Tadalafil for the treatment of pulmonary arterial hypertension

Expert Opinion on Pharmacotherapy

Volumn 13, Issue 5, 2012, Pages 747-755

  Frey, Maria Klara ^a   Lang, Irene ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

Phosphodiesterase inhibitors; Pulmonary hypertension; Tadalafil; Treatment

Indexed keywords

AMBRISENTAN; BOSENTAN; DIGOXIN; DOXAZOSIN; ILOPROST; MEVINOLIN; MIDAZOLAM; NITRENDIPINE; PROSTACYCLIN; SILDENAFIL; SITAXSENTAN; TADALAFIL; THEOPHYLLINE; UNIPROST; VARDENAFIL; WARFARIN;

ARTHRALGIA; ARTICLE; BACKACHE; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG MARKETING; DRUG MECHANISM; DYSPEPSIA; FLUSHING; HEADACHE; HUMAN; JAW PAIN; LIVER TOXICITY; MYALGIA; NAUSEA; PULMONARY HYPERTENSION; RASH; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; STOMACH PAIN;

CARBOLINES; HYPERTENSION, PULMONARY; PHOSPHODIESTERASE 5 INHIBITORS; VASODILATOR AGENTS;

EID: 84858678482     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2012.662220     Document Type: Article

References (49)

1. Badesch DB, Champion HC, Sanchez MA, et al. Diagnosis and assessment of pulmonary arterial hypertension. J Am Coll Cardiol 2009;54(1 Suppl):S55-66
2. Simonneau G, Robbins IM, Beghetti M, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol 2009;54(1 Suppl):S43-54
3. 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):343-9
4. Galie 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(20):2493-537
5. 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(9):1023-30
6. Schermuly RT, Ghofrani HA, Wilkins MR, Grimminger F. Mechanisms of disease: Pulmonary arterial hypertension. Nat Rev Cardiol 2011;8(8):443-55
7. Wise H. Multiple signaling options for prostacyclin. Acta Pharmacol Sin 2003;24(7):625-30
8. Moncada S, Gryglewski R, Bunting S, Vane JR. An enzyme isolated from arteries transforms prostaglandin endoperoxides to an unstable substance that inhibits platelet aggregation. Nature 1976;263(5579):663-5
9. Olschewski H, Olschewski A, Rose F, et al. Physiologic basis for the treatment of pulmonary hypertension. J Lab Clin Med 2001;138(5):287-97 (Pubitemid 33066151)
10. Tuder RM, Cool CD, Geraci MW, et al. Prostacyclin synthase expression is decreased in lungs from patients with severe pulmonary hypertension. Am J Respir Crit Care Med 1999;159(6):1925-32 (Pubitemid 29275065)
11. Sastry BK. Pharmacologic treatment for pulmonary arterial hypertension. Curr Opin Cardiol 2006;21(6):561-8 (Pubitemid 44624540)
12. Davie N, Haleen SJ, Upton PD, et al. ET(A) and ET(B) receptors modulate the proliferation of human pulmonary artery smooth muscle cells. Am J Respir Crit Care Med 2002;165(3):398-405 (Pubitemid 34118516)
13. Chua BH, Krebs CJ, Chua CC, Diglio CA. Endothelin stimulates protein synthesis in smooth muscle cells. Am J Physiol 1992;262(4 Pt 1):E412-16
14. Galie N, Manes A, Branzi A. The endothelin system in pulmonary arterial hypertension. Cardiovasc Res 2004;61(2):227-37 (Pubitemid 38091763)
15. Stewart DJ, Kubac G, Costello KB, Cernacek P. Increased plasma endothelin-1 in the early hours of acute myocardial infarction. J Am Coll Cardiol 1991;18(1):38-43
16. Miyauchi T, Yorikane R, Sakai S, et al. Contribution of endogenous endothelin-1 to the progression of cardiopulmonary alterations in rats with monocrotaline-induced pulmonary hypertension. Circ Res 1993;73(5):887-97 (Pubitemid 23306133)
17. McLaughlin VV, Sitbon O, Badesch DB, et al. Survival with first-line bosentan in patients with primary pulmonary hypertension. Eur Respir J 2005;25(2):244-9 (Pubitemid 40246523)
18. Beavo JA. cGMP inhibition of heart phosphodiesterase: Is it clinically releVant? J Clin Invest 1995;95(2):445
19. Ahn HS, Foster M, Cable M, et al. Ca/ CaM-stimulated and cGMP-specific phosphodiesterases in vascular and non-vascular tissues. Adv Exp Med Biol 1991;308:191-7
20. Galie N, Ghofrani HA, Torbicki A, et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med 2005;353(20):2148-57 (Pubitemid 41653106)
21. Ghofrani HA, Voswinckel R, Reichenberger F, et al. Differences in hemodynamic and oxygenation responses to three different phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension: A randomized prospective study. J Am Coll Cardiol 2004;44(7):1488-96 (Pubitemid 39303954)
22. Jing ZC, Yu ZX, Shen JY, et al. Vardenafil in pulmonary arterial hypertension: A randomized, double-blind, placebo-controlled study. Am J Respir Crit Care Med 2011;183(12):1723-9
23. Curran M, Keating G. Tadalafil. Drugs 2003;63(20):2203-12; discussion 13-4 (Pubitemid 37289920)
24. Tantini B, Manes A, Fiumana E, et al. Antiproliferative effect of sildenafil on human pulmonary artery smooth muscle cells. Basic Res Cardiol 2005;100(2):131-8 (Pubitemid 40361605)
25. Michelakis E, Tymchak W, Lien D, et al. Oral sildenafil is an effective and specific pulmonary vasodilator in patients with pulmonary arterial hypertension: Comparison with inhaled nitric oxide. Circulation 2002;105(20):2398-403 (Pubitemid 34556392)
26. Rosen RC, Kostis JB. Overview of phosphodiesterase 5 inhibition in erectile dysfunction. Am J Cardiol 2003;92(9A):9M-18M (Pubitemid 37386271)
27. Yuasa K, Kanoh Y, Okumura K, Omori K. Genomic organization of the human phosphodiesterase PDE11A gene. Evolutionary relatedness with other PDEs containing GAF domains. Eur J Biochem 2001;268(1):168-78 (Pubitemid 32052261)
28. Guillaume M, Lonsdale F, Darstein C, et al. Hemodynamic interaction between a daily dosed phosphodiesterase 5 inhibitor, tadalafil, and the alpha-adrenergic blockers, doxazosin and tamsulosin, in middle-aged healthy male subjects. J Clin Pharmacol 2007;47(10):1303-10 (Pubitemid 47459669)
29. Reffelmann T, Kieback A, Kloner RA. The cardiovascular safety of tadalafil. Expert Opin Drug Saf 2008;7(1):43-52 (Pubitemid 351222962)
30. Kang DH, Lee JY, Park SY, et al. Efficacy and safety of tadalafil 5 mg administered once daily in korean men with erectile dysfunction: A Prospective, Multicenter Study. Korean J Urol 2010;51(9):647-52
31. Kloner RA, Hutter AM, Emmick JT, et al. Time course of the interaction between tadalafil and nitrates. J Am Coll Cardiol 2003;42(10):1855-60 (Pubitemid 37433669)
32. Park JW, Leithauser B, Jung F. Sublingual application of liquid nitrendipine does not result in critical hypotension in healthy volunteers under phosphodiesterase-5 inhibition. Clin Hemorheol Microcirc 2008;39(1-4):323-8 (Pubitemid 352040011)
33. EMEA. Adcirca, tadalafil. European Public Assessment Report (EPAR). 2010; EMEA/753653/2009 EMEA/H/C/1021
34. Beasley CM Jr, Mitchell MI, Dmitrienko AA, et al. The combined use of ibutilide as an active control with intensive electrocardiographic sampling and signal averaging as a sensitive method to assess the effects of tadalafil on the human QT interval. J Am Coll Cardiol 2005;46(4):678-87 (Pubitemid 41132697)
35. Ring BJ, Patterson BE, Mitchell MI, et al. Effect of tadalafil on cytochrome P450 3A4-mediated clearance: Studies in vitro and in vivo. Clin Pharmacol Ther 2005;77(1):63-75 (Pubitemid 40075390)
36. Gupta M, Kovar A, Meibohm B. The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. J Clin Pharmacol 2005;45(9):987-1003 (Pubitemid 41192358)
37. Forgue ST, Phillips DL, Bedding AW, et al. Effects of gender, age, diabetes mellitus and renal and hepatic impairment on tadalafil pharmacokinetics. Br J Clin Pharmacol 2007;63(1):24-35 (Pubitemid 44902874)
38. Adcirca. Prescribing Information FDA. 2011 PV 6472 AMP
39. Wrishko RE, Dingemanse J, Yu A, et al. Pharmacokinetic interaction between tadalafil and bosentan in healthy male subjects. J Clin Pharmacol 2008;48(5):610-18 (Pubitemid 351503516)
40. Spence R, Mandagere A, Harrison B, et al. No clinically releVant pharmacokinetic and safety interactions of ambrisentan in combination with tadalafil in healthy volunteers. J Pharm Sci 2009;98(12):4962-74
41. Palmieri EA, Affuso F, Fazio S, Lembo D. Tadalafil in primary pulmonary arterial hypertension. Ann Intern Med 2004;141(9):743-4 (Pubitemid 39434855)
42. Tay EL, Geok-Mui MK, Poh-Hoon MC, Yip J. Sustained benefit of tadalafil in patients with pulmonary arterial hypertension with prior response to sildenafil: A case series of 12 patients. Int J Cardiol 2008;125(3):416-17 (Pubitemid 351418033)
43. Galie N, Brundage BH, Ghofrani HA, et al. Tadalafil therapy for pulmonary arterial hypertension. Circulation 2009;119(22):2894-903
44. Pepke-Zaba J, Beardsworth A, Chan M, Angalakuditi M. Tadalafil therapy and health-related quality of life in pulmonary arterial hypertension. Curr Med Res Opin 2009;25(10):2479-85
45. Oudiz RJ, Beardsworth A, Chan MLS, et al. for the PHIRST Study group. Blinded, Long-Term Safety and Efficacy of Tadalafil in Treatment for Pulmonary Arterial Hypertension. American Thoracic Society meeting 2009 - Poster - A17; 2009
46. Barst RJ, Oudiz RJ, Beardsworth A, et al. Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension. J Heart Lung Transplant 2011;30(6):632-43
47. Bendayan D, Shitrit D, Kramer MR. Combination therapy with prostacyclin and tadalafil for severe pulmonary arterial hypertension: A pilot study. Respirology 2008;13(6):916-18
48. Faruqi S, Fathi H, Morice AH. Combination of sitaxentan and tadalafil for idiopathic pulmonary arterial hypertension following relapse on bosentan. Int J Cardiol 2010;144(3):e43-5
49. Rosenzweig EB. Tadalafil for the treatment of pulmonary arterial hypertension. Expert Opin Pharmacother 2010;11(1):127-32