Oral Sildenafil Citrate (Viagra) for Erectile Dysfunction: A Systematic Review and Meta-analysis of Harms

Urology

Volumn 74, Issue 4, 2009, Pages

  Tsertsvadze, Alexander ^a   Yazdi, Fatemeh ^a   Fink, Howard A ^b,c   MacDonald, Roderick ^c   Wilt, Timothy J ^c   Bella, Anthony J ^d   Ansari, Mohammed T ^a   Garritty, Chantelle ^a   Soares Weiser, Karla ^e   Daniel, Raymond ^a   Sampson, Margaret ^f   Moher, David ^a,g  

^a OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^b VA MEDICAL CENTER   (United States)

^c VETERANS AFFAIRS MEDICAL CENTER   (United States)

^d Division of Urology   (Canada)

^e Enhance Reviews   (Israel)

^f CHILDREN S HOSPITAL OF EASTERN ONTARIO   (Canada)

^g UNIVERSITY OF OTTAWA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; SILDENAFIL;

ANGINA PECTORIS; ARTICLE; CEREBROVASCULAR DISEASE; CLINICAL TRIAL; COCHRANE LIBRARY; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; EMBASE; ERECTILE DYSFUNCTION; FLUSHING; HEADACHE; HEART ARREST; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; HYPERTENSION; LUNG EDEMA; MALE; MEDLINE; META ANALYSIS; NOSE CONGESTION; PRIORITY JOURNAL; PSYCINFO; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SYSTEMATIC REVIEW; THORAX PAIN; THROMBOPHLEBITIS; VISUAL DISORDER;

EID: 70349451714     PISSN: 00904295     EISSN: 15279995     Source Type: Journal    
DOI: 10.1016/j.urology.2009.04.026     Document Type: Article

References (67)

1. NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA 270 (1993) 83-90
2. Feldman H.A., Goldstein I., Hatzichristou D.G., et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts male aging study. J Urol 151 (1994) 54-61
3. Johannes C.B., Araujo A.B., Feldman H.A., et al., [see comment]. Incidence of erectile dysfunction in men 40-69 years old: longitudinal results from the Massachusetts male aging study. J Urol 163 (2000) 460-463
4. Fazio L., and Brock G. Erectile dysfunction: management update. Can Med Assoc J 170 (2004) 1429-1437
5. Boolell M., Allen M.J., Ballard S.A., et al. Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Int J Impot Res 8 (1996) 47-52
6. Morales A., Gingell C., Collins M., et al. Clinical safety of oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction. Int J Impot Res 10 (1998) 69-73
7. Tomsak R. PDE5 inhibitors and permanent visual loss. Int J Impot Res 17 (2005) 547-549
8. Tsertsvadze A, Yazdi F, Fink HA, et al. Diagnosis and treatment of erectile dysfunction. AHRQ Evidence Report/Technology Assessment 171. Available at: http://www.ahrq.gov/downloads/pub/evidence/pdf/erectiledys/erecdys.pdf on 26-5-2009. Accessed May 26, 2009.
9. Jadad A.R., Moore R.A., Carroll D., et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 17 (1996) 1-12
10. Schulz K.F., and Grimes D.A. Allocation concealment in randomised trials: defending against deciphering. Lancet 359 (2002) 614-618
11. Higgins J.P., Thompson S.G., Deeks J.J., et al. Measuring inconsistency in meta-analyses. BMJ 327 (2003) 557-560
12. DerSimonian R., and Laird N. Meta-analysis in clinical trials. Control Clin Trials 7 (1986) 177-188
13. Seidman S.N., Roose S.P., Menza M.A., et al. Treatment of erectile dysfunction in men with depressive symptoms: results of a placebo-controlled trial with sildenafil citrate. Am J Psychiatry 158 (2001) 1623-1630
14. Kongkanand A., Ratana-Olarn K., Ruangdilokrat S., et al. The efficacy and safety of oral sildenafil in Thai men with erectile dysfunction: a randomized, double-blind, placebo controlled, flexible-dose study. J Med Assoc Thai 86 (2003) 195-205
15. Stuckey B.G., Jadzinsky M.N., Murphy L.J., et al. Sildenafil citrate for treatment of erectile dysfunction in men with type 1 diabetes: results of a randomized controlled trial. Diab Care 26 (2003) 279-284
16. Choi H.K., Ahn T.Y., Kim J.J., et al. A double-blind, randomised-placebo, controlled, parallel group, multicenter, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea. Int J Impot Res 15 (2003) 80-86
17. Levinson I.P., Khalaf I.M., Shaeer K.Z., et al. Efficacy and safety of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in Egypt and South Africa. Int J Impot Res 15 suppl 1 (2003) 25-29
18. DeBusk R.F., Pepine C.J., Glasser D.B., et al. Efficacy and safety of sildenafil citrate in men with erectile dysfunction and stable coronary artery disease. Am J Cardiol 93 (2004) 147-153
19. Boolell M., Gepi-Attee S., Gingell J.C., et al. Sildenafil, a novel effective oral therapy for male erectile dysfunction. Br J Urol 78 (1996) 257-261
20. Goldstein I., Lue T.F., Padma-Nathan H., et al. for Sildenafil Study Group. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med 338 (1998) 1397-1404
21. Tan H.M., Moh C.L., Mendoza J.B., et al. for The assess-1 Study Group. Asian sildenafil efficacy and safety study (assess-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction. Urology 56 (2000) 635-640
22. Meuleman E., Cuzin B., Opsomer R.J., et al. A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction. BJU Int 87 (2001) 75-81
23. Eardley I., Morgan R., Dinsmore W., et al. Efficacy and safety of sildenafil citrate in the treatment of men with mild to moderate erectile dysfunction. Br J Psychiatry 178 (2001) 325-330
24. Young J.M., Bennett C., Gilhooly P., et al. Efficacy and safety of sildenafil citrate (Viagra) in black and Hispanic American men. Urology 60 suppl 2 (2002) 39-48
25. Nurnberg H.G., Hensley P.L., Gelenberg A.J., et al. Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial. JAMA 289 (2003) 56-64
26. Price D.E., Gingell J.C., Gepi-Attee S., et al. Sildenafil: study of a novel oral treatment for erectile dysfunction in diabetic men. Diabet Med 15 (1998) 821-825
27. Rendell M.S., Rajfer J., Wicker P.A., et al. for Sildenafil Diabetes Study Group. Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. JAMA 281 (1999) 421-426
28. Christiansen E., Guirguis W.R., Cox D., et al. Long-term efficacy and safety of oral Viagra (sildenafil citrate) in men with erectile dysfunction and the effect of randomised treatment withdrawal. Int J Impot Res 12 (2000) 177-182
29. Olsson A.M., Speakman M.J., Dinsmore W.W., et al. Sildenafil citrate (Viagra) is effective and well tolerated for treating erectile dysfunction of psychogenic or mixed aetiology. Int J Clin Pract 54 (2000) 561-566
30. Chen K.K., Hsieh J.T., Huang S.T., et al. Assess-3: a randomised, double-blind, flexible-dose clinical trial of the efficacy and safety of oral sildenafil in the treatment of men with erectile dysfunction in Taiwan. Int J Impot Res 13 (2001) 221-229
31. Boulton A.J., Selam J.L., Sweeney M., et al. Sildenafil citrate for the treatment of erectile dysfunction in men with type II diabetes mellitus. Diabetologia 44 (2001) 1296-1301
32. Safarinejad M.R. Oral sildenafil in the treatment of erectile dysfunction in diabetic men: a randomized double-blind and placebo-controlled study. J Diab Complications 18 (2004) 205-210
33. Webster L.J., Michelakis E.D., Davis T., et al. Use of sildenafil for safe improvement of erectile function and quality of life in men with New York Heart Association classes II and III congestive heart failure: a prospective, placebo-controlled, double-blind crossover trial. Arch Intern Med 164 (2004) 514-520
34. Cavallini G., Modenini F., Vitali G., et al. Acetyl-L-carnitine plus propionyl-L-carnitine improve efficacy of sildenafil in treatment of erectile dysfunction after bilateral nerve-sparing radical retropubic prostatectomy. Urology 66 (2005) 1080-1085
35. Katz S.D., Parker J.D., Glasser D.B., et al. Efficacy and safety of sildenafil citrate in men with erectile dysfunction and chronic heart failure. Am J Cardiol 95 (2005) 36-42
36. Abdel-Naser M.B., Imam A., and Wollina U. Sildenafil citrate significantly improves nocturnal penile erections in sildenafil non-responding patients with psychogenic erectile dysfunction. Int J Impot Res 16 (2004) 552-556
37. Deveci S., Peskircioglu L., Aygun C., et al. Sublingual sildenafil in the treatment of erectile dysfunction: faster onset of action with less dose. Int J Urol 11 (2004) 989-992
38. Tignol J., Furlan P.M., Gomez-Beneyto M., et al. Efficacy of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in remission from depression. Int Clin Psychopharmacol 19 (2004) 191-199
39. Padma-Nathan H., Stecher V.J., Sweeney M., et al. Minimal time to successful intercourse after sildenafil citrate: results of a randomized, double-blind, placebo-controlled trial. Urology 62 (2003) 400-403
40. Gomez F., Davila H., Costa A., et al. Efficacy and safety of oral sildenafil citrate (Viagra) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study. Int J Impot Res 14 suppl 2 (2002) 42-47
41. Becher E., Tejada N.A., Gomez R., et al. Sildenafil citrate (Viagra) in the treatment of men with erectile dysfunction in southern Latin America: a double-blind, randomized, placebo-controlled, parallel-group, multicenter, flexible-dose escalation study. Int J Impot Res 14 suppl 2 (2002) 33-41
42. Incrocci L., Koper P.C., Hop W.C., et al. Sildenafil citrate (Viagra) and erectile dysfunction following external beam radiotherapy for prostate cancer: a randomized, double-blind, placebo-controlled, cross-over study. Int J Radiat Oncol Biol Phys 51 (2001) 1190-1195
43. Choppin A., Blue D.R., Hegde S.S., et al. Evaluation of oral RO 70-US$0004/003, an alpha1A-adrenoceptor antagonist, in the treatment of male erectile dysfunction. Int J Impot Res 13 (2001) 157-161
44. Olsson A.M., Persson C.A., and for Swedish Sildenafil Investigators Group. Efficacy and safety of sildenafil citrate for the treatment of erectile dysfunction in men with cardiovascular disease. Int J Clin Pract 55 (2001) 171-176
45. Montorsi F., Maga T., Strambi L.F., et al. Sildenafil taken at bedtime significantly increases nocturnal erections: results of a placebo-controlled study. Urology 56 (2000) 906-911
46. Cappelleri J.C., Siegel R.L., Osterloh I.H., et al. Relationship between patient self-assessment of erectile function and the erectile function domain of the international index of erectile function. Urology 56 (2000) 477-481
47. Montorsi F., McDermott T.E., Morgan R., et al. Efficacy and safety of fixed-dose oral sildenafil in the treatment of erectile dysfunction of various etiologies. Urology 53 (1999) 1011-1018
48. Dinsmore W.W., Hodges M., Hargreaves C., et al. Sildenafil citrate (Viagra) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects [Erratum appears in Urology. 1999;53:1072]. Urology 53 (1999) 800-805
49. Padma-Nathan H., Steers W.D., Wicker P.A., and for Sildenafil Study Group. Efficacy and safety of oral sildenafil in the treatment of erectile dysfunction: A double-blind, placebo-controlled study of 329 patients. Int J Clin Pract 52 (1998) 375-379
50. Albuquerque D.C., Miziara L.J., Saraiva J.F.K., et al. Efficacy, safety and tolerability of sildenafil in Brazilian hypertensive patients on multiple antihypertensive drugs. Int Braz J Urol 31 (2005) 342-355
51. Gingell C., Sultana S.R., Wulff M.B., et al. Duration of action of sildenafil citrate in men with erectile dysfunction. J Sex Med 1 (2004) 179-184
52. Pickering T.G., Shepherd A.M.M., Puddey I., et al. Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive agents: a randomized controlled trial. Am J Hypertens 17 (2004) 1135-1142
53. Glina S., Bertero E., Claro J., et al. Efficacy and safety of sildenafil citrate for the treatment of erectile dysfunction in Latin America. Braz J Urol 27 (2001) 148-154
54. Heiman J.R., Talley D.R., Bailen J.L., et al. Sexual function and satisfaction in heterosexual couples when men are administered sildenafil citrate (Viagra) for erectile dysfunction: a multicenter, randomised, double-blind, placebo-controlled trial. Br J Obstet Gynaecol 114 (2007) 437-447
55. McVary K.T., Monnig W., Camps Jr. J.L., et al. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: A randomized, double-blind trial. J Urol 177 (2007) 1071-1077
56. Orr G., Weiser M., Polliack M., et al. Effectiveness of sildenafil in treating erectile dysfunction in PTSD patients: a double-blind, placebo-controlled crossover study. J Clin Psychopharmacol 26 (2006) 426-430
57. Althof S.E., O'Leary M.P., Cappelleri J.C., et al. Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: results from an international, multi-center, double-blind, placebo-controlled trial. J Sex Med 3 (2006) 521-529
58. Fava M., Nurnberg H.G., Seidman S.N., et al. Efficacy and safety of sildenafil in men with serotonergic antidepressant-associated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 67 (2006) 240-246
59. O'Leary M.P., Althof S.E., Cappelleri J.C., et al. Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group, double-blind, placebo controlled study in the United States. J Urol 175 (2006) 1058-1062
60. Friedman L.M., Furberg C., and DeMets D.L. Fundamentals of Clinical Trials (1998), Springer, New York
61. Montague D.K., Jarow J., Broderick G.A., et al. AUA guideline on the pharmacologic management of premature ejaculation. J Urol 172 (2004) 290-294
62. Wessells H., Joyce G.F., Wise M., et al. Erectile dysfunction. J Urol 177 (2007) 1675-1681
63. Fink H.A., Mac D.R., Rutks I.R., et al. Sildenafil for male erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med 162 (2002) 1349-1360
64. Moore R.A., Edwards J.E., and McQuay H.J. Sildenafil (Viagra) for male erectile dysfunction: a meta-analysis of clinical trial reports. BMC Urol 2 (2002) 6
65. Moher D., Schulz K.F., and Altman D.G. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 134 (2001) 657-662
66. Bannowsky A., Schulze H., Van der H.C., et al. Recovery of erectile function after nerve-sparing radical prostatectomy: improvement with nightly low-dose sildenafil. BJU Int 101 (2008) 1279-1283
67. Mathers M.J., Klotz T., Brandt A.S., et al. Long-term treatment of erectile dysfunction with a phosphodiesterase-5 inhibitor and dose optimization based on nocturnal penile tumescence. BJU Int 101 (2008) 1129-1134