Inhaled treprostinil: A therapeutic review

Drug Design, Development and Therapy

Volumn 6, Issue , 2012, Pages 19-28

  Channick, Richard N ^a   Voswinckel, Robert ^b,c   Rubin, Lewis J ^d  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b JUSTUS LIEBIG UNIVERSITY GIESSEN   (Germany)

^c MAX PLANCK INSTITUTE FOR HEART AND LUNG RESEARCH   (Germany)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Inhaled; Nebulizer; Prostacyclin; Pulmonary arterial hypertension; Treprostinil

Indexed keywords

AMBRISENTAN; BOSENTAN; ENDOTHELIN RECEPTOR ANTAGONIST; ILOPROST; PHOSPHODIESTERASE V INHIBITOR; PLACEBO; PROSTACYCLIN; PROSTACYCLIN DERIVATIVE; SILDENAFIL; TADALAFIL; UNIPROST;

AREA UNDER THE CURVE; CLINICAL PRACTICE; CONNECTIVE TISSUE DISEASE; CONTINUOUS INFUSION; COUGHING; DIARRHEA; DISEASE ASSOCIATION; DIZZINESS; DOSE RESPONSE; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDICATION; DRUG INDUCED HEADACHE; DRUG INTERMITTENT THERAPY; DRUG MECHANISM; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRUG SELECTIVITY; DRUG STRUCTURE; DRUG TOLERABILITY; EXERCISE TEST; EXERCISE TOLERANCE; FLUSHING; FOOD AND DRUG ADMINISTRATION; HEART RIGHT VENTRICLE FAILURE; HEMODYNAMICS; HUMAN; LUNG VASCULAR RESISTANCE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; METERED DOSE INHALER; NAUSEA; NEBULIZER; NONHUMAN; OUTCOME ASSESSMENT; PATIENT SATISFACTION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PILOT STUDY; PULMONARY HYPERTENSION; QUALITY OF LIFE; REVIEW; RISK BENEFIT ANALYSIS; SIDE EFFECT; SINGLE DRUG DOSE; SORE THROAT; THROAT IRRITATION; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION;

ADMINISTRATION, INHALATION; ANTIHYPERTENSIVE AGENTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; EPOPROSTENOL; HUMANS; HYPERTENSION, PULMONARY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84857077469     PISSN: 11778881     EISSN: None     Source Type: Journal    
DOI: 10.2147/DDDT.S19281     Document Type: Review

References (32)

1. D'Alonzo GE, Barst RJ, Ayres SM, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991;115:343-349.
2. 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.
3. Simonneau G, Barst RJ, Galie N, et al; Treprostinil Study Group. Continuous subcutaneous infusion of treprostinil, a prostacyclin analog, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002;165:800-804.
4. Olschewski H, Simonneau G, Galie N, et al; Aerosolized Iloprost Randomized Study Group. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med. 2002;347:322-329.
5. Channick RN, Simonneau G, Sitbon O, et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomized placebo-controlled study. Lancet. 2001;358:1119-1123.
6. Rubin LJ, Badesch DB, Barst RJ, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002;346:896-903.
7. Galie N, Ghofrani HA, Torbicki A, et al; Sildenafil Use in Pulmonary Arterial Hypertension (SUPER) Study Group. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005;353:2148-2157.
8. Galiè N, Olschewski H, Oudiz RJ, et al; Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Studies (ARIES) Group. Ambrisentan for the treatment of pulmonary arterial hypertension: results of the ambrisentan in pulmonary arterial hypertension, randomized, double-blind, placebocontrolled, multicenter, efficacy (ARIES) study 1 and 2. Circulation. 2008;117:3010-3019.
9. Galiè N, Brundage BH, Ghofrani HA, et al; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009;119:2894-2903.
10. Barst RJ, Gibbs JS, Ghofrani HA, et al. Updated evidence- based treatment algorithm in pulmonary arterial hypertension. J Am Coll Cardiol. 2009; 54(Suppl):S78-S84.
11. McLaughlin VV, Archer SL, Badesch DB, et al. 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. J Am Coll Cardiol. 2009;53:1573-1619.
12. Galiè 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;30:2493-2537.
13. 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: 1915-1922.
14. Sandifer B, Brigham K, Lawrence E, et al. Potent effects of aerosol compared with intravenous treprostinil on the pulmonary circulation. J Appl Physiol. 2005;99:2363-2368.
15. Laliberte K, Arneson C, Jeffs R, Hunt T, Wade M. Pharmacokinetics and steady-state bioequivalence of treprostinil sodium (Remodulin) administered by the intravenous and subcutaneous route to normal volunteers. J Cardiovasc Pharmacol. 2004;44:209-214.
16. 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. 2010;50:829-834.
17. 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. 2006;48: 1672-1681.
18. Channick RN, Olschewski H, Seeger W, et al. Safety and efficacy of inhaled treprostinil as add-on therapy to bosentan in pulmonary arterial hypertension. J Am Coll Cardiol. 2006;48:1433-1437.
19. Nelsen AC, Laliberte KJ, Zaccardelli DS, Gotzkowsky SK. Pharmacokinetics of inhaled treprostinil sodium in healthy volunteers. Am J Respir Crit Care Med. 2010;181:A3348.
20. Barst RJ, Galie N, Naeije R, et al. Long-term outcome in pulmonary arterial hypertension patients treated with subcutaneous treprostinil. Eur Respir J. 2006;28:1195-1203.
21. Mathier MA, McDevitt S, Saggar R. Subcutaneous treprostinil in pulmonary arterial hypertension: Practical considerations. J Heart Lung Transplant. 2010;29:1210-1217.
22. 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: 683-688.
23. 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 placebocontrolled trial. J Heart Lung Transplant. 2010;29:137-149.
24. Voswinckel R, Ghofrani H, Grimminger F, Seeger W. Inhaled treprostinil for treatment of chronic pulmonary hypertension. Ann Intern Med. 2006;144:149-150.
25. Voswinckel R, Reichenberger F, Enke B, et al. Acute effects of the combination of sildenafil and inhaled treprostinil on haemodynamics and gas exchange in pulmonary hypertension. Pulm Pharmacol Ther. 2008;21:824-832.
26. Benza R, Rubin LJ, McLaughlin VV, et al. TRIUMPH 1: Long-term safety and efficacy of inhaled treprostinil sodium in patients with PAH - two year follow-up. Am J Respir Crit Care Med. 2009;179:A1041.
27. Bourge R, Tapson VF, Safdar Z, et al. Safely transitioning from inhaled iloprost to inhaled treprostinil sodium - results from a multicenter open-label study in patients with pulmonary arterial hypertension. Am J Respir Crit Care Med. 2010;181:A3342.
28. Voswinckel R, Reichenberger F, Gall H, et al. Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension. Pulm Pharmacol Ther. 2009;22:50-56.
29. McLaughlin VV, Shillington A, Rich S. Survival in primary pulmonary hypertension: the impact of epoprostenol therapy. Circulation. 2002;106:1477-1482.
30. Sitbon O, Humbert M, Nunes H, et al. Long-term intravenous epoprostenol infusion in primary pulmonary hypertension: prognostic factors and survival. J Am Coll Cardiol. 2002;40:780-788.
31. Hoeper MM, Markevych I, Spiekerkoetter E, Welte T, Niedermeyer J. Goal-oriented treatment and combination therapy for pulmonary arterial hypertension. Eur Respir J. 2005;26:858-863.
32. Sitbon O, Galiè N. Treat-to-target strategies in pulmonary arterial hypertension: the importance of using multiple goals. Eur Respir Rev. 2010;19:272-278.