Macitentan 2.5mg dispersible tablets sugar free

Background: This systematic review and meta-analysis aimed to determine the efficacy of macitentan in patients with pulmonary hypertension (PH). Methods: A systematic search was made of PubMed, Embase, Cochrane Library, and clinicaltrials.gov, without language restrictions. Randomized controlled trials (RCTs) on treatment of PH with macitentan, compared with placebo or blank, were reviewed. Studies were pooled to weighted mean differences (WMDs) and risk ratios (RRs), with 95% confidence intervals (CIs). Results: Six RCTs (enrolling 1,003 participants) met the inclusion criteria. Macitentan showed significant effects on 6-min walk distance (6MWD) (WMD 12.06 m, 95% CI 2.12 to 21.99 m), pulmonary vascular resistance (PVR) (WMD –186.51 dyn·s/cm–5, 95% CI –232.72 to –140.29 dyn·s/cm–5), mean pulmonary artery pressure (mPAP) (WMD –3.20 mmHg, 95% CI –5.93 to –0.47 mmHg), N-terminal pro-brain natriuretic peptide (NT-proBNP) (WMD –232.47 ng/L, 95% wCI –318.22 to –146.72 ng/L), and cardiac index (WMD 0.39 L/min/m2, 95% CI 0.20 to 0.58 L/min/m2). Conclusion: Macitentan significantly improved 6MWD, PVR, mPAP, NT-proBNP, and cardiac index in patients with PH. Macitentan should be further validated in patients with PH.

Abstract licence: CC BY 4.0

Abstract Introduction Endothelin receptor antagonists (ERAs), including ambrisentan, bosentan, and macitentan, are central to the treatment of pulmonary arterial hypertension (PAH). As patient survival improves, long-term management increasingly requires systematic evaluation of these agents to balance their efficacy, safety, cost, and accessibility. However, standardized frameworks that integrate the multiple dimensions of clinical value remain limited. Aim This study aimed to establish and apply a six-dimensional Multi-Criteria Decision Analysis (MCDA) framework to comprehensively assess the clinical value of ambrisentan, bosentan, and macitentan in the treatment of PAH. Method A structured evaluation system was developed using Delphi expert consultation and evidence synthesis from systematic reviews, meta-analyses of randomized controlled trials (RCTs), pharmacoeconomic assessments, and regulatory documents. Six core dimensions were included: safety, efficacy, economic value, suitability, accessibility, and innovation. Quantitative and qualitative indicators were normalized and weighted using the Analytic Hierarchy Process and integrated using the MCDA model. Sensitivity analyses were performed to verify the robustness of rankings. Results The final framework comprised six primary dimensions, 13 secondary indicators, and 32 tertiary indicators. Twelve RCTs met the inclusion criteria for quantitative analysis. All three ERAs improved exercise capacity and hemodynamic parameters, whereas ambrisentan exhibited superior tolerability. Economic evaluation showed that ambrisentan and bosentan offered better cost-effectiveness, with incremental cost-effectiveness ratios of ࿥140.12 per meter and ࿥142.38 per meter, respectively, compared with ࿥1,470.71 per meter for macitentan. Suitability analysis favored ambrisentan and macitentan because of their once-daily dosing and favorable adherence profiles. Bosentan demonstrated advantages in affordability owing to its lower cost and National Reimbursement Drug List coverage. Innovation assessment ranked macitentans as the highest for technological advancement. Integrated MCDA scoring indicated that ambrisentan achieved the greatest overall clinical value. Conclusion This study developed a multidimensional, evidence-based evaluation model for PAH therapy using MCDA. Ambrisentan achieved the highest comprehensive score across the six key dimensions, reflecting its balanced efficacy, safety, and economic performance. The proposed framework provides a practical tool for clinicians, pharmacists, and policymakers to support rational drug use, formulary management, and value-based decision making in PAH and other rare diseases.

Abstract licence: CC BY

Abstract Background Inoperable or residual chronic thromboembolic pulmonary hypertension treatment modalities remain challenging due to limited comparison of alternatives between BPA and pharmacological agents. Objective To compare the relative efficacy and safety of BPA and pharmacological treatments in patients with inoperable or residual CTEPH. By integrating both direct and indirect comparisons, the study aims to provide a hierarchised, evidence-based framework to inform personalised treatment selection and guideline development for this high-risk population. Methods A systematic search of major databases through November 2024 identified randomized trials evaluating BPA, Riociguat, endothelin receptor antagonists (Bosentan, Ambrisentan, Macitentan), PDE-5 inhibitors (Sildenafil), and prostacyclin analogs (Selexipag). Outcomes included pulmonary vascular resistance (PVR), mean pulmonary artery pressure (mPAP), cardiac index (CI), 6-minute walk distance (6MWD), NT-proBNP, and Borg Dyspnea Index (BDI). A frequentist random-effects model was applied using the netmeta R package. Results Nine studies with 839 participants were analyzed. BPA showed the greatest reduction in PVR (MD -444.02 dyn·s·cm⁻⁵, 95% CI -606.99 to -281.05) and mPAP (MD -16.17 mmHg), with the highest SUCRA scores across outcomes. Riociguat ranked second overall, improving PVR, 6MWD, and CI. Macitentan and selexipag significantly improved CI, while bosentan reduced NT-proBNP. Ambrisentan and sildenafil did not demonstrate significant benefits over placebo. High heterogeneity was observed for PVR and BDI outcomes. Conclusions Ballon Pulmonary Angioplasty (BPA) demonstrates the most robust and consistent improvements in hemodynamics as evidenced by PVR, mPAP and mRAP measurements as well in functional and biomarker improvements (6MWD and NT-proBNP) in patients with inoperable CTEPH while Riociguat remains the most effective pharmacologic agent, offering significant benefits across multiple domains including PVR, 6MWD, mPAP and CI. Macitentan and Selexipag showed promising improvements in cardiac output while Bosentan provided NT-proBNP and pVR benefit. Ambrisentan and Sildenafil did not demonstrate significant advantages over placebo in this population. These findings support BPA as the most effective intervention for inoperable CTEPH, with Riociguat as the preferred pharmacologic therapy. However, limited direct comparisons and heterogeneity in some endpoints warrant long-term outcome studies to refine treatment sequencing, combination strategies and the consideration for future head-to-head trials between advanced oral therapies and BPA.

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Aim. To provide a pharmacoeconomic estimate of macitentan versus bosentan in therapy for pulmonary arterial hypertension (PAH). Subject and methods. An analysis was carried out on the basis of a social perspective for patients, whose mean age was 50 years. A budget impact analysis was performed without discounting; with the time horizon of the study being 5 years. Assessing the cost- effectiveness of endothelin receptor antagonists used a Markov model based on the meta-analysis of clinical trials. The cost of bosentan was calculated from the 2016 registered prices with VAT. That of macitentan was estimated from the expected price of 170,000 rubles per 10-mg dose pack №28 if the drug is included in the List of Essential Medicines with VAT. The cost of sildenafil and iloprost was consistent with the January-to-November 2016 auction results. At cost-effectiveness assessment costs and outcomes were both discounted at an annual rate of 3,5%. Results. After 5 years of therapy with macitentan in patients with baseline Functional Class (FC) II PAH, the proportion of patients with FC I-II was shown to be 2.6% more than that during therapy with bosentan (20.1 and 17.5%, respectively), and that of the died patients was 1.5% lower (69.5 and 71%, respectively). In baseline FC III PAH following 5 years, the proportion of patients with FC III PAH on initial macitentan treatment was 1% more than that on bosentan therapy (8.1 and 7.1%, respectively), and that of the died patients was 0.5% lower (87.2, and 87.7%, respectively). The cost-effectiveness analysis shows that therapy with macitentan versus bosentan not only causes some increase in life expectancy in terms of quality of life (by 0.414 and 0.230 QALYs in FC II and III PAH, respectively), but also results in a small cost decrease in FC II and III PAH (by 11,000 and 16,000 rubles per patient, respectively). Thus, macitentan is a dominant alternative versus bosentan. The budget impact analysis indicates that when bosentan is replaced with macitentan, the reduction in health care costs in the Russian Federation will amount to 1.9 million rubles over 5 years, and in all budgetary costs will be 14.7 million rubles. Conclusion. Treatment with macitentan in patients with FC II-III PAH is more cost-effective than that with bosentan and does not require an increase in budget costs.

Abstract licence: CC BY-NC-SA 4.0