Extended-release oral treprostinil for the treatment of pulmonary arterial hypertension

References

• Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med 2004;351(16):1655-65
   PubMed Web of Science ®Google Scholar
• Simonneau G, Gatzoulis MA, Adatia I, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol 2013;62:D34-41
   PubMed Web of Science ®Google Scholar
• McGoon MD, Benza RL, Escribano-Subias P, et al. Pulmonary arterial hypertension: epidemiology and registries. J Am Coll Cardiol 2013;62:D51-9
   PubMed Web of Science ®Google Scholar
• Peacock AJ, Murphy NF, McMurray JJ, et al. An epidemiological study of pulmonary arterial hypertension. Eur Respir J 2007;30:104-9
   PubMed Web of Science ®Google Scholar
• Humbert M, Sitbon O, Yaici A, et al. Survival in incident and prevalent cohorts of patients with pulmonary arterial hypertension. Eur Respir J 2010;36:549-55
   PubMed Web of Science ®Google Scholar
• Badesch DB, Raskob GE, Elliott CG, et al. Pulmonary arterial hypertension: baseline characteristics from the REVEAL Registry. Chest 2010;137:376-87
   PubMed Web of Science ®Google Scholar
• Escribano-Subias P, Blanco I, Lopez-Meseguer M, et al. Survival in pulmonary hypertension in Spain: insights from the Spanish registry. Eur Respir J 2012;40:596-603
   PubMed Web of Science ®Google Scholar
• Pulido T, Adzerikho I, Channick RN, et al. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med 2013;369:809-18
   PubMed Web of Science ®Google Scholar
• Galie N, Brundage BH, Ghofrani HA, et al. Tadalafil therapy for pulmonary arterial hypertension. Circulation 2009;119:2894-903
   PubMed Web of Science ®Google Scholar
• Ghofrani HA, Galie N, Grimminger F, et al. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med 2013;369:330-40
   PubMed Web of Science ®Google Scholar
• Benza RL, Gomberg-Maitland M, Miller DP, et al. The REVEAL Registry risk score calculator in patients newly diagnosed with pulmonary arterial hypertension. Chest 2012;141:354-62
   PubMed Web of Science ®Google Scholar
• Arena R, Cahalin LP, Borghi-Silva A, Myers J. The effect of exercise training on the pulmonary arterial system in patients with pulmonary hypertension. Prog Cardiovasc Dis 2014. [Epub ahead of print]
   Google Scholar
• Arena R, Guazzi M, Myers J, et al. Cardiopulmonary exercise testing in the assessment of pulmonary hypertension. Expert Rev Respir Med 2011;5(2):281-93
   PubMed Web of Science ®Google Scholar
• Guazzi M, Adams V, Conraads V, et al. EACPR/AHA Joint Scientific Statement. Clinical recommendations for cardiopulmonary exercise testing data assessment in specific patient populations. Eur Heart J 2012;33:2917-27
   PubMed Web of Science ®Google Scholar
• Arena R, Lavie CJ, Milani RV, et al. Cardiopulmonary exercise testing in patients with pulmonary arterial hypertension: an evidence-based review. J Heart Lung Transplant 2010;29:159-73
   PubMed Web of Science ®Google Scholar
• Hoeper MM, Bogaard HJ, Condliffe R, et al. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol 2013;62:D42-50
   PubMed Web of Science ®Google Scholar
• Christman BW, McPherson CD, Newman JH, et al. An imbalance between the excretion of thromboxane and prostacyclin metabolites in pulmonary hypertension. N Engl J Med 1992;327:70-5
   PubMed Web of Science ®Google Scholar
• Tuder RM Cool CC, et al. Prostacyclin synthase expression is decreased in lungs from patients with severe pulmonary hypertension. Am J Respir Crit Care Med 1999;159:1925-32
   PubMed Web of Science ®Google Scholar
• Galie N, Hoeper MM, Humbert M, et al. Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J 2009;30:2493-537
   PubMed Web of Science ®Google Scholar
• Rubin LJ, Groves BM, Reeves JT, et al. Prostacyclin-induced acute pulmonary vasodilation in primary pulmonary hypertension. Circulation 1982;66:334-8
   PubMed Web of Science ®Google Scholar
• Barst RJ, Rubin LJ, Long WA, 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;334:296-302
   PubMed Web of Science ®Google Scholar
• Simonneau G, Barst RJ, 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;165:800-4
   PubMed Web of Science ®Google Scholar
• Tapson VF, Gomberg-Maitland M, McLaughlin VV, et al. Safety and efficacy of IV treprostinil for pulmonary arterial hypertension: a prospective, multicenter, open-label, 12-week trial. Chest 2006;129:683-8
   PubMed Web of Science ®Google Scholar
• Olschewsky H, Simonneau G, Galie N, et al. Inhaled iloprost is an effective treatment for severe pulmonary hypertension. New Engl J Med 2002;347:322-9
   PubMedGoogle Scholar
• McLaughlin VV, Benza RL, Rubin LJ, et al. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. J Am Coll Cardiol 2010;55:1915-22
   PubMed Web of Science ®Google Scholar
• Galie N, Humbert M, Vachiery JL, et al. Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol 2002;39:1496-502
   PubMed Web of Science ®Google Scholar
• Ryerson CJ, Nayar S, Swiston JR, Sin DD. Pharmacotherapy in pulmonary arterial hypertension: a systematic review and meta-analysis. Respir Res 2010;11:12
   PubMed Web of Science ®Google Scholar
• Vachiery JL. Prostacyclins in pulmonary arterial hypertension: the need for earlier therapy. Adv Ther 2011;28:251-69
   PubMedGoogle Scholar
• Sitbon O, Jais X, Savale L, et al. Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study. Eur Respir J 2014;43:1691-7
   PubMed Web of Science ®Google Scholar
• Umetsu T, Murata T, Nishio S. Studies on the antiplatelet effect of the stable epoprostenol analogue beraprost sodium and its mechanism of action in rats. Arzneimittelforschung 1989;39:68-73
   PubMed Web of Science ®Google Scholar
• Barst RJ, McGoon M, McLaughlin V, et al. Beraprost therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2003;41:2119-25
   PubMed Web of Science ®Google Scholar
• McNulty MJ, Sailstad JM, Steffen RP. The pharmacokinetics and pharmacodynamics of the prostacyclin analog 15AU81 in the anesthetized beagle dog. Prostaglandins Leukot Essent Fatty Acids 1993;48:159-66
   PubMed Web of Science ®Google Scholar
• RemodulinTM. Treprostinil sodium. United Therapeutics Corporation; MD, USA: 2002
   Google Scholar
• Rollins K, Laliberte K, Gotzkowsky K, et al. Overview of the Drug-Drug Interaction Potential with Treprostinil. Am J Respir Crit Care Med 2009;179.1:A3367. American Thoracic Society International Conference; 15-20 May 2009, San Diego, CA
   Google Scholar
• Gotzkowsky SK, Dingemanse J, Lai A, et al. Lack of a pharmacokinetic interaction between oral treprostinil and bosentan in healthy adult volunteers. J Clin Pharmacol 2010;50:829-34
   PubMed Web of Science ®Google Scholar
• White RJ, Allen R, Torres F, et al. Sustained plasma concentrations of treprostinil following chronic dosing of oral treprostinil in patients with pulmonary arterial hypertension. Am J Respir Crit Care Med 2009. 179:A3360-Poster presented at: American Thoracic Society International Conference; 15-20 May 2009, San Diego, CA
   Google Scholar
• Wade M, Hunt TL, Lai AA. Effect of continuous subcutaneous treprostinil therapy on the pharmacodynamics and pharmacokinetics of warfarin. J Cardiovasc Pharmacol 2003;41:908-15
   PubMed Web of Science ®Google Scholar
• FREEDOM-C: oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH). Available from: http://clinicaltrials.gov/show/NCT00325442
   Google Scholar
• Tapson VF, Torres F, Kermeen F, et al. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients on background endothelin receptor antagonist and/or phosphodiesterase type 5 inhibitor therapy (The FREEDOM-C Study): a randomized controlled trial. Chest 2012;142:1383-90
   PubMed Web of Science ®Google Scholar
• Tapson VF, Jing ZC, Xu KF, et al. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C2 study): a randomized controlled trial. Chest 2013;144:952-8
   PubMed Web of Science ®Google Scholar
• Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension (FREEDOM-C2). Available from: http://clinicaltrials.gov/show/NCT00887978
   Google Scholar
• FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH). Available from: http://clinicaltrials.gov/show/NCT00325403
   Google Scholar
• Jing ZC, Parikh K, Pulido T, et al. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation 2013;127:624-33
   PubMed Web of Science ®Google Scholar
• White RJ, Torres F, Allen R, et al. Pharmacokinetics of oral treprostinil sustained release tablets during chronic administration to patients with pulmonary arterial hypertension. J Cardiovasc Pharmacol 2013;61:474-81
   PubMed Web of Science ®Google Scholar
• Waxman AB. Oral prostacyclin therapy for pulmonary arterial hypertension: another step forward. Circulation 2013;127:563-5
   PubMedGoogle Scholar
• ACTELION. Available from: www.actelion.com
   Google Scholar
• Trial of the Early Combination of Oral Treprostinil With a PDE-5 Inhibitor or ERA in Subjects With Pulmonary Arterial Hypertension (FREEDOM-EV). Available from: http://clinicaltrials.gov/show/NCT01560624
   Google Scholar