Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES

IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Gregory P. Geba , Ruifeng Chen , Kasturi Talapatra , Taylor Brackin , Kusha A. Mohammadi , Robert Pordy , Garen Manvelian , David J. Maron , Gregory G. Schwartz , Michael Szarek , Ph. Gabriel Steg , Sergio Fazio
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引用次数: 0

Abstract

Background

Patients with recent acute coronary syndrome (ACS) commonly experience chest pain, which affects quality of life even when not due to recurrence of ACS. This post hoc analysis of ODYSSEY OUTCOMES assessed the effect of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, on the incidence of chest pain not due to recurrent ACS.

Methods

Patients with recent ACS (n = 18,894) and elevated atherogenic lipoprotein levels despite optimized statin therapy were randomized to subcutaneous alirocumab or matching placebo every 2 weeks. Alirocumab dose was adjusted to target low-density lipoprotein cholesterol (LDL-C) 25–50 mg/dL (0.6–1.3 mmol/L) and to avoid consecutive LDL-C <15 mg/dL (0.39 mmol/L). Non-hospitalized chest pain adverse events and chest pain events requiring hospitalization but negatively adjudicated for recurrent ACS were assessed.

Results

Chest pain not requiring hospitalization was reported as an adverse event in 1490 patients, including 7.5 % and 8.3 % of alirocumab and placebo groups, respectively. Hospitalization for chest pain negatively adjudicated for recurrent ACS occurred in 952 patients, including 4.8 % and 5.3 % of alirocumab and placebo groups, respectively. Adjusting for baseline covariates, alirocumab use was associated with 8.1 % lower risk of chest pain (either non-hospitalized or hospitalized events) versus placebo (HR: 0.919; 95 % CI: 0.845–0.998; P = 0.046); a landmark analysis at 7 months showed a larger, 11.7 % risk reduction (HR: 0.883; 95 % CI: 0.793–0.984; P = 0.024).

Conclusions

Alirocumab use is associated with reduced incidence of chest pain events after ACS, including those not requiring hospitalization and those requiring hospitalization but not adjudicated as recurrent ACS.

Trial registration

NCT01663402
急性冠脉综合征后Alirocumab和胸痛:ODYSSEY结局分析
近期急性冠脉综合征(ACS)患者通常会经历胸痛,即使不是由于ACS复发,也会影响生活质量。这项对ODYSSEY OUTCOMES的事后分析评估了alirocumab(一种蛋白转化酶subtilisin/ keexin 9型抑制剂)对非复发性ACS引起的胸痛发生率的影响。方法采用优化的他汀类药物治疗,但近期ACS患者(n = 18894)动脉粥样硬化性脂蛋白水平升高,每2周随机分配到皮下alirocumab或匹配的安慰剂组。Alirocumab剂量调整为靶向低密度脂蛋白胆固醇(LDL-C) 25-50 mg/dL (0.6-1.3 mmol/L),避免连续LDL-C≤15 mg/dL (0.39 mmol/L)。评估非住院胸痛不良事件和需要住院但阴性判定为复发性ACS的胸痛事件。结果1490例患者报告了不需要住院治疗的测试疼痛作为不良事件,分别包括7.5 %和8.3 %的阿利单抗组和安慰剂组。952例患者因复发性ACS胸痛住院,分别包括阿利单抗组的4.8% %和安慰剂组的5.3% %。调整基线协变量,与安慰剂相比,alirocumab的使用与胸痛(非住院或住院事件)风险降低8.1 %相关(HR: 0.919;95 % ci: 0.845-0.998;P = 0.046);7个月的里程碑式分析显示,风险降低了11.7% % (HR: 0.883;95 % ci: 0.793-0.984;P = 0.024)。salirocumab的使用与ACS后胸痛事件的发生率降低相关,包括那些不需要住院治疗的患者和那些需要住院但未被判定为复发性ACS的患者。审判registrationNCT01663402
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来源期刊
American journal of preventive cardiology
American journal of preventive cardiology Cardiology and Cardiovascular Medicine
CiteScore
6.60
自引率
0.00%
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0
审稿时长
76 days
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