Endpoints in pulmonary arterial hypertension: The role of clinical worsening

Current Opinion in Pulmonary Medicine

Volumn 16, Issue SUPPL. 1, 2010, Pages

  Peacock, Andrew ^a   Keogh, Anne ^b   Humbert, Marc ^c  

^a Scottish Pulmonary Vascular Unit   (United Kingdom)

^b St Vincenta's Hospital   (Australia)

^c HÔPITAL ANTOINE BÉCLÈRE   (France)

Author keywords

Clinical worsening; Morbidity; Mortality; Survival; Time to clinical worsening

Indexed keywords

AMBRISENTAN; BOSENTAN; ENDOTHELIN RECEPTOR ANTAGONIST; ILOPROST; PHOSPHODIESTERASE V; PLACEBO; PROSTACYCLIN; PROSTANOID; SILDENAFIL; SITAXSENTAN; TADALAFIL;

CARDIOPULMONARY EXERCISE TEST; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DISEASE CLASSIFICATION; DISEASE COURSE; DRUG EFFICACY; EXERCISE; HEMODYNAMIC PARAMETERS; HUMAN; LUNG FUNCTION TEST; MORBIDITY; MORTALITY; PULMONARY HYPERTENSION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REVIEW; SIX MINUTE WALK DISTANCE; SURVIVAL RATE; TREATMENT OUTCOME; WORLD HEALTH ORGANIZATION;

DISEASE PROGRESSION; ENDPOINT DETERMINATION; HEMODYNAMICS; HUMANS; HYPERTENSION, PULMONARY; PHYSICAL ENDURANCE; TREATMENT OUTCOME; WORLD HEALTH ORGANIZATION;

EID: 77951054360     PISSN: 10705287     EISSN: 15316971     Source Type: Journal    
DOI: 10.1097/01.mcp.0000370205.22885.98     Document Type: Review

References (38)

1. 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.
2. Sitbon O, McLaughlin VV, Badesch DB, et al. Survival in patients with class III idiopathic pulmonary arterial hypertension treated with first line oral bosentan compared with an historical cohort of patients started on intravenous epoprostenol. Thorax 2005; 60:1025-1030.
3. McLaughlin VV. Survival in patients with pulmonary arterial hypertension treated with first-line bosentan. Eur J Clin Invest 2006; 36 (Suppl 3): 10-15.
4. 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.
5. American Thoracic Society committee on proficiency standards for clinical pulmonary function laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166:111-117.
6. Bittner V, Weiner DH, Yusuf S, et al. Prediction of mortality and morbidity with a 6-min walk test in patients with left ventricular dysfunction. SOLVD Investigators. JAMA 1993; 270:1702-1707.
7. Cahalin LP, Mathier MA, Semigran MJ, et al. The six-minute walk test predicts peak oxygen uptake and survival in patients with advanced heart failure. Chest 1996; 110:325-332.
8. Cote CG, Celli BR. Predictors of mortality in chronic obstructive pulmonary disease. Clin Chest Med 2007; 28:515-524.
9. Kessler R, Faller M, Fourgaut G, et al. Predictive factors of hospitalization for acute exacerbation in a series of 64 patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1999; 159:158-164.
10. Goode KM, Nabb S, Cleland JG, Clark AL. A comparison of patient and physician-rated New York heart association class in a community-based heart failure clinic. J Card Fail 2008; 14:379-387.
11. Channick RN, Simonneau G, Sitbon O, et al. Effects of the dual endothelinreceptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet 2001; 358:1119-1123. (Pubitemid 32971843)
12. Rubin LJ, Badesch DB, Barst RJ, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002; 346:896-903.
13. Barst RJ, Langleben D, Frost A, et al. Sitaxsentan therapy for pulmonary arterial hypertension. Am J Respir Crit Care Med 2004; 169:441-447.
14. Barst RJ, Langleben D, Badesch D, et al. Treatment of pulmonary arterial hypertension with the selective endothelin-A receptor antagonist sitaxsentan. J Am Coll Cardiol 2006; 47:2049-2056.
15. Galiè N, Olschewski H, Oudiz RJ, et al. Ambrisentan for the treatment of pulmonary arterial hypertension: results of the ambrisentan in pulmonary arterial hypertension, randomized, double-blind, placebo-controlled, multicenter, efficacy (ARIES) study 1 and 2. Circulation 2008; 117:3010-3019.
16. Galie N, Ghofrani HA, Torbicki A, et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med 2005; 353:2148-2157. (Pubitemid 41653106)
17. McLaughlin VV, Oudiz RJ, Frost A, et al. Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension. Am J Respir Crit Care Med 2006; 174:1257-1263.
18. Galiè N, Rubin LJ, Hoeper M, et al. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet 2008; 371:2093-2100.
19. Galiè N, Brundage BH, Ghofrani HA, et al. Tadalafil therapy for pulmonary arterial hypertension. Circulation 2009; 119:2894-2903.
20. Simonneau G, Rubin LJ, Galie N, et al. Addition of sildenafil to long-term intravenous epoprostenol therapy in patients with pulmonary arterial hypertension: a randomized trial. Ann Intern Med 2008; 149:521-530.
21. Ware JEJ, Kosinski M, Gandek B. SF-36 (Health Survey: Manual &Interpretation Guide). II ed. Lincoln RI: Qualitymetric, Inc.; 2000.
22. McKenna SP, Doughty N, Meads DM, et al. The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR): a measure of health-related quality of life and quality of life for patients with pulmonary hypertension. Qual Life Res 2006; 15:103-115.
23. Keogh AM, McNeil KD, Wlodarczyk J, et al. Quality of life in pulmonary arterial hypertension: improvement and maintenance with bosentan. J Heart Lung Transplant 2007; 26:181-187.
24. Vachié ry J-L, Coghlan G. Screening for pulmonary arterial hypertension in systemic sclerosis. Eur Respir Rev 2009; 18:162-169.
25. 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.
26. Barst RJ, Gibbs JS, Ghofrani HA, et al. Updated evidence-based treatment algorithm in pulmonary arterial hypertension. J Am Coll Cardiol 2009; 54 (1 Suppl):S78-S84.
27. Nagaya N, Nishikimi T, Uematsu M, et al. Plasma brain natriuretic peptide as a prognostic indicator in patients with primary pulmonary hypertension. Circulation 2000; 102:865-870.
28. Williams MH, Handler CE, Akram R, et al. Role of N-terminal brain natriuretic peptide (N-TproBNP) in scleroderma-associated pulmonary arterial hypertension. Eur Heart J 2006; 27:1485-1494.
29. Miyamoto S, Nagaya N, Satoh T, et al. Clinical correlates and prognostic significance of six-minute walk test in patients with primary pulmonary hypertension. Comparison with cardiopulmonary exercise testing. Am J Respir Crit Care Med 2000; 161 (2 Pt 1):487-492.
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. Provencher S, Sitbon O, Simonneau G. Treatment of pulmonary arterial hypertension with bosentan: from pathophysiology to clinical evidence. Expert Opin Pharmacother 2005; 6:1337-1348.
32. Humbert M, Sitbon O, Chaouat A, et al. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med 2006; 173:1023-1030.
33. Macchia A, Marchioli R, Marfisi R, et al. A meta-analysis of trials of pulmonary hypertension: a clinical condition looking for drugs and research methodology. Am Heart J 2007; 153:1037-1047.
34. Provencher S, Sitbon O, Humbert M, et al. Long-term outcome with first-line bosentan therapy in idiopathic pulmonary arterial hypertension. Eur Heart J 2006; 27:589-595.
35. Mereles D, Ehlken N, Kreuscher S, et al. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation 2006; 114:1482-1489.
36. Frost AE, Langleben D, Oudiz R, et al. The 6-min walk test (6MW) as an efficacy endpoint in pulmonary arterial hypertension clinical trials: demonstration of a ceiling effect. Vascul Pharmacol 2005; 43:36-39.
37. McLaughlin VV, Shillington A, Rich S. Survival in primary pulmonary hypertension: the impact of epoprostenol therapy. Circulation 2002; 106:1477-1482.
38. Ferreira-Gonzalez I, Permanyer-Miralda G, Busse JW, et al. Methodologic discussions for using and interpreting composite endpoints are limited, but still identify major concerns. J Clin Epidemiol 2007; 60:651-657.