More pulmonary arterial hypertension (PAH) patients were able to achieve complete daily inhalations after switching to a more concentrated formulation of Ventavis (iloprost), which also reduced the duration of each treatment administration, an observational study reports.
The study looked at the inhalation behavior of PAH patients who were switched from a 10 microgram/mL administration of Ventavis (V10) to 20 microgram/mL (V20). Findings suggest that the Ventavis V20 formulation may help more patients adhere to the treatment.
The study, “Switching inhaled iloprost formulations in patients with pulmonary arterial hypertension: The VENTASWITCH Trial,” was published in the journal Pulmonary Circulation.
Iloprost is a synthetic version of prostacyclin, a substance the body produces to widen blood vessels, reducing resistance to blood flow. The drug can be administered intravenously (into the blood), orally, or by inhalation.
The inhaled formulation of iloprost, marketed as Ventavis, sold by Bayer in Europe and Actelion in the U.S., is approved as a therapy for improving the exercise capacity of PAH patients, and to potentially delay or reduce disease worsening.
“In patients with PAH, inhaled iloprost has been shown to significantly increase exercise capacity, improve symptoms and PVR [pulmonary vascular resistance], and reduce the incidence of clinical events compared with placebo,” the researchers wrote.
Ventavis is delivered using a small, portable, and rechargeable nebulizer, called I-neb AAD, designed to optimize the therapy’s delivery.
Inhaled iloprost is available as 10 microgram/mL (V10) and 20 microgram/mL (V20) formulations for administration via the I-neb AAD. The V10 formulation delivers iloprost at 2.5 micrograms or 5 micrograms, while V20 delivers iloprost only at 5 micrograms.
However, patients using the V10 formulation, which can take longer to administer, are sometimes at risk of incomplete inhalations and reduced inhalation frequency, potentially leading to a dose too low to be fully effective.
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The VENTASWITCH study (NCT02826252) evaluated the inhalation behavior of PAH patients, enrolled in the VENTAPLUS German patient-support program for inhaled iloprost, who switched the V10 to the V20 formulation.
The study’s primary objectives were the proportion of complete inhalations and mean daily inhalation frequency. The secondary goal was mean daily inhalation duration. Researchers collected the data three months before and after switching treatment regimens.
In total, 62 patients, 59% of whom were women, completed the study. Of these patients, 62% were receiving a triple combo therapy for PAH.
Results of the trial showed that switching from the V10 to the V20 formulation of iloprost increased the mean daily number of complete inhalations from 92% to 97%. Additionally, the V20 formulation also led to more frequent inhalations — 4.9 inhalations per day, compared with 4.6 inhalations per day with the V10 formulation — and reduced the inhalation’s duration per session —from 11.8 minutes with V10 to 6.5 minutes with V20.
The switch was particularly effective in older patients over the age of 65 and in those receiving three PAH therapies, leading to more complete inhalations than in patients treated with two or fewer treatments. Patients treated with a triple PAH therapy also had a higher increase in mean daily inhalation frequency.
The results suggest that “due to a shortening of inhalation time, switching from the V10 to V20 formulation significantly improved inhalation behavior in patients with PAH, and may facilitate improved adherence to therapy,” according to the research team.