Results from a Phase 3 study showed that treating pulmonary arterial hypertension (PAH) patients with oral Opsumit (macitentan) improved both their physical and mental health, positively impacting their quality of life (QoL).
PAH is a progressive disease characterized by the difficulty to breathe and recurrent fatigue. Several studies have shown that PAH affects a person’s mental health and QoL, with patients frequently experiencing anxiety, depression, and stress.
The study, “Macitentan improves health-related quality of life for patients with pulmonary arterial hypertension: results from the randomized controlled SERAPHIN trial” published in the journal Chest, evaluated the effectiveness of Opsumit on quality of life in PAH patients. It resulted from the SERAPHIN (NCT00660179) clinical trial.
Previous trial results showed that 10 mg of Opsumit could reduce the risk of PAH-associated complications or mortality by 45 percent compared to placebo-treated patients.
In this new study, patients diagnosed with PAH were randomly assigned to receive either placebo, or Opsumit (3 or 10 mg once daily). Their QoL was measured using a questionnaire taking into account eight health areas: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. This allowed researchers to determine both the patients’ physical component summary (PCS) and mental component summary (MCS) scores.
Treatment with both Opsumit doses raised scores in seven of the eight questionnaire areas (except general health perceptions) compared with the placebo group. An overall improvement in their PCS and MCS scores after six months of treatment, compared their scores at the study’s beginning and compared to placebo-treated patients, was also seen.
Moreover, the researchers showed that higher values for PCS and MCS scores represented a lower risk of PAH-associated complications or mortality. Importantly, the Opsumit-treated patients showed a lower likelihood of deteriorating PCS and MCS scores during treatment compared to placebo.
“In conclusion, results from this study indicate significant improvements in overall quality of life in PAH patients treated with macitentan compared with placebo,” the researchers wrote.
“Macitentan’s convenient oral administration and its well-tolerated adverse event profile may contribute to the [quality of life] benefits, as compared to therapies that require parenteral administration or close monitoring for side effects,” they added.