Effects of taking tadalafil 5 mg once daily on erectile function and total testosterone levels in patients with metabolic syndrome

We aimed to evaluate the efficacy of tadalafil 5 mg once‐daily treatment on testosterone levels in patients with erectile dysfunction (ED) accompanied by the metabolic syndrome. A total of 40 men with metabolic syndrome were evaluated for ED in this study. All the patients received 5 mg tadalafil once a day for 3 months. Erectile function was assessed using the five‐item version of the International Index of Erectile Function (IIEF) questionnaire. Serum testosterone, follicle‐stimulating hormone and luteinising hormone levels were also evaluated, and blood samples were taken between 08.00 and 10.00 in the fasting state. All participants have three or more criteria of metabolic syndrome. At the end of 3 months, mean testosterone values and IIEF scores showed an improvement from baseline values (from 3.6 ± 0.5 to 5.2 ± 0.3, from 11.3 ± 1.9 to 19 ± 0.8 respectively). After the treatment, serum LH levels were decreased (from 5.6 ± 0.6 to 4.6 ± 0.5). There was significantly difference in terms of baseline testosterone and luteinising hormone values and IIEF scores (p < .05). Based on our findings, we recommend tadalafil 5 mg once daily in those men with erectile dysfunction especially low testosterone levels accompanied by metabolic syndrome.     

Comparison of efficacy and safety of daily oral L-arginine and PDE5Is alone or combination in treating erectile dysfunction: A systematic review and meta-analysis of randomised controlled trials

The meta-analysis was performed to assess the efficacy and safety of daily oral L-arginine and phosphodiesterase type 5 inhibitors (PDE5Is) alone or combination in treating patients with erectile dysfunction (ED). We performed a search of randomised controlled trials in the following databases: PubMed, EMBASE and Cochrane Library databases. Four articles including 373 patients were studied. Erectile functions were significantly improved in three therapy groups compared with baseline. Patients who received the combination of L-arginine and PDE5Is showed significant improvement compared to those treated with L-arginine and PDE5Is alone, as assessed by sexual function index (p <0.00001 and p =0.005, respectively) and total testosterone (p <0.00001 and p =0.0007, respectively). Furthermore, patients who treated with PDE5Is alone exhibited the better efficacy than those treated with L-arginine alone in respects of sexual function index (p <0.00001) and total testosterone (p =0.0001). However, the combination of L-arginine and PDE5Is had no obvious difference relative to PDE5Is alone in terms of various adverse events (AEs). Conclusively, compared with monotherapy, the combination of L-arginine and PDE5Is showed a greater improvement of sexual function and total testosterone, and did not significantly increase the AEs. Besides, PDE5Is alone revealed a better effect than those treated with L-arginine alone for patients with ED.     

Efficacy and safety of long‐term tadalafil 5 mg once daily combined with sildenafil 50 mg as needed at the early stage of treatment for patients with erectile dysfunction

This study aimed to evaluate the efficacy and safety of long‐term and low‐dose tadalafil combined with sildenafil as needed at the early stage of treatment for erectile dysfunction (ED). We enrolled 180 patients with ED 1 : 1 to tadalafil 5 mg once daily or once‐a‐day tadalafil 5 mg combined with sildenafil 50 mg as needed. The efficacy measures included the 5‐item version of the International Index of Erectile Function (IIEF‐5) and the Sexual Encounter Profile (SEP). The safety was assessed by observing drug tolerability and adverse events. Total IIEF‐5 scores of patients with severe ED in combined medication group were significantly higher than in tadalafil alone group. Question 2 scores of IIEF‐5 of patients with moderate and severe ED in combined medication group were significantly higher than in tadalafil alone group. The significant improvement in question 3 scores of IIEF‐5 existed only in patients with severe ED receiving combined medication. The percentage of ‘yes’ responses to SEP4, SEP5 and partner's SEP3 were improved significantly in combined medication group. There was no difference between two groups in the incidence of adverse events. Our results suggest that combined medication can better improve erectile function, especially for patients with severe ED.     

Efficacy and safety of daily use of tadalafil in treatment of patients with premature ejaculation: A randomised placebo‐controlled clinical trial

The study aimed to evaluate the efficacy and safety of the once‐daily use of 5 mg tadalafil in the treatment of patients with premature ejaculation (PE). In a single‐blind placebo‐controlled clinical study, it was carried out on 100 patients with PE. All patients were randomised equally divided into two groups (50 patients each). Group 1 was given placebo in the form of oral multivitamin tablet once a day for 6 weeks. Group 2 was given 5 mg tadalafil once a day for 6 weeks. All patients were asked to complete Arabic Index of Premature Ejaculation (AIPE) before and after the treatment. This study showed that there were no statistically significant differences between patients in the placebo and tadalafil groups regarding the mean values of the seven questions and total scores of the AIPE questionnaire before treatment (p value >.05). The mean values of the seven questions and total scores of AIPE questionnaire in the tadalafil group were significantly higher than the placebo group after treatment (p value = .001). This study concluded that once‐daily use of 5 mg tadalafil for 6 weeks was effective and well tolerated in the treatment of patients with PE.     

Serum nesfatin-1 is associated with testosterone and the severity of erectile dysfunction

This cross-sectional study aimed to evaluate serum nesfatin-1 concentrations in patients with erectile dysfunction (ED). Patients with ED were selected from the Department of Urology of the Second Affiliated Hospital of Anhui Medical University. The International Index of Erectile Function-5 (IIEF-5) was used to evaluate the severity of ED. Serum nesfatin-1 and gonadal hormone levels, including luteinising hormone (LH), follicle-stimulating hormone (FSH) and testosterone were measured. The IIEF-5 scores (t = −21.034, p < .001) and nesfatin-1 levels (t = −7.043, p < .001) in patients with ED were significantly lower than in healthy controls. Moreover, patients with ED showed decreased testosterone levels (t = −3.478, p = .001), whereas there were no significant differences in serum levels of FSH (t = −0.088, p = .930) and LH (t = 1.114, p = .270) between the two groups. Furthermore, positive relationships were found between serum nesfatin-1 and testosterone concentrations (r = .742, p = .001) and IIEF-5 scores (r = .395, p = .009) in ED patients. Additionally, based on receiver operating characteristic curve analysis, the area under curve for nesfatin-1 was 0.884 with 83.3% sensitivity and 81.4% specificity in discriminating ED patients from healthy controls. The decrease in serum nesfatin-1 level may be related to testosterone and the severity of ED.     

Effect of tadalafil and 3‐hydroxy‐3‐methylglutaryl coenzyme A inhibitor statin on the haemodynamics of cavernous and brachial arteries

Erectile dysfunction (ED) is usually associated with cardiovascular disease and reduced endothelial function. The aim of the present study was to examine the effect of tadalafil and statin on the endothelial function of cavernous and brachial arteries in healthy men and in patients with ED. The cases included in the study were as follows: 150 men with ED complaints for at least 6 months, and 50 healthy volunteers without sexual problems. Patients were randomly divided into four groups of equal numbers. Group 1 received 20 mg of tadalafil on alternate days, Group 2 received 10 mg of statin a day, Group 3 received tadalafil on alternate days and 10 mg of statin a day, and the last group served as controls. Noninvasive evaluation of brachial artery flow‐mediated dilatation (FMD) and percentage of increase in cavernosal arteries diameter (PICAD) was conducted via ultrasound at baseline and 4 weeks after administration of tadalafil or atorvastatin. Before drug administration, FMD and PICAD values did not significantly differ among the three treatment groups. After drug administration, FMD and PICAD values significantly increased in patients receiving tadalafil and tadalafil+statin (P < 0.001), but not in patients receiving only statin. These findings suggested that use of tadalafil alone and tadalafil combined with statin improved endothelial function of cavernous and brachial arteries.     

小剂量每日服用他达那非改善勃起功能障碍患者内皮舒张功能及勃起硬度的研究

目的:探讨小剂量每日服用他达那非对改善勃起功能障碍(ED)患者内皮舒张功能及勃起硬度的作用。方法:通过国际勃起功能问卷评分-5(IIEF-5)、勃起硬度分级评分(EHGS)以及肱动脉血流介导的舒张反应(FMD)等方法对24例勃起功能正常者及60例ED患者口服5mg/d他达那非6～8周治疗前后进行评估。结果:51例ED患者完成治疗及随访。与对照组相比,ED患者IIEF-5、EHGS以及FMD明显降低(P均<0.01)。他达那非治疗ED的有效率为96.1%(49/51),治疗后较治疗前IIEF-5、EHGS以及FMD明显改善(P均<0.01)。结论:长期小剂量服用他达那非可明显改善ED患者的血管内皮功能及勃起硬度。     

应用自尊心和性关系问卷评价小剂量他达拉非治疗ED疗效

目的:探讨小剂量他达拉非对勃起功能障碍(ED)患者的自尊心、自信心和性关系的影响。方法:17例ED患者每晚口服他达拉非5 mg 12周,用配对t检验比较治疗前后自尊心和性关系问卷(SEAR)、勃起功能国际问卷-5(IIEF-5)和夜间阴茎勃起(NEVA测定)的情况。结果:治疗后SEAR评分、IIEF-5两者均明显提高(P<0.01);夜间阴茎勃起明显改善(P<0.05)。结论:每日小剂量口服他达拉非可显著提高ED患者的自尊心、自信心和性关系满意度,改善ED患者的夜间勃起功能,是治疗ED的有效措施。     

小剂量他达拉非降阶梯治疗心因性勃起功能障碍

目的:探讨小剂量他达拉非降阶梯治疗对心因性勃起功能障碍的疗效。方法:采用勃起功能国际指数问卷(IIEF-5)、勃起硬度分级评分(EHS)。将门诊诊断为心因性勃起功能障碍共84例患者随机分小剂量他达拉非降阶梯治疗组(观察组,n=42)、按需治疗组(对照组,n=42)治疗2个月,进行治疗前后及组间对比评分。结果:对照组5例失访共79例完成观察研究。两组治疗后IIEF-5评分、EHS较治疗前均明显提高。观察组、对照组治疗ED有效率分别达95.2%、86.5%,与对照组相比,观察组有更高的有效率以及依从性(P<0.05)。结论:他达拉非对心因性勃起功能障碍具有良好作用,小剂量他达拉非降阶梯治疗优于按需治疗。     

The effect of using tadalafil 5 mg/day on neutrophil–lymphocyte and platelet–lymphocyte ratios in mild‐medium and severe erectile dysfunction patients; and comparison of clinical response

To examine the relation between NLR (neutrophil–lymphocyte ratio) and PLR (platelet–lymphocyte ratio) rates and the severity of ED (erectile dysfunction) and the effect of tadalafil 5 mg/day on these, a total of 143 patients were retrospectively evaluated. Sixty‐three patients with ED who came for follow‐up examinations in the 1st month of the treatment were included as the study group, and 80 men who were not diagnosed with ED were as the control group. The age and Charlson Comorbidity Indexes (CCI) of the study and control groups were compared with the IIEF 5, NLR and PLR values before and after the treatment. The mean age and median CCI were higher in the severe ED group (p < 0.05). The mean NLR and PLR values were lower in the control group (p < 0.001). In the study group, the NLR and PLR values decreased with the increase in the IIEF 5 scores (p < 0.001). The ROC curve was significant for the NLR and PLR scores (AUC = 0.779, [95% CI: 0.698–0.860]; AUC = 0.754, [95% CI: 0.670–0.838] p < 0.001). Although more prospective and randomized studies are needed, the systemic inflammation decreases and the clinical symptoms improve in patients who use tadalafil 5 mg/day.     

Dysfunction of the endothelial-platelet pathway in patients with erectile dysfunction before and after daily treatment with tadalafil

Platelet activation results from the exposure of receptors on the surface of the platelet to specific structures on the vessel wall. The aim of this study was to assess the serum concentrations of apoptotic endothelial microparticles (EMPa) and the vitronectin receptor (VR) in patients with erectile dysfunction (ED) before and after treatment with tadalafil. This study included 50 patients with arterial ED. EMPa and VR levels were measured by using flow cytometry. The CD45(neg)-CD144(pos)-annexin V(Pos) events were defined as EMPa, and the CD51(pos)-CD61(pos) events were defined as VR. Patients with ED were evaluated before and after daily treatment with 5 mg tadalafil for 90 days. Patients with arterial ED had serum concentrations of EMPa and VR significantly higher than the control group at baseline. After tadalafil, the serum concentrations of EMPa and VR of the patients with arterial ED were significantly lower than before treatment, but significantly higher than controls. Patients with arterial ED expressed higher levels of both EMPa that are associated with dysfunction of the arterial endothelial pathway and VR-expressing platelet-endothelial elements. Chronic treatment with tadalafil reduced endothelial apoptosis in these patients and also reduced VR expression.     

The effect of cardiovascular morbidity on clinical response provided by tadalafil in patients with erectile dysfunction

We aimed to investigate the association between erectile dysfunction and severity of cardiovascular morbidity and to assess clinical responses to tadalafil of patients in different cardiovascular risk groups. Between November 2019 and August 2020, a total of 258 male patients aged 45–70 years with ED were included. They were divided into three groups according to the Framingham risk score: low-risk (n: 86, 33.3%), intermediate-risk (n: 103, 39.9%) and high-risk (n: 69, 26.8%). At admission, all domains of the International Index of Erectile Function score were worse in high-risk group compared to other risk groups (p < .001). After a 12-week follow-up, a more significant improvement was observed in all domains of erectile function in all risk groups, but high-risk group had lower sexual scores (p < .001). The lowest rate for complete responsiveness to tadalafil was observed in the high-risk group (37.7%). The rate of failure in complete responsiveness was found to be 4.127 times greater with higher Framingham score and 3.102 times greater with higher erectile dysfunction severity at admission. Our preliminary findings show that more severe sexual disorders are observed in high-risk patients with cardiovascular morbidity. Individualised treatment may be important in high-risk group since they may benefit less from tadalafil, and failure in complete responsiveness can be more common in this group.     

小剂量他达那非治疗骨盆骨折后勃起功能障碍的疗效观察

目的:评估小剂量他达那非每日给药一次治疗骨盆骨折后勃起功能障碍(ED)的疗效。方法:42例骨盆骨折后ED患者依据外伤后时间分为3组,A组:<1个月组、B组:6～24个月组和C组:>24个月组,每天给予5 mg他达那非连续治疗12周,应用IIEF-5评分和"性活动日志"(SEP)评估疗效。结果:共34例患者完成研究,3组均对骨盆骨折后ED有一定的疗效。A组SEP1、SEP2和SEP5平均阳性回答率分别为70%、59%、52%,均显著高于B、C组(P均<0.05);12周后,3组IIEF-5评分分别增加(3.20±2.62)、(1.31±1.70)、(0.91±1.87)分,A组显著高于B、C组(P均<0.05)。结论:小剂量他达那非每日给药一次对骨盆骨折后ED有较好的康复作用,外伤后越早使用其疗效越好。     

每日小剂量他达拉非治疗骨盆骨折尿道断裂后勃起功能障碍的疗效观察

目的:评价每日小剂量他达拉非治疗骨盆骨折尿道断裂(PFUD)后勃起功能障碍(ED)的疗效。方法:2008年1月至2011年12月共有46例骨盆骨折尿道断裂后ED患者纳入观察。患者年龄25～51(33.9±7.2)岁,受伤时间3～72(19.6±12.7)个月。所有患者自诉受伤前的性功能正常。患者在未服用5型磷酸二酯酶抑制剂的情况下进行夜间勃起周径和硬度测量(NPTR)。根据NPTR检测结果将患者分为有夜间勃起异常组和无夜间勃起组。对所有患者给予每晚他达拉非10 mg治疗3个月,采用IIEF-5评分、性生活日记问题2和问题3评价治疗效果。结果:38例(82.6%)患者完成检查和治疗,8例失访。NPTR检测证实夜间勃起异常26例(68.4%),无夜间勃起12例(31.6%)。他达拉非治疗3个月后,夜间勃起异常组患者IIEF-5改善明显高于无夜间勃起组(P<0.05),夜间勃起异常组患者对SEP2和SEP3回答"是"的比例明显高于无夜间勃起组(76.9%vs41.7%,65.4%vs 25.0%,P<0.05)。结论:每日小剂量他达拉非可有效改善PFUD后ED患者的勃起功能,有夜间勃起的患者治疗效果更明显。     

Treatment of erectile dysfunction reduces psychological distress

Mental stress is a risk factor for cardiovascular events in men with vascular risk factors (VRFs) and is also associated with erectile dysfunction (ED), a frequent complaint of men with VRFs. The aim of this study was to investigate the effect of inhibition of phosphodiesterase-5 or of placebo in men with ED and VRFs on self-evaluated psychological distress, erectile function and quality of sexual life. Thirty-six men with ED and VRFs were randomized to 4 weeks of tadalafil (20 mg/every other day) or placebo treatment. Sexual Health Inventory for Men (SHIM), questions 1–3 of Life Satisfaction (LiSat) questionnaire, Symptom Check-List-90R, a multidimensional inventory exploring psychological dimensions were applied before and after treatment. The SHIM score improved after treatment with tadalafil compared with baseline and with placebo ( F  = 10.38; p  =   0.0030). Sexual life satisfaction (LiSat-2) was significantly improved after tadalafil and after placebo, but a strong positive correlation was observed between LiSat-2 and SHIM score after tadalafil treatment ( r  = 0.59, p  = 0.0003) and not after placebo ( r  = 0.22, p  = 0.189). Psychological features were significantly changed after treatment, although a specific effect of tadalafil vs. placebo was observed only for interpersonal sensitivity ( F  = 4.48; p  =   0.042). Obsessive–compulsive dimension, depression, anxiety, psychoticism were significantly improved in the tadalafil group and in the placebo group, although the improvement was always more relevant after treatment with tadalafil. These preliminary data suggest that a short treatment of ED reduced psychological distress and improved quality of sexual life in men with VRFs.     

Efficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian men

AIM: Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of on-demand tadalafil for the treatment of ED in South-East Asian men. METHODS: This was a randomized, double-blind, placebo-controlled study of men with mild to severe ED of various etiologies randomized to receive placebo (n = 122), tadalafil 10 mg (n = 120), or tadalafil 20 mg (n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). RESULTS: Men from China, Singapore, and the Philippines participated in this trial (n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes (P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF-EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per-patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group (P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group (P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. CONCLUSIONS: Tadalafil was an effective and well-tolerated treatment for South-East Asian men with ED.     

Efficacy and safety of tadalafil in a Western European population of men with erectile dysfunction

Section Editor Michael G. Wyllie Panel of Advisors Ian Eardley, UK Jean Fourcroy, USA Sidney Glina, Brazil Julia Heiman, USA Chris McMahon, Australia Bob Millar, UK Alvaro Morales, Canada Michael Perelman, USA

OBJECTIVE

To evaluate, in a randomized, double‐blind, placebo‐controlled, multicentre trial, the safety and efficacy of on‐demand tadalafil (an oral phosphodiesterase type‐5 inhibitor approved in many countries for treating erectile dysfunction, ED) in a Western European population of men with mild‐to‐severe ED.

PATIENTS AND METHODS

Patients were randomized according to baseline severity of ED in a ratio of 3 : 1 to receive either tadalafil 20 mg or placebo for 12 weeks. Primary efficacy endpoints were mean changes from baseline to endpoint (12 weeks) in the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and percentages of ‘Yes’ responses to Sexual Encounter Profile (SEP) diary Question 2 (‘Were you able to insert your penis into your partner's vagina?’) and Question 3 (‘Did your erection last long enough for you to have successful intercourse?’). Secondary endpoints included mean changes from baseline to endpoint in IIEF Intercourse Satisfaction and Overall Satisfaction domains, selected questions of the IIEF, and the percentage of ‘Yes’ responses to Global Assessment Questions (GAQ) at the last visit. Other analyses included the percentage of patients in each treatment group at endpoint with IIEF EF domain scores in the normal range (>26), the frequency of intercourse attempts and mean per‐patient intercourse success rate at various times after dosing.

RESULTS

The mean age of the patients was 53 years and 80% had a history of ED of ≥ 1 year. The mean baseline EF domain score was 13.5, with 40.5% of patients in the severe category. Tadalafil improved mean EF domain scores by 11.1, vs 0.4 for placebo (P < 0.001). In addition, 73.9% of sexual intercourse attempts were successful (SEP‐Q3) in tadalafil‐treated patients, compared with 29.9% in placebo‐treated patients during the period after baseline (P < 0.001). Tadalafil significantly improved the mean IIEF intercourse satisfaction (5.1, tadalafil; 1.1, placebo) and overall satisfaction domain scores (3.9, tadalafil; 0.5, placebo), P < 0.001. GAQs used to assess the overall effect of the treatment indicated that tadalafil was superior to placebo (P < 0.001) in improving erections (82.1%, tadalafil; 23.1%, placebo) and sexual activity (78.6% and 17.3%). The most common treatment‐emergent adverse events more frequent (>2%) with tadalafil than placebo were headache, dyspepsia, flushing, back pain, pain in limb and myalgia. These adverse events were mostly mild to moderate.

CONCLUSIONS

Tadalafil improved erectile function and was well tolerated when taken by men from Western Europe with mild‐to‐severe ED.

     

The relationship between the severity of erectile dysfunction and aortic stiffness

Aortic stiffness increases in patients with erectile dysfunction (ED) but it is not known whether aortic stiffness affects the degree of ED. In the present study, we aimed to determine whether there is any relationship between aortic stiffness and the severity of ED. Patients with ED were divided into 3 groups according to the International Index of Erectile Function (IIEF) scores. Mild ED was named as group 1, moderate ED as group 2 and severe ED as group 3. The values of fasting blood glucose (FBG), serum lipid values, total testosterone (T. tes), and free testosterone (F tes) were recorded. Aortic stiffness was determined by pulse wave velocity (PWV) and augmentation index (AIX) measurements. The mean or median values of the laboratory parameters among the groups were similar (p > .05). No statistical difference was found between the groups in terms of AIX value (p = .386). Mean PWV values were calculated as 7.26, 8.30 and 8.78 in group 1, group 2 and group 3 respectively. PWV values were significantly different between groups (p < .0001). PWV values were found to be increased with increasing severity of erectile dysfunction.     

Long-term safety and tolerability of tadalafil in the treatment of erectile dysfunction

OBJECTIVE: To assess the long-term safety and tolerability of tadalafil for patients with erectile dysfunction (ED). PATIENTS AND METHODS: This was a multicentre, open-label, 24-month extension trial involving 1173 men with ED. The mean age was 57 (range 23-83) years and 74.8% of patients were taking concomitant medications for comorbid conditions, including diabetes mellitus in 30.5% of men and hypertension in 29.5%. These patients had participated in 1 of 5 previous 8-week or 12-week randomised, double-blind, placebo-controlled tadalafil studies. In the present trial, the starting 10mg dose of tadalafil could be increased to 20mg if the patient could not achieve satisfactory intercourse or reduced to 5mg for an adverse event that was persistent, intolerable and judged by the investigator to be related to tadalafil. RESULTS: Four hundred ninety-three (42.0%) men completed 24 months of treatment. In addition, a further 234 (19.9%) completed 18 months of treatment due to a sponsor decision to reduce the study duration. The total tadalafil exposure was 1676.0 patient-years. Tadalafil was safe and well tolerated. Headache (15.8%), dyspepsia (11.8%), nasopharyngitis (11.4%), and back pain (8.2%) were the most common treatment-emergent adverse events. The rate of discontinuations due to adverse events for this 18-24-month study was 6.3% and the rate for any individual event was <1%. Serious adverse events occurred in 8.6% of patients. No consistent pattern of serious adverse events assessed as causally associated with tadalafil administration was observed. None of the four deaths that occurred during the study was assessed as tadalafil related. There were no clinically significant laboratory or electrocardiographic findings or changes in vital signs in mean baseline-to-endpoint analysis attributable to tadalafil. Tadalafil administration was not causally associated with drug-induced hepatotoxicity, neutropenia, thrombocytopenia, or renal dysfunction. CONCLUSION: Tadalafil at doses of 5, 10, or 20mg taken as needed up to once daily for 18 to 24 months was safe and well tolerated. These findings support the long-term use of tadalafil in the clinical management of erectile dysfunction.     

Response to treatment with tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline

The purpose of this post hoc analysis was to evaluate response to tadalafil in patients with erectile dysfunction (ED) who reported failures in all sexual intercourse attempts before treatment. In a multicenter, open-label study, 1911 men received tadalafil 20 mg dosed as needed (up to once daily), for 12 weeks following a 4-week treatment-free run-in period. Efficacy measures included the sexual encounter profile (SEP) and the erectile function (EF) domain of the International Index of Erectile Function (IIEF-EF). Approximately, one-half (n=952, 49.9%) of the patients reported no successful intercourse attempts during the 4-week run-in period. Of these, 771 patients (81.0%) had at least one successful intercourse attempt during the treatment period. Furthermore, among responders, mean IIEF-EF scores at study end were similar regardless of success or no success at baseline. Patients who are unable to have successful intercourse should be encouraged to try oral phosphodiesterase type 5 inhibitor treatment for ED.