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Dr Hayley Barnes
Inhaled treprostinil shows some promise as a treatment for pulmonary hypertension associated with ILD, according to US research.
The study randomised 326 patients to treprostinil (0.6 mg per ml) or placebo delivered by a nebuliser four times daily for 16 weeks. Doses were escalated from three to a maximum tolerated dose of up to 12 breaths per treatment session.
The study, published in the NEJM, found the change from baseline in 6-minute walk distance at 16 weeks was significantly improved by 31.12 m in the treated group as a whole compared to controls.
The 6MWD increased by 21.08 m in the treprostinil-treated group and decreased by 10.04 m in the controls.
“Similar effects were observed across subgroups, including subgroups defined by disease cause and severity (as measured by baseline 6-minute walk distance), baseline haemodynamics, and dose group,” the study said.
In secondary and exploratory endpoints, the NT-proBNP level decreased 15% from baseline with inhaled treprostinil and increased 46% from baseline with placebo.
Clinical worsening occurred in fewer treated patients than controls (22.7% v 33.1%; p<0.001) however there was no significant difference between the groups in patient-reported quality of life.
The most commonly reported adverse events included cough, headache, dyspnea, dizziness and nausea of mild to moderate intensity. Serious adverse events occurred in 23.3% of the treprostinil-treated group and 25.8% of controls.
Significantly fewer patients in the treprostinil group had exacerbations of underlying lung disease (26.4% v 38.7%; p=0.02) and treprostinil was not associated with any worsening of lung function measures.
“The safety profile of inhaled treprostinil observed in this vulnerable patient population was similar to that reported in previous studies,” the researchers said.
An accompanying editorial in NEJM said “demonstrating a placebo-corrected improvement in exercise capacity with treprostinil is exciting.”
“Will it be important for patients? Prevention of deterioration is not to be ignored, even if it does not make a patient feel better,” NEJM deputy editor Adjunct Professor Darren Taichman wrote.