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曲坦类药物在有或有心血管疾病高危因素患者中的安全性:一项目标试验模拟。

Safety of Triptans in Patients Who Have or Are at High Risk for Cardiovascular Disease: A Target Trial Emulation.

机构信息

Mayo Clinic Evidence-based Practice Center, Rochester, MN, USA; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Rochester, MN, USA.

Mayo Clinic Evidence-based Practice Center, Rochester, MN, USA; Department of Neurology, Mayo Clinic, Scottsdale, Arizona.

出版信息

Mayo Clin Proc. 2024 Nov;99(11):1722-1731. doi: 10.1016/j.mayocp.2024.03.023. Epub 2024 Aug 30.

Abstract

OBJECTIVE

To evaluate the safety of triptans in migraine patients with cardiovascular disease or elevated cardiovascular risk.

PATIENTS AND METHODS

We retrieved data from a multistate US-based health system (January 2000 to August 2022) on adults with migraine and confirmed cardiovascular/cerebrovascular disease, or at least two cardiovascular risk factors. We compared the effect of triptans to nontriptan treatments on major adverse cardiovascular events (MACE) and its components at 60 days of starting treatments. We emulated a target trial and used propensity score matching for analysis.

RESULTS

The 3518 patients in the triptan group were matched to the 3518 patients in the nontriptan group (median age, 55 years; 80.60% female). At 60 days, 52 patients (1.48%) in the triptan group had MACE, compared with 13 patients (0.37%) in the nontriptan group (relative risk [RR], 4.00; 95% CI, 2.24 to 7.14). Patients treated with triptans also had significantly higher risk of nonfatal myocardial infarction (15 patients (0.43%) vs 0 patients (0.00%)); heart failure (RR, 4.50; 95% CI, 1.91 to 10.61); and nonfatal stroke (RR, 8.00; 95% CI, 1.00 to 63.96). Five patients (0.14%) in each group died. The findings were consistent when analyses were restricted to sumatriptan, oral administration of triptan, patients with chronic migraine, history of cardiovascular disease, or history of cerebrovascular disease.

CONCLUSION

Triptans likely increase the risk of MACE; however, the incidence of MACE remains low in migraine patients with cardiovascular disease or elevated cardiovascular risk.

TRIAL REGISTRATION

Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk and in Pregnant Women.

CLINICALTRIALS

gov Identifier: NCT05854992 (https://classic.

CLINICALTRIALS

gov/ct2/show/NCT05854992).

摘要

目的

评估曲坦类药物在伴有心血管疾病或心血管风险升高的偏头痛患者中的安全性。

患者和方法

我们从一个基于美国多州的健康系统中检索了数据(2000 年 1 月至 2022 年 8 月),其中包括患有偏头痛并确诊为心血管/脑血管疾病或至少有两种心血管危险因素的成年人。我们比较了曲坦类药物与非曲坦类药物治疗在治疗开始后 60 天的主要不良心血管事件(MACE)及其各组成部分的效果。我们模拟了一个目标试验,并使用倾向评分匹配进行了分析。

结果

曲坦组的 3518 名患者与非曲坦组的 3518 名患者相匹配(中位年龄为 55 岁;80.60%为女性)。在 60 天内,曲坦组有 52 名患者(1.48%)发生 MACE,而非曲坦组有 13 名患者(0.37%)(相对风险 [RR],4.00;95%CI,2.24 至 7.14)。接受曲坦类药物治疗的患者发生非致命性心肌梗死的风险也显著升高(15 名患者[0.43%]与 0 名患者[0.00%]);心力衰竭(RR,4.50;95%CI,1.91 至 10.61);非致命性卒中(RR,8.00;95%CI,1.00 至 63.96)。每组各有 5 名患者(0.14%)死亡。当分析仅限于舒马曲坦、曲坦类药物口服给药、慢性偏头痛患者、心血管疾病史或脑血管疾病史时,结果仍然一致。

结论

曲坦类药物可能会增加 MACE 的风险;然而,在伴有心血管疾病或心血管风险升高的偏头痛患者中,MACE 的发生率仍然较低。

试验注册

曲坦类药物治疗心血管风险升高的偏头痛患者和孕妇的偏头痛。

临床试验

gov 标识符:NCT05854992(https://classic.clinicaltrials.gov/ct2/show/NCT05854992)。

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