Burger Charles D, Tang Wenze, Tsang Yuen, Panjabi Sumeet
Mayo Clinic Jacksonville Florida USA.
Janssen Scientific Affairs, LLC Titusville New Jersey USA.
Pulm Circ. 2024 Aug 18;14(3):e12415. doi: 10.1002/pul2.12415. eCollection 2024 Jul.
Selexipag is an oral selective agonist of the prostacyclin receptor approved to treat adults with pulmonary arterial hypertension (PAH). Selexipag is initiated at a dose of 200 μg twice daily (bid) and usually titrated up by 200 μg bid weekly (per label) or more slowly (e.g., every other week in real-world clinical practice) to the highest tolerated individualized dose (ID) ranging from 200 to 1600 µg bid. In the Phase 3 GRIPHON trial, selexipag delayed disease progression and reduced risk of PAH-related hospitalization compared with placebo; the effect was consistent across three prespecified ID groups: low (200-400 µg bid), medium (600-1000 µg bid), and high (1200-1600 µg bid). This study evaluated patient outcomes across selexipag dose ranges in real-world practice. Data were analyzed from 1186 US adult patients with PAH on selexipag from the Komodo closed-claims database (2015‒2022). Of these, 634 (53.5%) patients completed titration and reached their selexipag ID (43.8% high ID, 29.8% medium ID, 26.3% low ID). Subsequently, 72.4% of patients in the low ID group had dose adjustments compared with 61.9% (medium ID) and 34.5% (high ID; standardized mean difference 0.63). There were no significant differences in patient outcomes, i,e, persistence (time to discontinuation) and risk of all-cause and PAH-related hospitalization across ID groups. The findings in this diverse, real-world population of patients with PAH reinforced an individualized approach to the dosing scheme to maximize benefit-risk and achieve the highest tolerated dose with selexipag similar to findings from the GRIPHON trial and other studies.
司来帕格是一种口服的前列环素受体选择性激动剂,已被批准用于治疗成人肺动脉高压(PAH)。司来帕格起始剂量为每日两次(bid),每次200μg,通常每周bid增加200μg(根据药品标签),或更缓慢地增加(例如,在实际临床实践中每隔一周增加一次)至最高耐受个体化剂量(ID),范围为bid 200至1600μg。在3期GRIPHON试验中,与安慰剂相比司来帕格延缓了疾病进展并降低了PAH相关住院风险;该效应在三个预先设定的ID组中是一致的:低剂量组(bid 200 - 400μg)、中剂量组(bid 600 - 1000μg)和高剂量组(bid 1200 - 1600μg)。本研究评估了司来帕格在实际临床实践中不同剂量范围内的患者结局。对来自科莫多封闭索赔数据库(2015 - 2022年)中1186名接受司来帕格治疗的美国成年PAH患者的数据进行了分析。其中,634名(53.5%)患者完成了剂量滴定并达到了司来帕格个体化剂量(43.8%为高剂量组ID,29.8%为中剂量组ID,26.3%为低剂量组ID)。随后,低剂量组72.4%的患者进行了剂量调整,相比之下,中剂量组为61.9%,高剂量组为34.5%(标准化均值差为0.63)。各ID组在患者结局方面,即持续用药时间(停药时间)以及全因住院和PAH相关住院风险方面,均无显著差异。在这一多样化的PAH患者真实世界人群中的研究结果强化了个体化给药方案的方法,以实现效益风险最大化,并达到司来帕格的最高耐受剂量,这与GRIPHON试验和其他研究的结果相似。