Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis.
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ABSTRACT:
SUBMITTER: Guo YL
PROVIDER: S-EPMC3735316 | biostudies-other | 2009 Jul
REPOSITORIES: biostudies-other
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Project description:Various factors play a role in the development of erectile dysfunction (ED).To provide a descriptive comparison of erectile function response for tadalafil on-demand (PRN) and once-daily (OAD) dosing regimens in patients with common comorbid conditions, treatments, or risk factors that can be considered when treating ED.In total, 17 PRN and 4 OAD placebo-controlled studies were included in the integrated database in these pooled analyses. Data were analyzed from patients treated with placebo, tadalafil 10 mg (low dose), and 20 mg (high dose) for the PRN studies and placebo, tadalafil 2.5 mg (low dose), and 5 mg (high dose) for the OAD studies.The effects of tadalafil were measured using the International Index of Erectile Function administered from baseline to week 12. A descriptive comparison of the efficacy of tadalafil PRN vs OAD was examined in the clinical populations.Baseline characteristics of 4,354 men were comparable between the PRN and OAD groups, with differences seen only in the variables of race, body mass index (BMI) of at least 30 kg/m(2), and alcohol use. Tadalafil was efficacious at improving erectile function for all clinical populations, except for the low-dose OAD group, which demonstrated a weaker effect vs placebo than the high-dose OAD group, and the low- and high-dose PRN groups vs placebo for patients with BMI of at least 30 kg/m(2) for patients without a cardiovascular disorder, smokers, patients with ED duration shorter than 1 year, and patients without previous phosphodiesterase type 5 inhibitor use. Tadalafil was efficacious for patients with or without diabetes mellitus, arterial hypertension, hyperlipidemia, and alcohol use at baseline.Tadalafil OAD and PRN regimens showed efficacy in patients with ED. No clinical populations of patients with ED seemed to benefit overwhelmingly from one dose regimen over the other.
| S-EPMC5411983 | biostudies-literature
Project description:We report that two widely-used drugs for erectile dysfunction, tadalafil and vardenafil, trigger bone gain in mice through a combination of anabolic and antiresorptive actions on the skeleton. Both drugs were found to enhance osteoblastic bone formation in vivo using a unique gene footprint and to inhibit osteoclast formation. The target enzyme, phosphodiesterase 5A (PDE5A), was found to be expressed in mouse and human bone as well as in specific brain regions, namely the locus coeruleus, raphe pallidus, and paraventricular nucleus of the hypothalamus. Localization of PDE5A in sympathetic neurons was confirmed by coimmunolabeling with dopamine β-hydroxylase, as well as by retrograde bone-brain tracing using a sympathetic nerve-specific pseudorabies virus, PRV152. Both drugs elicited an antianabolic sympathetic imprint in osteoblasts, but with net bone gain. Unlike in humans, in whom vardenafil is more potent than tadalafil, the relative potencies were reversed with respect to their osteoprotective actions in mice. Structural modeling revealed a higher binding energy of tadalafil to mouse PDE5A compared with vardenafil, due to steric clashes of vardenafil with a single methionine residue at position 806 in mouse PDE5A. Collectively, our findings suggest that a balance between peripheral and central actions of PDE5A inhibitors on bone formation together with their antiresorptive actions specify the osteoprotective action of PDE5A blockade.
| S-EPMC7321982 | 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: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:BackgroundMen with erectile dysfunction often have concurrent medical conditions. Conversely, men with these conditions may also have underlying erectile dysfunction. The prevalence of unrecognized erectile dysfunction in men with comorbidities commonly associated with erectile dysfunction was determined in men invited to participate in a double-blind, randomized, placebo-controlled trial of sildenafil citrate.MethodsMen ≥30 years old presenting with ≥1 erectile dysfunction risk factor (controlled hypertension, hypercholesterolemia, smoking, metabolic syndrome, stable coronary artery disease, diabetes, depression, lower urinary tract symptoms, obesity [body mass index ≥30 kg/m2] or waist circumference ≥40 inches), and not previously diagnosed with erectile dysfunction were evaluated. The screening question, "Do you have erectile dysfunction?," with responses of "no," "yes," and "unsure," and the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) were administered.ResultsOf 1084 men screened, 1053 answered the screening question and also had IIEF-EF scores. IIEF-EF scores indicating erectile dysfunction occurred in 71% (744/1053), of whom 54% (399/744) had moderate or severe erectile dysfunction. Of 139 answering "yes," 526 answering "unsure," and 388 answering "no," 96%, 90%, and 36%, respectively, had some degree of erectile dysfunction. The mean±SD (range) number of risk factors was 2.9 ± 1.7 (3-8) in the "yes" group, 3.2 ± 1.7 (3-9) in the "unsure" group, and 2.6 ± 1.5 (2-8) in the "no" group.ConclusionAlthough awareness of having erectile dysfunction was low, most men with risk factors had IIEF-EF scores indicating erectile dysfunction. Erectile dysfunction should be suspected and assessed in men with risk factors, regardless of their apparent level of awareness of erectile dysfunction.Trial registrationClinicalTrials.gov Identifier NCT00343200.
| S-EPMC2991280 | biostudies-literature
Project description:BACKGROUND:Clinical study and practice data have shown sildenafil improves sexual function in men with erectile dysfunction (ED). However, some men treated with placebo in double-blind, placebo-controlled sildenafil studies also report improved erectile function as measured by International Index of Erectile Function (IIEF)-Erectile Function Domain (EFD) scores. AIM:This analysis estimated the relationship between post-baseline IIEF-EFD scores and demographic variables, including co-morbidities, in men with ED receiving placebo in flexible-dose sildenafil studies. METHODS:Placebo-treated participants in the intent-to-treat population of 42 double-blind, placebo-controlled, flexible-dose, sildenafil studies were included. A participant was classified as a placebo responder if the IIEF-EFD score was ?26 at the last visit. OUTCOMES:Variables assessed were age (<45, 45-64, ?65 years), race, body mass index, co-morbidities (cardiovascular disease/hypertension, diabetes mellitus, depression), date the last study dose was taken, study completion date, ED etiology (psychogenic, organic, mixed), history of cigarette smoking, ED duration, baseline IIEF-EFD score (?10, 11-16, ?17), and treatment duration. Stepwise multivariate logistic regression models assessed the odds of being a responder vs a non-responder for each variable. RESULTS:A total of 4,360 men were included; 13.5% were responders. Odds estimates indicated the largest likelihood of placebo response occurred in men who were black (odds = 20.2, P < .0001), were younger than 45 years (odds = 7.3, P < .0001), had mild ED (baseline IIEF-EFD ?17; odds >100, P < .0001), and did not have diabetes (odds = 4.5, P < .0001). The likelihood of a placebo response decreased as ED duration increased (odds = 0.74, P < .0001). The frequency of common adverse events was similar between placebo responders and non-responders. CLINICAL TRANSLATION:These findings contribute to the improved understanding of predictors of placebo response in sildenafil clinical studies. Elucidation of these factors may contribute to the development of further interventions and treatment strategies and best practices for clinical trials. STRENGTHS AND CONCLUSIONS:Strengths of this analysis include the large and diverse population and the duration of follow-up. Limitations include those associated with retrospective analyses and the inability to ascertain to what extent other demographic factors might have contributed to the placebo responses or how these placebo responses might be related to the natural course of ED. CONCLUSIONS:Certain demographics, co-morbidities, and condition characteristics predicted the odds of a placebo response in sildenafil clinical studies of ED. Underlying reasons behind a placebo response warrant further evaluation. Mulhall JP, Carlsson M, Stecher V, et al. Predictors of Erectile Function Normalization in Men With Erectile Dysfunction Treated With Placebo. J Sex Med 2018;15:866-872.
| S-EPMC6834358 | biostudies-literature
Project description:Endothelial dysfunction is the postulated link between coronary artery disease (CAD) and erectile dysfunction (ED). Brachial artery flow-mediated vasodilatation (FMD) is a non-invasive surrogate marker for endothelial function assessment. Despite Asian Indians representing a considerable global CAD burden, data on FMD and ED in these patients are lacking. Of the 225 patients undergoing coronary angiography, 72% had ED (assessed using the International Index of Erectile Function (IIEF-5) questionnaire); ED was moderate to severe in 61% of the patients. ED patients had a higher incidence of severe and diffuse angiographic CAD, a greater number of coronary vessels involved and a lower mean brachial artery FMD (6.40%±4.60% vs. 9.10%±4.87%, P<0.001) compared to non-ED patients. A progressive reduction in FMD was noted with increasing severity of ED. Impaired FMD (≤5.5%) was twice as common in ED patients (52% vs. 24% without ED). Patients with impaired FMD had higher ED prevalence (85% vs. 62%) and lower mean IIEF-5 scores compared to those with normal FMD. Impaired FMD was a significant ED predictor independent of other risk factors (odds ratio, 2.33; 95% confidence interval: 0.59-9.23; P=0.03). An inverse correlation between FMD and ED severity was observed (r=-0.22; P=0.004). ED is common among Asian Indians with angiographically documented CAD. Patients with ED have impaired FMD independent of other risk factors, suggesting that endothelial dysfunction is the underlying pathophysiology. Urologists and cardiologists need to be aware of the association between ED, CAD and endothelial dysfunction.
| S-EPMC3881633 | biostudies-other
Project description:IntroductionSeveral studies have investigated the association between erectile dysfunction (ED), its treatment, and female sexual dysfunction, but the impact of males blaming their female partners for their ED remains unknown.AimsTo investigate whether women who are blamed by their male partners for their ED experience worse overall sexual function and satisfaction.MethodsWe performed a global, cross-sectional web-based survey to investigate female perceptions of ED. We distributed the 30-item survey via email, Reddit, Amazon Mechanical Turk, and Facebook. Women 18 years of age or older were eligible to participate and answered questions based on a 5-point Likert scale. Women were grouped by ages 18-29, 30-39, and 40 and older.Main outcome measuresThe survey collected data that included general demographics and questions regarding experiencing male blame for ED and its relationship with each subject's sexual health and wellness.ResultsA total of 13,617 females participated in the survey. Of the women surveyed, 79% have experienced their partner losing their erection during sexual activity and approximately 1 out of 7 women (14.7%) had experienced being blamed by their partner for loss of their erection. Women who were blamed for their partner's ED were more likely to end the sexual encounter, were less sexually satisfied, and were more likely to end relationships due to their partner's ED.ConclusionApproximately 1 out of 7 women have experienced male blame for their partner's ED which is associated with negative impacts on female mental health, sexual satisfaction and the success of the overall partnership. Because of its widespread impact on female wellness, male blame should be considered during evaluation of female sexual history and men must be educated on the significant impact their reactions during intimacy have on their female partners and their relationships as a whole. Dubin JM, Wyant WA, Balaji NC, et al. Is Female Wellness Affected When Men Blame Them for Erectile Dysfunction?. Sex Med 2021;9:100352.
| S-EPMC8240332 | biostudies-literature
Project description:BACKGROUND:The primary aim of this study was to evaluate the effects of a once-a-day 5?mg dose of tadalafil, prescribed for 8 weeks, on the quality of life (QoL) of South Korean men with andropause symptoms, including erectile dysfunction (ED), using a single group, open-labeled, before-and-after preliminary trial. The secondary objective was to evaluate the effectiveness and safety of tadalafil for ED. METHODS:Forty South Korean men (>35 years of age) with andropause symptoms including ED were enrolled into our trial. Andropause syndrome was defined using the androgen deficiency in aging males (ADAM) questionnaire and other screening tests, including testosterone levels. The following outcome measures were obtained at baseline and at 4 and 8 weeks of tadalafil treatment: physical examination, adverse effects, Short Form 12 Health Survey (SF-12) score, International Index of Erectile Function (IIEF-5) score, bioelectrical impedance analysis (BIA), and free radical testing. RESULTS:Treatment increased the SF-12 Mental component score, used as a proxy measure of quality of life, from baseline to at 4 and 8 weeks (P?<?.05). In addition, the mean IIEF-5 score, which assesses sexual function, increased from baseline at 4 and 8 weeks (P?<?.05), with this increase being significant at both time points. No adverse effects were noted. CONCLUSION:Tadalafil (5?mg dose, once daily) is a safe and effective treatment to improve ED, and overall QoL, among Korean men with andropause symptoms, including ED.
| S-EPMC6320193 | biostudies-literature
Project description:BackgroundDiet, one of the components of lifestyle, has been believed to have associations with erectile dysfunction (ED). However, whether there is an association between plant-based diet and ED is remains to be explored. Thus, we conducted the nested case-control study to investigate the relationship between the plant-based diet and ED in China.ResultsED group (92 subjeczts) and ED free group (92 subjects) were similar in terms of basic features (P > 0.05), except for lifestyle (P < 0.05). The plant-diet index (PDI) and healthy plant-diet index (hPDI) in the ED group were significantly lower than those in the control group (P < 0.001). Adjusted multivariate analysis indicated that the presence of ED was negatively associated with nitric oxide levels, PDI, and hPDI (all P < 0.05), and was positively related to body mass index, metabolic syndrome, and E-selectin levels. Furthermore, both the PDI and hPDI increased significantly as the International Index of Erectile Function (IIEF-5) scores increased within the ED group (P < 0.05). Multi-model multivariate analysis indicated the robustness of results.ConclusionsMore plant-based diet intake was associated with a reduced presence of ED and less severe ED in China. Committing to plant-based diet can be encouraged for many health benefits and to lower ED burden. Further well-designed studies are warranted to validate our findings.
| S-EPMC8117588 | biostudies-literature