{"id":"b29f523091f0","type":"article","url":"https://hartvaat.nl/2026/10/02/ambrisentan-gebruik-geassocieerd-met-hartfalen-en-perifeer-oedeem-fda-farmacovig/","title":"Ambrisentan-gebruik geassocieerd met hartfalen en perifeer oedeem — FDA-farmacovigilantieanalyse","title_en":"Safety assessment of ambrisentan based on the FDA Adverse Event Reporting System.","category":"hypertensie","category_label":"Hypertensie","professions":["apotheker","cardioloog"],"tags":[],"journal":"Medicine","doi":"10.1097/MD.0000000000050893","source_url":"https://doi.org/10.1097/MD.0000000000050893","authors":["Yanggang Dan","Guodong Xu","Hang Chen","Hongxiang Li","Bingchuan Hu"],"significance":3,"published":"2026-10-11","source_date":"2026-10-02","image":"https://hartvaat.nl/global/img/6e2cc0469790.webp","kennis":["https://hartvaat.nl/kennis/hypertensie/therapietrouw-hypertensie/","https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"A retrospective disproportionality analysis of 30,060 FDA Adverse Event Reporting System reports identifies potential safety signals for ambrisentan, an endothelin receptor antagonist used in pulmonary arterial hypertension. Key signals included peripheral edema, dyspnea, cardiac failure, and palpitations, with a median time to onset of 240 days and nearly half of events occurring after one year of therapy. While hypothesis-generating, the findings underscore the need for ongoing pharmacovigilance and clinical monitoring in patients on long-term ambrisentan treatment.","created":"2026-10-04T01:20:31Z","updated":"2026-10-04T01:20:34Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Een retrospectieve analyse van 30.060 meldingen in het FDA Adverse Event Reporting System toont potentiële veiligheidssignalen voor ambrisentan, een endothelinreceptorantagonist bij pulmonale hypertensie. De meest voorkomende signalen betroffen perifeer oedeem, dyspnoe, hartfalen en palpitaties, met een mediane onset van 240 dagen en bijna de helft van de meldingen na meer dan een jaar gebruik. Hoewel de bevindingen vooral hypothese-genererend zijn, benadrukken ze het belang van continue farmacovigilantie en klinische monitoring bij langdurig gebruik van dit middel.","abstract_original":"Ambrisentan is an endothelin receptor antagonist broadly used for the treatment of pulmonary arterial hypertension. However, multiple adverse events (AEs) were reported with its use, and we intended to evaluate potential ambrisentan-associated AE signals through the US Food and Drug Administration Adverse Event Reporting System. Reports from March 2019 to December 2022 were selected for disproportionality analysis. Four signal detection methods were applied, namely the reporting odds ratio, the proportional reporting ratio, the information component, and the empirical Bayes geometric mean, to assess ambrisentan-associated AE signals. Ambrisentan was identified as a suspected drug in 30,060 reports. AEs associated with ambrisentan covered 8 system organ classes and showed potential signals at the preferred-term level, such as peripheral edema and dyspnea, as well as cardiac AE signals including palpitations and cardiac failure. The median time to onset of ambrisentan-associated AEs was 240 days, and approximately half (49.66%) of the AEs with documented time to onset occurred after 1 year of use. Our research identifies potential safety signals of cardiac AEs associated with ambrisentan use. These signals are hypothesis-generating and warrant confirmation in prospective studies, as well as continued pharmacovigilance monitoring."}