Long-term therapy with inhaled iloprost in patients with pulmonary hypertension

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Summary

Aims

To investigate the long-term safety of inhaled iloprost in patients with pulmonary hypertension (pH), including idiopathic PAH (IPAH group) and other forms of pulmonary hypertension (PHother).

Methods and results

Sixty-three patients (IPAH group, n = 40, PHother n = 23) were enrolled to receive inhaled iloprost either from baseline or after 3 months in a prospective, open-label 2-year study. Iloprost was inhaled 6–9 times daily with a night pause employing a jet nebulizer delivering an inhaled single dose of 4 μg at the mouthpiece. In the case of side effects the single dose was reduced to 2 μg. Sixty patients received at least 1 dose of inhaled iloprost. Thirty-six patients completed at least 630 days of therapy (25 IPAH, 11 PHother), 19 patients dropped out prematurely and 8 patients died (3 IPAH, 5 PHother). There were no drug-induced toxicities and only mild to moderate side effects. The most common side effects were coughing and flushing. Two-year survival was estimated at 85% (IPAH group 91%, PHother 78%). A modified analysis was performed to correct for differential drop-out. It included follow-up data from the premature discontinuations and revealed a 2-year survival of 87% [95% CI, 76%–98%] in the IPAH group while the predicted survival was 63%. The iloprost dose increased by 16% over 2 years.

Conclusion

Inhaled iloprost is well tolerated as long-term therapy and no substantial dose increase is required. Although uncontrolled, the data suggest a long-term clinical benefit from continued therapy with inhaled iloprost.

Keywords

Inhaled iloprost
Pulmonary arterial hypertension
Long-term treatment
Hypertension
pulmonary
Survival

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Funding Sources: This study was sponsored by Schering AG, Berlin, Germany; ClinicalTrials.gov Identifier: NCT00414687.