메뉴 건너뛰기




Volumn 11, Issue 1, 2011, Pages 1-11

Cardiovascular safety profile of dapoxetine during the premarketing evaluation

Author keywords

Dapoxetine; Premature ejaculation; therapeutic use

Indexed keywords

DAPOXETINE; PLACEBO;

EID: 79953156439     PISSN: 11745886     EISSN: 11796901     Source Type: Journal    
DOI: 10.2165/11587660-000000000-00000     Document Type: Review
Times cited : (16)

References (46)
  • 1
    • 0004235298 scopus 로고    scopus 로고
    • American Psychiatric Association, 4th ed. Washington, DC: American Psychiatric Association
    • American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington, DC: American Psychiatric Association, 2000
    • (2000) Diagnostic and Statistical Manual of Mental Disorders
  • 3
    • 33645744784 scopus 로고    scopus 로고
    • The second Princeton consensus on sexual dysfunction and cardiac risk: New guidelines for sexual medicine
    • Jan
    • Jackson G, Rosen RC, Kloner RA, et al. The second Princeton consensus on sexual dysfunction and cardiac risk: new guidelines for sexual medicine. J Sex Med 2006 Jan; 3(1):28-36
    • (2006) J. Sex Med. , vol.3 , Issue.1 , pp. 28-36
    • Jackson, G.1    Rosen, R.C.2    Kloner, R.A.3
  • 5
    • 79953133261 scopus 로고    scopus 로고
    • Public Assessment Report Scientific Discussion:, December, Available from, Accessed 2011 Jan 7
    • Public assessment report scientific discussion: priligy dapoxetine hydrochloride film-coated tablets, 30 and 60 mg. Läkemedelsverket Medical Products Agency, December 2008. Available from URL: http://www.lakemedelsverket. se/SPC-PIL/Pdf/par/Priligy%20film%20coated%20tablets% 2030%20and%2060%20mg.pdf [Accessed 2011 Jan 7]
    • (2008) Läkemedelsverket Medical Products Agency
  • 6
    • 77953643410 scopus 로고    scopus 로고
    • Dapoxetine for premature ejaculation
    • Jul
    • McMahon CG. Dapoxetine for premature ejaculation. Expert Opin Pharmacother 2010 Jul; 11(10):1741-52
    • (2010) Expert Opin. Pharmacother. , vol.11 , Issue.10 , pp. 1741-1752
    • McMahon, C.G.1
  • 7
    • 33747054182 scopus 로고    scopus 로고
    • Pharmacokinetics of dapoxetine, a new treatment for premature ejaculation: Impact of age and effects of a high-fat meal
    • DOI 10.1177/0091270006291033
    • Dresser MJ, Kang D, Staehr P, et al. Pharmacokinetics of dapoxetine, a new treatment for premature ejaculation: impact of age and effects of a high-fat meal. J Clin Pharmacol 2006 Sep; 46(9):1023-9 (Pubitemid 44215067)
    • (2006) Journal of Clinical Pharmacology , vol.46 , Issue.9 , pp. 1023-1029
    • Dresser, M.J.1    Kang, D.2    Staehr, P.3    Gidwani, S.4    Guo, C.5    Mulhall, J.P.6    Modi, N.B.7
  • 8
    • 32944463634 scopus 로고    scopus 로고
    • Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation
    • DOI 10.1177/0091270005284850
    • Modi NB, Dresser MJ, Simon M, et al. Single-and multipledose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. J Clin Pharmacol 2006 Mar; 46(3):301-9 (Pubitemid 43260317)
    • (2006) Journal of Clinical Pharmacology , vol.46 , Issue.3 , pp. 301-309
    • Modi, N.B.1    Dresser, M.J.2    Simon, M.3    Lin, D.4    Desai, D.5    Gupta, S.6
  • 9
    • 77953648907 scopus 로고    scopus 로고
    • Pharmacokinetics of dapoxetine hydrochloride in healthy chinese, Japanese, and caucasian men
    • Dec
    • Thyssen A, Sharma O, Tianmei S, et al. Pharmacokinetics of dapoxetine hydrochloride in healthy chinese, Japanese, and caucasian men. J Clin Pharmacol 2010 Dec; 50(12):1450-60
    • (2010) J. Clin. Pharmacol. , vol.50 , Issue.12 , pp. 1450-1460
    • Thyssen, A.1    Sharma, O.2    Tianmei, S.3
  • 10
    • 0035108671 scopus 로고    scopus 로고
    • Incidence of sexual dysfunction associated with antidepressant agents: A prospective multicenter study of 1022 outpatients
    • Montejo AL, Llorca G, Izquierdo JA, et al. Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients. Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction. J Clin Psychiatry 2001;62 Suppl. 3:10-21 (Pubitemid 32164676)
    • (2001) Journal of Clinical Psychiatry , vol.62 , Issue.SUPPL. 3 , pp. 10-21
    • Montejo, A.L.1    Llorca, G.2    Izquierdo, J.A.3    Rico-Villademoros, F.4
  • 12
    • 50049129061 scopus 로고    scopus 로고
    • The pharmacological treatment of premature ejaculation
    • Sep
    • Giuliano F, Hellstrom WJ. The pharmacological treatment of premature ejaculation. BJU Int 2008 Sep; 102(6):668-75
    • (2008) BJU Int. , vol.102 , Issue.6 , pp. 668-675
    • Giuliano, F.1    Hellstrom, W.J.2
  • 13
    • 3242773768 scopus 로고    scopus 로고
    • AUA guideline on the pharmacologic management of premature ejaculation
    • Jul
    • Montague DK, Jarow J, Broderick GA, et al. AUA guideline on the pharmacologic management of premature ejaculation. J Urol 2004 Jul; 172(1):290-4
    • (2004) J. Urol. , vol.172 , Issue.1 , pp. 290-294
    • Montague, D.K.1    Jarow, J.2    Broderick, G.A.3
  • 14
    • 0031732861 scopus 로고    scopus 로고
    • Selective serotonin reuptake inhibitors in the treatment of affective disorders - III. Tolerability, safety and pharmacoeconomics
    • Goldstein BJ, Goodnick PJ. Selective serotonin reuptake inhibitors in the treatment of affective disorders: III. Tolerability, safety and pharmacoeconomics. J Psychopharmacol 1998;12(3 Suppl. B): S55-87 (Pubitemid 28556670)
    • (1998) Journal of Psychopharmacology , vol.12 , Issue.3 SUPPL. B
    • Goldstein, B.J.1    Goodnick, P.J.2
  • 15
    • 3242884869 scopus 로고    scopus 로고
    • Cardiovascular side effects of new antidepressants and antipsychotics: New drugs, old concerns?
    • DOI 10.2174/1381612043383872
    • Pacher P, Kecskemeti V. Cardiovascular side effects of new antidepressants and antipsychotics: new drugs, old concerns? Curr Pharm des 2004;10(20):2463-75 (Pubitemid 38997427)
    • (2004) Current Pharmaceutical Design , vol.10 , Issue.20 , pp. 2463-2475
    • Pacher, P.1    Kecskemeti, V.2
  • 16
    • 33846501306 scopus 로고    scopus 로고
    • Adverse cardiovascular events in antidepressant trials involving high-risk patients: A systematic review of randomized trials
    • Swenson JR, Doucette S, Fergusson D. Adverse cardiovascular events in antidepressant trials involving high-risk patients: a systematic review of randomized trials. Can J Psychiatry 2006 Dec; 51(14):923-9 (Pubitemid 46354056)
    • (2006) Canadian Journal of Psychiatry , vol.51 , Issue.14 , pp. 923-929
    • Swenson, J.R.1    Doucette, S.2    Fergusson, D.3
  • 17
    • 79953138131 scopus 로고    scopus 로고
    • ZOLOFT sertraline hydrochloride prescribing information. New York NY: Pfizer Inc, 2008
    • ZOLOFT (sertraline hydrochloride) [prescribing information]. New York (NY): Pfizer Inc, 2008
  • 18
    • 79953141385 scopus 로고    scopus 로고
    • PAXIL paroxetine hydrochloride prescribing information
    • PAXIL (paroxetine hydrochloride) [prescribing information]. Research Triangle Park (NC): Glaxo Smith Kline, 2009
    • (2009) Research Triangle Park (NC): Glaxo Smith Kline
  • 19
    • 79953149814 scopus 로고    scopus 로고
    • PROZAC fluoxetine hydrochloride prescribing information
    • PROZAC (fluoxetine hydrochloride) [prescribing information]. Indianapolis (IN): Eli Lilly and Co, 2009
    • (2009) Indianapolis (IN): Eli Lilly and Co
  • 22
    • 78449258346 scopus 로고    scopus 로고
    • Available from, Accessed 2010 Aug. 2, 8 November
    • ICH Harmonized Tripartite Guideline S7A. Safety pharmacology studies for human pharmaceuticals; 8 November 2000. Available from URL: http://www.ich.org/ LOB/me dia/MEDIA504.pdf [Accessed 2010 Aug. 2]
    • (2000) Safety Pharmacology Studies for Human Pharmaceuticals;
  • 24
    • 67049119564 scopus 로고    scopus 로고
    • Pharmacokinetic, pharmacodynamic, and electrocardiographic effects of dapoxetine and moxifloxacin compared with placebo in healthy adultmale subjects
    • Jun
    • Modi NB, Nath R, Staehr P, et al. Pharmacokinetic, pharmacodynamic, and electrocardiographic effects of dapoxetine and moxifloxacin compared with placebo in healthy adultmale subjects. J Clin Pharmacol 2009 Jun; 49(6):634-42
    • (2009) J. Clin. Pharmacol. , vol.49 , Issue.6 , pp. 634-642
    • Modi, N.B.1    Nath, R.2    Staehr, P.3
  • 25
    • 79953155246 scopus 로고    scopus 로고
    • Dapoxetine treatment of men with premature ejaculation: Dose-finding analysis [abstract no. P-02-163]
    • Nilsson-Neijber A, Althof S, Gittelman M, et al. Dapoxetine treatment of men with premature ejaculation: dose-finding analysis [abstract no. P-02-163]. J Sex Med 2006; Suppl. 3:224-86.
    • (2006) J. Sex Med. , Issue.3 SUPPL. , pp. 224-286
    • Nilsson-Neijber, A.1    Althof, S.2    Gittelman, M.3
  • 27
    • 60249103913 scopus 로고    scopus 로고
    • Dapoxetine for the treatment of premature ejaculation: Results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries
    • Buvat J, Tesfaye F, Rothman M, et al. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Eur Urol 2009;55(4):957-67
    • (2009) Eur. Urol. , vol.55 , Issue.4 , pp. 957-967
    • Buvat, J.1    Tesfaye, F.2    Rothman, M.3
  • 28
    • 60449119173 scopus 로고    scopus 로고
    • Treatment benefit of dapoxetine for premature ejaculation: Results from a placebo-controlled phase III trial
    • Mar
    • Kaufman JM, Rosen RC, Mudumbi RV, et al. Treatment benefit of dapoxetine for premature ejaculation: results from a placebo-controlled phase III trial. BJU Int 2009 Mar; 103(5):651-8
    • (2009) BJU Int. , vol.103 , Issue.5 , pp. 651-658
    • Kaufman, J.M.1    Rosen, R.C.2    Mudumbi, R.V.3
  • 29
    • 74049101562 scopus 로고    scopus 로고
    • Treatment of premature ejaculation in the Asia-Pacific region: Results from a phase III double-blind, parallel-group study of dapoxetine
    • Jan, Pt 1
    • McMahon C, Kim SW, Park NC, et al. Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. J Sex Med 2010 Jan; 7 (1 Pt 1):256-68
    • (2010) J. Sex Med. , vol.7 , Issue.1 , pp. 256-268
    • McMahon, C.1    Kim, S.W.2    Park, N.C.3
  • 30
    • 33748316794 scopus 로고    scopus 로고
    • Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: An integrated analysis of two double-blind, randomised controlled trials
    • DOI 10.1016/S0140-6736(06)69373-2, PII S0140673606693732
    • Pryor JL, Althof SE, Steidle C, et al. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet 2006 Sep. 9; 368(9539):929-37 (Pubitemid 44331385)
    • (2006) Lancet , vol.368 , Issue.9539 , pp. 929-937
    • Pryor, J.L.1    Althof, S.E.2    Steidle, C.3    Rosen, R.C.4    Hellstrom, W.J.5    Shabsigh, R.6    Miloslavsky, M.7    Kell, S.8
  • 31
    • 50949110207 scopus 로고    scopus 로고
    • Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: Results from phase III trials with dapoxetine
    • Sep
    • Shabsigh R, Patrick DL, Rowland DL, et al. Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: results from phase III trials with dapoxetine. BJU Int 2008 Sep; 102(7):824-8
    • (2008) BJU Int. , vol.102 , Issue.7 , pp. 824-828
    • Shabsigh, R.1    Patrick, D.L.2    Rowland, D.L.3
  • 32
    • 33750303429 scopus 로고    scopus 로고
    • Treating patients with ventricular ectopic beats
    • DOI 10.1136/hrt.2005.067843
    • Ng GA. Treating patients with ventricular ectopic beats. Heart 2006 Nov; 92(11):1707-12 (Pubitemid 44629193)
    • (2006) Heart , vol.92 , Issue.11 , pp. 1707-1712
    • Ng, G.A.1
  • 33
    • 0038314757 scopus 로고    scopus 로고
    • National High Blood Pressure Education Program, AV Chobanian chair. U. S. Department of Health and Human Services, National High Blood Pressure Education Program. NIH Publication No. 04-5230. August, Available from, Accessed 2011 Jan 7
    • National High Blood Pressure Education Program. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. AV Chobanian (chair). U. S. Department of Health and Human Services, National Institutes of Health-National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program. NIH Publication No. 04-5230. August 2004. Available from URL: http://www.nhlbi.nih.gov/guidelines/ hypertension/jnc7full.pdf [Accessed 2011 Jan 7]
    • (2004) The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure
  • 35
    • 8444224197 scopus 로고    scopus 로고
    • Guidelines on management (diagnosis and treatment) of syncope-update 2004: Executive summary
    • Nov
    • Brignole M, Alboni P, Benditt DG, et al. Guidelines on management (diagnosis and treatment) of syncope-update 2004: executive summary. Eur Heart J 2004 Nov; 25(22):2054-72
    • (2004) Eur. Heart J. , vol.25 , Issue.22 , pp. 2054-2072
    • Brignole, M.1    Alboni, P.2    Benditt, D.G.3
  • 36
    • 0034658335 scopus 로고    scopus 로고
    • Risk factors for syncope in a community-based sample (The Framingham Heart Study)
    • DOI 10.1016/S0002-9149(00)00726-8, PII S0002914900007268
    • Chen L, Chen MH, Larson MG, et al. Risk factors for syncope in a community-based sample (the Framingham Heart Study). Am J Cardiol 2000 May 15; 85(10):1189-93 (Pubitemid 30232812)
    • (2000) American Journal of Cardiology , vol.85 , Issue.10 , pp. 1189-1193
    • Chen, L.1    Chen, M.H.2    Larson, M.G.3    Evans, J.4    Benjamin, E.J.5    Levy, D.6
  • 38
    • 14844295467 scopus 로고    scopus 로고
    • Clinical practice: Neurocardiogenic syncope
    • Mar. 10
    • Grubb BP. Clinical practice: neurocardiogenic syncope. N Engl J Med 2005 Mar. 10; 352(10):1004-10
    • (2005) N. Engl. J. Med. , vol.352 , Issue.10 , pp. 1004-1010
    • Grubb, B.P.1
  • 39
    • 0034610436 scopus 로고    scopus 로고
    • The elusive pathophysiology of neurally mediated syncope
    • Dec. 5
    • Mosqueda-Garcia R, Furlan R, Tank J, et al. The elusive pathophysiology of neurally mediated syncope. Circulation 2000 Dec. 5; 102(23):2898-906
    • (2000) Circulation , vol.102 , Issue.23 , pp. 2898-2906
    • Mosqueda-Garcia, R.1    Furlan, R.2    Tank, J.3
  • 41
    • 20444500213 scopus 로고    scopus 로고
    • Neurocardiogenic syncope and related disorders of orthostatic intolerance
    • DOI 10.1161/CIRCULATIONAHA.104.482018
    • Grubb BP. Neurocardiogenic syncope and related disorders of orthostatic intolerance. Circulation 2005 Jun. 7; 111(22):2997-3006 (Pubitemid 40814194)
    • (2005) Circulation , vol.111 , Issue.22 , pp. 2997-3006
    • Grubb, B.P.1
  • 42
    • 0032242725 scopus 로고    scopus 로고
    • The potential role of serotonin in the pathogenesis of neurocardiogenic syncope and related autonomic disturbances
    • Grubb BP, Karas BJ. The potential role of serotonin in the pathogenesis of neurocardiogenic syncope and related autonomic disturbances. J Interv Card Electrophysiol 1998 Dec; 2(4):325-32 (Pubitemid 128691591)
    • (1998) Journal of Interventional Cardiac Electrophysiology , vol.2 , Issue.4 , pp. 325-332
    • Grubb, B.P.1
  • 44
    • 0027409860 scopus 로고
    • Neurocardiogenic syncope
    • DOI 10.1056/NEJM199304153281510
    • Abboud FM. Neurocardiogenic syncope. N Engl J Med 1993 Apr. 15; 328(15):1117-20 (Pubitemid 23097803)
    • (1993) New England Journal of Medicine , vol.328 , Issue.15 , pp. 1117-1120
    • Abboud, F.M.1
  • 45
    • 33846488010 scopus 로고    scopus 로고
    • 5-Hydroxytryptamine in premature ejaculation: Opportunities for therapeutic intervention
    • DOI 10.1016/j.tins.2006.12.002, PII S0166223606002736
    • Giuliano F. 5-Hydroxytryptamine in premature ejaculation: opportunities for therapeutic intervention. Trends Neurosci 2007 Feb; 30(2):79-84 (Pubitemid 46164860)
    • (2007) Trends in Neurosciences , vol.30 , Issue.2 , pp. 79-84
    • Giuliano, F.1
  • 46
    • 0344110152 scopus 로고    scopus 로고
    • Pharmacokinetics of selective serotonin reuptake inhibitors
    • Jan
    • Hiemke C, Hartter S. Pharmacokinetics of selective serotonin reuptake inhibitors. Pharmacol Ther 2000 Jan; 85(1):11-28
    • (2000) Pharmacol. Ther. , vol.85 , Issue.1 , pp. 11-28
    • Hiemke, C.1    Hartter, S.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.