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Severe Pulmonary Hypertension Responds Well To Inhaled Iloprost

Inhaled iloprost is an effective therapy for patients with severe pulmonary hypertension.

This is the conclusion of a multicentre international study headed by Dr Horst Olschewski and colleagues from the University Clinic, Giessen, Germany, for the Aerosolized Iloprost Randomized Study Group

The number of effective, long-term treatments for pulmonary hypertension is limited.

Uncontrolled studies have suggested aerosolized iloprost, a stable analogue of prostacyclin, causes selective pulmonary vasodilatation and improves haemodynamics and exercise capacity in patients with pulmonary hypertension.

This 12-week investigation compared repeated daily inhaled iloprost (2.5 or 5.0 micrograms six or nine times per day; median inhaled dose, 30 microgram per day) with inhaled placebo.

Participants were 203 patients with selected forms of severe pulmonary arterial hypertension (New York Heart Association [NYHA] functional class III or IV) and chronic thromboembolic pulmonary hypertension.

Primary end point was met if, after week 12, the NYHA class improved by one class and distance walked in six minutes improved at least 10 percent in the absence of clinical deterioration by predefined criteria and death.

The combined clinical end point was met by 16.8 percent of the patients on iloprost versus 4.9 percent of those on placebo.

There were increases in distance walked in six minutes of 36.4 m in the iloprost group as a whole and of 58.8 m in the subgroup of iloprost patients with primary pulmonary hypertension.

Overall, 4.0 percent of patients on iloprost (including one who died) and 13.7 percent of those on placebo (including four who died) did not complete the study, with the most common reason being clinical deterioration.

At 12 weeks, compared to baseline values, haemodynamic values were largely unchanged when measured before iloprost inhalation, significantly improved when measured after iloprost inhalation and significantly worse in the placebo group.

Additional significant benefits of iloprost included an improvement in the NYHA class, dyspnoea and quality of life.

Although syncope occurred in both groups with similar frequency, it was more often rated as serious in patients on iloprost but was not linked with clinical deterioration.

An advantage of iloprost is that it can be administered by inhalation, thus avoiding the intravenous infusion required for the administration of prostacyclin and allowing delivery of the drug directly to the lungs.
N Engl J Med 2002;347:322-329.

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