Pulmonary
hypertension is chronic debilitating disease associated with high morbidity
and a poor prognosis.
After approval of riociguat (Adempas, Bayer), for the treatment of
PAH and the treatment of chronic thromboembolic pulmonary hypertension (CTEPH),
on October 8.
The US Food and Drug Administration (FDA) have approved the second agent
this month to treat pulmonary arterial hypertension (PAH) in adults which is macitentan (Opsumit, Actelion).
Support
for macitentan's approval comes from the 742-patient SERAPHIN trial, as reported by heartwire .
In SERAPHIN, published in August in the New England Journal of Medicine,
macitentan given at 10 mg/day over two years led to a 45% reduction (p<0.001)
in a clinical primary end point that included death, initiation of IV or
subcutaneous prostanoids, or worsening of PAH.
The
benefit, authors noted at the time, was driven primarily by reductions in PAH
worsening.
The most common side effects seen with macitentan are anemia, common cold-like symptoms (nasopharyngitis), sore throat, bronchitis, headache, influenza, and urinary tract infection.
The most common side effects seen with macitentan are anemia, common cold-like symptoms (nasopharyngitis), sore throat, bronchitis, headache, influenza, and urinary tract infection.
For pregnant
women : Opsumit carries a Boxed Warning alerting patients and health care
professionals that the drug should not be used in pregnant women because it can
harm the developing fetus," a press release notes.
"Female
patients can receive the drug only through the Opsumit Risk Evaluation and
Mitigation Strategy (REMS) Program."
According
to the REMS program, prescribers and pharmacies dispensing the drug need to be
certified in the program, as do female patients taking the drug. Specifically,
female patients need to comply with pregnancy testing and contraception
requirements before initiating treatment.
