SILDENAFIL-ORAL MEDICATION FOR ERECTILE DYSFUNCTION-A REVIEW.
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ABSTRACT:
SUBMITTER: Srinath N
PROVIDER: S-EPMC5531881 | biostudies-other | 1999 Jul
REPOSITORIES: biostudies-other
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Project description:BackgroundEvaluation of company clinical trial reports could provide information for meta-analysis at the commercial introduction of a new technology.MethodsClinical trial reports of sildenafil for erectile dysfunction from September 1997 were used for meta-analysis of randomised trials (at least four weeks duration) and using fixed or dose optimisation regimens. The main outcome sought was an erection, sufficiently rigid for penetration, followed by successful intercourse, and conducted at home.ResultsTen randomised controlled trials fulfilled the inclusion criteria (2123 men given sildenafil and 1131 placebo). NNT or NNH were calculated for important efficacy, adverse event and discontinuation outcomes. Dose optimisation led to at least 60% of attempts at sexual intercourse being successful in 49% of men, compared with 11% with placebo; the NNT was 2.7 (95% confidence interval 2.3 to 3.3). For global improvement in erections the NNT was 1.7 (1.6 to 1.9). Treatment-related adverse events occurred in 30% of men on dose optimised sildenafil compared with 11% on placebo; the NNH was 5.4 (4.3 to 7.3). All cause discontinuations were less frequent with sildenafil (10%) than with placebo (20%). Sildenafil dose optimisation gave efficacy equivalent to the highest fixed doses, and adverse events equivalent to the lowest fixed doses.ConclusionThis review of clinical trial reports available at the time of licensing agreed with later reviews that had many more trials and patients. Making reports submitted for marketing approval available publicly would provide better information when it was most needed, and would improve evidence-based introduction of new technologies.
| S-EPMC115867 | biostudies-literature
Project description:The aim of the study was to analyze the presence of undeclared sildenafil, tadalafil, and vardenafil in food supplements (FSs) for erectile dysfunction. The presence of sildenafil, tadalafil, and vardenafil was determined using the generated ultraviolet (UV)-spectra and mass-spectrometry (MS)-spectra as well as chromatograms produced by the photodiode array (PDA)-detector and ion trap MS-detector. The results were processed by Xcalibur ver. 2.0.7. Fourteen of the 20 analyzed FSs contained undeclared ingredients. Sildenafil was present in 12 of them. Many violations and discrepancies between the label information and the real composition of the FS were identified. 70% of the samples contained undeclared ingredients of an erectile dysfunction medicinal product. The quantities varied within broad limits from 2 mg per tablet to 116.55 mg per tablet. Sildenafil was present in amounts exceeding 16.55 mg that is the maximum recommended dose, thus creating risk of overdose. Besides that, food supplements adulterated with sildenafil analogues are a health risk for consumer's health as there is no evidence of modified sildenafil toxicity. All analyzed FSs were claimed to be 100% natural, not provoking side effects. No information for any FS contained indications of age limits or risk for interaction with other FSs or medical products.
| S-EPMC9288292 | biostudies-literature
Project description:Purpose. To describe a patient who developed bilateral, simultaneous nonarteritic anterior ischemic optic neuropathy (NAION) after ingestion of Sildenafil citrate (Viagra) for erectile dysfunction. Methods. Observational case report. Results. A 60-year-old diabetic man noted sudden decrease of vision in both eyes 16 hours after his third consecutive 50 mg daily Sildenafil ingestion. A diagnosis of bilateral NAION was made and he was treated for three days with methylprednisolone 1 g/d intravenously, followed by oral prednisone 75 mg/d. Final visual acuity was 20/50 right eye (OD) and 20/20 left eye (OS). He had preexisting diabetes. Conclusion. This is the first reported case of simultaneous bilateral NAION occurred in a diabetic patient early after Sildenafil intake. Patients with predisposing conditions such as diabetes have to be warned against the use of PDE inhibitors.
| S-EPMC3313560 | biostudies-literature
Project description:Background: Pentoxifylline (PTX) is a member of methylxanthine chemicals and a type of non-selective phosphodiesterase-5 inhibitors, which has been used in male infertility treatment to improve sperm quality and erectile dysfunction (ED) treatment. Mutually tight associations existed between ED and male infertility. Using PTX might kill two birds with one stone by improving sperm quality and erectile function in infertile men with ED. Methods: PubMed, Cochrane Library, EMBASE, and Web of Science were searched by October 2021. Based on available evidence from observational studies and randomized-controlled trials (RCTs), we conducted a systematic review to summarize the efficacy and safety of PTX in treating ED and male infertility. The protocol of the article was registered and updated in PROSPERO (CRD42021291396). Results: From 202 records, eight studies (7 RCTs) evaluating the role of PTX in ED and three studies (2 RCTs) assessing the efficacy of PTX in male infertility were included in the systematic review. Three studies (100.00%) and two studies (100.00%) reported the beneficial role of PTX in improving sperm progressive motility and normal sperm morphology rate, respectively. In contrast, only one study (33.33%) indicated the favorable role of PTX in enhancing sperm concentration. As for ED, three (60.00%) studies supported the treatment role of PTX alone in ED, and two studies (66.67%) favored the combination use of PTX and selective PDE5Is compared with selective PDE5Is alone. Safety analysis showed that PTX was a well-tolerated drug in ED and male infertility treatment. Conclusion: Given the association between ED and male infertility and satisfying findings from available evidence, PTX administration for the simultaneous treatment of poor sperm quality and mild ED in infertile men will highly enhance the treatment compliance. However, the finding should be treated carefully until validated by further studies.
| S-EPMC8790020 | biostudies-literature
Project description:IntroductionErectile dysfunction (ED) is a common diagnosis in up to 50% of men with HIV and prescription of erectile dysfunction medication (EDM) has been variably associated with increased risk behaviors and acquisition of sexually transmitted infections (STIs).AimWe measured the association of EDM prescription with bacterial STI testing, STI infection and sexual behavior among men engaged in HIV care.MethodsA retrospective cohort study was conducted among HIV-infected men in care at an urban HIV clinic in Birmingham, Alabama between 2008 and 2016. Paired data analysis was used to compare STI testing and behavioral outcomes during the 12-month period before and after EDM prescription.Main outcome measuresOur study outcomes were STI testing and infection rates for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and incident syphilis as well as risk behaviors before and after EDM prescription.ResultsOf 2924 HIV-infected men engaged in care, 589 (20%) initiated EDM with a new prescription from a clinic provider during the study period. During the year after EDM prescription, all STI testing rates decreased: CT (OR = 0.76; 95% CI: 0.58 - 1.01; P = .06), GC (OR = 0.76; 95% CI: 0.58 - 1.01; P = .06), and syphilis (OR = 0.28; 95% CI: 0.20 - 0.38; P < .001). A total of 43 STIs were detected in this study (10 CT, 8 GC, and 25 syphilis) and 42/43 occurred among men who have sex with men (MSM). Sexual activity rates were high before and after EDM (87.6% vs 82.9%; P = .08), and consistent condom use was rare (6.6% in both time periods). After EDM prescription, the median number of sexual partners in the past 6 months decreased from 2 to 1 among MSM and was stable at 1 among men who have sex with women.Clinical implicationManagement of ED in HIV clinic provides an excellent opportunity to discuss risk reduction, safer sex practices, and the importance of routine STI screening to prevent HIV/STI transmission.Strength & limitationsThis study provides insight into a common but understudied clinical scenario-ED in men with HIV-in an urban clinic population that is representative of the Southeastern United States. Adherence for ED medication was not assessed and STI risk behaviors were self-reported.ConclusionEDM prescription did not lead to any detectable change in risk behavior in this setting but bacterial STI was common among MSM who were tested. Heudebert JP, Tamhane A, Burkholder GA, Dionne-Odom J. Erectile Dysfunction Medication Prescription: STI and Risk Behavior in Men with HIV. J Sex Med 2019;16:691-700.
| S-EPMC6487224 | biostudies-literature
Project description:Erectile dysfunction (ED) is a growing health condition that needs safe and effective therapy. One of the main common treatments is sildenafil which is used in clinics for managing erectile dysfunction by enhancing the blood supply to the penis. In the current study, sildenafil was formulated as nanofibers and mixed with the root extract of Glycyrrhiza glabra (glycyrrhizin) as a natural sweetener to be administrated in the buccal cavity for enhanced drug bioavailability, rapid drug absorption and improved patient compliance. The formulated dual-loaded nanofibers were evaluated by measuring diameter, disintegration, drug loading efficiency, drug release profile, and in vitro cell viability assessment. The results showed that the sildenafil/glycyrrhizin-loaded fibers had a diameter of 0.719 ± 0.177 μm and lacked any beads and pores formation on their surfaces. The drug loading and encapsulation efficiency for sildenafil were measured as 52 ± 7 µg/mg and 67 ± 9 %, respectively, while they were 290 ± 32 μg/mg and 94 ± 10 %, respectively, for glycyrrhizin. The release rate of sildenafil and glycyrrhizin demonstrated a burst release in the first minute, followed by a gradual increment until a complete release after 120 min. The in vitro cell viability evaluation exhibited that the application of sildenafil and glycyrrhizin is safe upon 24-hour treatment on human skin fibroblast cells at all used concentrations (i.e., ≤ 1,000 and 4,000 μg/mL, respectively). However, the application of sildenafil-glycyrrhizin combination (in a ratio of 1:4) demonstrated more than 80 % cell viability at concentrations of ≤ 250 and 1000 μg/mL, respectively, following 24-hour cell exposure. Therefore, sildenafil/glycyrrhizin dual-loaded PVP nanofibers showed a potential buccal therapeutic approach for erectile dysfunction management.
| S-EPMC10960110 | biostudies-literature
Project description:Erectile dysfunction is a multidimensional but common male sexual dysfunction that involves an alteration in any of the components of the erectile response, including organic, relational and psychological. Roles for nonendocrine (neurogenic, vasculogenic and iatrogenic) and endocrine pathways have been proposed. Owing to its strong association with metabolic syndrome and cardiovascular disease, cardiac assessment may be warranted in men with symptoms of erectile dysfunction. Minimally invasive interventions to relieve the symptoms of erectile dysfunction include lifestyle modifications, oral drugs, injected vasodilator agents and vacuum erection devices. Surgical therapies are reserved for the subset of patients who have contraindications to these nonsurgical interventions, those who experience adverse effects from (or are refractory to) medical therapy and those who also have penile fibrosis or penile vascular insufficiency. Erectile dysfunction can have deleterious effects on a man's quality of life; most patients have symptoms of depression and anxiety related to sexual performance. These symptoms, in turn, affect his partner's sexual experience and the couple's quality of life. This Primer highlights numerous aspects of erectile dysfunction, summarizes new treatment targets and ongoing preclinical studies that evaluate new pharmacotherapies, and covers the topic of regenerative medicine, which represents the future of sexual medicine.
| S-EPMC5027992 | biostudies-literature
Project description:Sildenafil and tadalafil are efficacious and well tolerated in Chinese men with erectile dysfunction (ED). Recent study results indicate that men with ED in China who were naïve to phosphodiesterase inhibitor type 5 (PDE5) therapy prefer tadalafil 20-mg (on-demand) versus sildenafil 100-mg (on-demand). Differences in psychosocial outcomes may help to explain treatment preference in favor of tadalafil. This open-label, randomized, crossover study compared psychosocial outcomes and drug attribute choices between tadalafil and sildenafil in Chinese men with ED naïve to PDE5 inhibitor therapy. Eligible patients were randomized to sequential 20-mg tadalafil/100-mg sildenafil (n = 190) or 100-mg sildenafil/20-mg tadalafil (n = 193) for 8 weeks each and were asked which treatment they preferred to take for the 8-week extension phase. Psychosocial outcomes were assessed using the Psychological and Interpersonal Relationship Scale (PAIRS), Drug Attributes Questionnaire (DRAQ), and Sexual Life Quality Questionnaire (SLQQ). When taking tadalafil versus sildenafil, men had a higher mean endpoint score on the PAIRS Spontaneity Domain (tadalafil = 2.86 vs sildenafil = 2.72; P < 0.001), and a lower mean endpoint score on the Time Concerns Domain (tadalafil = 2.41 vs sildenafil = 2.55; P < 0.001). A numerical increase in the Sexual Self-Confidence Domain was observed when taking tadalafil versus sildenafil (tadalafil = 2.76 vs sildenafil = 2.72; P = 0.102). The most frequently chosen drug attributes explaining treatment preference were able to get an erection long after having drug, and ability to get an erection every time. SLQQ results were comparable between treatment groups. These psychosocial outcomes may explain why more Chinese men preferred tadalafil versus sildenafil for the treatment of ED in this clinical trial.
| S-EPMC5507101 | biostudies-literature
Project description:Type V-phosphodiesterase-inhibitors (PDE5i) are the first choice drugs in the treatment of erectile dysfunction (ED), being effective in 60-70% of patients. However, approximately 50% of patients per year discontinue the treatment with PDE5i after reporting poor drug efficacy or major adverse drug reactions (ADR). To identify early markers of efficacy/safety for the treatment of ED with PDE5i, the basal clinical characteristics of patients, integrated with metabolomics analysis of serum and urine and genomic data, were here correlated with the PDE5i efficacy and the occurrence of ADR upon administration. Thirty-six males with new diagnosis of ED were consecutively recruited and characterized at baseline for anthropometrics, blood pressure, blood glucose, lipid profile, serum levels of thyroid/sex hormones and erectile function evaluated by IIEF-15 questionnaire. Targeted Next Generation Sequencing (NGS) was applied to genes involved in PDE5i pharmacodynamics and pharmacokinetics. Fasting metabolic profiles of serum and urine were assessed by nuclear magnetic resonance (NMR)-based metabolomics analysis. Patients were prescribed on-demand therapy with Sildenafil oro-dispersible film and followed-up after 3 months from recruitment. Baseline data were compared with IIEF-15 score at follow-up and with the occurrence of ADR recorded by a dedicated questionnaire. Twenty-eight patients were finally included in the analysis. Serum LDL-cholesterol levels were increased in those reporting ADR (143.3 ± 13.2 mg/dl ADR vs. 133.1 ± 12.4 mg/dl No ADR; p = 0.046). NGS data showed that specific variants of PDE11A and CYP2D7 genes were more represented in drug responders (both relative risk = 2.7 [0.9-5.1]; p = 0.04). NMR-based metabolomics showed the highest association between serum LDL-cholesterol metabolites and the occurrence of ADR (Hazard ratio = 17.5; p = 0.019). The association between lipid profile and the ADR pattern suggests major cues in the tailoring of ED therapy with PDE5i.
| S-EPMC7849189 | biostudies-literature
Project description:Men with anxiety disorders have been identified as high risk of developing erectile dysfunction (ED). The aim of this review is to define the prevalence and severity of ED in the male anxiety disorder population. A literature search of three electronic databases (PubMed, Embase and PsychINFO) and a grey literature registry was conducted. Inclusion criteria were studies that investigated adult males, documented diagnosis of anxiety disorders made by a qualified psychiatrist and use of a validated tool to diagnose ED such as International Index of Erectile Function or ICD-10/DSM-IV. The search yielded 1220 articles and 12 studies were selected. The anxiety disorders investigated were post-traumatic stress disorder, obsessive-compulsive disorder, social phobia/social anxiety disorder and panic disorder. We found that the median [IQR] prevalence of ED was 20.0 [5.1-41.2]% and the median [IQR] International Index of Erectile Function-5 scores were 17.62 [13.88-20.88], indicating a mild to moderate severity. Our review suggests a high prevalence of ED in the anxiety disorder population and ED may be more severe in this cohort, therefore advocating this is an important clinical topic. However, the evidence is limited due to the high heterogeneity between the studies and more research is required in this field.
| S-EPMC8964411 | biostudies-literature