399
Views
23
CrossRef citations to date
0
Altmetric
Drug Profile

Treprostinil for the treatment of pulmonary arterial hypertension

&
Pages 13-25 | Published online: 10 Jan 2014

References

  • McLaughlin VV, Archer SL, Badesch DB et al.; American College of Cardiology Foundation Task Force on Expert Consensus Documents; American Heart Association; American College of Chest Physicians; American Thoracic Society, Inc; Pulmonary Hypertension Association. ACCF/AHA 2009 expert consensus document on pulmonary hypertension a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association developed in collaboration with the American College of Chest Physicians; American Thoracic Society, Inc.; and the Pulmonary Hypertension Association. J. Am. Coll. Cardiol. 53(17), 1573–1619 (2009).
  • Humbert M, Sitbon O, Simonneau G. Treatment of pulmonary arterial hypertension. N. Engl. J. Med. 351(14), 1425–1436 (2004).
  • Clapp LH, Finney P, Turcato S, Tran S, Rubin LJ, Tinker A. Differential effects of stable prostacyclin analogs on smooth muscle proliferation and cyclic AMP generation in human pulmonary artery. Am. J. Respir. Cell Mol. Biol. 26(2), 194–201 (2002).
  • Humbert M, Morrell NW, Archer SL et al. Cellular and molecular pathobiology of pulmonary arterial hypertension. J. Am. Coll. Cardiol. 43(12 Suppl. S), 13S–24S (2004).
  • Barst RJ, Rubin LJ, Long WA et al.; Primary Pulmonary Hypertension Study Group. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N. Engl. J. Med. 334(5), 296–301 (1996).
  • Rubin LJ, Mendoza J, Hood M et al. Treatment of primary pulmonary hypertension with continuous intravenous prostacyclin (epoprostenol). Results of a randomized trial. Ann. Intern. Med. 112(7), 485–491 (1990).
  • United Therapeutics Corporation. Tyvaso (treprostinil) inhalation solution. United States Food and Drug Administration Drug Product Label (2011).
  • United Therapeutics Corporation. Remodulin (treprostinil) injection solution. United States Food and Drug Administration Drug Product Label (2011).
  • Humbert M, Sitbon O, Chaouat A et al. Pulmonary arterial hypertension in France: results from a national registry. Am. J. Respir. Crit. Care Med. 173(9), 1023–1030 (2006).
  • Rich S, Dantzker DR, Ayres SM et al. Primary pulmonary hypertension. A national prospective study. Ann. Intern. Med. 107(2), 216–223 (1987).
  • Yigla M, Kramer MR, Bendayan D, Reisner SA, Solomonov A. Unexplained severe pulmonary hypertension in the elderly: report on 14 patients. Isr. Med. Assoc. J. 6(2), 78–81 (2004).
  • Machado RD, Aldred MA, James V et al. Mutations of the TGF-b type II receptor BMPR2 in pulmonary arterial hypertension. Hum. Mutat. 27(2), 121–132 (2006).
  • CoganJD, Vnencak-JonesCL, PhillipsJA 3rd et al. Gross BMPR2 gene rearrangements constitute a new cause for primary pulmonary hypertension. Genet. Med. 7(3), 169–174 (2005).
  • Koehler R, Grünig E, Pauciulo MW et al. Low frequency of BMPR2 mutations in a German cohort of patients with sporadic idiopathic pulmonary arterial hypertension. J. Med. Genet. 41(12), e127 (2004).
  • Thomson J, Machado R, Pauciulo M et al. Familial and sporadic primary pulmonary hypertension is caused by BMPR2 gene mutations resulting in haploinsufficiency of the bone morphogenetic protein tùype II receptor. J. Heart Lung Transplant. 20(2), 149 (2001).
  • Machado RD, Pauciulo MW, Thomson JR et al. BMPR2 haploinsufficiency as the inherited molecular mechanism for primary pulmonary hypertension. Am. J. Hum. Genet. 68(1), 92–102 (2001).
  • Thomson JR, Machado RD, Pauciulo MW et al. Sporadic primary pulmonary hypertension is associated with germline mutations of the gene encoding BMPR-II, a receptor member of the TGF-β family. J. Med. Genet. 37(10), 741–745 (2000).
  • Lane KB, Machado RD, Pauciulo MW et al. Heterozygous germline mutations in BMPR2, encoding a TGF-β receptor, cause familial primary pulmonary hypertension. Nat. Genet. 26(1), 81–84 (2000).
  • Loyd JE, Phillips JA. Heritable pulmonary arterial hypertension. In:Gene Reviews. Pagon RA, Bird TD, Dolan CR, Stephens K (Eds). GeneReviews™, University of Washington, Seattle, WA, USA (1993).
  • Benza RL, Miller DP, Barst RJ, Badesch DB, Frost AE, McGoon MD. An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from the REVEAL Registry. Chest 142(2), 448–456 (2012).
  • Barst RJ, Gibbs JS, Ghofrani HA et al. Updated evidence-based treatment algorithm in pulmonary arterial hypertension. J. Am. Coll. Cardiol. 54(1 Suppl.), S78–S84 (2009).
  • Galie N, Hoeper MM, Humbert M et al. Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur. Respir. J. 34(6), 1219–1263 (2009).
  • 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 48(2), 159–166 (1993).
  • Steffen RP, de la Mata M. The effects of I5AU8I, a chemically stable prostacyclin analog, on the cardiovascular and renin–angiotensin systems of anesthetized dogs [corrected]. Prostaglandins Leukot. Essent. Fatty Acids 43(4), 277–286 (1991).
  • Tuder RM, Cool CD, Geraci MW et al. Prostacyclin synthase expression is decreased in lungs from patients with severe pulmonary hypertension. Am. J. Respir. Crit. Care Med. 159(6), 1925–1932 (1999).
  • 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. 327(2), 70–75 (1992).
  • Whittle BJ, Silverstein AM, Mottola DM, Clapp LH. Binding and activity of the prostacyclin receptor (IP) agonists, treprostinil and iloprost, at human prostanoid receptors: treprostinil is a potent DP1 and EP2 agonist. Biochem. Pharmacol. 84(1), 68–75 (2012).
  • Vane JR, Botting RM. Pharmacodynamic profile of prostacyclin. Am. J. Cardiol. 75(3), 3A–10A (1995).
  • Li Y, Connolly M, Nagaraj C et al. Peroxisome proliferator-activated receptor-b/d, the acute signaling factor in prostacyclin-induced pulmonary vasodilation. Am. J. Respir. Cell Mol. Biol. 46(3), 372–379 (2012).
  • Falcetti E, Hall SM, Phillips PG et al. Smooth muscle proliferation and role of the prostacyclin (IP) receptor in idiopathic pulmonary arterial hypertension. Am. J. Respir. Crit. Care Med. 182(9), 1161–1170 (2010).
  • Falcetti E, Flavell DM, Staels B, Tinker A, Haworth SG, Clapp LH. IP receptor-dependent activation of PPARγ by stable prostacyclin analogues. Biochem. Biophys. Res. Commun. 360(4), 821–827 (2007).
  • Ali FY, Egan K, Fitzgerald GA et al. Role of prostacyclin versus peroxisome proliferator-activated receptor β receptors in prostacyclin sensing by lung fibroblasts. Am. J. Respir. Cell Mol. Biol. 34(2), 242–246 (2006).
  • Wade M, Baker FJ, Roscigno R, DellaMaestra W, Hunt TL, Lai AA. Absolute bioavailability and pharmacokinetics of treprostinil sodium administered by acute subcutaneous infusion. J. Clin. Pharmacol. 44(1), 83–88 (2004).
  • Nelsen AC, Laliberte KL, Zaccardelli DS, Gotzkowsky SK. Pharmacokinetics of inhaled treprostinil sodium in healthy volunteers. Am. J. Respir. Crit. Care Med. 181, (2010) (Abstract A3348).
  • White RJ, Allen R, Torres F et al. Sustained plasma concentrations of treprostinil following chronic dosing in patients with pulmonary arterial hypertension. Am. J. Respir. Crit. Care Med. 179, (2009) (Abstract A3360).
  • Laliberte K, Goetz B, Phares K, Mottola D. Sustained treprostinil concentrations following administration of UT-15C (treprostinil diethanolamine) sustained release tablets in healthy volunteers. Am. J. Respir. Crit. Care Med. 175, (2007) (Abstract A399).
  • McSwain CS, Benza R, Shapiro S et al. Dose proportionality of treprostinil sodium administered by continuous subcutaneous and intravenous infusion. J. Clin. Pharmacol. 48(1), 19–25 (2008).
  • Bourge RC, Tapson VF, Safdar Z et al. Rapid transition from inhaled iloprost to inhaled treprostinil in patients with pulmonary arterial hypertension. Cardiovasc. Ther. doi:10.1111/1755-5922.12008 (2012) (Epub ahead of print).
  • Rollins K, Laliberte K, Gotzkowsky K, Wade M, Mottola D. Overview of the drug–drug interaction potential with treprostinil. Am. J. Respir. Crit. Care Med. 179, Abstract A3367 (2009).
  • Gotzkowsky SK, Dingemanse J, Lai A, Mottola D, Laliberte K. Lack of a pharmacokinetic interaction between oral treprostinil and bosentan in healthy adult volunteers. J. Clin. Pharmacol. 50(7), 829–834 (2010).
  • Gotzkowsky K, Laliberte K, Goetz B, Mottala D. Lack of pharmacokinetic drug interaction following co-administration of UT-15C (treprostinil diethanolamine) SR and Revatio (sildenafil citrate) in healthy volunteers. Am. J. Respir. Crit. Care Med. 175, Abstract A398 (2007).
  • Peterson L, Marbury T, Laliberte K. An evaluation of the pharmacokinetics and safety of a single dose of UT-15CSR (treprostinil diethanolamine) in subjects with hepatic impairment compared with healthy volunteers. Am. J. Respir. Crit. Care Med. 183, (2011) (Abstract A5904).
  • Jenkins A, Walker S, Flinchbaugh R, Marbury T, Laliberte KJ. Pharmacokinetic evaluation of treprostinil diethanolamine in volunteers with end stage renal disease on dialysis. Am. J. Respir. Crit. Care Med. 183, (2011) (Abstract A5911).
  • Simonneau G, Barst RJ, Galie N et al.; Treprostinil Study Group. 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. 165(6), 800–804 (2002).
  • 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 129(3), 683–688 (2006).
  • Hiremath J, Thanikachalam S, Parikh K et al.; TRUST Study Group. Exercise improvement and plasma biomarker changes with intravenous treprostinil therapy for pulmonary arterial hypertension: a placebo-controlled trial. J. Heart Lung Transplant. 29(2), 137–149 (2010).
  • Vachiéry JL, Hill N, Zwicke D, Barst R, Blackburn S, Naeije R. Transitioning from i.v. epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension. Chest 121(5), 1561–1565 (2002).
  • Gomberg-Maitland M, Tapson VF, Benza RL et al. Transition from intravenous epoprostenol to intravenous treprostinil in pulmonary hypertension. Am. J. Respir. Crit. Care Med. 172(12), 1586–1589 (2005).
  • Rubenfire M, McLaughlin VV, Allen RP et al. Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. Chest 132(3), 757–763 (2007).
  • Sitbon O, Manes A, Jais X et al. Rapid switch from intravenous epoprostenol to intravenous treprostinil in patients with pulmonary arterial hypertension. J. Cardiovasc. Pharmacol. 49(1), 1–5 (2007).
  • McLaughlin VV, Gaine SP, Barst RJ et al.; Treprostinil Study Group. Efficacy and safety of treprostinil: an epoprostenol analog for primary pulmonary hypertension. J. Cardiovasc. Pharmacol. 41(2), 293–299 (2003).
  • Benza RL, Rayburn BK, Tallaj JA, Pamboukian SV, Bourge RC. Treprostinil-based therapy in the treatment of moderate-to-severe pulmonary arterial hypertension: long-term efficacy and combination with bosentan. Chest 134(1), 139–145 (2008).
  • Barst RJ, Galie N, Naeije R et al. Long-term outcome in pulmonary arterial hypertension patients treated with subcutaneous treprostinil. Eur. Respir. J. 28(6), 1195–1203 (2006).
  • Sadushi-Koliçi R, Skoro-Sajer N, Zimmer D et al. Long-term treatment, tolerability, and survival with sub-cutaneous treprostinil for severe pulmonary hypertension. J. Heart Lung Transplant. 31(7), 735–743 (2012).
  • 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. 55(18), 1915–1922 (2010).
  • Mathier MA, McDevitt S, Saggar R. Subcutaneous treprostinil in pulmonary arterial hypertension: practical considerations. J. Heart Lung Transplant. 29(11), 1210–1217 (2010).
  • Voswinckel R, van Dijk A, Edelmann R et al. Long-term open label treatment with inhaled treprostinil for pulmonary arterial hypertension. Am. J. Respir. Crit. Care Med. 179, (2009) (Abstract A3352).
  • Benza RL, Seeger W, McLaughlin VV et al. Long-term effects of inhaled treprostinil in patients with pulmonary arterial hypertension: the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study open-label extension. J. Heart Lung Transplant. 30(12), 1327–1333 (2011).
  • 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) (Epub ahead of print).
  • Rubin LJ, Parikh K, Pulido T et al. FREEDOM-M: efficacy and safety of oral treprostinil diethanolamine as monotherapy in patients with pulmonary arterial hypertension. Chest 140, Abstract 1044A (2011).
  • Tapson V, Jing ZC, Xu K et al. FREEDOM-C2: efficacy and safety of oral treprostinil diethanolamine in combination with an ERA and/or a PDE-5 inhibitor in patients with pulmonary arterial hypertension. Am. J. Respir. Crit. Care Med. 185, (2012) (Abstract A2493).
  • Soto FJ, Jain P, Kleczka J et al. Clinical and hemodynamic impact of subcutaneous (SQ) treprostinil (Remodulin) in the management of pulmonary arterial hypertension (PAH): single-center experience. Chest 130(Suppl.), S120 (2006).
  • Soto FJ, Derksen T, Janusz J et al. Single center experience with rapid dose escalation of sub-cutaneous (SQ) treprostinil for the treatment of pulmonary arterial hypertension. Presented at: the Pulmonary Hypertension Association 7th International PH Conference. Minneapolis, MN, USA, 23–25 June 2006.
  • Skoro-Sajer N, Lang IM, Harja E, Kneussl MP, Sing WG, Gibbs SJ. A clinical comparison of slow- and rapid-escalation treprostinil dosing regimens in patients with pulmonary hypertension. Clin. Pharmacokinet. 47(9), 611–618 (2008).
  • Voswinckel R, Enke B, Reichenberger F et al. Favorable effects of inhaled treprostinil in severe pulmonary hypertension: results from randomized controlled pilot studies. J. Am. Coll. Cardiol. 48(8), 1672–1681 (2006).
  • Voswinckel R, Reichenberger F, Gall H et al. Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension. Pulm. Pharmacol. Ther. 22(1), 50–56 (2009).
  • Steringer-Mascherbauer R, Andreassen A, Boonstra A et al. First multi-center long term experience and safety data of intravenous treprostinil administered by the implantable infusion pump Lenus Pro®. Am. J. Respir. Crit. Care Med. 185, (2012) (Abstract A4102).
  • Steringer-Mascherbuaer R, Eder V, Huber C et al. Transitioning from subcutaneous to intravenous treprostinil administered by the implantable infusion pump Lenus Pro®: a single-center pilot study. Am. J. Respir. Crit. Care Med. 185, (2012) (Abstract A4807).
  • Badesch DB, McLaughlin VV, Delcroix M et al. Prostanoid therapy for pulmonary arterial hypertension. J. Am. Coll. Cardiol. 43(12 Suppl. S), 56S–61S (2004).
  • Centers for Disease Control and Prevention. Bloodstream infections among patients treated with intravenous epoprostenol or intravenous treprostinil for pulmonary arterial hypertension – seven sites, United States, 2003–3006. MMWR Morb. Mortal. Wkly Rep. 56(8), 170–172 (2007).
  • Kitterman N, Poms A, Miller DP, Lombardi S, Farber HW, Barst RJ. Bloodstream infections in patients with pulmonary arterial hypertension treated with intravenous prostanoids: insights from the REVEAL REGISTRY®. Mayo Clin. Proc. 87(9), 825–834 (2012).
  • Rich JD, Glassner C, Wade M et al. The effect of diluent pH on bloodstream infection rates in patients receiving IV treprostinil for pulmonary arterial hypertension. Chest 141(1), 36–42 (2012).
  • Doran AK, Ivy DD, Barst RJ, Hill N, Murali S, Benza RL; Scientific Leadership Council of the Pulmonary Hypertension Association. Guidelines for the prevention of central venous catheter-related blood stream infections with prostanoid therapy for pulmonary arterial hypertension. Int. J. Clin. Pract. Suppl. 160, 5–9 (2008).
  • Skoro-Sajer N, Bonderman D, Wiesbauer F et al. Treprostinil for severe inoperable chronic thromboembolic pulmonary hypertension. J. Thromb. Haemost. 5(3), 483–489 (2007).
  • Levin Y, Frutiger K, Heininger A, Wessman K, White RJ. Assessing an established method for subcutaneous treprostinil: a formal study of aggressive pain management and infrequent site changes. Chest 138(4), 368A (2010).
  • Barst RJ, Galie N, Naeije R et al. Long-term outcome in pulmonary arterial hypertensions patients treated with subcutaneous treprostinil. Eur. Respir. J. 28(6), 1195–1203(2006).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.