Role of Inhaled Iloprost as an Emerging Therapeutic Option in Pulmonary Ar terial Hyper tension 2005
Role of Inhaled Iloprost as an Emerging Therapeutic Option in Pulmonary Ar terial Hyper tension 2005
2005
Published: November 2005
Published: November 2005
Three prostacyclin analogues are currently US Food and Drug Administration (FDA)-approved for the specific treatment of PAH – continuous intravenous epoprostenol (Flolan®; GlaxoSmithKline), continuous subcutaneous or intravenous treprostinil (Remodulin®; United Therapeutics Corporation) and inhaled iloprost (Ventavis®; Co-Therix, Inc.). Table 1 summarises the findings from the major randomised controlled trials that led to regulatory approval of these agents.4–7 Intravenous epoprostenol was approved in 1995 for patients with IPAH and PAH associated with connective tissue disease, while subcutaneous treprostinil was approved in 2002 for patients with PAH and WHO class II–IV symptoms. Inhaled aerosolised iloprost was approved in 2003 in the EU for IPAH patients in WHO class III and in December 2004 in the US for PAH patients in WHO class III and IV.
References:
- Simonneau G, Galie N, Rubin L J, et al., “Clinical classification of pulmonary hypertension”, J. Am. Coll. Cardiol. (2004), 43: pp. S5–S12.
- D’Alonzo G E, Barst R J, Ayres S M, et al., “Survival in patients with primary pulmonary hypertension. Results from a national prospective registry”, Ann. Intern. Med. (1991), 115: pp. 343–349.
- Badesch D B, McLaughlin V V, Delcroix M, et al., “Prostanoid therapy for Pulmonary Arterial Hypertension”, J. Am. Coll. Cardiol. (2004), 43 (12): pp. S65–S61.
- Barst R J, Rubin L J, Long W A, et al., “A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension”, The Primary Pulmonary Hypertension Study Group, N. Engl. J. Med. (1996), 334: pp. 296–302.
- Badesch D B, Tapson V F, McGoon M D, et al., “Continuous intravenous epoprostenol for pulmonary hypertension due to the scleroderma spectrum of disease. A randomized, controlled trial”, Ann. Intern. Med. (2000), 132: pp. 425–334.
- Simonneau G, Barst R J, Galie N, et al., “Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial”, Am. J. Respir. Crit. Care Med. (2002), 165: pp. 800–804.
- Olschewski H, Simonneau G, Galie N et al., “Inhaled iloprost for severe pulmonary hypertension”, N. Engl. J. Med. (2002), 347: pp. 322–329.
- Olschewski H, Ghofrani A, Schmehl T, et al., “Inhaled Iloprost To Treat Severe Pulmonary Hypertension. AnUncontrolled Trial”, Ann. Intern. Med. (2000), 132: pp. 435–443.
- Hoeper M M, Schwarze M, Ehlerding S, et al., “Long-term treatment of primary pulmonary hypertension with aerosolizediloprost, a prostacyclin analogue”, N. Engl. J. Med. (2000), 342: pp. 1,866–1,870.
- Ghofrani A H, Rose F, Schermuly R T, et al., “Oral Sildenafil as Long-Term Adjunct Therapy to Inhaled Iloprost inSevere Pulmonary Arterial Hypertension”, J. Am. Coll. Cardiol. (2003), 42 (1): pp. 158–164.
