Tadalafil In Patients Research Articles

Vacuum Erection Device Plus Once-Daily Tadalafil Improve Clinical Outcomes after Extracorporeal Shock Wave Therapy in Men Affected by Erectile Dysfunction Associated with Peyronie's Disease.

The purpose of this study is to examine the combination of the mechanical effects of penile therapy with vacuum erection devices (VEDs) plus PDE5i, which improve clinical outcomes after extracorporeal shockwave therapy (ESWT) in men affected by erectile dysfunction (ED) associated with Peyronie's disease (PD). A total of 153 medical records of patients affected by PD in stable stage with ED and treated with ESWT were divided into two groups. Group A (GA) included 72 men treated with ESWT, mechanical stretching with VEDs and PDE5ì (Tadalafil 5 mg), and Group B (GB) included 81 men who received only ESWT plus Tadalafil 5 mg with the same protocol of GA. The patients in both groups were assessed at baseline and follow-up for erectile function, painful erections, penile plaque size, and penile curvature. The results were evaluated at baseline and 3, 6, and 12 months after the treatments. Three months after the treatment, GA patients had a reduction in penile curvature degree from a mean ± SD of 33.91 ± 8.34° at baseline to a mean ± SD of 19.46 ± 7.15° after 12 months, whereas pain in an erection or during intercourse was resolved completely in 88.9% of the patients. The mean ± SD IIEF-15 score of patients affected by severe/moderate ED further improved significantly in the GA group (p < 0.001) after 3, 6, and 12 months of treatment. There were no permanent adverse sequelae after treatments. The regular use of a VED plus Tadalafil in patients who had undergone ESWT significantly provided more benefit in patients with PD in terms of penile deformity, pain, and erectile function.

Role of the Triglyceride-Glucose Index as a Predictor of Therapeutic Response to Tadalafil in Patients With Erectile Dysfunction.

The triglyceride-glucose (TyG) index is an easily calculable indicator of endothelial dysfunction. We aimed to evaluate the effect of the TyG index on treatment response in patients using tadalafil for the treatment of erectile dysfunction (ED). The data of patients who used tadalafil for ED in our urology clinic between January 2018 and January 2023 were reviewed. The patients completed the 5-item International Index of Erectile Function (IIEF-5) questionnaire before treatment and in the 3rd month of treatment. Response to tadalafil treatment was accepted as an increase in IIEF category. Patients were divided into 2 groups according to treatment response. Factors affecting response to treatment were evaluated with a multivariate analysis. Of the 134 patients included in the study, 99 (73.3%) responded to tadalafil treatment. Mean age and body mass index (BMI) of the patient group responding to treatment were significantly lower than in the untreated group. The rates of diabetes mellitus (DM) and metabolic syndrome (MetS) were significantly lower in the group responding to treatment. Fasting glucose, triglyceride and total cholesterol values were significantly lower in the group responding to treatment than in the treatment-resistant group. The TyG index was 130.0 (102.0-180.0) in the group responding to treatment and 245.0 (182.0-320.0) in the treatment-resistant group (p=0.001). In the multivariate analysis, age, BMI, DM, MetS, and TyG index were affecting treatment response. A high TyG index negatively affects the response to treatment in patients using tadalafil for ED. In addition, age, BMI, presence of DM and MetS are other factors affecting the response to treatment.

Initial combination therapy with macitentan and tadalafil in patients with pulmonary arterial hypertension, with and without cardiac comorbidities.

According to current guidelines, initial monotherapy should be considered for pulmonary arterial hypertension (PAH) patients with cardiopulmonary comorbidities. This analysis of combined data from the TRITON and REPAIR clinical trials, assesses efficacy and safety of initial double combination therapy in patients without vs. with 1-2 cardiac comorbidities. Data were combined for patients from TRITON (NCT02558231) and REPAIR (NCT02310672) on initial macitentan and tadalafil double combination therapy (overall set, n = 148) and two subgroups defined as patients without cardiac comorbidities (n = 62) and those with 1-2 cardiac comorbidities (n = 78). Patients with ≥3 comorbidities were excluded from these studies. For the overall set, the median (Q1-Q3) duration of combined macitentan and tadalafil exposure was 513.0 (364.0-778.0) days, and was similar between subgroups. Change from baseline to Week 26 for pulmonary vascular resistance was -55% and -50% for patients without and with 1-2 cardiac comorbidities, respectively; marked improvements in other hemodynamic and functional parameters were also observed, although functional parameters improved to a lesser extent in patients with comorbidities. At Week 26, the majority of patients had improved PAH risk status, according to the non-invasive four-strata and REVEAL Lite 2.0 methods. The safety profile of initial macitentan plus tadalafil combination therapy was consistent with the known profiles of the two drugs, and similar between the subgroups. Initial double combination therapy with macitentan plus tadalafil is efficacious in patients with PAH with 1-2 cardiac comorbidities and those without, with similar safety and tolerability profiles between the two groups.

Prospective, randomized, placebo-controlled, two-arm study to evaluate the efficacy of coadministration of garlic as a hydrogen sulfide donor and tadalafil in patients with erectile dysfunction not responding to tadalafil alone - A pilot study.

The objective is to evaluate the efficacy of coadministration of garlic (as a hydrogen sulfide [H2S] donor) and tadalafil for patients with ED using a placebo-controlled, prospective, randomized, two-arm pilot study in patients responding poorly to tadalafil alone. The patients with complaints of ED (with normal penile Doppler) who failed to maintain sustained improvement in erectile function with tadalafil were recruited after excluding those with comorbidities. The study sample was randomized into two groups. Group A received garlic 5 g twice a day orally and Group B received a placebo twice daily orally for 4 weeks. Both groups continued tadalafil 5 mg in the night for 4 weeks. Their erectile function was assessed at the beginning and at the end of 4 weeks using the International Index of Erectile Function (IIEF-EF), erectile function domain and compared. A value of P ≤ 0.05 was considered statistically significant. Nineteen patients in Group A (mean age 37.5 ± 10.6 years) and 16 patients in Group B (mean age 39.6 ± 9.6 years) participated in the pilot study conducted from May 2022 to August 2022. The participants treated with garlic (as an H2S donor) as a coadministrant had statistically significant improvement in IIEF-EF score (P ≤ 0.0001) at the end of 4 weeks compared to placebo. Garlic (as an H2S donor) as adjunctive therapy was beneficial in our study participants responding poorly to tadalafil alone.

Comparative study of tamsulosin, tadalafil, and combination of tamsulosin with tadalafil in the treatment of patients with lower urinary tract symptoms

Purpose: Benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) commonly coexist in aging men. Tamsulosin and tadalafil are widely used for lower urinary tract symptoms (LUTS) and ED, respectively. A combination of these 2 drugs might be useful to design new management strategies, as treatment of LUTS might affect ED. Furthermore, the effect of tadalafil alone or in combination with tamsulosin on LUTS has not been widely studied, especially in our country. We conducted a study to compare the effects of tamsulosin, tadalafil, and a combination of tamsulosin and tadalafil in patients with LUTS with or without ED. Materials and methods: In this observational study, 81 men with LUTS due to BPH were included. Patients were divided into 3 groups of 27 patients each. Group A received tamsulosin 0.4 mg/d alone, group B tadalafil 5 mg/d alone, and group C combination therapy (tamsulosin and tadalafil both). All patients were evaluated for the International Prostate Symptom Score (IPSS), the International Index of Erectile Function 5 score, the maximum urinary flow rate, and postvoid residual urine volume. Results: IPSS improvement was seen in all groups (−50.90%, P &lt; 0.05; −28.57%, P &lt; 0.05; and −54.83%, P &lt; 0.05, respectively). An improvement in International Index of Erectile Function 5 was also seen in all 3 groups (+39.28%, P &lt; 0.05; +45.9%, P &lt; 0.05; and +55.4%, P &lt; 0.05, respectively). Maximum urinary flow rate and postvoid residual also showed improvement in all 3 groups (33.9%, P &lt; 0.05; 29.92%, P &lt; 0.05; and 39.71%, P &lt; 0.05 and −60.60%, P &lt; 0.05; −48.51%, P &lt; 0.05; and −62.18%, P &lt; 0.05, respectively). Conclusion: In patients with LUTS due to BPH, tadalafil and tamsulosin, either alone or in combination, significantly reduce LUTS. In addition, these drugs significantly enhance erectile function in males with LUTS, whether taken alone or in combination. We found no statistically significant improvement in either the IPSS or the ED scores when comparing the combination group to the tamsulosin-alone and the tadalafil-alone groups.

Long-term effects of combination treatment comprising low-intensity extracorporeal shockwave therapy and tadalafil for patients with erectile dysfunction: a retrospective study.

This study retrospectively examined the effects of low-intensity extracorporeal shockwave therapy and tadalafil on erectile dysfunction patients. 116 patients got low-intensity extracorporeal shockwave therapy twice weekly for 3 weeks, 5 mg of tadalafil daily for 3 weeks, and adjuvant therapy for 6 months. Group A (1 year), Group B (2 years), Group C (3 years), and Group D (4+ years) were treated patients' follow-up groups. The patients' International Index of Erectile Function-5 (IIEF-5) scores were gathered at the start of treatment via face-to-face interviews and at the end of follow-ups by telephone conversations. IIEF-5 scores and the minimal clinically significant differences were the main outcomes. Mean follow-up length, age, and IIEF-5 scores of the patients were 2 ± 1.16 years, 47.34 ± 12.65 years, and 12.09 ± 3.66 points, respectively. Compared to baseline, treatment increased the median IIEF-5 scores of patients in groups A, B, C, and D by 7 [3-12], 6 [0-8], 7 [1-9], and 6.5 [2.5-10] points, respectively (p = 0.001). 71%, 63%, 65.8%, and 65% of treated patients in groups A, B, C, and D met the minimal clinically significant differences criteria (n = 77). Mild disease patients were 9.14 times more likely to respond to treatment than severe illness patients (OR, 9.14; 95% CI, 1.28-65.46; P = 0.02). Low-intensity extracorporeal shockwave therapy and 5 mg of tadalafil can treat erectile dysfunction for up to 4 years with sustained outcomes. This treatment is optimal for mild illnesses.

Do Patients With Low-Risk Pulmonary Arterial Hypertension Really Benefit From Upfront Combination Therapy?: Insight From the AMBITION Trial

Based on results of the Ambrisentan and Tadalafil in Patients with Pulmonary Arterial Hypertension (AMBITION) trial, upfront combination therapy is recommended for treatment-naive patients with low-risk pulmonary arterial hypertension (PAH). However, conflicting data exist whether adopting this treatment strategy in this risk group is beneficial or well tolerated. Do patients with low-risk PAH really benefit from upfront combination therapy? Using the data from the original AMBITION trial, patients with PAH were classified as low, intermediate, or high risk using the Registry to Evaluate Early and Long-term PAH Disease Management 2.0 (REVEAL 2.0) score and the Pulmonary Hypertension Outcomes and Risk Assessment (PHORA) tool. The primary end point was time to clinical worsening (including death, hospitalization for PAH worsening, and disease progression) censored at 1- and 3-year post-enrollment. Side effects that led to withdrawal of treatment were also considered. Patients with low-risk PAH categorized by REVEAL 2.0 and PHORA did not see a statistically significant benefit of upfront combination therapy vsmonotherapy for time to clinical worsening at 1 and 3 years' post-enrollment using Cox proportional analysis (3-year hazard ratio of 0.40 [95%CI, 0.15-1.06; P= .07] and 0.55 [95%CI, 0.26-1.18; P= .12] for REVEAL 2.0 and PHORA, respectively) or considering time to clinical worsening or side effects (3-year hazard ratio of 0.75 [95%CI, 0.39-1.47; P= .4] and 0.87 [95%CI, 0.49-1.54; P= .63] for REVEAL 2.0 and PHORA). Patients with low-risk PAH on upfront combination therapy experienced a higher but not significant incidence of side effects using REVEAL 2.0 and PHORA. In contrast, patients at intermediate or high risk saw a statistically significant benefit of upfront combination therapy considering each of the end points regardless of side effects. This analysis suggests that perhaps some patients with low-risk PAH should be further stratified using other modalities prior to committing to upfront combination therapy, especially when the occurrence of side effects is considered. Further prospective data are needed to validate this hypothesis prior to changes in current guideline directed therapy are contemplated.

Daily low-dose tadalafil may reduce the penile curvature progression rate in patients with acute Peyronie's disease: a retrospective comparative analysis.

The aim of this study was to evaluate the clinical outcomes of patients in acute phase of Peyronie's disease (PD) treated with daily low-dose of Tadalafil. An observational retrospective study involving patients in acute phase of PD with erectile dysfunction (ED) was designed. All subjects were offered Tadalafil 5 mg one tablet a day. Men who accepted treatment were compared to patients who refused Tadalafil. Penile curvature progression was chosen as the primary outcome. PD Questionnaire (PDQ) and IIEF-5 scores were selected as secondary outcomes. A total of 191 patients were included in the study (108 intervention vs. 83 control). Penile curvature progression rate was significantly lower in subjects taking Tadalafil at 12 weeks (25.9% vs. 39.7%, p = 0.042). Mean IIEF-5 score improved in the intervention group, becoming significantly higher compared to the observation group at 12 weeks (19.3 vs. 11.2 points, p < 0.001). Mean PDQ-Overall and PDQ-Penile Pain scores only improved in the intervention group and the statistically significant differences at baseline between groups became not statistically significant at 12 weeks (p = 0.001 vs. p = 0.232 and p < 0.001 vs. p = 0.078, respectively). Daily low-dose Tadalafil in patients with acute phase of PD seems to significantly reduce the penile curvature progression rate compared to observation, especially when it is administrated early. It also appears to improve erectile function and PD-related symptoms.

Concomitant initiation of combination therapy with macitentan and tadalafil in pulmonary arterial hypertension (PAH) patients with comorbidities: real-world data from OPUS and OrPHeUS

Abstract Background Guidelines for the management of pulmonary arterial hypertension (PAH) recommend early combination therapy of an endothelial receptor antagonist (ERA) and a phosphodiesterase type-5 inhibitor (PDE5i) [1]. There is, however, limited guidance about the management of PAH patients with comorbidities. Purpose To describe the demographics, clinical characteristics, safety, tolerability, and outcomes associated with initiation of the ERA macitentan and the PDE5i tadalafil in patients with comorbidities in the US OPsumit® USers (OPUS) and the OPsumit® Historical USers cohort (OrPHeUS) combined dataset. Methods This analysis reports data from the OPUS registry (Apr 2014–Jun 2020) and OrPHeUS medical chart review (Oct 2013–Mar 2017) on PAH patients initiating macitentan and tadalafil (M+T) combination therapy, in any order, as concomitant initiation (≤60 days apart, concomitant initiation group). The index date was defined as the start date of the second therapy (i.e., the start of combination therapy). Patients were further grouped by the number of comorbidities present prior to or at macitentan initiation: systemic hypertension, diabetes, renal insufficiency, BMI ≥30 kg/m2, other signs of right heart failure and atrial fibrillation. Results are presented descriptively alongside results for all PAH patients receiving M+T combination therapy (overall M+T group). Results Of the 1336 PAH patients that received M+T combination therapy, 431 (32%) were in the concomitant initiation group. In the concomitant initiation and overall M+T groups, respectively: 72% and 68% had ≥1 comorbidity, and the most common were systemic hypertension (47% and 47%), obesity (32% and 26%) and diabetes (23% and 22%). Patients were more likely to be older, male and have idiopathic/heritable PAH with increasing comorbidity burden (Table 1). Patients in the concomitant initiation group were more likely to be incident (median time from diagnosis: 1–2 months vs 9–24 months in the overall M+T group; Table 1). Most patients had ≥1 adverse event (AE); in both groups, patients with a high comorbidity burden (≥3) were more likely to have had an AE and to have discontinued treatment (Table 2). The incidence rate of first all-cause hospitalisation and mortality by comorbidity was comparable between the concomitant initiation and overall M+T groups. Conclusions In the real-world, concomitant initiation of M+T is used in PAH patients with comorbidities, usually shortly after diagnosis. Patient characteristics were similar for the concomitant initiation and overall M+T groups, with the exception of time from diagnosis. At index date, age, gender proportion, and PAH aetiology differed between the comorbidity groups. The safety profile of M+T combination therapy in the concomitant initiation group was consistent with that in the overall M+T group. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson &amp; Johnson

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.

The role of Tadalafil in the treatment of benign prostatic hyperplasia and erectile dysfunction

The aim of this study is to investigate the effectiveness of a single 5 mg daily dose of Tadalafil in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) accompanied by erectile dysfunction (ED). The data of patients who applied to the urology outpatient clinic between 2014 and 2019 and were diagnosed with BPH and ED were retrospectively analysed. Before and after the treatment with 5 mg tadalafil daily for 12 weeks; maximum flow rate (Qmax), average flow rate (Qave), postvoid residual volume (PVR), prostate volume (PV), PSA values, IPSS and IIEF scores of the patients were compared. The mean age of 66 male patients diagnosed with ED and BPH was 48.1±6.9 years. The mean IPSS score of the patients before the treatment was 9.85 which represents moderate LUTS. After the treatment, the mean score decreased to 5.7 which represents mild LUTS. Before the treatment, the mean IIEF score showed mild ED with 18.79. After the treatment, the mean IIEF score increased to 29,9. The treatment statistically significantly decreased ED and increased the IIEF score (p=0.000). While the mean Qmax and Qave were increased statistically significantly (p=0.000). A statistically significant decrease was observed in the mean PVR from 60.1 ml to 37.6 ml (p=0.000). The decrease in PV was not statistically significant (p=0.321). The decrease in PSA values before and after treatment was found to be statistically significant with p=0.046. It has been shown that the daily use of 5 mg Tadalafil alone for 12 weeks can be a preferable treatment option, especially in younger patients with BPH / LUTS and ED.

MP35-07 COMPARISON OF THREE DIFFERENT TADALAFIL REGIMES FOR THE TREATMENT OF ERECTILE DYSFUNCTION IN DIABETES MELLITUS PATIENTS WITH MICROVASCULAR COMPLICATIONS

You have accessJournal of UrologyCME1 May 2022MP35-07 COMPARISON OF THREE DIFFERENT TADALAFIL REGIMES FOR THE TREATMENT OF ERECTILE DYSFUNCTION IN DIABETES MELLITUS PATIENTS WITH MICROVASCULAR COMPLICATIONS Goksel Bayar, and Caglar Yildirim Goksel BayarGoksel Bayar More articles by this author , and Caglar YildirimCaglar Yildirim More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002589.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We aimed to compare the efficacy and safety of daily, on-demand and daily plus optional tadalafil use in patients with microvascular complications due to diabetes mellitus (DM) and erectile dysfunction (ED). METHODS: Patients who came to our urology outpatient clinic with ED between May 2018 and March 2020, those with at least one microvascular complication due to DM (retinopathy, nephropathy, neuropathy or diabetic foot without macrovascular complications) were selected. Those with an international erectile function index score (IIEF-5) below 11 (severe and moderate) were included in the study. The patients were divided into three groups; the first group 5 mg tadalafil (Cialis™, Lilly, USA) daily, the second group 20 mg tadalafil (Cialis™, Lilly, USA) twice a week two hours before intercourse, and the third group 5 mg tadalafil daily and 2 hours before intercourse twice a week was formed to take an extra 15 mg (20 mg total on the intercourse day) tadalafil. The IIEF-5 form filled with at the first admission. The IIEF-5, SEP-2, SEP-3, GAQ-1 and GAQ-2 inquiry forms were filled 3 months after the treatment. RESULTS: A total of 60 patients, 20 in each group, were included in the study. The mean age, body mass index and baseline IIEF-5 scores of the patients were similar. In the post-treatment IIEF-5 scores, the third group (13+4.7) was significantly higher than the first (8.35+2.6) (p=0.001) and the second group (10+3.6) (p=0.035); there was no significant difference between the first and second groups (p=0.345). Although the percentage of positive answers to SEP-2 and GAQ-1 questions was different between the groups, this difference was not statistically significant. However, the percentage of patients who answered positively to the questions SEP-3 (20%, 40% and 75%, respectively) (p=0.002) and GAQ-2 (20%, 45%, and 75%, respectively) (p=0.002) was significant higher in the third group. There was no difference in the incidence of side effects between the groups (p= 0.392). CONCLUSIONS: Treatment of ED with oral tadalafil in patients with DM-related microvascular complications is ineffective when given daily or before intercourse. In these patients, giving the combination in the first step can provide higher efficacy and patient satisfaction with the same safety. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e589 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Goksel Bayar More articles by this author Caglar Yildirim More articles by this author Expand All Advertisement PDF DownloadLoading ...

Dutasteride add-on treatment to tadalafil for patients with benign prostatic enlargement is similarly effective as dutasteride add-on treatment to alpha blocker: a propensity-score matching analysis.

To investigate the efficacy of dutasteride add-on treatment to tadalafil in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic enlargement (BPE). A prospective study was conducted in patients with BPE who had not been satisfied with tadalafil monotherapy for more than 3months. Inclusion criteria were prostate volume (PV) ≥ 30ml and IPSS ≥ 8 or QOL index ≥ 3 under administration of tadalafil without anticholinergic agent. Before and 24weeks after dutasteride add-on treatment to tadalafil, we assessed IPSS, overactive bladder symptom score (OABSS), serum PSA and testosterone, and uroflowmetry (UFM) to compare these parameters before and after dutasteride add-on treatment. Using a propensity-score matching analysis, the efficacy of dutasteride add-on treatment to tadalafil was compared with the previous study of dutasteride add-on treatment to alpha blocker. Of 52 patients who were enrolled in this study, 48 patients completed the study (mean age: 72 ± 5years old). Dutasteride add-on treatment to tadalafil significantly improved IPSS (from 16.4 ± 5.2 to 13.3 ± 6.4) and IPSS-QOL (from 4.0 ± 1.2 to 3.3 ± 1.1), and reduced PV from 55 ± 26 to 39 ± 22ml. Propensity-score matching identified 42 matched pairs of patients. The improvement rate of IPSS and reduction rate of PV were similar between patients treated with dutasteride add-on treatment to tadalafil and dutasteride add-on treatment to alpha blocker. The logistic regression analysis showed that PV at baseline and reduction rate of PV after treatment were associated with the effective symptomatic outcome. The dutasteride add-on is a reasonable treatment option for male patients with LUTS who are not satisfied with tadalafil monotherapy.

Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications.

This pooled safety analysis assessed the incidence of hypotension‐related treatment‐emergent adverse events (TEAEs) and major adverse cardiovascular events (MACEs) in patients with concomitant use of tadalafil and antihypertensive medications. Data were pooled from seventy‐two Phase II–IV studies conducted on patients with a diagnosis of erectile dysfunction (ED) and/or benign prostate hyperplasia (BPH). Studies were categorized as either All placebo‐controlled studies or All studies. The incidences of hypotension‐related TEAEs and MACEs were analyzed by indication; by use of concomitant antihypertensive medications; and by the number of concomitant antihypertensive medications. A total of 15 030 and 22 825 patients were included in the analyses for All placebo‐controlled studies and All studies, respectively. In the All placebo‐controlled studies, the incidence of hypotension‐related TEAEs and MACEs was ranging between 0.6–1.5% and 0.0–1.0%, respectively, across all indications. Tadalafil was associated with an increase in hypotension‐related TEAEs only in the ED as‐needed group not receiving any concomitant antihypertensive medications (p‐value = .0070); no significant difference was reported between placebo and tadalafil in the groups of patients receiving ≥1 antihypertensive medication (p‐values ≥ .7386). Similarly, no significant differences (p‐values≥ .2238) were observed in the incidence of MACEs between tadalafil and placebo treatment groups, with or without concomitant use of antihypertensive medications, and across all indication categories. In the All studies group, results were similar. The pooled analysis showed no evidence that taking tadalafil alongside antihypertensive medications increases the risk of hypotension‐related TEAEs or MACEs compared with antihypertensive medications alone.

Tadalafil in patients on antihypertensive medications: Does safety remain an issue?

Tadalafil in patients on antihypertensive medications: Does safety remain an issue?

Positive Predictors for Response to Ambrisentan Combination Therapy in Pulmonary Arterial Hypertension.

The AMBITION study (NCT01178073) provided the first long-term clinical evidence for initial combination therapy with ambrisentan and tadalafil in patients with pulmonary arterial hypertension (PAH). Nevertheless, predictors of treatment response were not assessed.To identify predictors for response to initial combination therapy, we examined data from 302 patients with PAH (World Health Organization Functional Class II or III) who received initial combination therapy from the modified intention-to-treat population of the AMBITION study (n = 605). A responder was defined as not having undergone a clinical failure event. Univariate and multivariate analyses were performed. Multivariate logistic regression with interactive backward selection was used to assess the independent association of potential predictors with response.Treatment responders were younger, more often female, and less likely to have comorbidities or a requirement for oxygen therapy, compared with nonresponders. At multivariate analysis, female sex (odds ratio [OR] 2.67; 95% confidence interval [CI] 1.29, 5.52; P = 0.0081), longer 6-minute walk distance (OR 1.01; 95% CI 1.00, 1.01; P = 0.0039), lower baseline log N-terminal-prohormone of brain natriuretic peptide (OR 0.70; 95% CI 0.52, 0.94; P = 0.0190), and aldosterone antagonist use (OR 2.54; 95% CI 1.03, 6.26; P = 0.0436) independently predicted response to initial combination therapy.Besides demographic factors, the absence of comorbidities and less severe disease state, and the use of aldosterone antagonist therapy identified patients with PAH most likely to respond to initial combination therapy with ambrisentan and tadalafil. Further study to evaluate the role of aldosterone antagonist therapy in PAH is warranted.

Evaluation of prescribing pattern of phosphodiesterase-5 inhibitors and assessing effectiveness of sildenafil and tadalafil in patients with erectile dysfunction

Several factors may affect identification and treatment of erectile dysfunction by health care providers, this study evaluates prescribing pattern of PDE-5 inhibitors and assess effectiveness of Sildenafil and Tadalafil in patients with erectile dysfunction.This is a descriptive and observational study, observed participants without providing any interventions, after fulfilling inclusion and exclusion criteria, patients were enrolled into study and informed written consent was obtained from all patients, data was obtained from medical records, analysed descriptively. International Index of Erectile Function (IIEF) Questionnaire is used in assessment of erectile dysfunction and treatment outcomes.In our study, 80% of patients were prescribed with phosphodiesterase inhibitors and 20% received nutritional supplements. 80 percent of drugs were prescribed under generic name, subjects treated with Sildenafil/Tadalafil were found to be associated with higher mean scores for questions of International Index of Erectile Function (IIEF). Tadalafil scored high in terms of sexual desire domain.PDE5 inhibitors represent major first-line oral therapy option for men with erectile dysfunction, shift of market from brand to generic products allows more freedom of choice, although multiple reports suggest general equivalency of four major PDE5 inhibitors, tadalafil suggested to be preferable.

Role of shear wave elastography (SWE) in erectile dysfunction patients for evaluation of daily tadalafil treatment outcome.

The purpose of this study was to evaluate and anticipate the outcome of daily use of tadalafil in patients with erectile dysfunction using elastography. 183 volunteers and 183 patients with erectile dysfunction were included. Pretreatment SWE readings for our patients were calculated with a linear probe. IIEF score Q was measured once at the start of the study for volunteers and twice for patients, one prior to the start of tadalafil administration and the other on one year of 5mg daily tadalafil after the second post-washout (one month post-treatment stopped). There was no significant difference between patients and volunteers in mean age or risk factors except in SWE values as mean SWE of volunteers was 14.03±1.54kpasc, while mean SWE of patients was 21.278±8.228kpasc. The presence of comorbid diabetes, severe disease and pre-SWE ≥23.635 was significantly associated with poor outcome. We conclude that penile SWE could be useful to select probable good responders for a continuous tadalafil use, thus avoiding the unnecessary cost and time in non-responders.

Abstract 10964: Clinical Safety of Tadalafil in Patients Receiving Concomitant Antihypertensive Medication

Introduction: It is important that physicians and patients are aware of the cardiovascular safety of options available to treat erectile dysfunction (ED)/benign prostatic hyperplasia (BPH) while on concomitant antihypertensive medications (AHM). Objective: This integrated safety analysis assessed the incidence of hypotension-related treatment-emergent adverse events (TEAEs) and major adverse cardiovascular events (MACE) in patients with concomitant use of tadalafil and AHM. Methods: Data were integrated from seventy-two Phase II-IV studies conducted on patients with a diagnosis of ED and/or BPH. Studies were categorized as either All placebo-controlled studies or All studies. The incidences of hypotensive-related TEAEs and MACE were analyzed by indication; by use of concomitant AHM; and by the number of concomitant AHM. Results: A total of 15,030 and 22,825 patients were included in the analyses for All placebo-controlled studies and All studies, respectively. In the All placebo-controlled studies, the incidence of hypotension-related TEAEs and MACE was ranging between 0.6-1.5% and 0.0-1.0%, respectively, across all indications and use of AHM. Tadalafil was associated with an increase in hypotension-related TEAEs only in the ED as-needed category not receiving any concomitant AHM (p-value=0.0070); no difference was reported between placebo and tadalafil in all indication categories of patients receiving ≥1 AHM (p-value≥ 0.7386). Similarly, no differences (p-value≥ 0.2238) were observed in the incidence of MACE between tadalafil and placebo treatment groups, with or without concomitant use of AHM, and across all indication categories. In the All studies results were similar. Conclusion: The concomitant use of tadalafil alongside AHM did not increase the risk of hypotension-related TEAEs or MACE compared with AHM alone. Figure Odds ratio of incidences of hypotension-related TEAEs between placebo and tadalafil groups by number of concomitant AHM

Tadalafil improves erectile dysfunction and quality of life in men with cirrhosis: a randomized double blind placebo controlled trial.

Patients with cirrhosis have high prevalence of erectile dysfunction (ED). The aim of this study was to study the efficacy and safety of tadalafil for ED in patients with cirrhosis. 140 cirrhotic males with ED were randomized into tadalafil 10mg daily (n = 70) or placebo (n = 70) for 12weeks. ED was diagnosed if erectile function (EF) domain score was < 25 in International Index of Erectile Function (IIEF) questionnaire. The erectile function domain consists of six questions concerning erection frequency, erection firmness, frequency of partner penetration, frequency of maintaining erection after penetration, ability to maintain erection to completion of intercourse and confidence in achieving and maintaining erection. Primary outcome was proportion of patients having an increase in > 5 points in EF domain of the IIEF. Generalized Anxiety Disorder 7(GAD-7) questionnaire was used for screening and severity measuring of GAD. The presence of depression was screened using the Patient Health Questionnaire (PHQ-9) and the assessment of health related quality of life was done using the Short Form (36) Health Survey. At the end of 12weeks, more patients in tadalafil group achieved > 5 points increase in the EF domain of the IIEF when compared with the placebo group [44(62.9%) vs. 21(30%), p < 0.001]. At the end of 12weeks, patients receiving tadalafil had significantly more change in scores on the erectile function domain, orgasmic function domain, intercourse satisfaction domain, overall satisfaction domain, erection vaginal penetration rates and successful intercourse; significantly more decline in the GAD-7 and PHQ-9 scores; significantly more improvement in scores of five of the eight domains of SF-36 (general health perception, vitality score, social functioning, role emotional and mental health) and the mental component summary rates when compared with placebo. The development of side effects and the changes in HVPG were not significantly different between the two groups. Tadalafil therapy may enhance erectile function, improve anxiety, depression and quality of life; and is well tolerated by men with cirrhosis (CTP score < 10) and ED. However, further larger and long-term studies are needed to confirm these results and look for rarer side effects of using tadalafil in patients with cirrhosis. ClinicalTrials.gov identifier number NCT03566914; first posted date: June 25, 2018.