Riociguat (adempas): A novel agent for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension

P and T

Volumn 39, Issue 11, 2014, Pages 749-758

  Khaybullina, Diana ^a   Patel, Ami ^c   Zerilli, Tina ^b  

^a WEILL CORNELL MEDICAL CENTER   (United States)

^b LONG ISLAND UNIVERSITY   (United States)

^c NONE

Author keywords

[No Author keywords available]

Indexed keywords

ACTIVIN RECEPTOR LIKE KINASE 1; ALBUMIN; AMBRISENTAN; AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; BONE MORPHOGENETIC PROTEIN RECEPTOR 2; BOSENTAN; BREAST CANCER RESISTANCE PROTEIN; CARBAMAZEPINE; CAVEOLIN 1; CYCLIC GMP; CYTOCHROME P450 1A1; CYTOCHROME P450 2C8; CYTOCHROME P450 2J2; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; ENDOGLIN; HYPERICUM PERFORATUM EXTRACT; ILOPROST; KETOCONAZOLE; MACITENTAN; MULTIDRUG RESISTANCE PROTEIN; NITRIC OXIDE; OROSOMUCOID; PHENOBARBITAL; PHENYTOIN; RIFAMPICIN; RIOCIGUAT; SILDENAFIL; TADALAFIL; TREPROSTINIL;

ANEMIA; AREA UNDER THE CURVE; ARTICLE; CHEMICAL STRUCTURE; CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION; CONSTIPATION; DIARRHEA; DIZZINESS; DRUG COST; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; FEVER; GASTRITIS; GASTROESOPHAGEAL REFLUX; HEADACHE; HEART PALPITATION; HUMAN; HYPOTENSION; INTRACELLULAR SIGNALING; NAUSEA; NOSE OBSTRUCTION; PERIPHERAL EDEMA; PULMONARY HYPERTENSION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHINOPHARYNGITIS; UPPER RESPIRATORY TRACT INFECTION; VASCULAR RESISTANCE; VOMITING;

EID: 84912528100     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (38)

1. Hoeper MM, Bogaard HJ, Condliffe R, et al. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol 2013;62(25 suppl):D42–50.
2. Simonneau G, Gatzoulis MA, Adatia I, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol 2013;62(25 suppl):D34–41.
3. 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.
4. Frost AE, Badesch DB, Barst RJ, et al. The changing picture of patients with pulmonary arterial hypertension in the United States: how REVEAL differs from historic and non-US contemporary registries. Chest 2011;139(1):128–137.
5. Benza RL, Miller DP, Barst RJ, et al. An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from the REVEAL Registry. Chest 2012;142(2):448–456.
6. McGoon MD, Benza RL, Escribano-Subias P, et al. Pulmonary arterial hypertension: epidemiology and registries. J Am Coll Cardiol 2013;62(25 suppl):D51–59.
7. Galiè N, Corris PA, Frost A, et al. Updated treatment algorithm of pulmonary arterial hypertension. J Am Coll Cardiol 2013;62(25 suppl):D60–72.
8. Food and Drug Administration. FDA approves Adempas to treat pulmonary hypertension. October 10, 2013. Available at: www.fda.gov/newsevents/newsroom/pressannouncements/ucm370866.htm. Accessed April 29, 2014.
9. Adempas (riociguat) prescribing information. Whippany, New Jersey: Bayer HealthCare Pharmaceuticals Inc.; October 2013.
10. Letairis (ambrisentan) prescribing information. Foster City, California: Gilead Sciences, Inc.; January 2014.
11. Tracleer (bosentan) prescribing information. South San Francisco, California: Actelion Pharmaceuticals US, Inc.; October 2012.
12. Opsumit (macitentan) prescribing information. South San Francisco, California: Actelion Pharmaceuticals US, Inc.; October 2013.
13. Revatio (sildenafl) prescribing information. New York, New York: Pfzer Inc.; January 2014.
14. Adcirca (tadalafl) prescribing information. Indianapolis, Indiana: Eli Lilly and Company; December 2013.
15. Ventavis (iloprost) prescribing information. South San Francisco, California: Actelion Pharmaceuticals US, Inc.; November 2013.
16. Tyvaso (treprostinil) prescribing information. Research Triangle Park, North Carolina: United Therapeutics Corp.; May 2013.
17. Orenitram (treprostinil) prescribing information. Research Triangle Park, North Carolina: United Therapeutics Corp.; February 2014.
18. Remodulin (treprostinil) prescribing information. Research Triangle Park, North Carolina: United Therapeutics Corp.; October 2013.
19. Flolan (epoprostenol sodium) prescribing information. Research Triangle Park, North Carolina: GlaxoSmithKline, LLC; March 2011.
20. Veletri (epoprostenol) prescribing information. South San Francisco, California: Acte-lion Pharmaceuticals US, Inc.; June 2012.
21. Ghofrani HA, Grimminger F. Soluble gua-nylate cyclase stimulation: an emerging option in pulmonary hypertension therapy. Eur Respir Rev 2009;18(111):35–41.
22. Grimminger F, Weimann G, Frey R, et al. First acute haemodynamic study of soluble guanylate cyclase stimulator riociguat in pulmonary hypertension. Eur Respir J 2009;33(4):785–792.
23. Ghofrani HA, Hoeper MM, Halank M, et al. Riociguat for chronic thromboem-bolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study. Eur Respir J 2010;36(4):792–799.
24. Ghofrani HA, Galiè N, Grimminger F, et al. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med 2013;369(4):330–340.
25. Ghofrani HA, D’Armini AM, Grim-minger F, et al. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med 2013; 369(4):319–329.
26. Frey R, Mück W, Unger S, et al. Single-dose pharmacokinetics, pharmaco-dynamics, tolerability, and safety of the soluble guanylate cyclase stimulator BAY 63-2521: an ascending-dose study in healthy male volunteers. J Clin Pharmacol 2008;48(8):926–934.
27. Food and Drug Administration, Center for Drug Evaluation and Research. Application number: 204819Orig1s000: clinical pharmacology and biopharma-ceutics review(s). June 2013. Available at: http://www.accessdata.fda.gov/drug-satfda_docs/nda/2013/204819Orig1s000 ClinPharmR.pdf. Accessed April 29, 2014.
28. Bonderman D, Ghio S, Felix SB, et al. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: a phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation 2013;128(5):502–511.
29. Hoeper MM, Halank M, Wilkens H, et al. Riociguat for interstitial lung disease and pulmonary hypertension: a pilot trial. Eur Respir J 2013;41(4):853–860.
30. Rubin LJ, Galiè N, Grimminger F, et al. Riociguat for the treatment of pulmonary arterial hypertension (PAH): a phase III long-term extension study (PATENT-2). Presentation at American Thoracic Society 2013 International Conference, Philadelphia, May 17–22, 2013. Available at: http://www.atsjour-nals.org/doi/abs/10.1164/ajrccm-con-ference.2013.187.1_MeetingAbstracts. A3531. Accessed April 29, 2014.
31. Bayer HealthCare Press Center. Interim results from CHEST-2 study support benefts of Bayer’s riociguat as demonstrated in phase III CHEST-1 study. March 4, 2013. Available at: http://press.healthcare.bayer.com/en/press/auth/news-details-page.php/14933/2013-0143. Accessed April 29, 2014.
32. Food and Drug Administration, Center for Drug Evaluation and Research. Application number: 204819Orig1s000: medical review(s). April 26, 2013. Available at: http://www.access-data.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000MedR.pdf. Accessed April 29, 2014.
33. Food and Drug Administration. Adem-pas (riociguat tablets): Risk Evaluation and Mitigation Strategy (REMS). June 11, 2014. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor-PatientsandProviders/UCM370907.pdf. Accessed October 9, 2014.
34. Rickert V, Haefeli WE, Weiss J. Phar-macokinetic interaction profile of rio-ciguat, a new soluble guanylate cyclase stimulator, in vitro. Pulm Pharmacol Ther 2014;28(2):130–137.
35. Frey R, Mück W, Kirschbaum N, et al. Riociguat (BAY 63-2521) and warfarin: a pharmacodynamic and pharmaco kinetic interaction study. J Clin Pharmacol 2011;51(7):1051–1060.
36. Red Book Online. Ann Arbor, Michigan: Truven Health Analytics. Accessed October 9, 2014.
37. Archer SL. Riociguat for pulmonary hypertension—a glass half full. N Engl J Med. 2013;369(4):386–388.
38. Kim NH, Delcroix M, Jenkins D P, et al. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol 2013;62(25 suppl):D92–99.