Inhaled iloprost in primary pulmonary hypertension: profile report
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Inhaled iloprost in primary pulmonary hypertension: profile report Adapted and reproduced from Drugs 2004; 64 (7): 763-75[1-4] Primary pulmonary hypertension (PPH) is characterised by raised (mean) pulmonary artery pressure (PAP) [>25mm Hg at rest or >30mm Hg during exercise] without an established secondary cause.[5] New cases occur in one to two people per million per year, with a natural history of death from progressive right heart failure after a median 2.8 years without treatment.[1,5] Iloprost, a stable analogue of prostacyclin, has a pharmacokinetic profile that allows nebulised administration in patients with PPH.[1,5,6] Inhaled iloprost (Ventavis®)1 is a potent acute pulmonary vasodilator with a duration of action of about 60 minutes. It may exert additional long-term benefit through antiproliferative and antithrombotic effects.[1] Inhaled iloprost 2.5 or 5μg six or nine times daily for 12 weeks (n = 101) significantly (p < 0.01) improved a combined clinical endpoint of a ≥10% increase in distance walked in 6 minutes and an improvement of ≥1 class in New York Heart Association (NYHA) functional class without clinical deterioration or death (16.8% vs 4.9% of placebo recipients; n = 102) in patients with severe PPH or selected forms of nonprimary pulmonary hypertension.[7] Statistical analysis of the response for the PPH subgroup (20.8% vs 5.5% with placebo; n = 51 and 51) was not reported. Improvements from baseline in exercise capacity and haemodynamic/gas exchange variables have been reported in patients with PPH with continued use of inhaled iloprost.[8-10] In addition, improvement in preinhalation vascular resistance occurred after 12 weeks of inhaled iloprost (p < 0.01 versus placebo) in the large randomised trial.[7] Increased cough, headache, flushing and an influenza-like syndrome were the most common adverse events in the largest trial of patients receiving inhaled iloprost.[7] Headache, flushing and jaw pain occurred significantly more frequently with inhaled iloprost than with placebo.
Inhaled iloprost Nazzareno Gali`e[2] 1
Features and properties of inhaled iloprost (Ventavis®)[1] Indication To improve exercise capacity and symptoms in patients with New York Heart Association functional class III primary pulmonary hypertension Mechanism of action Pulmonary vasodilator
Route of administration
Nebulised (over ≈10min)
Dose (at the mouthpiece)
2.5 or 5μg
Frequency of administration
Six or nine times daily
Pharmacokinetic profile (following 5μg inhaled dose in patients with pulmonary hypertension) Bioavailability
≈80%
Time to peak concentration in intravascular compartment
≈10–15 min
Peak serum concentration
≈160 pg/mL
Elimination half-life in plasma
6.5–9.4 min
Adverse effects Significantly more frequent than with placebo
Headache, flushing and jaw pain
Institute of Cardiology, University of Bologna, Bologna, Italy PPH is a severe disease characterised by a progressive increase of pulmonary vascular resistance leading to right ventricular failure and premature death. A reduced pr
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