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A complete list of the members of the Sildenafil Diabetes Study Group appears at the end of this article. Objective To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes.
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Design A multicenter, randomized, double-blind, placebo-controlled, flexible dose-escalation study conducted May through November Patients A total of men mean age, 57 years with erectile dysfunction mean duration, 5.
Patients took the study drug or placebo 1 hour before anticipated sexual activity.
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The starting dose of sildenafil citrate was 50 mg, with the option to adjust the dose to mg or 25 mg based on efficacy and tolerability, to be taken as needed. Main Outcome Measures Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events.
Conclusion Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes.
Diabetes mellitus affects an estimated Erectile dysfunction in men with diabetes is often associated with diabetic neuropathy and peripheral vascular disease.
Penile erection is a hemodynamic event dependent on the relaxation of smooth muscle cells and arteries of the corpus cavernosum.
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Sildenafil citrate is an orally active and selective inhibitor of PDE5. When sexual stimulation causes local release of nitric oxide, sildenafil enhances the effect of nitric oxide on the corpus cavernosum by increasing the levels of cGMP in this tissue.
Sildenafil is rapidly absorbed following oral administration, has an onset of action within 25 to 60 minutes after dosing, 15 and has a plasma half-life of approximately 4 hours. Sildenafil has been shown to be an effective and well-tolerated treatment in patients with ED of various etiologies.
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In a pilot study of 21 men with ED and diabetes, treatment with sildenafil improved erectile function, as assessed by penile plethysmography in a clinic setting. The protocol for this multicenter, randomized, double-blind, placebo-controlled, flexible-dose study was approved by the institutional review boards at the 19 clinical practice centers, and all participants provided written informed consent.
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The study consisted of a 4-week, no-treatment, run-in phase, followed by a week, double-blind treatment period. Sildenafil citrate Viagra and placebo of matching appearance were supplied by Pfizer Inc. Patients were instructed to take a single dose of study medication as needed, 1 hour prior to sexual activity but not more than once daily, during the week treatment period. The initial dose was 50 mg of sildenafil citrate or a medium dose of placebo.
Based on the investigator's judgment of efficacy and tolerability, the dose could be increased to mg or decreased to 25 mg of sildenafil citrate or placebo. Patients were eligible for inclusion in the study if they were aged 18 years or older, had medically documented ED as defined by the National Institutes of Health Consensus Panel 2 , which was documented in the prior medical record to be of at least 6 months' duration, and a clinical diagnosis as defined by the National Diabetes Data Group 18 of at least 5 years duration for type 1 and at least 2 years duration for type 2 diabetes.
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The diagnosis and etiology classification ie, organic, psychogenic, or mixed of ED was based on the patient's medical history, a physical examination, standard laboratory testing, and other diagnostic procedures performed prior to the study. The medical management of patients' diabetes had to be stable for at least 3 months prior to screening, with a hemoglobin A 1c value of less than 0. The patients also had to be in a stable relationship with a female partner for at least the previous 6 months.
Patients were required to discontinue other therapies for ED at screening. Patients meeting inclusion criteria had their medical histories and demographic information recorded and underwent a full physical examination, which included blood pressure and heart rate measurements, a lead electrocardiogram, and standard biochemistry and hematological laboratory tests.
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At week 0 baseline , each eligible patient was given a randomization number using an interactive voice response system, which followed a randomization table generated by the method of random permuted blocks.
The system generating the randomization assignment was geographically and operationally independent from the study investigators who executed the randomization assignment and conducted the study. The efficacy of oral sildenafil was assessed using the self-administered International Index of Erectile Function IIEF , a question, validated measure of erectile dysfunction, 20 a global efficacy question "Did the treatment improve your erections?
International Index of Erectile Function question 3, which assesses the ability to achieve an erection for sexual intercourse, and question 4, which assesses the ability to maintain an erection after penetration, specifically address the key aspects of ED as defined by the National Institutes of Health.
Where applicable, a score of 0 indicated no attempts at sexual intercourse.
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Patients completed the IIEF at week 0 baseline and week All adverse events occurring during treatment or within 7 days of the end of treatment were recorded, regardless of causal relationship to study drug, and standard biochemistry and hematological laboratory tests were conducted at baseline and at 2, 4, 8, and 12 weeks of treatment. The number of patients required for enrollment in the study was determined by the responses to questions 3 and 4 of the IIEF.
Least squares mean response scores to the IIEF questions were analyzed using analysis of covariance, which included main-effect terms for treatment, investigational center, and baseline score, with covariates for age, etiology of disease, duration of disease, and smoking status.
Responses to the global efficacy question and the proportion of attempts at sexual intercourse that were successful were analyzed using a logistic regression model with the same terms and covariates as mentioned above for the analysis of covariance model. Each subgroup analysis used the same model and terms as the full analysis, omitting the subgroup variable as a covariate when appropriate. Intention-to-treat analyses were performed on all efficacy variables and included all subjects who had a baseline measurement and at least 1 measurement after the start of treatment.
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All patients who received the study drug were included in the safety analysis. A total of patients were randomized to treatment, with patients receiving sildenafil and patients receiving placebo Figure 1. The baseline characteristics of the patients in the 2 the treatment groups were similar Table 1.
The majority of patients had type 2 diabetes, were between the ages of 45 and 64 years, and had had ED for several years. The median length of treatment was 85 days for both the sildenafil and the placebo treatment groups.
The median number of doses taken as needed was 31 range, for patients receiving sildenafil and 25 range, for patients receiving placebo.
Your cost may free viagra for diabetics on your treatment plan, your insurance dlabetics if you have itand the pharmacy you use. Viagra for women. Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
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After 12 weeks of treatment, patients receiving sildenafil demonstrated significantly improved erectile function compared with those receiving placebo. For question 3, the mean score was 3.
For question 4, the mean score was 2. Data from patient event logs showed that the proportion of attempts at sexual intercourse that were successful during the last 4 weeks of treatment was significantly greater for all patients both responders and nonresponders.
The efficacy of treatment, as assessed with IIEF questions 3 and 4 and the global efficacy question, was also analyzed for various subgroups of patients Table 3. For patients with type 1 diabetes and those with type 2 diabetes, the baseline mean scores for question 3 of the IIEF were 1. The baseline mean scores for question 4 for patients with type 1 and type 2 diabetes were 1.
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A 0few patients taking sildenafil experienced flushing, rhinitis, or abnormal vision predominantly reported as a mild and transient change in brightness perception. In the sildenafil group, 1 patient manifested a Q wave on electrocardiogram with no myocardial infarction documented, 1 patient had congestive heart failure, 1 patient had hypertension, and 1 patient had a varicose vein.
In the placebo group, 4 patients had new or worsening chest pain, 1 patient had hypertension, and 1 patient had thrombophlebitis. The majority of adverse events were transient and mild to moderate in nature. No case of priapism was reported. No patient in the sildenafil group discontinued treatment because of a treatment-related adverse event.
The reasons for discontinuation of treatment are listed in Figure 1.
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This could explain why Viagra has less of a physical effect in females than it does in males. If a person experiences any of the followingthey should seek immediate medical attention:. The only way to decide on the best drug may be through trial and error. But, keep in mind that ED might signal an underlying medical problem, like high blood pressure, heart disease, diabetes, low testosterone, or sleep apnea.
There were no laboratory test abnormalities attributable to sildenafil use. Erectile dysfunction, which is a common complication of diabetes, impairs a patient's quality of life, self-esteem, and relationship with his partner.
Sildenafil is a novel, orally active agent that is an effective and well-tolerated treatment for patients with ED of organic, psychogenic, or mixed etiology. Mean scores for the 2 IIEF questions assessing the ability to achieve and maintain erections indicated significant improvements after treatment with sildenafil compared with mean scores after treatment with placebo.
The proportion of attempts at sexual intercourse that were successful was 4-fold higher for patients receiving sildenafil than for those receiving placebo.
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Thus, treatment with sildenafil was shown to be consistently superior to placebo for the efficacy end points evaluated in the study. The results of the present study support the findings of a placebo-controlled pilot study of 21 diabetic men with ED, which evaluated the efficacy of sildenafil citrate 25 or 50 mg using penile plethysmography during sexual stimulation, a global efficacy question, and a patient event log.
In a previously reported study of patients with broad-spectrum ED, 16 the mean final scores for IIEF questions 3 and 4 for patients taking sildenafil citrate 25 mg were higher than those reported herein for patients with ED and diabetes. However, mean baseline scores for these questions also were somewhat higher in the patients with broad-spectrum ED, suggesting a greater severity of ED in patients with diabetes.
In analyses of various subgroups of patients with ED and diabetes, the efficacy of sildenafil was not affected by patient age, the duration of ED, or the duration of diabetes.
Although the present study was not specifically designed to evaluate the subgroup of patients with type 1 diabetes, the results for this subgroup were broadly similar to those for patients with type 2 diabetes.
Additional studies with appropriate sample sizes are needed to evaluate the efficacy of sildenafil in patients with type 1 diabetes, diabetes and arterial insufficiency, and diabetes and neuropathy. Although patients with diabetes frequently are included in placebo-controlled studies evaluating the efficacy of treatments for ED, published articles have not reported treatment outcomes specific to this patient population.
Since different studies use different criteria for defining a response, comparative studies are needed to appropriately assess treatment outcomes with different types of therapies in patients with diabetes and ED. In this study, treatment with sildenafil was well tolerated.
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The safety profile of sildenafil in patients with diabetes was reassuring given the chronic complications associated with diabetes. The most common adverse events associated with sildenafil treatment were headache, dyspepsia, and respiratory tract disorder sinus congestion or drainage , which were predominantly transient and mild or moderate in nature.
These adverse events reflect the known pharmacological properties of sildenafil as a PDE5 inhibitor. The incidences of cardiovascular adverse events were comparable in the sildenafil and placebo treatment groups.
However, since a degree of risk is associated with sexual activity, physicians should consider the cardiovascular status of their patients prior to initiating any treatment for ED. No patient discontinued treatment with sildenafil due to a treatment-related adverse event, and laboratory test results showed no evidence of abnormalities related to sildenafil treatment.
Erectile dysfunction and diabetes: Take control today - Mayo Clinic
The exact pathogenesis of ED in men with diabetes remains to be determined. However, advanced glycosylated end products, which accumulate in tissue proteins and play a role in many of the complications of diabetes, have been shown to decrease nitric oxide activity and to modulate endothelium-dependent relaxation, possibly via regulation of penile nitric oxide synthase isozymes.
However, studies in animal models of diabetes are needed to confirm or refute this hypothesis. In summary, the results of this study indicate that oral sildenafil is an effective and well-tolerated treatment for organic ED in men with diabetes.
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Figure 1. In the placebo group, 5 patients withdrew consent, 3 were withdrawn due to abnormalities in laboratory test results, and 1 was withdrawn for missing a follow-up appointment. Two patients in the sildenafil group withdrew consent. Figure 2. Mean SE scores at baseline and after 12 weeks of treatment with placebo or sildenafil citrate.
Table 1. Table 2. Table 3. Table 4.
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Centers for Disease Control and Prevention. Google Scholar.
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Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. Saenz de Tejada I, Goldstein I.
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