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开具口服司来帕格的合并和未合并结缔组织病的肺动脉高压患者的住院情况

Hospitalization Among Pulmonary Arterial Hypertension Patients With and Without Connective Tissue Disease Comorbidities Prescribed Oral Selexipag.

作者信息

Tsang Yuen, Singh Risho, Verma Sumit, Panjabi Sumeet

机构信息

Janssen Scientific Affairs, Titusville, NJ, USA.

STATinMED, LLC, 13101 Preston Rd Suite 110, #3395, Dallas, TX, 75240, USA.

出版信息

Rheumatol Ther. 2023 Jun;10(3):741-756. doi: 10.1007/s40744-023-00547-z. Epub 2023 Mar 23.

Abstract

INTRODUCTION

Patients with connective tissue disorders (CTD) and pulmonary arterial hypertension (PAH) have a poorer prognosis than those with other PAH etiologies. This study assessed the impact of CTD on healthcare outcomes among PAH patients with and without CTD comorbidities that were treated with oral selexipag.

METHODS

The study utilized Optum's de-identified Clinformatics Data Mart Database (2007-2021) from January 1, 2014 to June 30, 2019, and identified patients with PAH without CTD and PAH with CTD treated with oral selexipag. Patients had ≥ 12-month baseline period with no requirement for a minimum follow-up period. Patients were followed until any of the following events: discontinuation of oral selexipag, or health plan disenrollment, or death, or presence of a diagnosis claim for CTEPH, or study end date, whichever occurred first. PAH-related hospitalizations, PAH disease progression, and healthcare utilizations and costs were assessed in the follow-up period. The Cox proportional hazards model was used to evaluate the time to hospitalization and generalized linear models were used to examine healthcare costs and utilization between the two cohorts.

RESULTS

In the analysis, 237 PAH without CTD, and 80 PAH patients with CTD comorbidities prescribed oral selexipag were included. The PAH without CTD comorbidities cohort was older (65 vs. 63 years old), had proportionately less females (72 vs. 83%), and higher comorbidity burden than PAH with CTD comorbidities (mean CCI index 3 vs. 2). After adjusting for potential confounders, the risk for PAH-related hospitalization (hazard ratio (HR) 1.13, p value 0.641), all-cause hospitalization (HR 1.09, p value: 0.765), and PAH disease progression (HR 1.14, p value 0.522) between the two cohorts were similar. After adjusting for baseline demographic and clinical characteristics, PAH with CTD comorbidities incurred higher total mean all-cause PAH-related medical care costs compared to PAH without CTD comorbidities.

CONCLUSIONS

In this real-world study, the risk of hospitalization and PAH disease progression were similar between the two cohorts who received oral selexipag. The results from this study corroborate findings of the GRIPHON post hoc analysis of PAH-associated CTD patients and support oral selexipag use in PAH-CTD patients.

摘要

引言

结缔组织病(CTD)合并肺动脉高压(PAH)的患者预后比其他PAH病因的患者更差。本研究评估了CTD对接受口服司来帕格治疗的PAH患者(无论有无CTD合并症)医疗结局的影响。

方法

本研究使用了Optum公司去识别化的临床信息数据集市数据库(2007 - 2021年),时间范围为2014年1月1日至2019年6月30日,识别出接受口服司来帕格治疗的无CTD的PAH患者和合并CTD的PAH患者。患者有≥12个月的基线期,对随访期无最短要求。对患者进行随访,直至发生以下任何事件:口服司来帕格停药、医保计划退出、死亡、慢性血栓栓塞性肺动脉高压(CTEPH)诊断索赔或研究结束日期,以先发生者为准。在随访期评估PAH相关住院、PAH疾病进展以及医疗利用和费用。采用Cox比例风险模型评估住院时间,采用广义线性模型检查两组之间的医疗费用和利用情况。

结果

分析纳入了237例无CTD的PAH患者和80例合并CTD且开具口服司来帕格处方的PAH患者。无CTD合并症的PAH患者队列年龄更大(65岁对63岁),女性比例相对较低(72%对83%),且合并症负担高于合并CTD的PAH患者(平均CCI指数3对2)。在调整潜在混杂因素后,两组之间PAH相关住院风险(风险比(HR)1.13,p值0.641)、全因住院风险(HR 1.09,p值:0.765)和PAH疾病进展风险(HR 1.14,p值0.522)相似。在调整基线人口统计学和临床特征后,合并CTD的PAH患者的全因PAH相关医疗总平均费用高于无CTD合并症的PAH患者。

结论

在这项真实世界研究中,接受口服司来帕格治疗的两组患者的住院风险和PAH疾病进展相似。本研究结果证实了GRIPHON对PAH相关CTD患者的事后分析结果,并支持在PAH - CTD患者中使用口服司来帕格。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38be/10140235/607c1d226362/40744_2023_547_Fig1_HTML.jpg

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