Clinical Effects of Treprostinil for Pulmonary Arterial Hypertension: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

 ZHAOHong-lin ¹ , YAOLiang ² , ZHANGXin-dao ³

1. Department of Cardiovascular Surgery, the First Hospital of Lanzhou University, Lanzhou 730000, China;
2. School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China;
3. Department of Pediatrics, the First Hospital of Lanzhou University, Lanzhou 730000, China;

Corresponding author：

Keywords：

Pulmonary arterial hypertension; Treprostinil; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20160033

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Objective To systematically review the efficacy and safety of treprostinil for patients with pulmonary arterial hypertension (PAH). Method Databases including PubMed, EMbase, The Cochrane Library (Issue 2, 2015) , WanFang Data, CBM and CNKI were searched to collect randomized controlled trials (RCTs) about treprostinil for PAH from inception to 1^st May 2015. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software. Results A total of seven RCTs including 1 662 participants were finally included. The results of meta-analysis showed that, compared with placebo, treprostinil could increase patients' 6-min walk distance (MD=19.62, 95%CI 0.55 to 38.69, P=0.63) , reduce Brog score (MD=-0.52, 95%CI -0.96 to -0.07, P=0.06) , decrease pulmonary vascular resistance (MD=-3.23, 95%CI -4.80 to -1.66, P=0.42) and improve cardiac index (MD=0.19, 95%CI 0.08 to 0.30, P=0.44) , but there were no significant differences between two groups in incidence of mortality (OR=0.84, 95%CI 0.47 to 1.50, P=0.82) and clinical deterioration (OR=0.84, 95%CI 0.56 to 1.26, P=0.95) . Conclusions Current evidence reveals that treprostinil can improve excise capacity, respiratory function and ameliorate hemodynamic index, but can't reduce the incidence of mortality and clinical deterioration in patients with PAH.

Citation： ZHAOHong-lin, YAOLiang, ZHANGXin-dao. Clinical Effects of Treprostinil for Pulmonary Arterial Hypertension: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2016, 16(2): 212-218. doi: 10.7507/1672-2531.20160033 Copy

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12.	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(6) :1383-1390.
13.	Higgins JPT, Altman DG, Sterne, JAC (editors). Chapter 8:Assessing risk of bias in included studies. In:Higgins JPT, Green S (editors). Cochrane handbook for systematic reviews of interventions. Version 5.1.0. The Cochrane Collaboration, 2011. Available at:http:// handbook.cochrane.org.
14.	Nathan SD. Hypersensitivity pneumonitis and pulmonary hypertension:How the breeze affects the squeeze. Eur Respir J, 2014, 44(2) :287-288.
15.	Galiè N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension:The joint 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:Association for european paediatric and congenital cardiology (AEPC), international society for heart and lung transplantation (ISHLT). Eur Heart J, 2016, 37(1) :67-119.
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17.	Paramothayan NS, Lasserson TJ, Wells AU, et al. Prostacyclin for pulmonary hypertension in adults. Cochrane Database Syst Rev, 2005, 18(2) :CD002994.
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20.	He B, Zhang F, Li X, et al. Meta-analysis of randomized controlled trials on treatment of pulmonary arterial hypertension. Circ J, 2010, 74(7) :1458-1464.

1. 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: Developed in collaboration with the american college of chest physicians, american thoracic society, inc., and the pulmonary hypertension association. Circulation, 2009, 119(16) :2250-2294.
2. 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(5) :343-349.
3. Thenappan T, Shah SJ, Rich S, et al. A USA-based registry for pulmonary arterial hypertension:1982-2006. Eur Respir J, 2007, 30(6) :1103-1110.
4. Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med, 2004, 351(16) :1655-1665.
5. Nakanishi N, European Society of Cardiology, European Respiratory Society. 2009 ESC/ERS pulmonary hypertension guidelines and connective tissue disease. Allergol Int, 2011, 60(4) :419-424.
6. Hiremath J, Thanikachalam S, Parikh K, et al. Exercise improvement and plasma biomarker changes with intravenous treprostinil therapy for pulmonary arterial hypertension:A placebo-controlled trial. J Heart Lung Transplant, 2010, 29(2) :137-149.
7. 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(5) :624-633.
8. 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 Cardio, 2010, 55(18) : 1915-1922.
9. McLaughlin VV, Gaine SP, Barst RJ, et al. Efficacy and safety of treprostinil:An epoprostenol analog for primary pulmonary hypertension. J Cardiovasc Pharmacol, 2003, 41(2) :293-299.
10. 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(6) : 800-804.
11. 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(3) :952-958.
12. 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(6) :1383-1390.
13. Higgins JPT, Altman DG, Sterne, JAC (editors). Chapter 8:Assessing risk of bias in included studies. In:Higgins JPT, Green S (editors). Cochrane handbook for systematic reviews of interventions. Version 5.1.0. The Cochrane Collaboration, 2011. Available at:http:// handbook.cochrane.org.
14. Nathan SD. Hypersensitivity pneumonitis and pulmonary hypertension:How the breeze affects the squeeze. Eur Respir J, 2014, 44(2) :287-288.
15. Galiè N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension:The joint 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:Association for european paediatric and congenital cardiology (AEPC), international society for heart and lung transplantation (ISHLT). Eur Heart J, 2016, 37(1) :67-119.
16. Gabler NB, French B, Strom BL, et al. Validation of 6-minute walk distance as a surrogate end point in pulmonary arterial hypertension trials. Circulation, 2012, 126(3) :349-356.
17. Paramothayan NS, Lasserson TJ, Wells AU, et al. Prostacyclin for pulmonary hypertension in adults. Cochrane Database Syst Rev, 2005, 18(2) :CD002994.
18. Galiè N, Manes A, Negro L, et al. A meta-analysis of randomized controlled trials in pulmonary arterial hypertension. Eur Heart J, 2009, 30(4) :394-403.
19. Coeytaux RR, Schmit KM, Kraft BD, et al. Comparative effectiveness and safety of drug therapy for pulmonary arterial hypertension:A systematic review and meta-analysis. Chest, 2014, 145(5) :1055-1063.
20. He B, Zhang F, Li X, et al. Meta-analysis of randomized controlled trials on treatment of pulmonary arterial hypertension. Circ J, 2010, 74(7) :1458-1464.

Chinese Journal of Evidence-Based Medicine

Clinical Effects of Treprostinil for Pulmonary Arterial Hypertension: A Systematic Review

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