Cardiovascular and ocular safety of α1-adrenoceptor antagonists in the treatment of male lower urinary tract symptoms

Expert Opinion on Drug Safety

Volumn 13, Issue 9, 2014, Pages 1187-1197

  Oelke, Matthias ^a   Gericke, Adrian ^b   Michel, Martin C ^b,c  

^a HANNOVER MEDICAL SCHOOL   (Germany)

^b JOHANNES GUTENBERG UNIVERSITY   (Germany)

^c BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Adverse drug event; Alfuzosin; Blood pressure; Doxazosin; Hypotension; Intraoperative floppy iris syndrome; Silodosin; Tamsulosin; Terazosin; 1 adrenoceptor antagonist

Indexed keywords

ALFUZOSIN; ALPHA 1 ADRENERGIC RECEPTOR BLOCKING AGENT; ANTIHYPERTENSIVE AGENT; DOXAZOSIN; INDORAMIN; PRAZOSIN; SILODOSIN; TAMSULOSIN; TERAZOSIN;

ASTHENIA; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CATARACT EXTRACTION; DIZZINESS; DRUG SAFETY; DRUG TOLERABILITY; EJACULATION DISORDER; EXTRAOCULAR MUSCLE; EYE DISEASE; FATIGUE; HUMAN; HYPOTENSION; INCIDENCE; INTRAOPERATIVE FLOPPY IRIS SYNDROME; LOWER URINARY TRACT SYMPTOM; MALE; MEDICAL HISTORY; MUSCLE CONTRACTION; MYDRIASIS; NOSE OBSTRUCTION; PATIENT COUNSELING; REVIEW; SEXUAL DYSFUNCTION; SOMNOLENCE; URINARY TRACT INFECTION; ANIMAL; CHEMICALLY INDUCED; COMPARATIVE STUDY; FEMALE; LOWER URINARY TRACT SYMPTOMS; PATHOPHYSIOLOGY; PATIENT EDUCATION; PROCEDURES;

ADRENERGIC ALPHA-1 RECEPTOR ANTAGONISTS; ANIMALS; CARDIOVASCULAR DISEASES; CATARACT EXTRACTION; EYE DISEASES; FEMALE; HUMANS; LOWER URINARY TRACT SYMPTOMS; MALE; PATIENT EDUCATION AS TOPIC;

EID: 84906276375     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2014.936376     Document Type: Review

References (79)

1. Weber MA, Schiffrin EL, White WB, et al. Clinical practice guidelines for the management of hypertension in the community: a statement by the Amcerican Society of Hypertension and the International Society of Hypertension. J Clin Hypertens 2014;16:14-26
2. Oelke M, Bachmann A, Descazeaud A, et al. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms (LUTS), including benign prostatic obstruction. Eur Urol 2013;64:118-40
3. Michel MC, Korstanje C, Krauwinkel W, et al. Cardiovascular safety of the oral controlled absorption system (OCAS) formulation of tamsulosin compared to the modified release (MR) formulation. Eur Urol Suppl 2005;4:53-60
4. Michel MC. The forefront of novel therapeutic agents based on the pathophysiology of lower urinary tract dysfunction: alpha-blockers in the treatment of male voiding dysfunction - How do they work and why do they differ in tolerability? J Pharmacol Sci 2010;112:151-7
5. Milani S, Djavan B. Lower urinary tract symptoms suggestive of benign prostatic hyperplasia: latest updated on alpha1- adrenoceptor antagonists. BJU Int 2005;95(Suppl 4):29-36
6. Michel MC, Mehlburger L, Bressel H-U, et al. Tamsulosin treatment of 19,365 patients with lower urinary tract symptoms: does comorbidity alter tolerability? J Urol 1998;160:784-91
7. Bird ST, Delaney JA, Brophy JM, et al. Tamsulosin treatment for benign prostatic hyperplasia and risk of severe hypotension in men aged 40-85 years in the United States: risk window analyses using between and within patient methodology. BMJ 2013;347:f6320
8. Djavan B, Chapple C, Milani S, et al. State of the art on the efficacy and tolerability of alpha1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Urology 2004;64:1081-8
9. Franco-Salinas G, de la Rosette JJ, Michel MC. Pharmacokinetics and pharmacodynamics of tamsulosin in its modified-release and oral-controlled absorption system formulations. Clin Pharmacokinet 2010;49:177-88
10. Rouquier I, Claustre Y, Benavides J. Alpha1-Adrenoceptor antagonists differentially control serotonin release in the hippocampcus and striatum: a microdialysis study. Eur J Pharmacol 1994;261:59-64
11. Guo TZ, Tinklenberg J, Oliker R, et al. Central alpha1-adrenoceptor stimulation functionally antagonizes the hypnotic response to dexmedetomidine, an alpha2- adrenoceptor agonist. Anesthesiology 1991;75:252-6
12. van Dijk MM, Skrekas T, de la Rosette JJ. The association between lower urinary tract symptoms and sexual dysfunction: fact or fiction? Curr Opin Urol 2005;15:39-44
13. van Dijk MM, de la Rosette JJ, Michel MC. Effects of alpha1- adrenoceptor antagonists on male sexual function. Drugs 2006;66:287-301
14. Giuliano F, Oelke M, Jungwirth A, et al. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggstive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamulsosin-controlled, 12- week double-blind study. J Sex Med 2013;10:857-65
15. Homma Y, Kawabe K, Takeda M, et al. Ejaculation disorder is associated with increased efficacy of silodosin for benign prostatic hyperplasia. Urology 2010;76:1446-50
16. Rosen RC, Fitzpatrick JM. Ejaculatory dysfunction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. BJU Int 2009;104:974-83
17. Narayan P, O'Leary MP, Davidai G. Early effect of tamsulosin versus terazosin in the treatment of men with benign prostatic hyperplasia: a randomized, open-label trial. J Appl Res 2005;5:237-45
18. Buzelin JM, Fonteyne E, Kontturi MJ, et al. Comparison of tamsulosin with alfuzosin in the treatment of patients with lower urinary tract symptoms suggestive of bladder outlet obstruction (symptomatic benign prostatic hyperplasia). Br J Urol 1997;80:597-605
19. Nordling J. Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia. BJU Int 2005;95:1006-12
20. Wu YJ, Dong Q, Liu LR, et al. A metaanalysis of efficacy and safety of the new alpha1A-adrenoceptor-selective antagonist silodosin for treating lower urinary tract symptoms associated with BPH. Prostate Cancer Prost Dis 2013;16:78-83
21. Chapple CR, Montorsi F, Tammela TL, et al. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trials performed in Europe. Eur Urol 2011;59:342-52
22. Sanbe A, Tanaka Y, Fujiwara Y, et al. Alpha1-Adrenoceptors are required for normal male sexual function. Br J Pharmacol 2007;152:332-40
23. Lowe FC. Safety assessment of terazosin in the treatment of patients with symptomatic benign prostatic hyperplasia: a combined analysis. Urology 1994;44:46-51
24. Fulton B, Wagstaff AJ, Sorkin EM. Doxazosin. An update of its clinical pharmacology and therapeutic applications in hypertension and benign prostatic hyperplasia. Drugs 1995;49:295-320
25. Goldsmith DR, Plosker GL. Doxazosin gastrointestinal therapeutic system: a review of its use in benign prostatic hyperplasia. Drugs 2005;65:2037-47
26. Guimaraes S, Moura D. Vascular adrenoceptors: an update. Pharmacol Rev 2001;53:319-56
27. Brodde O-E, Michel MC. Adrenergic and muscarinic receptors in the human heart. Pharmacol Rev 1999;51:651-89
28. Lee SH, Park KK, Mah SY, et al. Effects of alpha-blocker 'add on' treatment on blood pressure in symptomatic BPH with or without concomitant hypertension. Prostate Cancer Prost Dis 2010;13:333-7
29. Nickel JC, Sander S, Moon TD. A metaanalysis of the vascular-related safety profile and efficacy of alpha-adrenergic blockers for symptoms related to benign prostatic hyperplasia. Int J Clin Pract 2008;62:1547-59
30. Lukacs B, Blondin P, MacCarthy C, et al. Safety profile of 3 months' therapy with alfuzosin in 13,389 patients suffering from benign prostatic hypertrophy. Eur Urol 1996;29:29-35
31. Michel MC, Korstanje C, Krauwinkel W. Cardiovascular safety of tamsulosin modified release in the fasted and fed state in elderly healthy subjects. Eur Urol Suppl 2005;4:9-14
32. Barendrecht MM, Koopmans RP, de la Rosette JJ, et al. Treatment for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: the cardiovascular system. BJU Int 2005;95(Suppl 4):19-28
33. Lukacs B, Grange JC, Comet D, et al. History of 7,093 patients with lower urinary tract symptoms related to benign prostatic hyperplasia treated with alfuzosin in general practice up to 3 years. Eur Urol 2000;37:183-90
34. Lukacs B, Leplege A, Thibault P, et al. Prospective study of men with clinical benign prostatic hyperplasia treated with alfuzosin by general practitioners: 1-year results. Urology 1996;48:731-40
35. Michel MC, Bressel H-U, Goepel M, et al. A 6-months large-scale study into the safety of tamsulosin. Br J Clin Pharmacol 2001;51:609-14
36. Lowe FC. Coadministration of tamsulosin and three antihypertensive agents in patients with benign prostatic hyperplasia: pharmacodynamic effect. Clin Ther 1997;19:730-42
37. Singh DV, Mete UK, Mandal AK, et al. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. J Sex Med 2014;11:187-96
38. Troost J, Tatami S, Tsuda Y, et al. Effects of strong CYP2D6 and 3A4 inhibitors, paroxetine and ketoconazole, on the pharmacokinetics and cardiovascular safety of tamsulosin. Br J Clin Pharmacol 2011;72:247-56
39. Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. J Cataract Refract Surg 2005;31:664-73
40. Chang DF, Osher RH, Wang L, et al. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology 2007;114:957-64
41. Chadha V, Borooah S, Tey A, et al. Floppy iris behaviour during cataract surgery: associations and variations. Br J Ophthalmol 2007;91:40-2
42. Issa SA, Hadid OH, Baylis O, et al. Alpha antagonists and intraoperative floppy iris syndrom: a spectrum. Clin Ophthalmol 2008;2:735-41
43. Nguyen DQ, Sebastian RT, Kyle G. Surgeon's experiences of the intraoperative floppy iris syndrome in the United Kingdom. Eye(Lond) 2007;21:443-4
44. Blouin MC, Blouin J, Perreault S, et al. Intraoperative floppy-iris syndrome associated with alpha1-adrenoreceptors. Comparison of tamsulosin and alfuzosin. J Cataract Refract Surg 2007;33:1227-34
45. Cheung CM, Awan MA, Sandramouli S. Prevalence and clinical findings of tamsulosin-associated intraoperative floopy-iris syndrom. J Cataract Refract Surg 2006;32:1336-9
46. Oshika T, Ohashi Y, Inamura M, et al. Incidence of intraoperative floopy iris syndrome in patients on either systemic or topical alpha1-adrenoceptor antagonist. Am J Ophthalmol 2007;143:150-1
47. Takmaz T, Can I. Clinical features, complications, and incidence of intraoperative floppy iris syndrome in patients taking tamsulosin. Eur J Ophthalmol 2007;17:909-13
48. Keklikci U, Isen K, Unlu K, et al. Incidence, clinical findings and management of intraoperative floppy iris syndrome associated with tamsulosin. Acta Ophthalmol 2009;87:306-9
49. Neff KD, Sandoval HP, Fernandez de Castro LE, et al. Factors associated with intraoperative floppy iris syndrome. Ophthalmology 2009;116:658-63
50. Chen AA, Kelly JP, Bhandari A, et al. Pharmacologic prophylaxis and risk factors for intraoperative floppy-iris syndrome in phacoemulsification performed by resident physicians. J Cataract Refract Surg 2010;36:898-905
51. Haridas A, Syrimi M, Al-Ahmar B, et al. Intraoperative floppy iris syndrome (IFIS) in patients receiving tamsulosin or doxazosin - a UK-based comparison of incidence and complication rates. Graefes Arch Clin Exp Ophthalmol 2013;251:1541-5
52. Storr-Paulsen A, Jorgensen JS, Norregaard JC, et al. Corneal endothelial. cell changes after cataract surgery in patients on systemic sympathetic alpha1a antagonist medication (tamsulosin). Acta Ophthalmol 2014;92(4):359-63
53. Chang DF, Campbell JR, Colin J, et al. Prospective masked comparison of intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121:829-34
54. Herd MK. Intraoperative floppy-iris syndrome with doxazosin. J Cataract Refract Surg 2010;33:562-2
55. Casuccio A, Cillino G, Pavone C, et al. Pharmacologic pupil dilation as a predictive test for the risk for intraoperative floppy-iris syndrome. J Cataract Refract Surg 2011;37:1447-54
56. Pärssinen O, Leppänen E, Keski-Rahkonen P, et al. Influence of tamsulosin on the iris and its implications for cataract surgery. Invest Ophthalmol Vis Sci 2006;47:3766-71
57. Venkatesh R, Veena K, Gupta S, et al. Intraoperative floppy iris syndrome associated with terazosin. Indian J Ophthalmol 2007;55:395-6
58. Chatziralli IP, Sergentanis TN. Risk factors for intraoperative floppy iris syndrome: a meta-analysis. Ophthalmology 2011;118:730-5
59. Michel MC, Okutsu H, Noguchi Y, et al. In vivo studies on the effects of alpha1-adrenoceptor antagonists on pupil diameter and urethral tone in rabbits. Naunyn-Schmiedebergs Arch Pharmacol 2006;372:346-53
60. Palea S, Chang DF, Rekik M, et al. Comparative effect of alfuzosin and tamsulosin on the contractile response of isolated rabbit prostatic and iris dilator smooth muscles. Possible model for intraoperative floppy-iris syndrome. J Cataract Refract Surg 2008;34:489-96
61. Goseki T, Ishikawa H, Ogasawara S, et al. Effects of tamsulosin and silodosin on isolated albino and pigmented rabbits iris dilators: possible mechanism of intraoperative floppy iris syndrome. J Cataract Refract Surg 2013;38:1643-9
62. Osher RH. Association between IFIS and Flomax. J Cataract Refract Surg 2006;32:547-7
63. Santaella RM, Destafeno JJ, Stinnett SS, et al. The effect of alpha1-adrenergic receptor antagonist tamsulosin (Flomax) on iris dilator smooth muscle anatomy. Ophthalmology 2010;117:1743-9
64. Prata TS, Palmiero P-M, Angelilli A, et al. Iris morphologic changes related to alpha1-adrenergic receptor antagonists. Implications for intraoperative floppy iris syndrome. Ophthalmology 2009;116:877-81
65. Knowlton KU, Michel MC, Itani M, et al. The alpha1A-adrenergic receptor subtype mediates biochemical, molecular, and morphologic features of cultured myocardial cell hypertrophy. J Biol Chem 1993;268:15374-80
66. Altan-Yaycioglu R, Yaycioglu O, Gul U, et al. The effects of two systemic alpha1- adrenergic blockers on pupil diameter: a prospective randomized single-blind study. Naunyn-Schmiedeberg's Arch Pharmacol 2007;375:199-203
67. Pringle E, Packard R. Antipsychotic agent as an etiologic agent of IFIS. J Cataract Refract Surg 2005;31:2240-1
68. Ford RL, Sallam A, Towler HM. Intraoperative floppy iris syndrome associated with risperidone intake. Eur J Ophthalmol 2011;21:210-11
69. Ugarte M, Leong T, Rassam S, et al. Intraoperative floppy-iris syndrome, alpha1-adrenergic antagonists, and chronic intake of mianserin: is there an association? J Cataract Refract Surg 2007;33:170-0
70. Calotti F, Steen D. Labetalol causing intraoperative floppy-iris syndrome. J Cataract Refract Surg 2007;33:170-1
71. Chatziralli IP, Sergentanis TN, Papazisis L, et al. Risk factors for intraoperative floppy iris syndrome: a retrospective study. Acta Ophthalmol 2012;90:e152-3
72. Wong AC, Mak ST. Finasteride-associated cataract and intraoperative floppy-iris syndrome. J Cataract Refract Surg 2011;37:1351-4
73. Issa SA, Dagres E. Intraoperative floppyiris syndrom and finasteride intake. J Cataract Refract Surg 2007;33:2141-3
74. Yeu E, Grostern R. Saw palmetto and intraoperative floppy-iris syndrome. J Cataract Refract Surg 2007;33:927-8
75. Goepel M, Hecker U, Krege S, et al. Saw palmetto extracts potently and noncompetitively inhibit human alpha1- adrenoceptors in vitro. Prostate 1999;38:208-15
76. Storr-Paulsen A, Norregaard JC, Borne KK, et al. Intraoperative floppy iris syndrome (IFIS): a practical approach to medical and surgical considerations in cataract extractions. Acta Ophthalmol 2009;87:704-8
77. Martin-Moro JG, Negrete FM, Escobar IL, et al. Sindrome del iris flacido intraoperatorio. Arch Soc Espan Oftalmol 2013;88:64-76
78. The Ophthalmic News & Education Network. Clinical statement on IRIS. 2014. Available from: http://one.aao.org/clinical-statement/intraoperative- floppyiris-syndrome-ifis-associate-2 [Last accessed 4 June 2014]
79. Oelke M, Giuliano F, Mirone V, et al. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controleld clinical trial. Eur Urol 2012;61:917-25