Drug interactions with phosphodiesterase-5 inhibitors used for the treatment of erectile dysfunction or pulmonary hypertension

Circulation

Volumn 122, Issue 1, 2010, Pages 88-95

  Schwartz, Bryan G ^a   Kloner, Robert A ^a,b  

^a GOOD SAMARITAN HOSPITAL   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADCIRCA; AMLODIPINE; BOSENTAN; CIMETIDINE; CIPROFLOXACIN; CLARITHROMYCIN; DOXAZOSIN; ERYTHROMYCIN; INDINAVIR; KETOCONAZOLE; RIFAMPICIN; RITONAVIR; SAQUINAVIR; SILDENAFIL; TACROLIMUS; TADALAFIL; TAMSULOSIN; UNCLASSIFIED DRUG; VARDENAFIL;

CLINICAL TRIAL; DRUG ABSORPTION; DRUG EFFECT; DRUG HALF LIFE; DRUG RESPONSE; ERECTILE DYSFUNCTION; HUMAN; PATIENT EDUCATION; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; PULMONARY HYPERTENSION; REVIEW; THROMBOCYTE AGGREGATION; VASODILATATION;

ANTIHYPERTENSIVE AGENTS; CORONARY DISEASE; CYCLIC NUCLEOTIDE PHOSPHODIESTERASES, TYPE 5; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; ERECTILE DYSFUNCTION; FEMALE; HUMANS; HYPERTENSION, PULMONARY; HYPOTENSION; IMIDAZOLES; MALE; PHOSPHODIESTERASE INHIBITORS; PIPERAZINES; PURINES; SULFONES; TRIAZINES; VASODILATOR AGENTS;

EID: 77954606060     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.110.944603     Document Type: Review

References (63)

1. Seftel AD, Sun P, Swindle R. The prevalence of hypertension, hyperlip-idemia, diabetes mellitus and depression in men with erectile dysfunction. J Urol. 2004;171:2341-2345.
2. Pfizer. VIAGRA (sildenafil citrate) prescribing information. Available at: http://www.pfizer.com/files/products/uspi-viagra.pdf. Accessed March 29, 2010.
3. Bayer Health Care Pharmaceuticals. Product monograph for LEVITRA (vardenafil HCL). Available at: http://www.univgraph.com/bayer/inserts/levitra. pdf. Accessed March 29, 2010.
4. Eli Lilly and Co. CIALIS (tadalafil) prescribing information. Available at: http://pi.lilly.com/us/cialis-pi.pdf. Accessed March 29, 2010.
5. Pfizer. REVATIO (sildenafil) prescribing information. Available at: http://media.pfizer.com/files/products/uspi-revatio.pdf. Accessed March 29, 2010.
6. Eli Lilly and Co. ADCIRCA (tadalafil) prescribing information. Available at: http://pi.lilly.com/us/adcirca-pi.pdf. Accessed March 29, 2010.
7. Barst RJ, Gibbs JS, Ghofrani HA, Hoeper MM, McLaughlin VV, Rubin LJ, Sitbon O, Tapson VF, Galie N. Updated evidence-based treatment algorithm in pulmonary arterial hypertension. J Am Coll Cardiol. 2009; 54:S78-S84.
8. Badesch DB, Abman SH, Simonneau G, Rubin LJ, McLaughlin VV. Medical therapy for pulmonary arterial hypertension: updated ACCP evidence-based clinical practice guidelines. Chest. 2007;131:1917-1928.
9. Mittleman MA, Glasser DB, Orazem J. Clinical trials of sildenafil citrate (Viagra) demonstrate no increase in risk of myocardial infarction and cardiovascular death compared with placebo. Int J Clin Pract. 2003;57: 597-600.
10. Morales A, Gingell C, Collins M, Wicker PA, Osterloh IH. Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Int J Impot Res. 1998;10:69-73.
11. Kloner RA, Jackson G, Hutter AM, Mittleman MA, Chan M, Warner MR, Costigan TM, Vail GM. Cardiovascular safety update of Tadalafil: retrospective analysis of data from placebo-controlled and open-label clinical trials of Tadalafil with as needed, three times-per-week or once-a-day dosing. Am J Cardiol. 2006;97:1778-1784.
12. Kloner RA, Mohan P, Segeron T, Thibonnier M, Norenberg C, Padma-Nathan H. Cardiovascular safety of vardenafil in patients receiving anti-hypertensive medications: a post-hoc analysis of five placebo-controlled clinical trials. J Am Coll Cardiol. 2003;41:276A-277A. Abstract.
13. Wallis RM, Corbin JD, Francis SH, Ellis P. Tissue distribution of phos-phodiesterase families and the effects of sildenafil on tissue cyclic nu-cleotides, platelet function, and the contractile responses of trabeculae carneae and aortic rings in vitro. Am J Cardiol. 1999;83:3C-12C.
14. Warrington JS, Shader RI, von Moltke LL, Greenblatt DJ. In vitro biotransformation of sildenafil (Viagra): identification of human cyto-chromes and potential drug interactions. Drug Metab Dispos. 2000;28: 392-397.
15. Gupta M, Kovar A, Meibohm B. The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. J Clin Pharmacol. 2005;45:987-1003.
16. Muirhead GJ, Faulkner S, Harness JA, Taubel J. The effects of steady-state erythromycin and azithromycin on the pharmacokinetics of sildenafil in healthy volunteers. Br J Clin Pharmacol. 2002;53:37S-43S.
17. Hedaya MA, El-Afify DR, El-Maghraby GM. The effect of ciprofloxacin and clarithromycin on sildenafil oral bioavailability in human volunteers. Biopharm Drug Dispos. 2006;27:103-110.
18. Muirhead GJ, Wulff MB, Fielding A, Kleinermans D, Buss N. Pharma-cokinetic interactions between sildenafil and saquinavir/ritonavir. Br J Clin Pharmacol. 2000;50:99-107.
19. Christ B, Brockmeier D, Hauck EW, Friemann S. Interactions of sil-denafil and tacrolimus in men with erectile dysfunction after kidney transplantation. Urology. 2001;58:589-593.
20. Bailey DG, Dresser GK. Interactions between grapefruit juice and cardiovascular drugs. Am J Cardiovasc Drugs. 2004;4:281-297.
21. Wilner K, Laboy L, LeBel M. The effects of cimetidine and antacid on the pharmacokinetic profile of sildenafil citrate in healthy male volunteers. Br J Clin Pharmacol. 2002;53:31S-36S.
22. Burgess G, Hoogkamer H, Collings L, Dingemanse J. Mutual pharmacokinetic interactions between steady-state bosentan and sildenafil. Eur J Clin Pharmacol. 2008;64:43-50.
23. Cheitlin MD, Hutter AM Jr, Brindis RG, Ganz P, Kaul S, Russell RO Jr, Zusman RM. Use of sildenafil (Viagra) in patients with cardiovascular disease: Technology and Practice Executive Committee. Circulation. 1999;99:168-177.
24. Galatti L, Fioravanti A, Salvo F, Polimeni G, Giustini SE. Interaction between tadalafil and itraconazole. Ann Pharmacother. 2005;39:200.
25. Webb DJ, Freestone S, Allen MJ, Muirhead GJ. Sildenafil citrate and blood-pressure-lowering drugs: results of drug interaction studies with an organic nitrate and a calcium antagonist. Am J Cardiol. 1999;83: 21C-28C.
26. Nichols DJ, Muirhead GJ, Harness JA. Pharmacokinetics of sildenafil after single oral doses in healthy male subjects: absolute bioavailability, food effects and dose proportionality. Br J Clin Pharmacol. 2002;53: 5S-12S.
27. 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 DB. 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.
28. Galie N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, Fleming T, Parpia T, Burgess G, Branzi A, Grimminger F, Kurzyna M, Simonneau G. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005;353:2148-2157. (Pubitemid 41653106)
29. Kloner RA, Mitchell M, Emmick JT. Cardiovascular effects of tadalafil in patients on common antihypertensive therapies. Am J Cardiol. 2003;92: 47M-57M.
30. Kloner RA, Brown M, Prisant LM, Collins M. Effect of sildenafil in patients with erectile dysfunction taking antihypertensive therapy: Sildenafil Study Group. Am J Hypertens. 2001;14:70-73.
31. Kloner RA, Sadovsky R, Johnson EG, Mo D, Ahuja S. Efficacy of tadalafil in the treatment of erectile dysfunction in hypertensive men on concomitant thiazide diuretic therapy. Int J Impot Res. 2005;17:450-454.
32. Zusman RM, Morales A, Glasser DB, Osterloh IH. Overall cardiovascular profile of sildenafil citrate. Am J Cardiol. 1999;83:35C-44C.
33. Kloner RA, Mitchell M, Emmick JT. Cardiovascular effects of tadalafil. Am J Cardiol. 2003;92:37M-46M.
34. Jackson G, Benjamin N, Jackson N, Allen MJ. Effects of sildenafil citrate on human hemodynamics. Am J Cardiol. 1999;83:13C-20C.
35. Rohde G, Jordan P. Influence of vardenafil on blood pressure and pharmacokinetics in hypertensive patients on nifedipine therapy. Pharmacotherapy. 2002;22:418. Abstract.
36. Zusman RM, Prisant LM, Brown MJ. Effect of sildenafil citrate on blood pressure and heart rate in men with erectile dysfunction taking concomitant antihypertensive medication: Sildenafil Study Group. J Hypertens. 2000;18:1865-1869.
37. Emmick JT, Stuewe SR, Mitchell M. Overview of the cardiovascular effects of tadalafil. Eur Heart J Suppl. 2002;4:H32-H47.
38. Crowley AR, Muirhead GJ, Gillies H, Osterloh I. Interaction between glyceryl trinitrate and sildenafil citrate (Viagra®) may last less than 4 hours. Am J Hypertens. 2004;17:S37. Abstract.
39. Kloner RA, Hutter AM, Emmick JT, Mitchell MI, Denne J, Jackson G. Time course of the interaction between tadalafil and nitrates. J Am Coll Cardiol. 2003;42:1855-1860.
40. Guillaume M, Lonsdale F, Darstein C, Jimenez MC, Mitchell MI. Hemodynamic interaction between a daily dosed phosphodiesterase 5 inhibitor, tadalafil, and the alpha-adrenergic blockers, doxazosin and tam-sulosin, in middle-aged healthy male subjects. J Clin Pharmacol. 2007; 47:1303-1310.
41. Giuliano F, Kaplan SA, Cabanis MJ, Astruc B. Hemodynamic interaction study between the alpha1-blocker alfuzosin and the phosphodiesterase-5 inhibitor tadalafil in middle-aged healthy male subjects. Urology. 2006; 67:1199-1204.
42. Kloner RA. Pharmacology and drug interaction effects of the phosphodiesterase 5 inhibitors: focus on alpha-blocker interactions. Am J Cardiol. 2005;96:42M-46M.
43. Kloner RA, Jackson G, Emmick JT, Mitchell MI, Bedding A, Warner MR, Pereira A. Interaction between the phosphodiesterase 5 inhibitor tadalafil and 2 alpha-blockers, doxazosin and tamsulosin in healthy nor-motensive men. J Urol. 2004;172:1935-1940.
44. Auerback S, Gittelman M, Mazzu A, Sundaresan PR, White WB. Coad-ministered vardenafil (for erectile dysfunction) and tamsulosin do not induce hypotension in patients with benign prostatic hypertrophy. Am J Hypertens. 2004;17:16A. Abstract.
45. Nieminen T, Tammela TL, Koobi T, Kahonen M. The effects of tam-sulosin and sildenafil in separate and combined regimens on detailed hemodynamics in patients with benign prostatic enlargement. J Urol. 2006;176:2551-2556.
46. Wilkens H, Guth A, Konig J, Forestier N, Cremers B, Hennen B, Bohm M, Sybrecht GW. Effect of inhaled iloprost plus oral sildenafil in patients with primary pulmonary hypertension. Circulation. 2001;104:1218-1222.
47. Ghofrani HA, Rose F, Schermuly RT, Olschewski H, Wiedemann R, Kreckel A, Weissmann N, Ghofrani S, Enke B, Seeger W, Grimminger F. Oral sildenafil as long-term adjunct therapy to inhaled iloprost in severe pulmonary arterial hypertension. J Am Coll Cardiol. 2003;42:158-164.
48. Michelakis E, Tymchak W, Lien D, Webster L, Hashimoto K, Archer S. Oral sildenafil is an effective and specific pulmonary vasodilator in patients with pulmonary arterial hypertension: comparison with inhaled nitric oxide. Circulation. 2002;105:2398-2403.
49. Lepore JJ, Maroo A, Pereira NL, Ginns LC, Dec GW, Zapol WM, Bloch KD, Semigran MJ. Effect of sildenafil on the acute pulmonary vasodilator response to inhaled nitric oxide in adults with primary pulmonary hypertension. Am J Cardiol. 2002;90:677-680.
50. Gruenig E, Michelakis E, Vachiery JL, Vizza CD, Meyer FJ, Doelberg M, Bach D, Dingemanse J, Galie N. Acute hemodynamic effects of single-dose sildenafil when added to established bosentan therapy in patients with pulmonary arterial hypertension: results of the COMPASS-1 study. J Clin Pharmacol. 2009;49:1343-1352.
51. Hoeper MM, Faulenbach C, Golpon H, Winkler J, Welte T, Niedermeyer J. Combination therapy with bosentan and sildenafil in idiopathic pulmonary arterial hypertension. Eur Respir J. 2004;24:1007-1010.
52. Humbert M, Segal ES, Kiely DG, Carlsen J, Schwierin B, Hoeper MM. Results of European post-marketing surveillance of bosentan in pulmonary hypertension. Eur Respir J. 2007;30:338-344.
53. Galie N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009; 119:2894-2903.
54. Stehlik J, Movsesian MA. Combined use of PDE5 inhibitors and nitrates in the treatment of pulmonary arterial hypertension in patients with heart failure. J Card Fail. 2009;15:31-34.
55. Berkels R, Klotz T, Sticht G, Englemann U, Klaus W. Modulation of human platelet aggregation by the phosphodiesterase type 5 inhibitor sildenafil. J Cardiovasc Pharmacol. 2001;37:413-421.
56. Pomara G, Morelli G, Menchini-Fabris F, Dinelli N, Campo G, LiGuori G, Selli C. Epistaxis after PDE-5 inhibitors misuse. Int J Impot Res. 2006;18:213-214.
57. Ismail H, Harries PG. Recurrent epistaxis after treatment with tadalafil (Cialis). Acta Otolaryngol. 2005;125:334-335.
58. Brixius K, Middeke M, Lichtenthal A, Jahn E, Schwinger RH. Nitric oxide, erectile dysfunction and beta-blocker treatment (MR NOED study): benefit of nebivolol versus metoprolol in hypertensive men. Clin Exp Pharmacol Physiol. 2007;34:327-331.
59. Cordero A, Bertomeu-Martinez V, Mazon P, Facila L, Bertomeu-Gonzalez V, Conthe P, Gonzalez-Juanatey JR. Erectile dysfunction in high-risk hypertensive patients treated with beta-blockade agents. Car-diovasc Ther. 2010;28:15-22.
60. Forest Laboratories, Inc. BYSTOLIC (nebivolol) prescribing information. Available at: http://www.frx.com/pi/Bystolic-pi.pdf. Accessed March 29, 2010.
61. Rosenkranz S, Brixius K, Halbach R, Diedrichs H, Schwinger RH. Phos-phodiesterase type 5 inhibitor sildenafil citrate does not potentiate the vasodilative properties of nebivolol in rat aorta. Life Sci. 2006;78: 1103-1107.
62. Beasley CM Jr, Mitchell MI, Dmitrienko AA, Emmick JT, Shen W, Costigan TM, Bedding AW, Turik MA, Bakhtyari A, Warner MR, Ruskin JN, Cantilena LR Jr, Kloner RA. 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;46:678-687.
63. Morganroth J, Ilson BE, Shaddinger BC, Dabiri GA, Patel BR, Boyle DA, Sethuraman VS, Montague TH. Evaluation of vardenafil and sildenafil on cardiac repolarization. Am J Cardiol. 2004;93:1378-1383.