Randomized study of adding tadalafil to existing ambrisentan in pulmonary arterial hypertension

Hypertension Research

Volumn 37, Issue 6, 2014, Pages 507-512

  Zhuang, Yugang ^a   Jiang, Bojie ^a   Gao, Hui ^b   Zhao, Wei ^a  

^a TONGJI UNIVERSITY   (China)

^b QINGDAO UNIVERSITY   (China)

Author keywords

ambrisentan; combination therapy; pulmonary arterial hypertension; tadalafil

Indexed keywords

AMBRISENTAN; PLACEBO; TADALAFIL; CARBOLINE DERIVATIVE; ENDOTHELIN RECEPTOR ANTAGONIST; PHENYLPROPIONIC ACID DERIVATIVE; PHOSPHODIESTERASE V INHIBITOR; PYRIDAZINE DERIVATIVE;

ADD ON THERAPY; ADULT; AGED; ANTIHYPERTENSIVE THERAPY; ARTHRALGIA; ARTICLE; BACKACHE; BLURRED VISION; CONTROLLED STUDY; COUGHING; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; EPISTAXIS; EXERCISE; FAINTNESS; FATIGUE; FEMALE; HEADACHE; HEART OUTPUT; HEART PALPITATION; HEMODYNAMIC PARAMETERS; HOT FLUSH; HUMAN; HYPOTENSION; LUNG ARTERY PRESSURE; LUNG VASCULAR RESISTANCE; MAJOR CLINICAL STUDY; MALE; MYALGIA; NAUSEA; NOSE OBSTRUCTION; PAIN; PROSPECTIVE STUDY; PULMONARY HYPERTENSION; RANDOMIZED CONTROLLED TRIAL; THORAX PAIN; TREATMENT OUTCOME; TREATMENT RESPONSE; ADOLESCENT; DOSE RESPONSE; DRUG COMBINATION; HEMODYNAMICS; HYPERTENSION, PULMONARY; MIDDLE AGED; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; PHYSIOLOGY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; CARBOLINES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; ENDOTHELIN RECEPTOR ANTAGONISTS; FEMALE; HEMODYNAMICS; HUMANS; HYPERTENSION, PULMONARY; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PHENYLPROPIONATES; PHOSPHODIESTERASE 5 INHIBITORS; PYRIDAZINES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84902012561     PISSN: 09169636     EISSN: 13484214     Source Type: Journal    
DOI: 10.1038/hr.2014.28     Document Type: Article

References (27)

1. Rubin LJ. Primary pulmonary hypertension. New Engl J Med 1997; 336: 111-117.
2. Galie N, Manes A, Branzi A. [New insights on pulmonary arterial hypertension]. RevistaEspanola de Cardiologia 2004; 57: 603-607.
3. D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT. Survival in patients with primary pulmonaryhypertension. Results from a national prospective registry. Ann Intern Med 1991; 115:343-349.
4. Channick RN, Simonneau G, Sitbon O, Robbins IM, Frost A, Tapson VF, Badesch DB, Roux S, Rainisio M, Bodin F, Rubin LJ. Effects of the dual endothelin-receptorantagonist bosentan in patients with pulmonary hypertension: a randomised placebocontrolledstudy. Lancet 2001; 358: 1119-1123.
5. Hirata Y, Emori T, Eguchi S, Kanno K, Imai T, Ohta K, Marumo F. Endothelin receptorsubtype B mediates synthesis of nitric oxide by cultured bovine endothelial cells. J ClinInvest 1993; 91: 1367-1373.
6. Fujitani Y, Ueda H, Okada T, Urade Y, Karaki H. A selective agonist of endothelin type Breceptor, IRL 1620, stimulates cyclic GMP increase via nitric oxide formation in rataorta. J Pharmacol Exp Ther 1993; 267: 683-689.
7. Galie N, Rubin L, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G. Treatment of patients with mildly symptomatic pulmonary arterialhypertension with bosentan (EARLY study): a double-blind, randomised controlled trial.Lancet 2008; 371: 2093-2100.
8. Akagi S, Matsubara H, Miyaji K, Ikeda E, Dan K, Tokunaga N, Hisamatsu K, Munemasa M, Fujimoto Y, Ohe T. Additional effects of bosentan in patients withidiopathic pulmonary arterial hypertension already treated with high-dose epoprostenol.Circ J 2008; 72: 1142-1146.
9. Humbert M, Barst RJ, Robbins IM, Channick RN, Galiè N, Boonstra A, Rubin LJ, Horn EM, Manes A, Simonneau G. Combination of bosentan with epoprostenol inpulmonary arterial hypertension: BREATHE-2. Eur Respir J 2004; 24: 353-359.
10. Seyfarth HJ, Pankau H, Hammerschmidt S, Schauer J, Wirtz H, Winkler J. Bosentanimproves exercise tolerance and Tei index in patients with pulmonary hypertension andprostanoid therapy. Chest 2005; 128: 709-713.
11. McLaughlin VV, Oudiz RJ, Frost A, Tapson VF, Murali S, Channick RN, Badesch DB, Barst RJ, Hsu HH, Rubin LJ. Randomized study of adding inhaled iloprost to existingbosentan in pulmonary arterial hypertension. Am J Respir Crit Care Med 2006; 174:1257-1263.
12. Simonneau G, Rubin LJ, Galie N, Barst RJ, Fleming TR, Frost AE, Engel PJ, Kramer MR, Burgess G, Collings L, Cossons N, Sitbon O, Badesch DBPACES StudyGroup. Addition of sildenafil to long-term intravenous epoprostenol therapy in patientswith pulmonary arterial hypertension: a randomized trial. Ann Intern Med 2008; 149:521-530.
13. Hoeper MM, Leuchte H, Halank M, Wilkens H, Meyer FJ, Seyfarth HJ, Wensel R, Ripken F, Bremer H, Kluge S, Hoeffken G, Behr J. Combining inhaled iloprost withbosentan in patients with idiopathic pulmonary arterial hypertension. Eur Respir J2006; 28: 691-694.
14. McLaughlin VV, Benza RL, Rubin LJ, Channick RN, Voswinckel R, Tapson VF, Robbins IM, Olschewski H, Rubenfire M, Seeger W. Addition of inhaled treprostinilto oral therapy for pulmonary arterial hypertension: a randomized controlled clinicaltrial. J Am Coll Cardiol 2010; 55: 1915-1922.
15. Benza RL, Rayburn BK, Tallaj JA, Pamboukian SV, Bourge RC. Treprostinil-basedtherapy in the treatment of moderate-to-severe pulmonary arterial hypertension: longtermefficacy and combination with bosentan. Chest 2008; 134: 139-145.
16. Kemp K, Savale L, O'Callaghan DS, Ja?̈s X, Montani D, Humbert M, Simonneau G, Sitbon O. Usefulness of first-line combination therapy with epoprostenol and bosentanin pulmonary arterial hypertension: an observational study. J Heart Lung Transplant2012; 31: 150-158.
17. Tapson VF, Torres F, Kermeen F, Keogh AM, Allen RP, Frantz RP, Badesch DB, Frost AE, Shapiro SM, Laliberte K, Sigman J, Arneson C, Galiè N. Oral treprostinil for thetreatment of pulmonary arterial hypertension in patients on background endothelinreceptor antagonist and/or phosphodiesterase type 5 inhibitor therapy (the FREEDOMCstudy): a randomized controlled trial. Chest 2012; 142: 1383-1390.
18. Spence R, Mandagere A, Harrison B, Dufton C, Boinpally R. No clinically relevantpharmacokinetic and safety interactions of ambrisentan in combination with tadalafilin healthy volunteers. J Pharm Sci 2009; 98: 4962-4974.
19. Anderson JR, Nawarskas JJ. Pharmacotherapeutic management of pulmonary arterialhypertension. Cardiol Rev 2010; 18: 148-162.
20. Barst RJ, Oudiz RJ, Beardsworth A, Brundage BH, Simonneau G, Ghofrani HA, Sundin DP, Galiè N, Pulmonary Arterial Hypertension and Response to Tadalafil(PHIRST) Study Group. Tadalafil monotherapy and as add-on to background bosentanin patients with pulmonary arterial hypertension. J Heart Lung Transplant 2011; 30:632-643.
21. Maki H, Yao A, Inaba T, Shiga T, Hatano M, Kinugawa K, Yamashita T, Aizawa T, Nagai R. Initial and programmed combination therapy with oral drugs for severeidiopathic pulmonary arterial hypertension. Int Heart J 2011; 52: 323-326.
22. Chin KM, Rubin LJ. Pulmonary arterial hypertension. J Am Coll Cardiol 2008; 51:1527-1538.
23. Hoeper MM, Markevych I, Spiekerkoetter E, Welte T, Niedermeyer J. Goal-orientedtreatment and combination therapy for pulmonary arterial hypertension. Eur Respir J2005; 26: 858-863.
24. Sidorenko BA, Preobrazhenskii DV, Batyraliev TA, Belenkov IuN. [Pulmonary arterialhypertension: changing approaches to management]. Kardiologiia 2011; 51:100-108.
25. Liang F, Yang S, Yao L, Belardinelli L, Shryock J. Ambrisentan and tadalafilsynergistically relax endothelin-induced contraction of rat pulmonary arteries. Hypertension2012; 59: 705-711.
26. Wrishko RE, Dingemanse J, Yu A, Darstein C, Phillips DL, Mitchell MI. Pharmacokineticinteraction between tadalafil and bosentan in healthy male subjects. J ClinPharmacol 2008; 48: 610-618.
27. Yao A. Recent advances and future perspectives in therapeutic strategies for pulmonaryarterial hypertension. J Cardiol 2012; 60: 344-349.