Switching inhaled iloprost formulations in patients with pulmonary arterial hypertension: the VENTASWITCH Trial

Abstract

Inhaled iloprost is an effective therapy for patients with pulmonary arterial hypertension (PAH); however, some patients experience extended inhalation times when using the V10 formulation (10.0 µg/mL) to deliver a 5 -µg dose (at mouthpiece) and are at risk of incomplete inhalations and reduced inhalation frequency. VENTASWITCH was an observational, case-crossover study to evaluate inhalation behavior in patients with PAH switched from iloprost V10 to V20 (20.0 µg/mL) formulation for delivering a 5 -µg dose using the I-Neb® AAD® device. Adults with PAH participating in a German Ventavis® (iloprost) patient-support program, who were switched from the V10 to V20 formulation, were enrolled. The co-primary endpoints were mean daily proportion of complete inhalations and mean daily inhalation frequency. The secondary endpoint was mean daily inhalation duration. Data were collected for three months before and after switching. Overall, 63 patients were included. Switching from V10 to V20 resulted in a significant increase in the mean daily proportion of complete inhalations (92% vs. 97%, P < 0.0001) and inhalation frequency (4.6 vs. 4.9 inhalations/day, P = 0.0430), and reduction in mean inhalation duration (11.8 vs. 6.5 min; P < 0.0001). Greater increases in daily proportions of complete inhalations were observed in older patients (≥ 65 vs. < 65 years) and those receiving more (3 vs. < 3) concomitant PAH medications. Switching from V10 to V20 iloprost formulation significantly improved inhalation behavior in patients with PAH and may facilitate improved adherence to therapy.

The Effects of Iloprost on Oxygenation During One-Lung Ventilation for Lung Surgery: A Randomized Controlled Trial

“…Its delivery is simple, cost-effective, and predictable compared to NO and epoprostenol [22]. Recently, new devices and formulations have been introduced to increase drug deposition and plasma levels of iloprost while shortening inhalation time [24,25,26]. Currently, application of these methods in the operating room setting during anesthesia is challenging.…”

Clinical efficacy, safety, tolerability, and survival outcome of long-term inhaled iloprost treatment in the management of pulmonary arterial hypertension: Data from prospective multicenter observational OPTION study

“…Iloprost is an inhaled prostacyclin-based therapy for PAH with vasodilatory and anti-proliferative effects (9)(10)(11), enabling significant improvements in exercise capacity, symptoms, and PVR and lesser incidence of clinical events in patients with PAH than with placebo (2,9,12). Thus, inhaled iloprost is currently recommended as class I monotherapy for patients with PAH in New York Heart Association (NYHA) functional class III, as class IIb monotherapy for patients in NYHA functional class IV, and as class IIb sequential combination therapy (add on to bosentan) for those in NYHA functional class II to IV (2,13,14).…”

Acute response to rapid iloprost inhalation using the Breelib™ nebulizer in pulmonary arterial hypertension: the Breelib™ acute study

“…1,2 With the standard I-neb nebulizer (Philips Respironics, Chichester, UK), each inhalation session is estimated to last up to 10 min, but some patients experience even longer inhalation times. 3,4 There has been much interest in approaches to reduce inhalation times and thus improve treatment convenience and adherence, with examples including a change in the iloprost formulation 5 and unapproved modification of the I-neb device. 6 The Breelib™ nebulizer (Vectura Group plc, Chippenham, UK) was approved in the EU in 2016.…”