Macitentan in Pulmonary Arterial Hypertension

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Questions and Answers

What is the primary use of Macitentan?

Managing diabetes

Treating pulmonary arterial hypertension (correct)

Preventing asthma attacks

Lowering cholesterol levels

What class of medications does Macitentan belong to?

Beta-blockers

Angiotensin-converting enzyme (ACE) inhibitors

Endothelin receptor antagonists (correct)

Calcium channel blockers

How does Macitentan work in managing PAH?

By reducing heart rate

By stopping the action of endothelin (correct)

By increasing endothelin levels

By dilating blood vessels

What is the recommended daily dose strength of Maacy?

10 MG once daily Signup and view all the answers

What is the primary mechanism of action of Macitentan?

Inhibiting the binding of endothelin-1 to ETA and ETB receptors Signup and view all the answers

Which receptor subtype blocking is more important in the treatment of PAH?

ETA receptor Signup and view all the answers

What is the market share percentage of Macitentan in 2022?

67% Signup and view all the answers

Which brand represents 44% market share in the 1st year and grows by 487%?

Maacy (Sudair) Signup and view all the answers

Which molecule gained market share by 10% and grew by 1,696% in 2022?

Ambrisentan Signup and view all the answers

What is the growth percentage of the market from 2021 to 2022?

22% Signup and view all the answers

Which product significantly reduced the risk of the first morbidity and mortality event by 45%?

Macitentan Signup and view all the answers

Which product is owned by EXCELLA GmbH & Co. KG (Johnson & Johnson)?

Opsumit Signup and view all the answers

What is the average growth of PAH patients in KSA from 2021 to 2022?

22% Signup and view all the answers

What was the estimated 5.9-year survival rate for PAH patients receiving Macitentan combination therapy?

95% Signup and view all the answers

How much did the Macitentan combination therapy decrease PAH-related events compared to placebo?

38% Signup and view all the answers

Which molecule had the highest market share in the ERA market for PAH treatment?

Macitentan Signup and view all the answers

What was the year-on-year growth rate of the total PAH market in 2022?

1.8% Signup and view all the answers

Which PAH molecule experienced a decline in market share in 2022?

Phosphodiesterase-5 Inhibitor (PDE-5i) Signup and view all the answers

How much did the Macitentan combination therapy increase the 6-minute walk distance compared to placebo?

25.9 meters Signup and view all the answers

What was the primary objective of the SERAPHIN study?

To measure the change in 6-minute walk distance and WHO functional class improvement at month 6 Signup and view all the answers

What was the effect of Macitentan on the risk of the first morbidity and mortality event in the SERAPHIN study?

Reduced the risk by 45% Signup and view all the answers

What was the terminal half-life of Macitentan according to its pharmacokinetics?

17 hours Signup and view all the answers

How did Macitentan affect the 6-minute walk distance in the SERAPHIN study compared to placebo?

Increased by 22 meters Signup and view all the answers

What was the greater chance of improving WHO functional class status in the SERAPHIN study for patients on 10mg Macitentan?

74% Signup and view all the answers

What was the inclusion criteria for the SERAPHIN study?

Patients 12 years and older with various forms of pulmonary arterial hypertension, confirmed by right heart catheterization Signup and view all the answers

Study Notes

Macitentan Clinical Trial Overview

Macitentan's pharmacokinetics indicate a Cmax reached within 8 hours, hepatic metabolism, and a terminal half-life of 17 hours.
In the SERAPHIN study, 742 patients aged 12 and older were randomized into three groups: placebo, 3mg Macitentan, and 10mg Macitentan.
The SERAPHIN study's primary objective was to measure the change in 6-minute walk distance and WHO functional class improvement at month 6.
Macitentan significantly reduced the risk of the first morbidity and mortality event by 45% in the SERAPHIN study.
The SERAPHIN study also found that Macitentan reduced death due to PAH or hospitalization by 50% and increased the 6-minute walk distance by 22 meters compared to placebo.
Patients on 10mg Macitentan had a 74% greater chance of improving WHO functional class status in the SERAPHIN study.
The SERAPHIN OP EXTENSION study, a 36-month survival study, examined Macitentan's long-term effects in combination therapy for pulmonary arterial hypertension.
The study included 550 patients aged 12 and older, with one group focusing on survival rates and the other on combinational therapy with Macitentan.
Macitentan bound to human plasma proteins >99% and is proposed to be taken with or without food, according to its pharmacokinetics.
The SERAPHIN study's inclusion criteria included patients 12 years and older with various forms of pulmonary arterial hypertension, confirmed by right heart catheterization.
The primary outcome of the SERAPHIN study was the change from baseline to month 6 in the 6-minute walk distance, while secondary outcomes included WHO functional class improvement and safety end points.
Macitentan's effect on pulmonary arterial hypertension was assessed in the SERAPHIN study, which found significant improvements in morbidity, mortality, exercise capacity, and WHO functional class status.

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Description

Test your knowledge about the clinical trials and pharmacokinetics of Macitentan in treating pulmonary arterial hypertension. Learn about the SERAPHIN study, its primary objectives, and the long-term effects of Macitentan in combination therapy.