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Men with ED who had previously completed 1 of 4 double-blind trials with short-term open-label extension combined duration, 0. Adverse events that were serious or led to dosing changes or discontinuation temporary or permanent were recorded. Many of the participants mean age, 58 [range, 27—82] years; mean ED duration, 4.
Overall, 37 3. Thus, the long-term safety and effectiveness of sildenafil can now be evaluated in men who have been taking the drug for several years. The efficacy, safety, and tolerability of sildenafil in the treatment of men with ED have been demonstrated in numerous studies of 1-year duration or less.
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For example, 1, men with ED completed 1 of 4 double-blind trials and continued with open-label sildenafil treatment in extension studies for a total treatment duration of approximately 1 year Morales et al ; Steers et al In the current study, of these men subsequently received up to 4 more years of open-label, flexible-dose 25, 50, and mg sildenafil.
Preliminary 3-year results were reported previously Carson et al ; Padma-Nathan et al , and we now present the final data. The population included patients with ED of organic and psychogenic etiology and typical concomitant medical conditions for this population ie, hypertension, diabetes, hyperlipidemia, and a history of ischemic heart disease.
Our objective was to assess the long-term safety and effectiveness of sildenafil treatment in men with ED. This was a 4-year, open-label, flexible-dose 25, 50, and mg study of sildenafil.
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Men who previously completed and were compliant with sildenafil or placebo treatment in 1 of 4 double-blind, placebo-controlled trials, and subsequently completed and were compliant with sildenafil treatment in initial open-label extension, were eligible for inclusion in this long-term extension study.
Study medication was provided at no cost. Compliance was assessed by medication diaries and by continued study participation. A total of 1, men were originally enrolled in the double-blind trials, with 1, of these men continuing in the initial open-label extension studies.
The current study includes of the original patients, who agreed to participate in the long-term extension Figure 1.
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The procedures were in accordance with the ethical standards of the responsible committee on human experimentation institutional or regional. Number of patients and treatment duration in the original double-blind trials and the initial open-label extensions and disposition throughout 4 years of open-label, flexible-dose 25, 50, and mg sildenafil long-term extension study.
Reasons for discontinuation, other than insufficient clinical response and treatment-related adverse event AE , included AE unrelated to treatment, protocol violation, loss to follow-up, and other eg, loss of interest in participation in a clinical study, loss of sexual partner, and ability to afford sildenafil after approval [thus, no longer needing to participate in a clinical study to obtain the medication].
At the time the study started, the FDA stated that there were sufficient routine safety data on sildenafil to make collection of standard adverse event data unnecessary. Therefore, only serious adverse events and adverse events leading to changes in dosing or to temporary or permanent discontinuation were recorded and evaluated by the investigators for relatedness to sildenafil treatment.
Descriptive statistics were calculated.
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The duration of the double-blind trials plus initial open-label extension was 0. Reasons for discontinuation included loss of interest in participation in a clinical study, loss of sexual partner, loss to follow-up, ability to afford sildenafil after approval thus, no longer needing to participate in a clinical study to obtain the medication , insufficient clinical response, and adverse events.
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Usage of flexible-dose 25, 50, and mg sildenafil over 2— days by the participants who entered the study. Over the 4-year study period, 37 3. Of the few cardiovascular events determined by the investigator to be treatment related 4 cases of mild flushing and 1 each of moderate flushing, mild palpitations, and moderate tachycardia , only 1 led to permanent discontinuation.
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In this case the man experienced mild flushing with the first dose of sildenafil mg but continued therapy after a dose reduction. After days of therapy, at which time his dosage was once again mg, he permanently discontinued sildenafil because of the flushing. Two other cardiovascular events led to temporary discontinuation mild flushing and moderate tachycardia , and the remainder were addressed with a change in dosing.
Of the serious adverse events that occurred during the 4 years of the study, including 18 acute myocardial infarctions, none were considered by the investigator to be treatment related.
Almost all of these men reported improved ability to engage in sexual activity. Over the 4 years of the study, only 62 6. There are numerous data published on the efficacy and safety of sildenafil treatment for ED. Pooled data from these trials demonstrated that sildenafil is a well-tolerated oral therapy for ED Morales et al Adverse events were mostly transient and mild to moderate in severity and included most commonly headache, flushing, dyspepsia, and rhinitis.
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The rate of discontinuation because of adverse events was low and comparable between patients who received sildenafil and those who received placebo. A more recent retrospective analysis, in which data were pooled from 35 Pfizer-sponsored double-blind trials involving patients who received sildenafil and patients who received placebo, supports the conclusions of the earlier pooled data but also found that sildenafil is well tolerated among patients taking antihypertensive medications, including those on multidrug regimens Padma-Nathan et al Pooled data also support the efficacy of sildenafil; results from 11 double-blind, flexible-dose, placebo-controlled trials that included a total of 2, men ages 23 to 89 years with ED of broad-spectrum etiology show significantly improved erectile function for sildenafil compared with placebo as measured by the International Index of Erectile Function, a global efficacy question, and a patient-recorded event log of sexual activity Carson et al The population of the current 4-year open-label study of sildenafil differed from those of the pooled double-blind studies in that it was self-selected.
Consequently, it is likely that men with poor tolerability or inadequate effectiveness did not opt to participate and that the population included mostly men who had previously experienced a good response to sildenafil.
Also, men who could afford to purchase sildenafil may have lost incentive to participate in the long-term study when sildenafil became commercially available.
This phenomenon necessitated discontinuation of a European long-term OL study when sildenafil became commercially availabile in Europe Padma-Nathan et al Another limitation was the use of unvalidated general efficacy questions, explained by the fact that the major focus of the study was safety and by the absence at the time of the study design of appropriate validated questionnaires to assess satisfaction with ED treatment.
Regardless, the results add to the previously published reports by showing continued safety and effectiveness during prolonged treatment. During 4 years of open-label, flexible-dose administration, there were few discontinuations because of either intolerable adverse events or insufficient clinical response.
The majority of men were satisfied with sildenafil treatment for their ED and reported improved ability to engage in sexual activity. There were no treatment-related acute myocardial infarctions or other serious adverse events. Only 1. In comparison, treatment-related adverse events were responsible for discontinuation by 1.
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Adverse events were responsible for similarly low rates of discontinuation in clinical practice studies of varying duration conducted worldwide; in California 2. Among 22, men treated with sildenafil in general practice in the UK, headache was the most frequently reported treatment-related adverse event and was cited as the reason for discontinuation in 0.
The satisfaction with the effectiveness of sildenafil for the treatment of ED that was reported in the current study confirms previous results.
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In one multicenter, open-label study, men with ED completed the validated Erectile Dysfunction Inventory of Treatment Satisfaction EDITS questionnaire after long-term successful intracavernosal prostaglandin E 1 and again 12 weeks after switching to flexible-dose oral sildenafil 25, 50, and mg Montorsi et al Sildenafil treatment was associated with significantly greater overall treatment satisfaction, ease of use, and intention to continue treatment.
Moreover, partners were more satisfied with sildenafil overall, and their responses correlated with the satisfaction of the patients. Other well-controlled studies using EDITS have shown similarly high degrees of satisfaction with sildenafil Eardley et al ; Lewis et al In this 4-year, open-label study, there was a low incidence of adverse events that resulted in dosage change or discontinuation, and most continuing participants were satisfied with sildenafil treatment for their ED.
These data are consistent with previous reports and argue against loss of tolerability or development of tachyphylaxis.
Generic versions cost much less than the brand-name options, and insurance isn't accepted. An inability to have sex with penetration can result in a stigma around being unable to…. Also, your goals for your viagra superdrug life are important for viagra superdrug a treatment and evaluating whether or not it's working for you. If you have these symptoms while taking Cialis, tell your doctor right away.
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The study was sponsored by Pfizer Inc. The research reported was sponsored and supported by Pfizer Inc. The authors actively participated in the collection of data and interpretation of the results. Although the sponsor held the data, all authors had full access.
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The writing, review, and final approval of the manuscript were performed by a committee of 7 persons, including 4 representatives from the research and development departments of Pfizer Inc. James McMurray has no relevant financial interest in the manuscript ie, honoraria, stock ownership or options, expert testimony, grants received or pending, patents, royalties, or other.
Robert Feldman has consulted on drug development for Pfizer Inc in the past, received honoraria for lectures, and owns Pfizer Inc stock.
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As a library, NLM provides access to scientific literature. Ther Clin Risk Manag.
Sildenafil (Viagra) | healthdirect
All rights reserved. Abstract Because sildenafil citrate is a treatment, not a cure, for erectile dysfunction ED , many men may choose to use it for an extended period. Keywords: sildenafil citrate, erectile dysfunction, tolerability, effectiveness. Methods This was a 4-year, open-label, flexible-dose 25, 50, and mg study of sildenafil. Open in a separate window. Figure 1.
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Our superdrhg team of Mayo Clinic experts can help you with your health concerns. How to store dapoxetine Important information about all medicines. Several clinical studies have investigated the effects of Viagra on ED. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Daily doses are often between 2.
Figure 2. Table 1 Baseline characteristics of the men. Age, mean range years Tolerability Over the 4-year study period, 37 3. Table 2 Adverse events that led to changes in dosing or to temporary or permanent discontinuation.
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Table 3 Discontinuations over 4 years. Table 4 Sildenafil treatment outcome over 4 years.
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More research, and research in humans, is necessary. How does Amazon Clinic protect my health information. Dispose of any unused suspension after 60 days. Older adults may also be more sensitive in how they react to Cialis, which may increase their risk for side effects. GoodRx saves you money on prescription medications through its partnerships with pharmacies and licensed providers. After 12 weeks, sildenafil, though well-tolerated, was not perceived as improving the sexual response in either group.
For the respective sexual activity analyses, N is equal to the number of men who answered the satisfaction question affirmatively and answered the sexual activity question. Discussion There are numerous data published on the efficacy and safety of sildenafil treatment for ED. Conclusions In this 4-year, open-label study, there was a low incidence of adverse events that resulted in dosage change or discontinuation, and most continuing participants were satisfied with sildenafil treatment for their ED.
Acknowledgments The study was sponsored by Pfizer Inc. Notes Disclosures The research reported was sponsored and supported by Pfizer Inc. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Evaluation of the safety of sildenafil for male erectile dysfunction: experience gained in general practice use in England in BJU Int.
An open-label, randomized, flexible-dose, crossover study to assess the comparative efficacy and safety of sildenafil citrate and apomorphine hydrochloride in men with erectile dysfunction. Accessed February 27, What to learn about sildenafil in the treatment of erectile dysfunction from 3-year clinical experience. Int J Impot Res. Patient and partner satisfaction with VIAGRA sildenafil citrate treatment as determined by the erectile dysfunction inventory of treatment satisfaction questionnaire.