Long-term efficacy and safety of oral Viagra® (sildenafil citrate) in men with erectile dysfunction and the effect of randomised treatment withdrawal

被引:38
作者
Christiansen, E
Guirguis, WR
Cox, D
Osterloh, IH
机构
[1] Androl Ctr, N-0212 Oslo, Norway
[2] St Clements Hosp, Sexual Dysfunct Clin, Ipswich IP3 8LS, Suffolk, England
[3] Pfizer Ltd, Cent Res, Sandwich CT13 9NJ, Kent, England
关键词
impotence; sildenafil; 3; 5 '-cyclic-GMP phosphodiesterase inhibitors; penile erection;
D O I
10.1038/sj.ijir.3900527
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
The long-term efficacy and safety of oral Viagra(R) (sildenafil citrate), a selective phosphodiesterase 5 inhibitor, and the effect of withdrawing treatment were evaluated in men with erectile dysfunction (ED). In 233 men with ED of psychogenic or mixed organic/psychogenic aetiology, 16 weeks of open-label, flexible-dose sildenafil treatment (10 - 100 mg) was followed by eight weeks of double-blind, fixed-dose, randomised withdrawal to placebo or continued treatment with sildenafil, Sildenafil was taken as needed (not more than once daily) approximately Ih prior to sexual activity. The main outcome measures were a global efficacy question, a sexual function questionnaire, an event log of erections, and adverse event recording, In the open-label phase, 200 of 216 patients (93%) reported improved erections with sildenafil; 28 patients (12%) discontinued treatment. In the double-blind phase, the significant improvements in the frequency and duration of erections were maintained in the sildenafil group but returned to pre-treatment values in patients on placebo (P values < 0.0001 versus placebo). The most Frequent adverse events in the sildenafil group during the double-blind phase were flushing (7%), headache (6%), and dyspepsia (5%), Of the 192 patients enrolled in the 1-y extension, 90% completed the study; only two patients (1%) were withdrawn due to lack of efficacy. Tn men with ED of psychogenic or mixed aetiology, oral sildenafil is effective and well-tolerated both at the initiation of therapy and during long-term treatment. For most patients, sildenafil treatment must be continued for improvements in erectile function to be maintained.
引用
收藏
页码:177 / 182
页数:6
相关论文
共 22 条
  • [11] Oral sildenafil in the treatment of erectile dysfunction
    Goldstein, I
    Lue, TF
    Padma-Nathan, H
    Rosen, RC
    Steers, WD
    Wicker, PA
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1998, 338 (20) : 1397 - 1404
  • [12] Predictors of success and risk factors for attrition in the use of intracavernous injection
    Gupta, R
    Kirschen, J
    Barrow, RC
    Francois, J
    [J]. JOURNAL OF UROLOGY, 1997, 157 (05) : 1681 - 1686
  • [13] Kinsey A. C., 1948, SEXUAL BEHAV HUMAN M, P218
  • [14] EVALUATION OF 1ST 406 PATIENTS IN UROLOGY DEPARTMENT BASED CENTER FOR MALE SEXUAL DYSFUNCTION
    MELMAN, A
    TIEFER, L
    PEDERSEN, R
    [J]. UROLOGY, 1988, 32 (01) : 6 - 10
  • [15] Clinical guidelines panel on erectile dysfunction: Summary report on the treatment of organic erectile dysfunction
    Montague, DK
    Barada, JH
    Belker, AM
    Levine, LA
    Nadig, PW
    Roehrborn, CG
    Sharlip, ID
    Bennett, AH
    [J]. JOURNAL OF UROLOGY, 1996, 156 (06) : 2007 - 2011
  • [16] IMPOTENCE
    MORLEY, JE
    [J]. AMERICAN JOURNAL OF MEDICINE, 1986, 80 (05) : 897 - 905
  • [17] The international index of erectile function (IIEF): A multidimensional scale for assessment of erectile dysfunction
    Rosen, RC
    Riley, A
    Wagner, G
    Osterloh, IH
    Kirkpatrick, J
    Mishra, A
    [J]. UROLOGY, 1997, 49 (06) : 822 - 830
  • [18] Schein M, 1988, Fam Pract Res J, V7, P122
  • [19] Comparison of long-term outcomes of penile prostheses and intracavernosal injection therapy
    Sexton, WJ
    Benedict, JF
    Jarow, JP
    [J]. JOURNAL OF UROLOGY, 1998, 159 (03) : 811 - 815
  • [20] IMPOTENCE IN MEDICAL CLINIC OUTPATIENTS
    SLAG, MF
    MORLEY, JE
    ELSON, MK
    TRENCE, DL
    NELSON, CJ
    NELSON, AE
    KINLAW, WB
    BEYER, HS
    NUTTALL, FQ
    SHAFER, RB
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1983, 249 (13): : 1736 - 1740