Mining and analysis of adverse drug event signals related to macitentan
- VernacularTitle:马昔腾坦相关不良事件信号的挖掘与分析
- Author:
Zhenhu WU
1
;
Xinyao CHEN
2
;
Yaoxin CHEN
3
;
Yinji XU
1
Author Information
1. Dept. of Respiratory and Critical Care Medicine，Guangdong Provincial Hospital of Chinese Medicine，Guangzhou 510120，China
2. The Second Clinical Medical College，Guangzhou University of Chinese Medicine，Guangzhou 510405，China
3. School of Public Health，Sun Yat-sen University，Guangzhou 510080，China
- Publication Type:Journal Article
- Keywords:
macitentan;
pulmonary arterial hypertension
- From:
China Pharmacy
2024;35(13):1628-1633
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To mine adverse drug event （ADE） signals related to the pulmonary arterial hypertension （PAH） therapeutic drug macitentan， and to provide reference for safe clinical medication. METHODS Macitentan-related ADE reports were collected from the US FDA Adverse Event Reporting System （FAERS） database from the fourth quarter of 2013 to the third quarter of 2023. Data mining was conducted by using the reporting odds ratio （ROR） method and the comprehensive standard method established by the UK Medicines and Healthcare Products Regulatory Agency （referred to as “MHRA method”） under the proportional imbalance approach. According to the systemic organ class （SOC） and preferred term （PT） stated in 26.0 edition of Medical Dictionary of Regulatory Activities， standardized coding of ADE names was performed， followed by the analysis of time to onset （TTO） and the Weibull shape parameter （WSP） test. RESULTS Overall， a total of 26 079 ADE reports were identified with macitentan as the primary suspect drug. These reports predominantly involved female patients （73.25%） and were concentrated in the age range of 18 to 65 years （42.39%）. The majority of reports originated from the US （84.42%）， with hospitalization or prolonged hospital stays （59.82%） being the most common in severe treatment outcome. A total of 269 ADE positive signals related to macitentan were identified. Among these， hypothyroidism， ADE related to renal injury such as the increase of serum creatinine and blood urea nitrogen， and ADE related to psychiatric disorders like apathy and despair were not included in the drug label. TTO analysis indicated that the majority of macitentan-related ADE signals occurred between 0-30 days after initial treatment （492 reports， 21.52%） and over 360 days （411 reports， 17.98%）. The results of WSP test showed that most of the top 20 reported ADE signals conformed to the characteristics of an early failure curve. CONCLUSIONS When clinically using macitentan in patients with PAH， attention should be given not only to the adverse reactions mentioned on the drug label but also to thyroid dysfunction， kidney dysfunction and mental disorder-related ADEs.
