Veletri (epoprostenol AS) is an approved intravenous treatment for pulmonary arterial hypertension, or PAH.

The Actelion Pharmaceuticals therapy won U.S. Food and Drug Administration approval in 2008.

How Veletri works

Veletri is a synthetic version of prostacyclin, a naturally occurring substance responsible for widening blood vessels.

In pulmonary hypertension, the body cannot make enough prostacyclin. This causes the blood vessels that carry oxygen from the heart to the lungs to narrow, forcing the heart to work harder to pump enough blood through the lungs.

Veletri widens blood vessels in the lungs, making oxygen-rich blood flow more easily.

Veletri in clinical trials

An initial formulation of epoprostenol known as Flolan needed ice to keep it from deteriorating. Veletri is stable at room temperature.

Researchers evaluated Veletri’s ability to improve PAH in the EPITOME clinical trials. The studies also compared Veletri’s effectiveness with Flolan’s.

EPITOME-1 (NCT01105091) was a Phase 4 trial comparing Veletri and Flolan’s effectiveness as a PAH treatment, its safety, and patients’ ability to tolerate it. The 30 patients received one of the two formulations for 28 days. Researchers checked them during the treatment, then followed them for another 30 days.

The most common adverse effects researchers saw were jaw pain, headache, nausea, and flushing. Two patients on Veletri died during the study, but the attending physician said the deaths were not related to the treatment.

The impact of switching from Flolan to Veletri was investigated in two Phase 3 trials, EPITOME-2 and EPITOME-4.

EPITOME-2 (NCT01431716) was a multicenter study in Europe and Canada. It included 41 patients with PAH whose condition had become stable with long-term Flolan treatment. Researchers switched the group to Veletri, then followed them for three months.

The switch from Flolan to Veletri did not affect the treatment’s effectiveness and raised no new concerns about safety or patients’ ability to tolerate it. It also showed that patients were happier with Veletri because it was more convenient than Flolan.

EPITOME-4 (JapicCTI-122017) was a study at two sites in Japan. It generates results similar to those in EPITOME-2: Patients with PAH could switch from Flolan to the same dose of Veletri with no difference in effectiveness or safety.

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