Cardiovascular outcomes 50 years after antenatal exposure to betamethasone: Follow-up of a randomised double-blind, placebo-controlled trial.

IF 15.8 1区 医学 Q1 Medicine PLoS Medicine Pub Date : 2024-04-01 DOI:10.1371/journal.pmed.1004378
Anthony G B Walters, Greg D Gamble, Caroline A Crowther, Stuart R Dalziel, Carl L Eagleton, Christopher J D McKinlay, Barry J Milne, Jane E Harding
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Abstract

Background: Antenatal corticosteroids for women at risk of preterm birth reduce neonatal morbidity and mortality, but there is limited evidence regarding their effects on long-term health. This study assessed cardiovascular outcomes at 50 years after antenatal exposure to corticosteroids.

Methods and findings: We assessed the adult offspring of women who participated in the first randomised, double-blind, placebo-controlled trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome (RDS) (1969 to 1974). The first 717 mothers received 2 intramuscular injections of 12 mg betamethasone or placebo 24 h apart and the subsequent 398 received 2 injections of 24 mg betamethasone or equivalent volume of placebo. Follow-up included a health questionnaire and consent to access administrative data sources. The co-primary outcomes were the prevalence of cardiovascular risk factors (any of hypertension, hyperlipidaemia, diabetes mellitus, gestational diabetes mellitus, or prediabetes) and age at first major adverse cardiovascular event (MACE) (cardiovascular death, myocardial infarction, coronary revascularisation, stroke, admission for peripheral vascular disease, and admission for heart failure). Analyses were adjusted for gestational age at entry, sex, and clustering. Of 1,218 infants born to 1,115 mothers, we followed up 424 (46% of survivors; 212 [50%] female) at mean (standard deviation) age 49.3 (1.0) years. There were no differences between those exposed to betamethasone or placebo for cardiovascular risk factors (159/229 [69.4%] versus 131/195 [67.2%]; adjusted relative risk 1.02, 95% confidence interval [CI] [0.89, 1.18;]; p = 0.735) or age at first MACE (adjusted hazard ratio 0.58, 95% CI [0.23, 1.49]; p = 0.261). There were also no differences in the components of these composite outcomes or in any of the other secondary outcomes. Key limitations were follow-up rate and lack of in-person assessments.

Conclusions: There is no evidence that antenatal corticosteroids increase the prevalence of cardiovascular risk factors or incidence of cardiovascular events up to 50 years of age. Established benefits of antenatal corticosteroids are not outweighed by an increase in adult cardiovascular disease.

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产前接触倍他米松 50 年后的心血管后果:随机双盲安慰剂对照试验的后续研究。
背景:对有早产风险的妇女使用产前皮质类固醇可降低新生儿发病率和死亡率,但有关其对长期健康影响的证据却很有限。本研究评估了产前接触皮质类固醇后50年的心血管结果:我们对参加了首例产前倍他米松预防新生儿呼吸窘迫综合征(RDS)随机、双盲、安慰剂对照试验(1969 年至 1974 年)的妇女的成年后代进行了评估。首批 717 名母亲接受了两次 12 毫克倍他米松或安慰剂的肌肉注射,每次间隔 24 小时,随后的 398 名母亲接受了两次 24 毫克倍他米松或等量安慰剂的注射。随访包括健康问卷调查和同意访问管理数据源。共同主要结果是心血管风险因素(任何高血压、高脂血症、糖尿病、妊娠糖尿病或糖尿病前期)的发病率和首次发生重大不良心血管事件(MACE)(心血管死亡、心肌梗死、冠状动脉血运重建、中风、因外周血管疾病入院和因心力衰竭入院)的年龄。分析根据入院时的胎龄、性别和聚类进行了调整。在 1,115 名母亲所生的 1,218 名婴儿中,我们对 424 名婴儿(占存活婴儿的 46%;212 [50%] 名女性)进行了随访,平均(标准差)年龄为 49.3 (1.0)岁。接受倍他米松或安慰剂治疗的患者在心血管风险因素(159/229 [69.4%] 对 131/195 [67.2%];调整后相对风险 1.02,95% 置信区间 [CI] [0.89, 1.18;];P = 0.735)或首次 MACE 的年龄(调整后危险比 0.58,95% CI [0.23, 1.49];P = 0.261)方面没有差异。这些综合结果的组成部分或任何其他次要结果也没有差异。主要的局限性在于随访率和缺乏亲自评估:没有证据表明产前皮质类固醇会增加心血管风险因素的发生率或50岁前心血管事件的发生率。产前皮质类固醇的既定益处不会因成人心血管疾病的增加而被抵消。
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来源期刊
PLoS Medicine
PLoS Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
17.60
自引率
0.60%
发文量
227
审稿时长
4-8 weeks
期刊介绍: PLOS Medicine is a prominent platform for discussing and researching global health challenges. The journal covers a wide range of topics, including biomedical, environmental, social, and political factors affecting health. It prioritizes articles that contribute to clinical practice, health policy, or a better understanding of pathophysiology, ultimately aiming to improve health outcomes across different settings. The journal is unwavering in its commitment to uphold the highest ethical standards in medical publishing. This includes actively managing and disclosing any conflicts of interest related to reporting, reviewing, and publishing. PLOS Medicine promotes transparency in the entire review and publication process. The journal also encourages data sharing and encourages the reuse of published work. Additionally, authors retain copyright for their work, and the publication is made accessible through Open Access with no restrictions on availability and dissemination. PLOS Medicine takes measures to avoid conflicts of interest associated with advertising drugs and medical devices or engaging in the exclusive sale of reprints.
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