Studer Sean, Hull Michael, Pruett Janis, Elliott Caitlin, Tsang Yuen, Drake William
NYC Health + Hospitals/Kings County, New York, NY, USA.
Optum, Eden Prairie, MN, USA.
Pulm Ther. 2020 Jun;6(1):79-92. doi: 10.1007/s41030-019-00106-4. Epub 2019 Dec 19.
Release of the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines put increased emphasis on using combination therapy, either as upfront or sequential therapy among patients with pulmonary arterial hypertension (PAH). However, with these recommendations and the therapy advances made in the last several years, little is known on the real-world treatment patterns among patients with PAH, particularly before and after publication of the 2015 ESC/ERS guidelines.
This was a retrospective study of adult commercial and Medicare Advantage with Part D (MAPD) enrollees with at least one claim for a PAH-related medication from January 01, 2012 to March 31, 2017, at least one medical claim with a pulmonary hypertension diagnosis, and continuous health plan enrollment at least 6 months prior to and at least 12 months following the date of the first pharmacy claim for PAH-related therapy (index date). Patients were divided into cohorts based on prescription of monotherapy or combination therapy and index date category (2012-2013, January 2014-July 2015, and August 2015-March 2017).
Out of 1878 patients, 90.8% initiated with monotherapy and 9.2% initiated with combination therapy. The percentage of patients with index combination therapy increased from 5.7% in 2012-2013 to 13.0% in August 2015-March 2017. Patients with index combination therapy had better persistence (11.6 months versus 10.3 months) and adherence (0.95 versus 0.85). Overall, the discontinuation rate was 40% and was higher in monotherapy versus combination therapy patients (42.8% versus 12.2%). Approximately 30.2% of patients had a second regimen, of which 50% were combination regimens. The time to combination therapy initiation decreased from 10.5 months in 2012-2013 to 3.4 months in August 2015-March 2017.
The majority of patients initiated monotherapy treatment for PAH, most often a phosphodiesterase 5 inhibitor (PDE5i). Patients with upfront combination therapy increased following publication of the 2015 ESC/ERS guidelines, indicating that physicians responded to the guideline's option of prescribing upfront combination therapy.
2015年欧洲心脏病学会（ESC）/欧洲呼吸学会（ERS）指南发布后，更加重视在肺动脉高压（PAH）患者中使用联合治疗，无论是作为初始治疗还是序贯治疗。然而，随着这些建议以及过去几年治疗方法的进展，对于PAH患者的实际治疗模式知之甚少，尤其是在2015年ESC/ERS指南发布之前和之后。
这是一项回顾性研究，研究对象为2012年1月1日至2017年3月31日期间至少有一次PAH相关药物索赔、至少有一次肺动脉高压诊断医疗索赔且在首次PAH相关治疗药房索赔日期（索引日期）前至少6个月和后至少12个月持续参加健康计划的成年商业保险和医疗保险优势计划（MAPD）参保者。根据单一疗法或联合疗法的处方以及索引日期类别（2012 - 2013年、2014年1月 - 2015年7月、2015年8月 - 2017年3月）将患者分为不同队列。
在1878例患者中，90.8%开始采用单一疗法，9.2%开始采用联合疗法。索引联合疗法患者的比例从2012 - 2013年的5.7%增加到2015年8月 - 2017年3月的13.0%。索引联合疗法患者的持续时间更长（11.6个月对10.3个月）且依从性更好（0.95对0.85）。总体而言，停药率为40%，单一疗法患者的停药率高于联合疗法患者（42.8%对12.2%）。约30.2%的患者采用了第二种治疗方案，其中50%为联合治疗方案。开始联合治疗的时间从2012 - 2013年的10.5个月降至2015年8月 - 2017年3月的3.4个月。
大多数PAH患者开始采用单一疗法治疗，最常用的是磷酸二酯酶5抑制剂（PDE5i）。2015年ESC/ERS指南发布后，初始联合治疗的患者有所增加，这表明医生对指南中初始联合治疗的建议做出了回应。
