Daily Tadalafil Research Articles

Letter to Editor on "Unresolved questions in the recovery of spontaneous erectile function in young men treated with daily tadalafil".

Letter to Editor on "Unresolved questions in the recovery of spontaneous erectile function in young men treated with daily tadalafil".

Evaluation of the effect of daily tadalafil 5 mg versus daily sildenafil 25 mg on neutrophil-lymphocyte and platelet-lymphocyte ratios in patients with erectile dysfunction: A comparative randomized controlled study

Background: Previous studies have shown that the neutrophils/lymphocytes (NLR) and platelets/lymphocytes (PLR) ratios could be used as markers of inflammatory load as well as prognostic factors in several medical conditions. The current study aimed to compare the effect of using daily tadalafil 5 mg/day versus daily sildenafil 25 mg/day in improving erectile function as well as their ability to reduce NLR and PLR.Methods: One hundred and four participants were recruited. Seventy-four randomized patients with erectile dysfunction were equally divided into 2 groups. Patients in group A used daily tadalafil 5 mg for 2 months while patients in group B used daily sildenafil 25 mg for 2 months. Patients were collected from June 2022 to June 2023. Thirty healthy individuals served as controls. All patients and controls were evaluated using the validated Arabic version of the international index of erectile function (ArIIEF-5) at baseline and after 2 months of medical treatment. Five cc of venous blood sample was obtained before and after 2 months of medical treatment to compare the effect of phosphodiestrase type 5 inhibitors (PDE-5Is) intake for erectile dysfunction on PLR and NLR before and after treatment.Results: The current study showed that there were no statistically significant differences between the cases and the controls apart from the ArIIEF-5 scores. Moreover, there was no significant difference between patients in group A and those in group B regarding PLR and NLR post administration of PDE-5Is. Interestingly, patients in group A demonstrated a highly significant difference between the ArIIEF-5 scores as well as the PLR and the NLR before and 2 months after administration of daily tadalafil 5 mg. On the other hand, patients in group B who were administrated daily sildenafil 25 mg for 2 months demonstrated only a highly significant difference between the ArIIEF-5 scores before and after administration. Meanwhile, patients in group B did not reveal any statistically significant difference in the PLR and the NLR before and 2 months after administration of sildenafil 25 mg. Further regression analysis after adjustment of different variables of the study showed a significant correlation between ArIIEF-5 and PLR in patients who received daily tadalafil 5 mg (r = 0.430, p=0.004).Conclusions: Tadalafil and sildenafil have similar clinical efficacy in treating erectile dysfunction. However, tadalafil is more effective in lowering PLR and NLR compared to sildenafil.

Nutraceutical interventions for erectile dysfunction: a systematic review and network meta-analysis.

Although nutraceutical-based treatments are often offered for erectile dysfunction (ED), their efficacy remains doubtful, and the choice of one substance over the other is challenged by the dearth of head-to-head comparative studies. We aimed to compare the efficacy of available nutraceutical interventions, alone or in combination with phosphodiesterase type 5 inhibitors (PDE5i), in improving erectile function in men with ED through a network meta-analysis (NMA), which incorporates direct and indirect evidence into one model thus generating a hierarchy of effectiveness. PubMed, Scopus, Web of Sciences, and Cochrane Library databases were searched for randomized placebo-controlled trials (RCTs) assessing the effect of any nutraceutical regimen in improving erectile function when compared to each other, placebo, and/or PDE5i in men with ED. Data were included in a random-effects NMA, where efficacy of treatments was ranked by surface under the cumulative ranking curve (SUCRA). Two NMAs were also conducted separately for organic and non-organic ED. Reciprocal comparisons between all treatments were analyzed by league tables. The main outcome was the standardized mean difference in the score of the International Index of Erectile Function (IIEF)-5 or IIEF-6. Fifteen RCTs provided information on 1000 men with ED. In the overall NMA, compared to placebo, the combination propionyl L-carnitine (PLC) + acetyl L-carnitine (ALC) + Sildenafil was associated with the highest SUCRA (97%) in improving erectile function score, followed by L-Arginine + Tadalafil (84%), Sildenafil (79%), Tadalafil (72%), and L-Arginine (52%). No other treatment regimen showed efficacy with statistical significance. In patients with organic ED, the efficacy of Sildenafil and Tadalafil was significantly improved by PLC + ALC and L-Arginine, respectively. On the contrary, in non-organic ED, nutraceuticals did not improve the therapeutic performance of daily Tadalafil. This NMA contributes valuable insights into the potential of nutraceutical interventions for ED. We employed strict inclusion criteria related to study design and diagnostic tool, ensuring the assumption of transitivity and the consistency of the analysis. Against a background of general ineffectiveness of most nutraceutical interventions, L-Arginine and the mix PLC + ALC appeared to be of some usefulness in improving erectile function, especially in combination with PDE5i in organic ED.

Serum CRP and Fibrinogen Levels as Inflammatory Biomarkers Before and After Oral Daily Tadalafil 5 mg Treatment in Patients with Erectile Dysfunction: Case-Control Study

Serum CRP and Fibrinogen Levels as Inflammatory Biomarkers Before and After Oral Daily Tadalafil 5 mg Treatment in Patients with Erectile Dysfunction: Case-Control Study

Spontaneous erectile function recovery among young men with erectile dysfunction taking tadalafil 5mg once a day.

Daily (once a day [OaD]) tadalafil intake is a valuable option for men favoring spontaneous over scheduled sexual intercourse. The study sought to assess the rate of and the clinical factors associated with spontaneous, medication-free erectile function (EF) recovery after discontinuation of tadalafil 5mg OaD in a cohort of young men seeking first medical help for psychogenic erectile dysfunction (ED) as their primary complaint. Data from 96 consecutive patients <50years of age seeking first medical help for ED and prescribed tadalafil 5mg OaD were analyzed. Patients completed the International Index of Erectile Function (IIEF) and underwent baseline penile color Doppler ultrasound. Follow-up involved clinical assessments or phone interviews. Spontaneous medication-free EF recovery was defined as IIEF EF domain score >22 after tadalafil discontinuation, prompting cessation of follow-up. Descriptive statistics compared tadalafil OaD responders and nonresponders. Cox regression hazard models explored the association between baseline characteristics and EF recovery risk post-drug discontinuation. Kaplan-Meier analyses estimated EF recovery probability over time. The primary outcome was EF recovery after discontinuation of tadalafil 5mg OaD. Overall, median age was 39 (interquartile range [IQR], 32-45) years. Of all, 82 (85.4%) patients achieved EF recovery after tadalafil OaD discontinuation, while 14 (14.6%) patients were identified as nonresponders. Median tadalafil usage time (from beginning to discontinuation) was 3 (IQR, 2-11) months. The most common treatment-emergent adverse event was headache in 9 (9.4%) patients. Nonresponders were older (43 [IQR, 42-45] years vs 38 [IQR, 31-44] years; P = .03), had higher body mass index (25.5 [IQR, 23.4-29.9] kg/m2 vs 23.6 [IQR, 21.8-25.9] kg/m2; P = .04), and reported lower baseline IIEF EF domain scores (12 [IQR, 7-15] vs 15 [IQR, 10-22]; P = .02) than responders. Nonresponders and responders did not differ in terms of baseline ED severity, Charlson comorbidity index, smoking, alcohol consumption, regular physical exercise, and color Doppler ultrasound parameters. Upon Cox regression analysis, younger age (hazard ratio, 0.95; 95% confidence interval, 0.92-0.99; P = .01) was associated to EF recovery, after adjusting for baseline ED severity, body mass index, smoking, and Charlson comorbidity index ≥1. The Kaplan-Meier analysis displays the probability of EF recovery over time, indicating rates of 43%, 60%, and 72% at 3-, 6-, and 12-month follow-up intervals, respectively. Tadalafil 5mg OaD is an effective short-term treatment for psychogenic ED, allowing its discontinuation after achieving a normal medication-free EF. The main limitations are the limited number of participants and the potential neglect of confounding factors. Almost 1 out of 2 young men with primary psychogenic ED who were prescribed with tadalafil 5mg OaD recovered spontaneous medication-free EF after 3months of treatment. Overall, the younger the patient was, the higher the chance there was of spontaneous EF recovery after drug discontinuation.

Multimodal treatments based on Tadalafil during acute phase of Peyronie's disease: experience at two referral academic centers.

The purpose of this study is to identify the clinical outcomes of patients during acute phase of Peyronie's disease (PD) treated with daily Tadalafil 5mg associated with non-surgical treatments such as intra-plaque verapamil injections (IVI), vacuum erection devices (VED) or extra corporeal shockwave therapy (ESWT). 445 patients with PD in acute stage were treated as it follows: Group 1(G1) 117 men with only Tadalafil 5mg once a day for 3months; Group 2(G2) 106 men with IVI plus Tadalafil 5mg for a period of 12weeks; Group 3(G3) 124 men that received ESWT for 6weeks plus Tadalafil with the same protocol of G1; Group 4(G4) 98 men with VED plus Tadalafil 5mg for 3months. There were assessed at baseline and follow-up: Erectile dysfunction (ED), presence and severity of painful erections, penile plaque size and penile curvature degree. The results were evaluated at baseline and 3,6,12months. Not statistically significant differences emerged between the two groups at baseline, except for higher presence of patients with ED in in G3(7.4%) vs other groups(p < 0.001). Three months after the treatment in G3 men had a significant reduction of penile curvature degrees after 1year by treatments, whereas pain in an erection or during intercourse was resolved completely in 75% of the patients. Our study highlights that multimodal therapy has beneficial long-term effects not only in the decrease of ED symptoms, but also in the relief of the penile curvature and the quality of life.

Recovery of optimal vitamin D improves responsiveness to phosphodiesterase-5 inhibitors therapy in pulmonary arterial hypertension

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – EU funding. Main funding source(s): R.A. has received funding from the European Union’s Horizon 2020 research and innovation programme under Marie-Curie grant agreement Nº 847635. Introduction Vitamin D (vitD) deficiency is highly prevalent in patients with pulmonary arterial hypertension (PAH). Moreover, PAH-patients with lower levels of vitD have worse prognosis. We demonstrated that in animals with PAH and severe deficit of vitD, restoring vitD levels to an optimal range partially improves some pathophysiological features of PAH. Also, recent evidence suggests that vitD deficiency may cause insufficient response to phosphodiesterase-5 inhibitors (PDE5i), such as sildenafil, in some patients with PAH. Thus, in this study, we hypothesize that the recovery of optimal vitD levels in experimental PAH might help to improve responsiveness to PDE5i therapy. Methods Male Wistar rats were fed a vitD-free diet for five weeks and then received a single dose of Su5416 (20 mg/Kg) and were exposed to vitD-free diet and chronic hypoxia (10% O2) for three weeks to induce PAH. Following this, vitD deficient rats with PAH were housed in room air and divided into two groups: (a) daily tadalafil therapy (oral;10mg/kg) + continued vitD-free diet (n=9) or (b) daily tadalafil therapy (oral;10mg/kg) + single oral dose of 50,000 IU/Kg of vitD plus standard diet (n=9) for four weeks. Animals were then used for exercise capacity evaluation, invasive haemodynamic, pulmonary vascular analysis, and sample collection. Evolution of cardiac (dys)function was assessed by echocardiography. Results Recovering optimal vitD levels improved pulmonary endothelial function, measured by an increase in the endothelium-dependent vasodilator response to acetylcholine. It also increased the vasodilator response to sildenafil. Moreover, pulmonary small artery (&amp;lt;55 µm) remodeling was decreased in vitD-restored group, as measured by a decline in mean lumen/total ratio and mean medial thickness. In a morphometric analysis, vitD treatment attenuated increases in both right ventricle (RV) and right atrial hypertrophy, as well as the fulton index. VitD supplementation also improved the exercise capacity with increases seen in distance run, evaluated by endurance tests in a treadmill set. RV catheterization showed that vitD did not decreased the RV dysfunction, evaluated by end-systolic and end-diastolic pressure. Similar to the RV, no alterations were observed in pulmonary artery pressures. However, echocardiographic analysis revealed an improved pulmonary flow in the vitD-restored group, where pulmonary artery acceleration time normalized to ejection time ratio and pulmonary artery velocity-time integral were increased. It also improved tricuspid annular plane systolic excursion (TAPSE). Conclusion Altogether, these data suggest that in animals with PAH treated with tadalafil, restoring vitD levels to an optimal range improves some pathophysiological features of PAH. Therefore, in addition to recovery of optimal vitD status being indicated to restore calcium homeostasis in those PAH patients with severe deficiency, it might help to improve responsiveness to PDE5i.

(112) Penile Rehabilitation by Daily Intake of 5 mg Tadalafil for Erectile Dysfunction After Penile Fracture

Abstract Introduction Penile fracture is a rare complication to penile trauma, characterized by a sudden injury of the tunica albuginea of one or both corpora cavernosa of the penis. This commonly occurs during the erect state, when the tunica is thinner and under tension of fully engorged corpora cavernosa. Erectile dysfunction (ED) may occur in up to 12% of these patients due to organic and psychosexual factors including penile fibrosis. Objective This study aimed to assess the potential predictors of erectile dysfunction in patients who had penile fracture repair and the role of rehabilitation course of daily tadalafil 5 mg in management of ED following penile fracture. Methods From January 2022 to February 2023, 25 patients were included. Patients' baseline data as well as history including the time of presentation, the pattern and length of the tunical tear, and the presence of urethral injury, were obtained. After a week, all patients were followed up on and told to resume intercourse after at least two weeks if their wound had epithelialized. Only patients with a complaint of a weak erection, as determined by the Arabic validated version of the international index of erectile function (ArIIEF-5), were started on daily tadalafil 5 mg as a penile rehabilitation for at least one month, or until they regained their normal erection. The Hospital Anxiety and Depression Scale (HADS) was used for assessing patients. Patients with confounding disease as metabolic syndrome or mental illness were eliminated. Results Significant indicators predicting erectile dysfunction, according to the multiple logistic regression model, are the patients' age and the length of the tunical tear. A 1% increase in age was linked with a 73.6% rise in the probability of erectile dysfunction (p = 0.046), and a 1 cm increase in tunical tear length was associated with a 20.04 times increased risk of erectile dysfunction (p = 0.04). With a mean score of 20 on the Arabic-approved version of the internal index of erectile function, 5 of 9 patients with erectile dysfunction (55%) had improved erections after one month of penile rehabilitation, while only 4 of 9 patients (44%) required an additional month of treatment. Conclusions We propose that patients with penile fractur be counselled about erectile dysfunction and begin penile rehabilitation as soon as possible following repair to regain a normal erection. Disclosure No.

Potential primary prevention of Peyronie's disease post prostatectomy?-retrospective analysis of peri-operative multi-modal penile rehabilitation.

The surgical management of prostate cancer through radical prostatectomy has the potential to impact patients' sexual function, including erectile dysfunction and Peyronie's disease (PD). Historical data suggests the incidence of PD in post-prostatectomy patients is higher than in the general population at 15.9%. Our study objective was to measure the rate of the development of PD among patients that receive penile rehabilitation (PR) regimen prior to and immediately after radical prostatectomy. In this study, we retrospectively reviewed the charts of 581 patients who were diagnosed with prostate cancer, treated with radical prostatectomy, and engaged in a PR program. Patients with the diagnosis of PD prior to prostatectomy were excluded from this study. The PR program consists of daily tadalafil, L-citrulline, and weekly vacuum erectile device with the option of intracavernosal injections if patients fail to respond to the regular regimen. We found the incidence of PD to be 2.9%, suggesting that PR regimens programs may be associated with a reduced incidence of PD in post-prostatectomy patients. Ten (out of 17) patients were diagnosed with PD after 2 years of follow up. The return of erections was not statistically different among patients who developed PD and the rest of the patients. Prospective, multi-institutional trials will be required to elucidate whether PR can prevent the development of PD in this patient population.

Role of penile rehabilitation through daily intake of 5 mg tadalafil on erectile dysfunction after different presentations of penile fracture: a prospective case–control study

PurposeWe aimed in the current study to identify the predictive factors of ED occurrence in healthy individuals following penile fracture surgical repair as well as the effect of penile rehabilitation in the form of daily tadalafil 5 mg intake for 1 month for patients who suffered from ED after penile fracture incident.MethodThe current study was a prospective case–control study. Twenty-five patients were enrolled into the study starting from January (2022) to February (2023). Furthermore, time of presentation was determined, and length of tear intra-operative was measured, and then, a follow-up 1 week postoperatively in the outpatient clinic was conducted. All patients were instructed to start intercourse at least 2 weeks after the first visit provided that the wound epithelialized. Potent patients returned back home. A rehabilitation course of daily tadalafil 5 mg for 1 month was prescribed for patients who started complaining of ED that was confirmed by evaluation with the Arabic validated version of the international index of erectile function (ArIIEF-5). The rehabilitation therapy was terminated by resumption of normal erectile function. Thus, re-evaluation with the ArIIEF-5 was determined according to their response to therapy. Also, the patients were evaluated by hospital anxiety and depression scale (HADS) before and after penile fracture repair.ResultsThe current study had demonstrated that a 1% increase in age determines an increase in odds ratio for post-penile fracture ED with 73.6% and 1 cm increase in the length of tear determines an increase in odds ratio for post-penile fracture ED with 20.04 times.ConclusionThe current study enhances the proper counseling of these patients prior to repairing the defect about the probability of ED occurrence as well as initiating early penile rehabilitation to help these patients resuming their normal sexual activity as soon as possible.

(119) The Effect of Tadalafil and Dutasteride Combination on Lower Urinary System Symptoms and Erectile Functions in Patients with and without Prostate Median Lobe

Abstract Introduction Alpha blockers, 5 alpha reductase inhibitors, anticholinergics and tadalafil are used in the treatment of LUTS due to BPH. Objective The aim of this study was to evaluate the effect of daily tadalafil+dutasteride treatment on lower urinary tract symptoms (LUTS) and erectile functions in male patients with and without a median prostate lobe. Methods Male patients over the age of 40 who applied to the Urology Outpatient Clinic due to LUTS/ED between January 2018 and December 2022 were included in the study. Ethics committee approval was obtained for the study. Detailed medical and sexual histories of the patients were taken. The International Prostate Symptom Index was used for the LUTS, and the International Erectile Function Index-Erectile Function section was used for the erectile function. PSA and total testosterone levels of the patients were recorded. Maximum urine flow rate (Qmax) was measured by uroflowmetry. Prostate volume, presence of median lobe, median lobe volume and post-void residual urine volume (PMR) were measured by transabdominal ultrasound. Then, patients with moderate and severe LUTS and prostate volume over 40 cc were divided into 2 groups as those with and without middle lobe. The patients were started on tadalafil 5mg and dutasteride 0.5mg daily. IPSS, IIEF-EF, Qmax, PV and PMR changes of the patients were compared after 24 weeks of treatment. Results A total of 96 patients were included in the study (42 with a median lobe (group-1), 54 without a median lobe (group-2). The mean age of the patients was 56.25±13.47, and the mean BMI was 29.12±7.76. The mean IPSS value of the patients was 14.25±6.69, and the IIEF-EF value was 12.11±9.93. Mean PSA value 2.25±1.36 ng/ml, total testosterone value 345.67±123.21 ng/ml, mean PV 46.71±23.22 ml, Qmax value 8.24±3.36 m/s, PVR 54.32±25.52 was ml. There was no significant difference between the baseline IPSS, IIEF-EF, PSA and Qmax values between the two groups (p&amp;gt;0.05). After daily tadalafil+dutasteride treatment, mean IPSS value of the patients at the 24th week controls was 5.42±4.09 (p&amp;lt;0.001), IIEF-EF score was 20.97±3.67p&amp;lt;0.001), PV was 38.20±10.68 ml (p= 0.021), the Qmax value was found to be 12.45±7.68 m/s (p&amp;lt;0.001). Significant improvements were observed in IPSS, IIEF-EF and Qmax values in both groups compared to the beginning of treatment when the parameters of the groups were changed at the beginning and at the 24th week. When the 24th week data of the two groups were compared, it was found that the IPSS decrease in group-2 was higher than in group-1 (p=0.012). IIEF-EF scores (p=0.034) and Qmax (p=0.001) values were found to be higher than group-1. Conclusions Daily tadalafil+dutasteride treatment is an effective and safe treatment combination in male patients with LUTS/ED. In the presence of the median lobe, the response from tadalafil+dutasteride treatment decreases. The 24-week preliminary results of the study allowed us to have an idea of the long-term results. Further studies are needed to evaluate the effect of tadalafil+dutasteride combination in the treatment of LUTS/ED. Disclosure No

Depolama semptomu baskın alt üriner sistem semptomu olan hastalarda günlük tadalafil ve solifenasin kombinasyonunun etkinliği

Objective: To evaluate the efficacy of tadalafil 5mg+solifenacin 5mg combination in terms of lower urinary tract symptoms (LUTS) and erectile functions in benign prostate hyperplasia patients with predominant storage symptoms. Material and Methods: Male patients over the age of 40 who presented with LUTS with predominant storage symptoms between January 2019 and December 2021 were included into the study. Daily tadalafil 5mg and solifenacin 5mg treatment were started to the patients. Overactive bladder symptom score (OABSS), international prostate symptom score (IPSS) for LUTS, and international erectile function index-erectile function (IIEF-EF) questionnaires were used for erectile function. Frequency of daily urinary frequency, frequency of nocturia, urgency and urinary incontinence were analyzed with a three-day bladder diary. Twelve weeks later, IPSS, OABSS and IIEF-EF scores of the patients were evaluated. Results: When the symptom scores and bladder diaries of the patients before and after 12 weeks of treatment were compared, significant decrease in IPSS scores (both voiding, storage and total) (p&lt;0.001 for each), significant increase in IIEF-EF scores (p&lt;0.001), and significant increase in Qmax value elevation was observed. When the bladder diaries were compared, the number of daytime micturitions, the number of nocturia and the number of urgency decreased in the 12th month after tadalafil+solifenacin treatment (p&lt;0.001). Conclusion: The combination of tadalafil 5mg and solifenacin 5mg daily is an effective and safe treatment for male patients with storage symptoms predominant LUTS/ED. Keywords: benign prostate hyperplasia, storage, tadalafil, solifenacin, erectile function

The efficacy and safety of tadalafil in the management of erectile dysfunction with diabetes and blood circulation issues

Background Erectile dysfunction (ED) is a common diabetes-related complication. Materials and methods This study examined the effect of daily low-dose tadalafil (5 mg) on patients’ quality of life (including that of sex life) and blood circulation. Erectile dysfunction questionnaires were administered to 20 patients with type 2 diabetes (T2DM) and ED. The safety and efficacy of tadalafil were evaluated using laboratory tests, and the effect on blood circulation was measured through nail fold capillaroscopy. Results Daily tadalafil use by patients with T2DM and ED showed a statistically significant increase in the erectile reliability score from of 1.15 to 3.20 (p < .00012). Capillary blood circulation improvement tests showed a statistically significant increase in apical limb width from 13.1 to 14.64 µm (p = .04829) and flow from 9035 to 11946 μm3/s (p = .04405). Although not significant, increased capillary width and speed (rate of blood flow) confirmed improved blood circulation. There were no significant changes in the cardiac indicators (troponin, prostate-specific antigen, or electrocardiogram tests) before and after tadalafil administration, supporting the safety of its low-dose daily administration. Conclusions A small dose of daily tadalafil was shown to safely improve erectile dysfunction and peripheral blood flow in patients with T2DM, in which peripheral arterial diseases should not be considered separately but rather as complex entities.

Multicenter review of a tadalafil suspension formulation in infants and children with pulmonary hypertension: a north american experience

Abstract Funding Acknowledgements Type of funding sources: None. Background Pulmonary arterial hypertension (PAH) is a disease characterised by an increase in pulmonary vascular resistance and pulmonary artery pressure. Phosphodiesterase type 5 (PDE5) inhibitors, with sildenafil the earliest among them, are widely used in the management of pediatric PAH. There has more recently been a transition to once-daily tadalafil suspensions. Herein, we present a multicenter experience detailing safety, tolerability and haemodynamic data utilizing tadalafil suspension alone or in combination for the management of pediatric PAH. Methods and materials We performed a retrospective review of all infants and children at two North American paediatric PH centres between December 2013 and April 2022. We included all patients less than 9 years of age who were treated with a tadalafil suspension after an initial treatment with sildenafil. Demographic, clinical, imaging, and laboratory data were collected. Results Over the study period, 158 children were treated with tadalafil therapy: 41 (25.9%) had group 1 PAH, 81 (51.3%) had group 3 PH, and 33 (20.9%) had group 5 PH. The median initial dose of tadalafil was 1.0 mg/kg once daily with a median time to maximum dose of 1 day. The majority of patients required the suspension formulation due to an inability to take oral tablets or the need for nasogastric or nasojejunal feeding. We observed improvements in median echocardiographic parameters in the six months following initiation, namely, in RVFAC from 34.7% (Q1 = 31.0%, Q3 = 42.0%) to 37.0% (Q1 = 31.0%, Q3 = 44.0%) and in TAPSE from 1.0 (Q1 = 0.8, Q3 = 1.7) cm to 1.3 (Q1 = 1.0, Q3 = 1.7) cm. We observed median decreases in RVSp from 51.0 (Q1 = 35.0, Q3 = 69.0) mmHg to 37.0 (Q1 = 30.0, Q3 = 50.0) mmHg and in NT pro BNP levels from 439.0 (Q1 = 217.0, Q3 = 2051.0) ng/L to 313.0 (Q1 = 193.0, Q3 = 1110.0) ng/L. Tadalafil therapy was well tolerated over the six-month period: at baseline, only four patients (2.5%) reported gastrointestinal side effects, two (1.3%) reported adverse skin adverse effects (i.e., rash and flushing), and one (0.6%) reported adverse neurological effects. At six months, 150 patients (94.9%) reported no adverse effects. Conclusion Tadalafil, a long-acting PDE5 inhibitor, when administered in a suspension formulation, has a safe and tolerable adverse effect profile once patients are established on sildenafil therapy. Following 6 months of once daily tadalafil suspension, alone or in combination, showed a trend towards improvement in clinical parameters, echocardiographic measurements, and laboratory results for pediatric PAH. All patient adverse effects were managed with non pharmacological measures and there was good patient compliance.

Erektil disfonksiyon şikâyeti ile başvurup eşlik eden prematür ejakulasyonu olan heteroseksüel hastalarda günlük tadalafil ve sertralin kombinasyon tedavisinin etkinliği ve güvenilirliği

Efficacy and safety of daily tadalafil and sertraline combination therapy in heterosexual patients presenting with erectile dysfunction and concomitant premature ejaculation OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of daily tadalafil 5 mg and sertraline 50 mg treatment in 3-month follow-up in patients presenting with erectile dysfunction (ED) complaints and accompanying premature ejaculation (PE) symptoms. MATERIAL and METHODS: This prospective, observational single-arm study was conducted between March and September 2021 among patients suffering from ED and concomitant Lifetime/acquired PE. The Turkish validity of the International Erectile Function-Erectile Function Index (IIEF-EF) was used for the diagnosis of ED in the patients. The patients filled the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire for the diagnosis of PE. Additionally, the Premature Ejaculation Profile (PEP) score was filled. A detailed medical history was taken from all patients and a complete physical examination was performed. After a fourweek follow-up period, patients were given 5 mg tadalafil and sertraline 50 mg tablets daily. The IELT durations of the patients were recorded after 12 weeks of treatment. Premature ejaculation profile and IIEF-EF questionnaires administered to the patients at the beginning were filled again. In addition, the Global Impression of Change (GIC) questionnaire was applied in terms of treatment satisfaction. RESULTS: A total of 71 patients were included in the study. Sixty-three patients completed the study (88.73%). As a result of 3-month daily tadalafil 5 mg + sertraline 50 mg combination therapy, the geometric mean IELT, PEP index scores and subgroup scores of the patients improved and a statistically significant increase in the IIEF-EF scores (p&lt;0.001). In addition, considering the GIC questionnaire, 81.69% (58/71) of the patients stated that they were satisfied with the treatment. CONCLUSION: In conclusion, daily administration of tadalafil and sertraline provides an effective and reliable objective and subjective improvement in the management of patients with ED and accompanying PE. Keywords: premature ejaculation, erectile dysfunction, sertraline, tadalafil, IELT

Is there a relationship between mean platelet volume and response to treatment with daily tadalafil in patients with erectile dysfunction?

Mean platelet volume (MPV) has been related to erectile dysfunction (ED). However, its value in predicting therapeutic response to phosphodiesterase-5 inhibitors is not evaluated. This study aimed to investigate the value of MPV as a marker for the prediction of the response of the tadalafil treatment of ED. A retrospective analysis of patients who were admitted to the andrology outpatient clinic between 2020-2022 were performed. The inclusion criteria were, ≥40 years old male, International Index of Erectile Function-Erectile Function domain score < 26, not received any ED treatment before, have a stable heterosexual relationship, and prescribed 5mg daily tadalafil for primary treatment of ED. A total of 116 patients were included in the study. The mean age of the patients was 53.7 ± 8.7 years. The response rate to 5mg tadalafil treatment was 52.6% (Group-1; N=61). An MPV value 3 10.05 fL was associated with 66% sensitivity and 75,4% specificity for no response to 5mg daily tadalafil treatment (Area under curve=76.9% [95% CI 68.2%-85.6%; p < 0.001]). Initial IIEF-EF score, fasting blood glucose, and MPV level was independently associated with the response to the tadalafil treatment. This is the only study to evaluate the value of MPV level on the therapeutic response of ED to tadalafil. Strict inclusion criteria were applied to the cohort. However, the diagnose of vascular ED has been made by clinical evaluation and retrospective design of the study were the limitations of the study. The results of our study suggest that MPV might be used to predict the result of 5mg daily tadalafil treatment in selected ED patients as a fast and cost-effective test.

Efficacy of tadalafil on symptom-specific bother in men with lower urinary tract symptoms.

This multicenter and prospective study was performed to evaluate the efficacy of tadalafil on patient-reported bother for each symptom in men with lower urinary tract symptoms (LUTS). Men with LUTS received 5mg of tadalafil daily for 4 weeks. We assessed change in symptom severity using both international prostate symptom score (IPSS), and overactive bladder symptom score (OABSS), as well as patient-reported quality of life (QOL: bother or satisfaction) for each symptoms using IPSS-visual analog scale (IPSS-VAS) and OABSS-VAS. We found significant improvements in total IPSS (P < 0.001), including voiding symptoms (P < 0.001), storage symptoms (P < 0.001), and QOL (P < 0.001). All VAS measures corresponding to symptoms in IPSS and OABSS also significantly improved (P < 0.001). The most bothersome symptoms for each patient at baseline evaluated by VAS measures significantly improved (P < 0.001). Patients whose most bothersome symptoms at baseline included IPSS-Q7 (nocturia) showed significantly smaller improvement of VAS measure after treatment than those without it (P=0.024). Daily tadalafil significantly improved not only symptom severity of LUTS but also patient-reported QOL on each symptom.

Response to Comment on 'Comparison of the efficacy of the early LI-SWT plus daily tadalafil with daily tadalafil only as penile rehabilitation for postprostatectomy erectile dysfunction'.

Response to Comment on 'Comparison of the efficacy of the early LI-SWT plus daily tadalafil with daily tadalafil only as penile rehabilitation for postprostatectomy erectile dysfunction'.

Selecting an Individualized Treatment Approach: The Predictive Value of Erotic Stimulation and Nocturnal Erections for Efficacy of Tadalafil and Cure in Patients With Erectile Dysfunction.

PurposeThis study aimed to evaluate two modes of Rigiscan for predicting tadalafil response, and to identify which Rigiscan variables are the most efficient at making these predictions.MethodsAll patients received at least two rounds of nocturnal penile tumescence and rigidity (NPTR) testing and/or audiovisual sexual stimulation (AVSS), then completed the International Index of Erectile Function-5 (IIEF-5) questionnaire, followed by oral 5 mg tadalafil daily for 4 weeks. After a 4-week washout period, all respondents underwent an the IIEF-5 questionnaire again. ED patients were then categorized into tadalafil responders and tadalafil non-responders, who were then further divided into cured patients and uncured patients.ResultsWhen predicting tadalafil responders, the area under the curve (AUC) of NPTR was superior to that of AVSS (0.68~0.84 VS 0.69~0.73), and the predicted optimal cut-off values were DOEE60≥17.75 min in NPTR, compared to other parameters regardless of AVSS or NPTR (P<0.05). When predicting which patients would be cured, the AUC of AVSS was superior to NPTR parameters (0.77~0.81 vs 0.61~0.76), and the determined best diagnostic cut-off values were DOEE≥4.125min in AVSS, compared to other parameters regardless of AVSS or NPTR (P < 0.05).ConclusionRigiscan was able to predict the efficacy of daily tadalafil accurately and efficiently. Its diagnostic value was at maximum when DOEE60 ≥17.75 min of NPTR in tadalafil responders and DOEE ≥ 4.125 min of AVSS in cured patients.

Sex-specific effects of daily tadalafil on diabetic heart kinetics in RECOGITO, a randomized, double-blind, placebo-controlled trial.

Cyclic GMP-phosphodiesterase type 5 (PDE5) inhibition has been shown to counteract maladaptive cardiac changes triggered by diabetes in some but not all studies. We performed a single-center, 20-week, double-blind, randomized, placebo-controlled trial (NCT01803828) to assess sex differences in cardiac remodeling after PDE5 inhibition in patients with diabetic cardiomyopathy. A total of 122 men and women (45 to 80 years) with long-duration (>3 years) and well-controlled type 2 diabetes mellitus (T2DM; HbA1c < 86 mmol/mol) were selected according to echocardiographic signs of cardiac remodeling. Patients were randomly assigned (1:1) to placebo or oral tadalafil (20 mg, once daily). The primary outcome was to evaluate sex differences in cardiac torsion change. Secondary outcomes were changes in cardiovascular, metabolic, immune, and renal function. At 20 weeks, the treatment-by-sex interaction documented an improvement in cardiac torsion (-3.40°, -5.96; -0.84, P = 0.011) and fiber shortening (-1.19%, -2.24; -0.14, P = 0.027) in men but not women. The primary outcome could not be explained by differences in cGMP concentrations or tadalafil pharmacodynamics. In both sexes, tadalafil improved hsa-miR-199-5p expression, biomarkers of cardiovascular remodeling, albuminuria, renal artery resistive index, and circulating Klotho concentrations. Immune cell profiling revealed an improvement in low-grade chronic inflammation: Classic CD14++CD16- monocytes reduced, and Tie2+ monocytes increased. Nine patients (14.5%) had minor adverse reactions after tadalafil administration. Continuous PDE5 inhibition could offer a strategy to target cardiorenal complications of T2DM, with sex- and tissue-specific responses. Further studies are needed to confirm Klotho and hsa-miR-199-5p as markers for T2DM complications.