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发作性睡病患者起始使用羟丁酸钠后新发高血压风险增加:一项真实世界研究。

Increased Risk of New-Onset Hypertension in Patients With Narcolepsy Initiating Sodium Oxybate: A Real-World Study.

机构信息

Jazz Pharmaceuticals, Inc, Palo Alto, CA.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.

出版信息

Mayo Clin Proc. 2024 Nov;99(11):1710-1721. doi: 10.1016/j.mayocp.2024.05.029. Epub 2024 Aug 23.

DOI:10.1016/j.mayocp.2024.05.029
PMID:39177543
Abstract

OBJECTIVE

To compare intermediate-term risk of new-onset hypertension between normotensive patients with narcolepsy initiating sodium oxybate (SXB cohort) and those not initiating sodium oxybate (control cohort).

PATIENTS AND METHODS

This retrospective cohort study used MarketScan administrative claims data from January 1, 2014, to February 29, 2020. Eligible patients were 18 years of age or older with continuous enrollment (≥180 days before and after cohort entry), had one or more narcolepsy claims or a prescription fill for sodium oxybate, had no history of hypertension or antihypertensive medication use, and had no use of sodium oxybate within 13 months before cohort entry. Patients in the SXB and control cohorts were matched 1:2 for the propensity score to balance baseline characteristics. End points were (1) a composite of new-onset hypertension diagnosis or antihypertensive medication initiation and (2) new-onset hypertension diagnosis. Patients were monitored for 180 days, until outcome occurrence, sodium oxybate discontinuation (SXB cohort), or sodium oxybate initiation (control cohort). Risk per 100 patients was reported; differences were evaluated using logistic regression to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs).

RESULTS

The SXB and control cohorts included 954 and 1908 patients, respectively. Risk of new-onset hypertension diagnosis or antihypertensive medication initiation was higher in the SXB cohort than in the control cohort (6.60 vs 4.20 per 100 patients; OR, 1.61; 95% CI, 1.15 to 2.27). Risk of a new-onset hypertension diagnosis only in the SXB cohort was 0.94 per 100 patients and 0.52 per 100 patients in the control cohort (OR, 1.81; 95% CI, 0.73 to 4.46).

CONCLUSION

In this study, sodium oxybate use was associated with a new-onset hypertension diagnosis or antihypertensive medication initiation in normotensive patients with narcolepsy.

摘要

目的

比较发作性睡病患者中开始使用羟丁酸钠(SXB 队列)和未开始使用羟丁酸钠(对照组)的血压正常患者的新发高血压的中期风险。

方法

本回顾性队列研究使用了 2014 年 1 月 1 日至 2020 年 2 月 29 日的 MarketScan 行政索赔数据。合格的患者年龄在 18 岁或以上,有连续参保(队列入组前和入组后≥180 天),有一个或多个发作性睡病的索赔或羟丁酸钠的处方记录,无高血压或抗高血压药物使用史,并且在队列入组前 13 个月内未使用过羟丁酸钠。SXB 和对照组患者根据倾向评分进行 1:2 匹配,以平衡基线特征。终点为(1)新发高血压诊断或抗高血压药物治疗开始的复合终点和(2)新发高血压诊断。患者接受了 180 天的监测,直到出现结局、羟丁酸钠停药(SXB 队列)或羟丁酸钠开始使用(对照组)。每 100 例患者的风险以比例表示;使用逻辑回归评估差异,以估计调整后的比值比(OR)和 95%置信区间(CI)。

结果

SXB 和对照组分别纳入了 954 例和 1908 例患者。SXB 队列的新发高血压诊断或抗高血压药物治疗开始的风险高于对照组(6.60 例比 4.20 例/100 例患者;OR,1.61;95%CI,1.15 至 2.27)。仅在 SXB 队列中,新发高血压诊断的风险为每 100 例患者 0.94 例,对照组为每 100 例患者 0.52 例(OR,1.81;95%CI,0.73 至 4.46)。

结论

在这项研究中,发作性睡病患者使用羟丁酸钠与血压正常患者新发高血压诊断或抗高血压药物治疗开始相关。

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