- 1.
Galie N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, 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 [Internet]. 2009 Oct;30(20):2493–2537. [cited 2014 Jul 14]; Available from:
http://eurheartj.oxfordjournals.org/content/30/20/2493.full.pdf+html. [
PubMed: 19713419]
- 2.
Tapson VF, Humbert M. Incidence and prevalence of chronic thromboembolic pulmonary hypertension: from acute to chronic pulmonary embolism.
Proc Am Thorac Soc. 2006 Sep;3(7):564–567. [
PubMed: 16963534]
- 3.
- 4.
Tanabe N, Sugiura T, Tatsumi K. Recent progress in the diagnosis and management of chronic thromboembolic pulmonary hypertension.
Respir Investig. 2013 Sep;51(3):134–146. [
PubMed: 23978639]
- 5.
Corsico AG, D'Armini AM, Cerveri I, Klersy C, Ansaldo E, Niniano R, et al. Long-term outcome after pulmonary endarterectomy.
Am J Respir Crit Care Med. 2008 Aug 15;178(4):419–424. [
PubMed: 18556630]
- 6.
Pepke-Zaba J, Jansa P, Kim NH, Naeije R, Simonneau G. Chronic thromboembolic pulmonary hypertension: role of medical therapy.
Eur Respir J. 2013 Apr;41(4):985–990. [
PubMed: 23397304]
- 7.
Clinical study report no. A62508. Randomized, double-blind, placebo-controlled, multicentre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (I mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) [CONFIDENTIAL internal manufacturer's report]. Leverkusen (DE): Bayer Healthcare; Oct 30, 2012.
- 8.
CDR submission: PrAdempas® riociguat (film-coated) tablet 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg; Company: Bayer Inc.[CONFIDENTIAL manufacturer's submission]. Toronto: Bayer Inc.; Sep 27, 2013.
- 9.
Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
Adempas (riociguat) tablets. Company: Bayer Healthcare Pharmaceuticals Inc. Application no.: 204819. Approval date: 10/8/2013. Rockville (MD): FDA; 2013. [cited 2014 Feb 28]. Statistical review(s) [Internet] (FDA drug approval package). Available from:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000TOC.cfm.
- 10.
- 11.
PrRemodulin® treprostinil sodium Injection, 1.0, 2.5, 5.0 and 10.0 mg/mL of treprostinil [product monograph]. Research Triangle Park (NC): United Therapeutics Corporation; Sep 25, 2008.
- 12.
PrFlolan® for injection. Epoprostenal sodium 0.5 or 1.5 mg per vial [product monograph]. Mississauga (ON): GlaxoSmithKline Inc.; Nov 11, 2011.
- 13.
Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, et al. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension.
N Engl J Med. 2013 Jul 25;369(4):319–329. [
PubMed: 23883377]
- 14.
Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
Adempas (riociguat) tablets. Company: Bayer Healthcare Pharmaceuticals Inc. Application no.: 204819. Approval date: 10/8/2013. Rockville (MD): FDA; 2013. [cited 2014 Feb 28]. Medical review(s) [Internet] (FDA drug approval package). Available from:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000TOC.cfm.
- 15.
Health Canada reviewer's report: Adempas (riociguat) [CONFIDENTIAL internal report]. Ottawa: Therapeutic Products Directorate, Health Canada; 2013.
- 16.
Sinnott PL, Joyce VR, Barnett PG.
Preference measurement in economic analysis. Guidebook [Internet]. Menlo Park (CA): Health Economics Resource Center (HERC); Mar, 2007. [cited 2014 Apr 22]. Available from:
http://www.herc.research.va.gov/files/BOOK_419.pdf.
- 17.
- 18.
Jais X, D'Armini AM, Jansa P, Torbicki A, Delcroix M, Ghofrani HA, et al. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial.
J Am Coll Cardiol. 2008 Dec 16;52(25):2127–2134. [
PubMed: 19095129]
- 19.
- 20.
Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, et al. Supplementary appendix: riociguat for the treatment of chronic thromboembolic pulmonary hypertension.
N Engl J Med. 2013 Jul 25;369(4):319–329. [
PubMed: 23883377]
- 21.
ClinicalTrials.gov [Internet]
Bethesda (MD); National Library of Medicine (US); 2000 Feb 29 -. NCT00313222 - Bosentan effects in inoperable forms of chronic thromboembolic pulmonary hypertension. Feb, 2010. [cited 2014 Apr 1]. Available from:
http://www.clinicaltrials.gov/ct2/show/NCT00313222.
- 22.
Bayer's comments on riociguat (ADEMPAS®) pharmacoeconomic and clinical review [CONFIDENTIAL additional manufacturer's information]. Toronto: Bayer Inc.; May 1, 2014.
- 23.
- 24.
Miyamoto S, Nagaya N, Satoh T, Kyotani S, Sakamaki F, Fujita M, 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 Feb;161(2 Pt 1):487–492. [
PubMed: 10673190]
- 25.
Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension.
N Engl J Med [Internet]. 1996 Feb 1;334(5):296–302. [cited 2014 Mar 10]; Available from:
http://www.nejm.org/doi/pdf/10.1056/NEJM199602013340504. [
PubMed: 8532025]
- 26.
McLaughlin VV, Presberg KW, Doyle RL, Abman SH, McCrory DC, Fortin T, et al. Prognosis of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines.
Chest. 2004 Jul;126(1 Suppl):78S–92S. [
PubMed: 15249497]
- 27.
Hoeper MM, Oudiz RJ, Peacock A, Tapson VF, Haworth SG, Frost AE, et al. End points and clinical trial designs in pulmonary arterial hypertension: clinical and regulatory perspectives.
J Am Coll Cardiol. 2004 Jun 16;43(12 Suppl S):48S–55S. [
PubMed: 15194178]
- 28.
Rasekaba T, Lee AL, Naughton MT, Williams TJ, Holland AE. The six-minute walk test: a useful metric for the cardiopulmonary patient.
Intern Med J. 2009 Aug;39(8):495–501. [
PubMed: 19732197]
- 29.
De Feo S, Tramarin R, Lorusso R, Faggiano P. Six-minute walking test after cardiac surgery: instructions for an appropriate use.
Eur J Cardiovasc Prev Rehabil. 2009 Apr;16(2):144–149. [
PubMed: 19378394]
- 30.
- 31.
Oudiz RJ, Barst RJ, Hansen JE, Sun XG, Garofano R, Wu X, et al. Cardiopulmonary exercise testing and six-minute walk correlations in pulmonary arterial hypertension.
Am J Cardiol. 2006 Jan 1;97(1):123–126. [
PubMed: 16377296]
- 32.
- 33.
Fritz JS, Blair C, Oudiz RJ, Dufton C, Olschewski H, Despain D, et al. Baseline and follow-up 6-min walk distance and brain natriuretic peptide predict 2-year mortality in pulmonary arterial hypertension.
Chest. 2013 Feb 1;143(2):315–323. [
PMC free article: PMC4694187] [
PubMed: 22814814]
- 34.
Savarese G, Paolillo S, Costanzo P, D'Amore C, Cecere M, Losco T, et al. Do changes of 6-minute walk distance predict clinical events in patients with pulmonary arterial hypertension? A meta-analysis of 22 randomized trials.
J Am Coll Cardiol. 2012 Sep 25;60(13):1192–1201. [
PubMed: 22995024]
- 35.
Peacock AJ, Naeije R, Galie N, Rubin L. End-points and clinical trial design in pulmonary arterial hypertension: have we made progress?
Eur Respir J. 2009 Jul;34(1):231–242. [
PubMed: 19567606]
- 36.
Ventetuolo CE, Benza RL, Peacock AJ, Zamanian RT, Badesch DB, Kawut SM. Surrogate and combined end points in pulmonary arterial hypertension.
Proc Am Thorac Soc. 2008 Jul;5(5):617–622. [
PubMed: 18625754]
- 37.
Frost AE, Badesch DB, Miller DP, Benza RL, Meltzer LA, McGoon MD. Evaluation of the predictive value of a clinical worsening definition using 2-year outcomes in patients with pulmonary arterial hypertension: a REVEAL Registry Analysis.
Chest. 2013 Nov 1;144(5):1521–1529. [
PubMed: 23907471]
- 38.
Rubin L, Gaile N, Badesch D, Oudiz R, Simonneau G, McGoon M, et al. Ambrisentan improves exercise capacity and clinical measures in pulmonary arterial hypertension (PAH) [abstract] Am J Respir Crit Care Med. 2004;169(7 Suppl):A210.
- 39.
Kendrick KR, Baxi SC, Smith RM. Usefulness of the modified 0–10 Borg scale in assessing the degree of dyspnea in patients with COPD and asthma.
J Emerg Nurs. 2000 Jun;26(3):216–222. [
PubMed: 10839848]
- 40.
Belman MJ, Brooks LR, Ross DJ, Mohsenifar Z. Variability of breathlessness measurement in patients with chronic obstructive pulmonary disease.
Chest. 1991 Mar;99(3):566–571. [
PubMed: 1899818]
- 41.
Mador MJ, Rodis A, Magalang UJ. Reproducibility of Borg scale measurements of dyspnea during exercise in patients with COPD.
Chest. 1995 Jun;107(6):1590–1597. [
PubMed: 7781352]
- 42.
EuroQol -- a new facility for the measurement of health-related quality of life.
The EuroQol Group. Health Policy. 1990 Dec;16(3):199–208. [
PubMed: 10109801]
- 43.
Taichman DB, McGoon MD, Harhay MO, Archer-Chicko C, Sager JS, Murugappan M, et al. Wide variation in clinicians' assessment of New York Heart Association/World Health Organization functional class in patients with pulmonary arterial hypertension.
Mayo Clin Proc. 2009 Jul;84(7):586–592. [
PMC free article: PMC2704130] [
PubMed: 19567712]
- 44.
Paciocco G, Martinez FJ, Bossone E, Pielsticker E, Gillespie B, Rubenfire M. Oxygen desaturation on the six-minute walk test and mortality in untreated primary pulmonary hypertension.
Eur Respir J. 2001 Apr;17(4):647–652. [
PubMed: 11401059]
- 45.
American Thoracic Society. ATS statement: guidelines for the six-minute walk test.
Am J Respir Crit Care Med. 2002 Jul 1;166(1):111–117. [
PubMed: 12091180]
- 46.
Kadikar A, Maurer J, Kesten S. The six-minute walk test: a guide to assessment for lung transplantation.
J Heart Lung Transplant. 1997 Mar;16(3):313–319. [
PubMed: 9087875]
- 47.
Frost AE, Langleben D, Oudiz R, Hill N, Horn E, McLaughlin V, 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(1):36–39. [
PubMed: 15890561]
- 48.
Saouti N, de Man F, Westerhof N, Boonstra A, Twisk J, Postmus PE, et al. Predictors of mortality in inoperable chronic thromboembolic pulmonary hypertension.
Respir Med. 2009 Jul;103(7):1013–1019. [
PubMed: 19230641]
- 49.
Reesink HJ, van der Plas MN, Verhey NE, van Steenwijk RP, Kloek JJ, Bresser P. Six-minute walk distance as parameter of functional outcome after pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension.
J Thorac Cardiovasc Surg. 2007;133(2):510–516. [
PubMed: 17258590]
- 50.
- 51.
Brooks R. EuroQol: the current state of play.
Health Policy. 1996 Jul;37(1):53–72. [
PubMed: 10158943]
- 52.
Punekar YS, Rodriguez-Roisin R, Sculpher M, Jones P, Spencer M. Implications of chronic obstructive pulmonary disease (COPD) on patients' health status: a western view.
Respir Med. 2007 Mar;101(3):661–669. [
PubMed: 17197164]
- 53.
Clinical Study Report No. A62509 Bay-632521 (study 11349). 14. Tables and figures referred to but not included in the text [CONFIDENTIAL internal manufacturer's report]. Leverkusen (DE): Bayer Healthcare;
- 54.
Byrnes M, Ashaye A, Iheanacho I, Cadarette S, Travers K. A systematic literature review and indirect treatment comparison in support of riociguat for chronic thromboembolic pulmonary hypertension (CTEPH) [CONFIDENTIAL internal manufacturer's report]. Lexington (MA): United BioSource Corporation; Jun 20, 2013.
- 55.
Jansen JP, Fleurence R, Devine B, Itzler R, Barrett A, Hawkins N, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1.
Value Health. 2011 Jun;14(4):417–428. [
PubMed: 21669366]
