PURPOSE: Tadalafil is a phosphodiesterase type 5 inhibitor that is used for the treatment of erectile dysfunction (ED). Previous clinical trials have assessed its efficacy and safety in Western populations, but this drug has not been investigated in a large clinical trial involving Korean men with ED. Thus, the aim of this study was to assess the efficacy and safety of 20 mg tadalafil in comparison to placebo when it is taken on demand by Korean men suffering with ED over a study period of 12 weeks. MATERIALS AND METHODS: Men more than 18 years of age with mild to severe ED of various etiologies were randomized to receive placebo or tadalafil 20 mg that was taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary and Global Assessment Questions (GAQ). RESULTS: Tadalafil significantly improved erectile function, as measured by the erectile function domain of the IIEF, compared to placebo (p<0.001). At the endpoint, the patients receiving tadalafil 20mg reported a greater mean per-patient percentage of successful intercourse attempts (SEP3: 71% compared to 31% for placebo) and a greater proportion of improved erections (GAQ: 80% compared to 44%). The most common treatment emergent adverse events were headache (16.3%), flushing (5%) and eye pain (5%), and most of the adverse events were mild or moderate in severity. CONCLUSIONS: Tadalafil was an effective, well-tolerated therapy for Korean men suffering with ED of broad-spectrum severity and etiology.
Erectile Dysfunction* ; Eye Pain ; Flushing ; Headache ; Humans ; Korea* ; Male ; Tadalafil

A simple, rapid, and reliable UPLC-MS/MS method was developed and validated for the determination of tadalafil in human plasma. The plasma samples were deproteinized with acetonitrile. Chromatographic separation was performed on a Shiseido C18 (100 × 2.1 mm, 2.7 µm) column with isocratic elution using 2.0 mM ammonium acetate and acetonitrile (55:45, v/v) with 0.1% formic acid at a flow rate of 0.7 mL/min. The total run time was 1 min per sample. The quantitative analysis was performed using multiple reaction monitoring at transition of m/z 390.4 → 268.3 for tadalafil and m/z 475.3 → 283.3 for sildenafil as an internal standard. The method was fully validated over a concentration range of 5–1,000 ng/mL with a lower quantification limit of 5 ng/mL. Intra- and inter-day precision (relative standard deviation, %RSD) were within 8.4% and accuracy (relative error, %RE) was lower than -3.2%. The developed and validated method was successfully applied to a pharmacokinetic study of tadalafil (20 mg) in Korean healthy male subjects (n = 12).
Ammonium Compounds ; Humans* ; Male ; Methods* ; Pharmacokinetics ; Plasma* ; Sildenafil Citrate ; Tadalafil*

PURPOSE: We evaluated the efficacy of tadalafil for the treatment of erectile dysfunction after nerve-sparing radical prostatectomy. MATERIALS AND METHODS: From April 2004 to February 2005, 28 patients who underwent nerve-sparing radical prostatectomy agreed this study and were enrolled. The subjects were divided into 2 groups: tadalafil group(n=15) and control group(n=13). The tadalafil group started medication(20 mg, 2 or 3 times a week) when daily pad requirement was less than 1(pad-free point, mean 74th day postoperatively). Efficacy assessments included the score on the International Index of Erectile Function(IIEF), erectile function domain(EF domain) and Sexual Encounter Profile questions 2(SEP2), and 3(SEP3). Questions were administered in the preoperative phase, pretreatment, and 6 months post-treatment. RESULTS: The preoperative score for the IIEF and EF domain were 46.0 and 18.5 in the tadalafil group and 44.8 and 17.9 in the control group, respectively(p>0.05, p>0.05). At pad-free point, the IIEF and EF domain scores in the tadalafil group were 9.8+/-7.5, 2.7+/-2.7 and in the control group 10.0+/-6.8, 3.1+/-2.5. The scores were reduced significantly at the pad-free point compared to the preoperative phase, but there was no significant difference between the 2 groups. At 6 months after treatment, the scores for the tadalafil group were 26.6+/-18.2, 10.3+/-7.3 and had increased significantly(p<0.05, p<0.05). There was a borderline difference in the EF domain score between the 2 groups(p=0.085). Four patients in the tadalafil group(26.7%) and 1 patient in the control group(7.7%) could penetrate successfully. CONCLUSIONS: Although there was no statistical significance between the 2 groups, early tadalafil treatment after nerve-sparing radical prostatectomy may enhance the early recovery of erectile function.
Erectile Dysfunction ; Humans ; Male ; Prostatectomy* ; Prostatic Neoplasms ; Tadalafil

Tadalafil is an effective drug in treating erectile dysfunction (ED), and its clinical efficacy has been confirmed by a great many researches. Tadalafil is distinguished from sildenafil and vardenafil by its prolonged action lasting 36 hours for a sigle dose, compared with about 4 hours for sildenafil. Furthermore, this drug is effective in improving the erectile function of ED patients including those with various comorbid conditions. Tadalafil can help ED patients to regain morning erection and recover the confidence as a man. More and more ED patients choose tadalafil as the first line therapy because of its long efficacy and its conformability to the therapeutic requirement by restoring ED patients to normal, natural and pleasurable sexual life.
Carbolines ; therapeutic use ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Tadalafil

We report here on a case of priapism that was associated with the use of tadalafil. A 41 year-old-man visited our urology outpatient department with a relapsed erection he'd experienced for 3 days. He had no contributing factors for the priapism. He had taken tadalafil, which was prescribed at a local medical center 3 days previously. After the development of priapism, he first visited the emergency department of other hospital. Aspiration was done and then the priapism was resolved. Yet the priapism recurred 2 days later, andaspiration and other bedside management failed to resolve it. After his arrival to our department, weimmediately performed a caverno-glandular shunt with 18-gauge needle and we observed bright reddish- color blood. An intracorporal ephedrine injection and saline irrigation were then done. After that, the patient gradually experienced detumescence. The priapism did not recur during the 2 days of the hospitalization period. At the outpatient follow-up of 3 months later, patient almost recovered to his full erectile function and he had normal sexual activity.
Carbolines ; Emergencies ; Ephedrine ; Follow-Up Studies ; Hospitalization ; Humans ; Needles ; Outpatients ; Priapism ; Sexual Behavior ; Urology ; Tadalafil

Priapism is an abnormal persistent penile erection that continues for more than 4 hours, without sexual stimulation according to the definition of the AUA (American Urological Association) guideline on the management of priapism. It was relatively rare in the past but has been increasing in the incidence since the advent of pharmacological agents. Stuttering priapism is a recurrent form of ischemic priapism and its treatment goal is to prevent the recurrences of priapism and resultant erectile dysfunction. We present the case of a patient who took tadalafil and thereafter had idiopathic recurrent episodes of ischemic priapism during the sleep and we show several treatment options of stuttering priapism with review of recent related articles.
Carbolines ; Erectile Dysfunction ; Humans ; Incidence ; Male ; Penile Erection ; Priapism ; Recurrence ; Stuttering ; Tadalafil

Oral phosphodiesterase type 5 (PDE5) inhibitors have provided non-invasive, effective, and well-tolerated treatments for patients with erectile dysfunction (ED). However, many patients with ED are unresponsive to 'on-demand' PDE5 inhibitors. In addition, the lack of spontaneity and naturalness of the on-demand regimen could be a reason for decreased compliance with PDE5 inhibitors. Recently, tadalafil and udenafil were approved for low-dose daily administration for the treatment of ED. Since the introduction of the concept of daily administration of PDE5 inhibitors, several reports have supported the potential benefits of this therapy for disease modification, improvement of the treatment response in difficult-to-treat populations, spontaneity, and safety, although further research is needed to better address these hypotheses. In this article, we reviewed the daily administration of PDE5 inhibitors in terms of pharmacokinetics, safety, efficacy, and distinct features.
Carbolines ; Compliance ; Erectile Dysfunction ; Humans ; Male ; Phosphodiesterase 5 Inhibitors ; Pyrimidines ; Sulfonamides ; Tadalafil

OBJECTIVETo investigate the efficacy of tadalafil on nocturnal penile tumescence (NPT).

METHODSThirty-four patients with organic erectile dysfunction (ED) were treated with oral tadalafil at the dose of 10 mg/3 d before bedtime. A month later, 14 of the patients were observed for NPT by nocturnal electrobioimpedance volumetric assessment (NEVA).

RESULTSThe parameters of erectile function significantly improved in the 14 patients (P < 0.05).

CONCLUSIONOral administration of minute dose of tadalafil can improve NPT in organic ED patients.

Adult ; Carbolines ; administration & dosage ; therapeutic use ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Penile Erection ; physiology ; Tadalafil

The benefit of tadalafil should be justified by its safety and tolerance in the chronic treatment of erectile dysfunction (ED) in general and high-risk population. The main treatment-emergent adverse events, chiefly induced by the interactions of tadalafil with PDE5 and isoforms, are mild or moderate in severity, transient and reversible, which may disappear without drug withdrawal. Tadalafil does not add to the risk and severity of cardiovascular problems, and can be safely co-administered with antihypertensives and selective a-receptor blockers.
Carbolines ; adverse effects ; therapeutic use ; Drug Tolerance ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Tadalafil ; Treatment Outcome

OBJECTIVETo explore the correlation between the results of the nocturnal penile tumescence (NPT) test and the efficacy of tadalafil in the treatment of ED.

METHODSA total of 188 ED patients were divided into a normal NPT group (n = 136) and an abnormal NPT group (n = 52) according to the results of the NPT test. All of them were treated with tadalafil at 20 mg 3 times a week. The IIEF-5 score, SEP2, SEP3 and GAQ score were compared between the two groups before and 1 month after the treatment.

RESULTSTadalafil treatment significantly improved IIEF-5 score, SEP2 and SEP3 of both groups of the patients (P < 0.01). Compared with the abnormal NPT group, the normal NPT group showed a remarkable increase in the IIEF-5 score, SEP2, SEP3 (P < 0.05) and GAQ score (P < 0.01).

CONCLUSIONAfter 1 month of tadalafil treatment, the normal NPT group achieved a more significant improvement of erectile function and sexual satisfaction than the abnormal NPT group, suggesting that tadalafil has a better therapeutic effect for ED patients with normal NPT.

Carbolines ; pharmacology ; therapeutic use ; Erectile Dysfunction ; drug therapy ; physiopathology ; Humans ; Male ; Penile Erection ; drug effects ; Tadalafil