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Background: Pulmonary arterial hypertension is a progressive disease of the lung vascular system which causes patients' functional limitations and reduces their Health-Related Quality of Life (HRQoL). This study was aimed at determining the effectiveness of Macitentan on the HRQoL of Iranian PAH patients by the emphasis 10 questionnaire. Methods: 31 idiopathic class I pulmonary hypertension patients were enrolled in this cohort study. Patients completed the emphasis 10 questionnaire at baseline and 6 months after Macitentan consumption. The absolute changes in emphasis 10 scores were calculated. The effect of Macitentan on functional activity and paraclinical indexes was assessed. Results: The mean quality of life scores before and after the Macitentan, were 25.83 (±11.80 SD) and 16.93 (±10.36 SD), respectively (p-value=0.001). Besides, administration of Macitentan increased the mean distance in the 6-minute walk test, from 227.00±(87.275 SD) to 263.67 (±115.855 SD) (p-value=0.044), led to a reduction in the mean hospitalization days from 2.23 (±4.049 SD) to 0.33 (±1.322 SD), (p-value=0.015) and reduction in times of hospitalization from 0.57(0.93) to 0.10(0.30), (p-value=0.017). Although it had a positive effect on mean PAP (81 to 68), O2 saturation at the beginning of 6MW (90 to 91%), final O2 Saturation in 6MW (81 to 85%), and pro-BNP (907 to 412), this effect was not statistically significant. Conclusion: Treatment with Macitentan significantly improved patient functional activity and reduced the mean hospitalization days. Thus, due to the low side effects and high efficacy, it can be advised as the first line of treatment. [ABSTRACT FROM AUTHOR]

Objectives: Pulmonary arterial hypertension (PAH) is a chronic and progressive disease that, if left untreated, shortens the life expectancy of patients. Endothelin receptor antagonists, such as macitentan and bosentan, play an essential role in improving the patient's symptoms, quality of life, and life expectancy. This study aimed to evaluate the cost-utility of macitentan compared with bosentan in treating PAH from the health system perspective in Iran., Methods: For evaluating the cost-effectiveness of macitentan, a Markov model consisting of 5 states, functional class (FC) I, FC II, FC III, FC IV, and death, was designed using the TreeAge software. The lifetime time horizon and a 3-month cycle length were set. Patients entered the model from FC II or FC III states based on the initial probabilities. Costs were measured in US dollars (USD), and outcomes were measured in terms of quality quality-adjusted life-years (QALYs). Consequently, the incremental cost-effectiveness ratio (ICER) was calculated. In addition, sensitivity analysis was performed to determine the robustness of the model by examining the possible effects of uncertainties on the final result., Results: The costs of treatment with macitentan and bosentan in PAH in Iran were calculated at 19 429 and 17 246 USD, and the outcomes were 4.02 and 3.04 QALYs, respectively. Therefore, ICER was calculated at 2233.46 USD/QALY. One-way sensitivity analysis demonstrates that the model is robust; nevertheless, it is most sensitive to the price of macitentan and bosentan., Conclusion: Treatment with macitentan was associated with both higher costs and QALYs than bosentan. Nevertheless, it is considered the cost-effective treatment strategy in Iran given that the calculated ICER falls below the willingness to pay threshold., (Copyright © 2022 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)