Baker Stacey E, Hockman Rebecca Haynes
Department of Pharmacy Services, University of Virginia Health System, Charlottesville, VA 22908-0674, USA.
Ann Pharmacother. 2005 Jul-Aug;39(7-8):1265-74. doi: 10.1345/aph.1E575.
To review the pharmacology, pharmacodynamics, and clinical trials evaluating inhaled iloprost in pulmonary arterial hypertension (PAH).
A MEDLINE search (1996-February 2005) was performed using the key words pulmonary hypertension, iloprost, and epoprostenol. Information regarding Food and Drug Administration approval was obtained via the Internet.
All clinical trials using inhaled iloprost in PAH published in English were identified. Additionally, references from the identified articles were reviewed.
A stable analog of prostacyclin, inhaled iloprost is thought to promote benefit in PAH through vasodilation, antiproliferative effects, and inhibition of platelet aggregation. In a placebo-controlled trial of 203 patients, inhaled iloprost significantly improved the combined endpoint of change in New York Heart Association functional class and 10% improvement in 6-minute walk distance (p = 0.007). Small, short-term clinical trials demonstrated hemodynamic benefits for inhaled iloprost alone and in combination with other pulmonary vasodilating agents. The aerosolized delivery route and low incidence of adverse events are positive attributes for inhaled iloprost, while the frequency of administration and lack of comparative data limit its role in PAH.
Currently, inhaled iloprost offers potential benefit for patients with contraindications to bosentan, preference for non-parenteral products, ineligibility for parenteral therapy, or as adjunctive therapy with other pulmonary vasodilators. Larger, long-term clinical trials are needed to solidify the role for inhaled iloprost in the management of PAH.
综述评估吸入用伊洛前列素治疗肺动脉高压(PAH)的药理学、药效学及临床试验。
使用关键词“肺动脉高压”“伊洛前列素”和“依前列醇”对MEDLINE(1996年至2005年2月)进行检索。通过互联网获取有关美国食品药品监督管理局批准的信息。
识别所有以英文发表的使用吸入用伊洛前列素治疗PAH的临床试验。此外,对已识别文章的参考文献进行了回顾。
吸入用伊洛前列素是前列环素的稳定类似物,被认为可通过血管舒张、抗增殖作用及抑制血小板聚集对PAH产生有益作用。在一项针对203例患者的安慰剂对照试验中,吸入用伊洛前列素显著改善了纽约心脏协会功能分级变化及6分钟步行距离改善10%的联合终点(p = 0.007)。小型短期临床试验表明,吸入用伊洛前列素单独使用以及与其他肺血管扩张剂联合使用均有血流动力学益处。雾化给药途径及不良事件发生率低是吸入用伊洛前列素的积极特性,而给药频率及缺乏比较数据限制了其在PAH治疗中的作用。
目前,吸入用伊洛前列素对于有波生坦禁忌证、偏爱非肠道外用药产品、不适合接受肠道外治疗或作为其他肺血管扩张剂辅助治疗的患者具有潜在益处。需要开展更大规模的长期临床试验,以明确吸入用伊洛前列素在PAH治疗中的作用。