.56 - 0.91）。
尽管在ACS合并血脂异常患者中，标准匹伐他汀加依折麦布强化降低血脂并未比标准匹伐他汀单一疗法显示出更多的心血管益处，但在胆固醇吸收较高的患者中，他汀加依折麦布可能比他汀单一疗法更有效；还需要进一步证实。
UMIN000002742，注册为一项国际标准随机对照试验。
To elucidate the effects of intensive LDL-C lowering treatment with a standard dose of statin and ezetimibe in patients with dyslipidaemia and high risk of coronary events, targeting LDL-C less than 70 mg/dL (1.8 mmol/L), compared with standard LDL-C lowering lipid monotherapy targeting less than 100 mg/dL (2.6 mmol/L). The HIJ-PROPER study is a prospective, randomized, open-label trial to assess whether intensive LDL-C lowering with standard-dose pitavastatin plus ezetimibe reduces cardiovascular events more than standard LDL-C lowering with pitavastatin monotherapy in patients with acute coronary syndrome (ACS) and dyslipidaemia. Patients were randomized to intensive lowering (target LDL-C < 70 mg/dL [1.8 mmol/L]; pitavastatin plus ezetimibe) or standard lowering (target LDL-C 90 mg/dL to 100 mg/dL [2.3–2.6 mmol/L]; pitavastatin monotherapy). The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, and ischaemia-driven revascularization. Between January 2010 and April 2013, 1734 patients were enroled at 19 hospitals in Japan. Patients were followed for at least 36 months. Median follow-up was 3.86 years. Mean follow-up LDL-C was 65.1 mg/dL (1.68 mmol/L) for pitavastatin plus ezetimibe and 84.6 mg/dL (2.19 mmol/L) for pitavastatin monotherapy. LDL-C lowering with statin plus ezetimibe did not reduce primary endpoint occurrence in comparison with standard statin monotherapy (283/864, 32.8% vs. 316/857, 36.9%; HR 0.89, 95% CI 0.76–1.04, P = 0.152). In, ACS patients with higher cholesterol absorption, represented by elevated pre-treatment sitosterol, was associated with significantly lower incidence of the primary endpoint in the statin plus ezetimibe group (HR 0.71, 95% CI 0.56–0.91). Although intensive lowering with standard pitavastatin plus ezetimibe showed no more cardiovascular benefit than standard pitavastatin monotherapy in ACS patients with dyslipidaemia, statin plus ezetimibe may be more effective than statin monotherapy in patients with higher cholesterol absorption; further confirmation is needed. UMIN000002742, registered as an International Standard Randomized Controlled Trial.
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