&lt;p&gt;Safety and tolerability of macitentan in the management of pulmonary arterial hypertension: an update&lt;/p&gt;

Wong, Alexandra K; Channick, Richard N.

doi:10.2147/dhps.s173050

Cited by 8 publications

(7 citation statements)

References 56 publications

(58 reference statements)

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“…Regarding safety, the most commonly observed AEs, with an incidence of 2% or more, were dyspnea, nasopharyngitis, worsening of PAH, headache, pneumonia, and headache. The profile of the most frequent AEs reported in this study is consistent with the known safety profile of macitentan [ 7 , 8 , 11 , 12 ]. All AEs of special interest associated with well-known side effects of approved endothelin receptor antagonists showed incidences of less than 2%, which were relatively lower than the corresponding incidences (range 3.4–18.2%) observed in the macitentan 10-mg treatment group in the SERAPHIN phase III study [ 7 ].…”

Section: Discussionsupporting

confidence: 87%

Real-World Safety and Clinical Outcomes of Macitentan in Asian Patients with Pulmonary Arterial Hypertension: A Prospective Multicenter Study

Jung

Chang

Song

et al. 2022

Drugs - Real World Outcomes

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Background and Objective Macitentan is approved for treating pulmonary arterial hypertension. However, the real-world evidence of macitentan use is limited. Therefore, we evaluated the safety and clinical outcomes of macitentan use in clinical practice under a post-marketing surveillance. Methods Patients with pulmonary arterial hypertension receiving macitentan treatment were prospectively and consecutively enrolled from 2014 to 2020 at 50 medical centers in Korea. Safety and clinical outcomes were monitored from baseline to the nearest timepoint of 24 weeks after macitentan initiation. The adverse events and adverse drug reactions were identified. Changes in the World Health Organization functional class were assessed as the primary clinical outcome, which was used to estimate the final effectiveness (both improved and maintained). Factors associated with safety and final effectiveness were identified. Results Among 474 patients enrolled in the study, 467 and 440 were included in the safety and clinical outcome analyses, respectively. Dyspnea, nasopharyngitis, and worsening pulmonary arterial hypertension were the most frequent adverse events with incidences of 5%, 3%, and 3%, respectively. The final effectiveness rate was 93%. Older age (adjusted odds ratio [aOR] = 1.021, p = 0.003) and higher level (III vs II) of baseline World Health Organization functional class (aOR = 1.784; p = 0.022) were significantly associated with a higher adverse event occurrence. Younger age (aOR = 0.947; p = 0.001) and shorter disease duration (aOR = 0.991; p = 0.010) were significantly associated with positive final effectiveness. Conclusions This real-world study demonstrated the safety and clinical outcomes of macitentan use in Korean patients with pulmonary arterial hypertension. Macitentan was well tolerated and significantly effective with no new safety concerns during the 24 weeks.

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Section: Discussionsupporting

confidence: 87%

Real-World Safety and Clinical Outcomes of Macitentan in Asian Patients with Pulmonary Arterial Hypertension: A Prospective Multicenter Study

Jung

Chang

Song

et al. 2022

Drugs - Real World Outcomes

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“…Overall, macitentan was well tolerated and adverse effects including nasopharyngitis, headache and anemia were similar in all groups [ 102 ]. It also reduced PAH-related hospitalization and chronic thromboembolic pulmonary hypertension [ 103 ]. In a case of Dasatinib-induced PAH with concurrent scleroderma, macitentan was used along with tadalafil and selexipag.…”

Section: Managementmentioning

confidence: 99%

A narrative review on adverse effects of dasatinib with a focus on pharmacotherapy of dasatinib-induced pulmonary toxicities

2021

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Chronic myeloid leukemia (CML), a myeloproliferative disorder caused by the over activity of BCR-ABL1 (breakpoint cluster region-Abelson), has been successfully treated by Tyrosine kinase inhibitors (TKIs). While imatinib is known as the first-line treatment of CML, in some cases other TKIs including dasatinib, nilotinib, bosutinib, and ponatinib may be preferred. Dasatinib, a second-generation TKI, inhibits multiple family kinases including BCR-ABL, SRC family kinases, receptor kinases, and TEC family kinases. It is effective against most imatinib-resistant cases except T315I mutation. Despite the superiority of dasatinib in its hematologic and cytogenetic responses in CML compared to imatinib, its potentially harmful pulmonary complications including pleural effusion (PE) and pulmonary arterial hypertension (PAH) may limit its use. Appropriate management of these serious adverse reactions is critical in both improving the quality of life and the outcome of the patient. In this narrative review, we will scrutinize the pulmonary complications of dasatinib and focus on the management of these toxicities.

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“…Neither macitentan nor its active metabolite has clinically significant inducer or inhibitory effects on cytochrome enzymes P450, and macitentan has a favorable hepatic safety profile relative to other ERAs. [ 9 ]…”

Section: Resultsmentioning

confidence: 99%

The clinical experience of macitentan in pulmonary hypertension in Indian cohort: 12-month follow-up

et al. 2021

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Background: The effectiveness and safety of macitentan, an endothelin-receptor antagonist (ERA) in the treatment of pulmonary arterial hypertension (PAH), has been demonstrated in numerous randomized clinical trials including SERAPHIN, focused on the reduction of morbidity and mortality. Objectives: Our aim was to demonstrate the clinical and echocardiographic progression using macitentan in Indian patients with PAH. Settings and Design: It was a retrospective study of 20 patients with multiple etiologies of PAH who had begun macitentan in routine clinical practice from a single center. There were 55% of patients with existing PAH therapies. Subjects and Methods: The World Health Organization functional class (WHO-FC), 6-min walking distance, N-terminal prohormone of brain natriuretic peptide level (NT-pro-BNP), and echocardiographic data such as tricuspid annular plane systolic excursion (TAPSE), systolic pulmonary artery pressure (sPAP), and the occurrence of pericardial effusion were collected at baseline and 12-month follow-up. The statistical analysis was performed using SPSS software. Results: Of the 20 PAH patients, 70% were women. The majority were in WHO FC II (50%), while 35% were in FC III and 15% were in FC IV. The mean age was 43.4 years at the start of the therapy with macitentan. After 6 months of macitentan therapy, 85% showed substantial improvement in their FC, each increased its 6-min walking distance test ( P < 0.0001), and there was a significant reduction in plasma levels of NT-pro BNP ( P < 0.0001). There has also been an improvement in echocardiographic parameters such as TAPSE and sPAP ( P < 0.0001). Conclusions: Our findings indicate that macitentan has been well tolerated and beneficial in Indian patients with PAH and further, future research is required to verify these results.

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<p>Safety and tolerability of macitentan in the management of pulmonary arterial hypertension: an update</p>

Cited by 8 publications

References 56 publications

Real-World Safety and Clinical Outcomes of Macitentan in Asian Patients with Pulmonary Arterial Hypertension: A Prospective Multicenter Study

Real-World Safety and Clinical Outcomes of Macitentan in Asian Patients with Pulmonary Arterial Hypertension: A Prospective Multicenter Study

A narrative review on adverse effects of dasatinib with a focus on pharmacotherapy of dasatinib-induced pulmonary toxicities

The clinical experience of macitentan in pulmonary hypertension in Indian cohort: 12-month follow-up

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