| Background:Pulmonary arterial hypertension(PAH)is a chronic progressive pulmonary vascular disease characterized by pulmonary vascular resistance and elevated pulmonary pressure.If PAH is not treated in time,it will eventually lead to right heart failure or even death.Endothelin receptor antagonists(ERAs)are one of the most important PAH targeted drugs,and they are also the most widely used PAH therapeutic medications in China.Ambrisentan is the only selective ERAs that can significantly improve the symptoms and signs of patients with PAH,but the long-term prognosis of patients with PAH is not clear.Macitentan is the latest approved ERAs.In the early stage of research and development,it shows better tissue permeability and receptor affinity than other similar drugs.It is also the first ERAs with evidence-based medicine evidence that can effectively improve the morbidity and mortality of PAH patients.In a long-term follow-up event-driven clinical trial,compared with placebo,macitentan can improve the symptoms of PAH patients,prolong the clinical deterioration time,and reduce the hospitalization rate related to PAH.Therefore,PAH patients and clinicians may consider changing the current use of ambrisentan to macitentan in order to prevent the aggravation,deterioration,or better therapeutic effect.Objective:To assess the safety,efficacy,and treatment satisfaction of PAH patients in the real world during the transition from ambrisentan to macitentan.Methods:This was a real-world,prospective study with a 12-month follow-up.The study included a screening period,followed by a transition phase,after which patients entered the long-term follow-up.PAH patients who had received at least 6 months of treatment and a stable dose of ambrisentan for over 3 months,were within the World Health Organization Functional Class II/III and 6-minute walk distance ≥ of 250 meters were enrolled.The patients in the study group were closely followed up and monitored at the 1st,3rd,6th,and 12 th months after taking macitentan.The clinical and laboratory data of patients before and after drug conversion were collected,and the cardiac function,risk stratification,and six-minute walking distance were evaluated.A questionnaire survey was conducted on the treatment satisfaction of patients.Results:1.A total of 157 patients with PAH were enrolled,all of whom were safely and smoothly converted from ambrisentan to macitentan,with 145patients(92.4%)meeting all criteria for sustained treatment conversion.The results of the study showed an increase in the proportion of patients with WHO cardiac function class I/II(58.6% vs 71.1%,P = 0.008);an increase in six-minute walking distance(424.74 ± 82.34 m vs 440.59 ±77.57 m,P = 0.004);and a decrease in N-terminal B brain natriuretic peptide at 1 year after the switch compared with baseline(443.00(140.90,1143.5)pg/ml vs 234.80(108.95,939.50 pg/ml),P < 0.001)and a significant decrease in pulmonary artery systolic pressure(86.10 ± 26.56 mm Hg vs 77.14 ± 22.69 mm Hg,P < 0.001)as assessed by echocardiography.2.There was no statistically significant difference in the overall incidence of adverse events before and after the patients took macitentan(46.3% vs 44.1%,P = 0.431),but the incidence of anemia(6.9% vs15.2%,P = 0.024)and menstrual irregularities in women of childbearing age(1.3% vs 11.4%,P < 0.001)was significantly higher before and after the drug switch compared with that on ambrisentan.During the study period,four patients discontinued taking macitentan due to adverse events and one patient died for other reasons.Quality of life scores showed that patients had a reduced financial burden of care and an increased overall satisfaction with the use of macitentan compared with(74.12 ± 5.65 vs79.46 ± 13.05,P = 0.003)the use of ambrisentan.Conclusion:Transition to macitentan from ambrisentan was successful and well-tolerated by PAH patients and was associated with greater efficacy and satisfaction.In addition,the economic burden of patients has been reduced. |
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