Gleason, Tucson, Ariz.; F. Govier, Seattle; L. Hoffman, Gurnee, Ill.; J.M. Kaufman, Aurora, Colo.; I.
| Condition | Caution / Notes | Risk Factors |
|---|---|---|
| Cardiovascular disease | Use with caution | Heart failure, recent MI |
| Concomitant nitrate use | Absolute contraindication | Risk of severe hypotension |
| Severe hepatic impairment | May require dose adjustment | Reduced clearance |
| Retinitis Pigmentosa | Cautious use | Potential for vision disturbances |
Klimberg, Ocala, Fla.; V. Longo, New London, Conn.; T. Malloy, Philadelphia; A.
Warnings & Precautions
The mean scores after sildenafil therapy approached those of normal men of the same age. The men we studied had a normal level of sexual desire, as might be expected of men with erectile dysfunction who enter a clinical trial,13 and sildenafil did not alter that level. Successful sexual intercourse was therefore a key end point for these men. Overall, the results of the efficacy assessments demonstrated that sildenafil significantly improved erectile function and quadrupled the success of intercourse, with effectiveness maintained for at least six months. Its main adverse effects were headache, flushing, dyspepsia, and visual disturbances and were usually mild.
Other Medical Problems
Only one man with a visual disturbance discontinued treatment, and he also had flushing. Few men discontinued sildenafil, suggesting a relatively high level of drug tolerability and acceptance. No man had priapism after sildenafil treatment. Sildenafil has modest vasodilator properties but no effect on heart rate. The American Urological Association Panel on the Treatment of Organic Erectile Dysfunction stated that the ultimate goal is a therapy that is reliable, has minimal side effects, and is simple to use.6 Sildenafil appears to meet these specifications.
New England Journal of Medicine
Oral therapy permits discreet administration and is less invasive than some other treatment options, including injections into the corpus cavernosum, transurethral drug delivery, and prosthesis implantation. Goldstein, Lue, Padma-Nathan, Rosen, and Steers have served as consultants to Pfizer, manufacturer of sildenafil, as well as to other companies making products for the treatment of erectile dysfunction. We are indebted to all the investigators who participated in the trials; to Dr. Ian Osterloh and Dr. David Cox of Pfizer for their sildenafil 100mg lowest price help with the study design and logistics; to Dr. McCullough, New York; J.
- Sildenafil may cause dizziness; avoid driving until effects are known.
- Seek immediate medical help if an erection lasts more than 4 hours.
- Do not mix sildenafil with other ED medications unless directed.
McMurray, Huntsville, Ala.; D.F.
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; J Susset, Providence, R.I.; J. Tuttle, Lexington, Ky.; G. Wells, Birmingham, Ala.; C. White, Mobile, Ala.; J.
Information & Authors
The most frequently reported adverse effects of sildenafil in the two studies were transient headache, flushing, dyspepsia, and rhinitis (Table 3). Transient visual disturbances (i.e., changes in the perception of color hue or brightness) were reported by some men. The frequency of these adverse effects increased with increasing doses of sildenafil, but the symptoms were usually mild and lasted a few minutes to a few hours after dosing. No man reported priapism during the studies. Of the 225 men enrolled in the open-label extension study, 207 (92 percent) completed an additional 32 weeks of sildenafil treatment.
Does sildenafil interact with other medicines (drug interactions)?
Four men (2 percent) withdrew because of treatment-related adverse effects (headache in two, intermittent flushing and blurred vision in one, and groin pain and headache in one). We found that sildenafil improves sexual function in men with erectile dysfunction. In keeping with sildenafil's mode of action (i.e., the drug causes erection only in response to sexual stimulation), the studies were performed entirely in a natural environment, which meant that we had to rely on the men's own reports of efficacy. However, the self-administered International Index of Erectile Function has a high degree of sensitivity and specificity for detecting treatment-related changes in men with erectile dysfunction.13 This questionnaire, together with the global-efficacy question, provided a comprehensive assessment of erectile function during a specified recall period (four weeks), and the event log provided information about individual events during treatment. The men's partners were questioned in each of the studies, and although the results corroborated the men's efficacy assessments, only 25 percent of the partners completed the optional questionnaire.
How does sildenafil work (mechanism of action)?
Recognizing the fact that in most men erectile dysfunction is a multifactorial problem, we enrolled men with a broad variety of causes of erectile dysfunction. The identification of an organic abnormality does not establish it as the cause of erectile dysfunction.14 Conversely, failure to identify an organic cause does not prove a psychogenic origin. In the dose–response study, increasing doses of sildenafil (25 to 100 mg) were increasingly effective in improving the frequency of penetration and the maintenance of erections after penetration, the mean score for the erectile-function domain of the International Index, and the percentage of men reporting better erections. In the dose-escalation study, sildenafil treatment was associated with improvements in the frequency of penetration and the maintenance of erections after penetration. The therapeutic response to sildenafil was similar in men with various causes of erectile dysfunction. Young, Laguna Hills, Calif.; and N. Zinner, Torrance, Calif. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study.
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Feldman, Waterbury, Conn.; W. Fitch III, San Antonio, Tex. ; T. Garland, Lawrence, N.J.; M. Gittelman, North Miami, Fla.; D. Sex-ual behavior in the human male. Efficacy and safety of intracavernosal alprostadil in men with erectile dysfunction. Treatment of men with erectile dysfunction with transurethral alprostadil.
Erratum in
The mean scores for the erectile-function domain on the International Index increased with increasing doses of sildenafil in the dose–response study (P< 0.001). The mean score for the erectile-function domain in the dose-escalation study was significantly higher for the men taking sildenafil (22.1) than for those taking placebo (12.2, P<0.001) (Figure 1A). The mean scores for the orgasmic-function, intercourse-satisfaction, and overall-satisfaction domains were also significantly higher in the sildenafil group (P<0.001) (Figure 1B), whereas the mean scores for sexual desire were not significantly different in the two groups (P = 0.13). The event-log data on the proportion of men achieving erections hard enough for sexual intercourse (i.e., grade 3 or 4) during the last four weeks of treatment showed a significant dose–response relation for sildenafil (72 percent, 80 percent, and 85 percent for doses of 25 mg, 50 mg, and 100 mg, respectively, as compared with 50 percent for placebo; P<0.001). The mean number of grade 3 and grade 4 erections and the mean number of grade 4 erections during the last four weeks of treatment were also significantly higher in the sildenafil group (P< 0.001) (Figure 2A), with 80 percent of the grade 3 erections and 94 percent of the grade 4 erections resulting in successful sexual intercourse.
Sildenafil Tablets for ED
In the dose-escalation study, 69 percent of all attempts at sexual intercourse by the men receiving sildenafil were successful in the last four weeks of treatment, as compared with 22 percent for those receiving placebo (P<0.001) (Figure 2B). During the last four weeks of treatment, the mean numbers of attempts at sexual intercourse that were successful were 5.9 for men in the sildenafil group and 1.5 for men in the placebo group (P<0.001) (Figure 2B). After 24 weeks of treatment in the dose–response study, improved erections were reported by 56, 77, and 84 percent of the men taking 25, 50, and 100 mg of sildenafil, respectively, as compared with 25 percent of those taking placebo (P<0.001 for treatment effect). After 12 weeks of treatment in the dose-escalation study, 101 of the 136 men in the sildenafil group who responded to the global-efficacy question (74 percent) reported improved erections, as compared with 23 of the 118 men in the placebo group who responded to the question (19 percent, P<0.001). During the dose–response study, 31 of the 316 men in the sildenafil group (10 percent) and 36 of the 216 men in the placebo group (17 percent) discontinued treatment (Table 3).
Full Text Sources
Four men (1 percent) in the sildenafil group stopped taking the drug because of treatment-related adverse effects (nausea and vomiting in one, leg pain and backache in one, intermittent headache and dyspepsia in one, and headache in one), as compared with one man (<1 percent) who stopped taking placebo (because of headache and nausea). Five men (2 percent) in the sildenafil group and 11 men (5 percent) in the placebo group discontinued treatment because of insufficient responses. In the dose-escalation study, 9 men (6 percent) stopped taking sildenafil and 13 men (8 percent) stopped taking placebo. One man stopped taking sildenafil because of treatment-related headache and flushing, and one man stopped because of an insufficient response. Laboratory-test results indicated no evidence of sildenafil-induced abnormalities. Clinical Guidelines Panel on Erectile Dysfunction: summary report on the treatment of organic erectile dysfunction.
- Some men may experience minor flushing after taking sildenafil.
- If an adverse reaction occurs, stop medication and contact your doctor.
- Be aware of possible symptoms like sudden vision loss.
Nitric oxide as a mediator of relaxation of the corpus cavernosum in response to nonadrenergic, noncholinergic neurotransmission. N Engl J Med 1992;326:90-94 Andersson, K-E, Wagner, G.
Comment in
Michael Collins and Dr. Michael Smith of Pfizer for their assistance with data analysis; and to Dr. Patricia Leinen and Dr. Michael Sweeney for aid in the preparation of the manuscript. The other members of the Sildenafil Study Group are S.
Clinics in Endocrinology and Metabolism
Auerbach, Newport Beach, Calif.; A.L. Burnett, Baltimore; R. Castellanos, Fort Myers, Fla.; L. Charles, Stratford, N.J.; F. Eid, New York; R. Physiology of penile erection.
- Women are generally not treated with sildenafil for sexual arousal.
- Research on sildenafil's effects on women is ongoing.
- Use in women should only occur under medical supervision.
The role of nitric oxide in the physiology of erection. Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Sildenafil, a novel effective oral therapy for male erectile dysfunction. Br J Urol 1996;78:257-261 Rosen, RC, Riley, A, Wagner, G, Osterloh, IH, Kirkpatrick, J, Mishra, A. The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Riley, AJ, Athanasiadis, L. Impotence and its non-surgical management.
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