Cialis scientific update |
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Asian J Androl. 2007 May;9(3):395-402.
Mirone V, Imbimbo C, Rossi A, Sicuteri R, Valle D, Longo N, Fusco F, Italian Sure Study Group IS.
Urologic Clinic, University Federico II of Naples, Via S. Pansini, Naples 5-80132, Italy.
Evaluation of an alternative dosing regimen with tadalafil, three times per week, for men with erectile dysfunction: SURE study in Italy.
Aim: To examine the preference for two dosing regimens of 20 mg of tadalafil, on demand or three times per week, in men affected with erectile dysfunction (ED) in Italy. Methods: Scheduled Use versus on demand Regimen Evaluation (SURE) is a multicenter, crossover and open-label study, involving 94 urology centers in Italy. Patients aged 18 years or older affected with ED for at least 3 months were enrolled and randomized to 20 mg of tadalafil treatment on demand or three times per week for 5-6 weeks. After a 1-week washout, patients were crossed over to the alternate regimen for 5-6 weeks. A treatment preference question was used to determine the preferred treatment regimen. International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) questionnaire were used as efficacy measures. Results: A total of 1 058 men (mean age 54.8 years), were randomized to treatment. Overall, 59.1% of patients preferred the on-demand regimen and 41.9% preferred the three times per week dosing. Both regimens were efficacious and well tolerated. Although a statistically higher improvement of the IIEF erectile function (IIEF-EF) domain score and the SEP questionnaire was reported for the three times per week compared to the on-demand treatment regimen, this difference was numerically minimal and lacking in clinical significance.Conclusion: Tadalafil is effective and well tolerated whether used on demand or three times per week. Patients should be given the option to choose the best treatment regimen according to personal needs and preferences.
Korean J Intern Med. 2007 Mar;22(1):37-9.
Kim HS, Park JH, Park SJ, Park JK, Lee HB.
Department of Cardiology, Chonbuk National University Medical School, Jeonju, Korea.
Use of tadalafil for treating pulmonary arterial hypertension secondary to chronic obstructive pulmonary disease.
Pulmonary arterial hypertension (PAH) secondary to chronic obstructive pulmonary disease (COPD) is incurable and it has an unpredictable survival rate. Two men who suffered from COPD presented with progressive dyspnea and edema, respectively. PAH, as estimated by the peak velocity of tricuspidal regurgitation, and the depressed myocardial performance index (MPI) of the right ventricle (RV) were noted on echocardiography. In addition to the baseline therapy for their depressed ventilatory function, we prescribed tadalafil 10 mg orally every other day for 2 weeks and then we doubled the dosage. They well tolerated the medication without any notable side effects. After 4 weeks of tadalafil treatment, the patients' pulmonary arterial pressure was decreased and the MPI of the RV was improved in both. The exercise capacity, as measured by the respiratory oxygen uptake, also improved from 10.9 mL/kg/min to 13.8 mL/kg/min in one patient. We report here on 2 patients with PAH secondary to COPD, and they showed notable improvement of their pulmonary hemodynamics and exercise capacity with the administration of tadalafil.
Eur J Clin Pharmacol. 2007 Jun;63(6):583-90. Epub 2007 Apr 13.
Troconiz IF, Tillmann C, Staab A, Rapado J, Forgue ST.
Department of Pharmacy and Pharmaceutical Technology, University of Navarra, 31080, Pamplona, Spain.
Tadalafil population pharmacokinetics in patients with erectile dysfunction.
OBJECTIVE: The purpose of this study was to characterize pharmacokinetics of tadalafil (Cialis) and potential sources of variability in patients with erectile dysfunction (ED). METHODS: Population models were developed to describe tadalafil pharmacokinetics in 227 patients with mild to severe ED in a phase III trial. Parallel groups of patients received 2, 5, or 10 mg tadalafil or placebo orally, as needed, for 12 weeks. RESULTS: Tadalafil pharmacokinetics in patients with ED were linear with respect to dose and duration of treatment, and a one-compartment model adequately described the data. The absorption rate was rapid (1.86 h(-1)), and the typical population estimates of the apparent oral clearance (CL/F) and apparent volume of distribution were 1.6 l/h and 63.8 l, respectively. Disposition parameters showed a moderate degree of interindividual variability (39-45%). The value of CL/F decreased slightly with increasing serum gamma-glutamyl transferase (GGT) concentration, the only statistically significant covariate detected. Systemic exposure to tadalafil was not influenced by age, weight, smoking status, alcohol consumption, liver enzyme status, ED severity, cardiovascular condition, or diabetes mellitus. CONCLUSION: Pharmacokinetics in the efficacy/safety trial population are essentially similar to pharmacokinetics in healthy subjects, and no patient-specific factor warranting clinical consideration of dose regimen adjustment was identified in these analyses.
Singapore Med J. 2006 Oct;47(10):886-91.
Tan HH, Wong ML, Chan RK.
National Skin Centre, 1 Mandalay Road, Singapore 308205.
An epidemiological and knowledge, attitudes, beliefs and practices study of sexually transmitted infections in older men.
Introduction: This study was conducted to determine the disease patterns of sexually transmitted infections (STI) in older men, as well as to gather information on their knowledge, attitudes, beliefs and sexual practices. Methods: A prospective study was carried out from January to June 2005 in men aged 50 years or older who attended the Department of STI Control clinic. Results: There were 104 men enrolled. The majority (92.3 percent) were Chinese, and 62.5 percent were aged between 50 and 59 years, 25.9 percent between 60 and 69 years, and 11.5 percent aged 70 years or older. The patients were predominantly heterosexual, and had fairly low levels of education - 85.6 percent of the patients had received primary or secondary school level of education. Majority (79.8 percent) of the men had been sexually active in the preceding six months, and 37.3 percent had paid sex during that time. 29.8 percent of men reported having taken drugs such as sildenafil (Viagra, Pfizer, New York, NY, USA) or similar drugs such as vardenafil (Levitra, Bayer, Wuppertal, Germany) or tadalafil (Cialis, Eli Lilly, Indianapolis, IN, USA). 56.7 percent of the men had active infections, with non-gonococcal urethritis (15.4 percent), genital warts (12.5 percent) and gonorrhoea (10.6 percent) being the commonest. Generally, condom usage was accepted as an effective way to prevent transmission of STI. However, many of the men surveyed felt that condom usage reduced their sexual pleasure, and 38.5 percent felt that condoms were inconvenient. There were also areas of human immunodeficiency virus (HIV) knowledge that were lacking. Most patients listed the media as their main source of knowledge about STI and HIV. Conclusion: Older males attending the clinic remain at significant risk of STI and targeted educational efforts are warranted.
Urology. 2006 Sep;68(3):631-5. Epub 2006 Sep 18.
Althof SE, Eid JF, Talley DR, Brock GB, Dunn ME, Tomlin ME, Natanegara F, Ahuja S.
Department of Urology, Case School of Medicine, Cleveland, Ohio.
Through the eyes of women: The partners' perspective on tadalafil.
OBJECTIVES: To evaluate patient and female partner responses on the efficacy of, and overall satisfaction with, tadalafil to treat erectile dysfunction using sexual encounter profile (SEP) diaries. METHODS: Data were pooled from four double-blind, placebo-controlled, 12-week trials that included 746 couples. Patients were randomized to placebo or tadalafil 10 or 20 mg. Efficacy was evaluated by the mean per-patient/per-partner percentage of "yes" responses to patient SEP questions 1, 2, and 5 and partner SEP questions 1 to 3 (erection achievement, penetration, and overall satisfaction with the sexual experience, respectively) for tadalafil versus placebo. For each SEP question, the number of postbaseline intercourse attempts when each couple agreed on the outcome was tabulated and divided by the total number of postbaseline attempts to calculate the mean percentage of agreement by couple. The overall satisfaction with successful postbaseline intercourse attempts was determined. RESULTS: Tadalafil significantly improved the responses for the patient and partner-evaluated SEP questions (P <0.001, both doses versus placebo). Partners tended to report greater overall satisfaction than patients at baseline and postbaseline. The mean percentage of agreement by couple was approximately 98% for erection achievement and penetration and 85% for overall satisfaction. For successful intercourse attempts, patients and partners treated with tadalafil reported more overall satisfaction than those treated with placebo (P <0.05, tadalafil versus placebo comparisons). CONCLUSIONS: Partners reported significantly improved overall sexual satisfaction and corroborated the man's report of improved erections and penetration ability with tadalafil 10 mg or 20 mg. Men reported improved erection achievement, penetration, and overall satisfaction with the sexual experience after taking tadalafil.
Clin Pharmacol Ther. 2005 Jan;77(1):63-75.
Ring BJ, Patterson BE, Mitchell MI, Vandenbranden M, Gillespie J, Bedding AW, Jewell H, Payne CD, Forgue ST, Eckstein J, Wrighton SA, Phillips DL.
Eli Lilly and Company, Indianapolis, IN 46285, USA.
Effect of tadalafil on cytochrome P450 3A4-mediated clearance: studies in vitro and in vivo.
OBJECTIVES: Tadalafil was examined in vitro and in vivo for its ability to affect human cytochrome P450 (CYP) 3A-mediated metabolism. METHODS: Reversible and mechanism-based inhibition of CYP3A by tadalafil was examined in human liver microsomes. The ability of tadalafil to influence CYP3A activity was also examined in primary cultures of human hepatocytes. The effect of tadalafil on the pharmacokinetics of CYP3A probe substrates was evaluated in human volunteers before and after coadministration with either a single dose or multiple doses of tadalafil (10 or 20 mg). RESULTS: Negligible competitive inhibition of CYP3A was observed in vitro. Mechanism-based inhibition of CYP3A was detected, albeit with a low potency. In human hepatocytes, exposure to 1 micromol/L or greater of tadalafil resulted in increased CYP3A protein expression; however, as with a combined effect of induction and inhibition, a corresponding increase in CYP3A activity did not occur. The clinical pharmacokinetics of midazolam and lovastatin, probe substrates of CYP3A, were unaffected by up to 14 days of tadalafil administration (90% confidence intervals for the ratio of least squares means for the pharmacokinetic parameters of tadalafil were contained within the no-effect boundaries of 0.7 to 1.43). CONCLUSIONS: In vitro results suggested that tadalafil would have little effect on the pharmacokinetics of drugs metabolized by CYP3A. Clinical studies demonstrated that the pharmacokinetics of 2 different CYP3A substrates, midazolam and lovastatin, were virtually unchanged after tadalafil coadministration. Thus therapeutic concentrations of tadalafil do not produce clinically significant changes in the clearance of drugs metabolized by CYP3A.
Expert Opin Pharmacother. 2005 Jan;6(1):75-84.
Doggrell SA.
Doggrell Biomedical Communications, 47 Caronia Crescent, Lynfield, Auckland, New Zealand.
Comparison of clinical trials with sildenafil, vardenafil and tadalafil in erectile dysfunction.
Erectile dysfunction (ED) affects up to 50% of men, between 40 and 70years of age. In the first major trial of sildenafil in ED, at 24weeks, improved erections were reported by 77 and 84% of men taking sildenafil 50 and 100mg, respectively. Subsequently, sildenafil has been reported to be effective in men with ED associated with diabetes and prostate cancer, and in psychogenic ED. Sildenafil is safe in men with coronary artery disease, provided it is not used with the nitrates (a contraindication). The most commonly reported adverse effects with sildenafil are headache, flushing and dyspepsia. Vardena-fil is more potent and more selective than sildenafil at inhibiting phosphodiesterase-5. Vardenafil is similarly effective to sildenafil in the treatment of ED. The only advantage that vardenafil has over sildenafil is that it does not inhibit phosphodiesterase-6 to alter colour perception, a rare side effect which sometimes occurs with sildenafil. Tadalafil has a longer duration of action than sildenafil and vardenafil. Tadalafil is similarly effective as sildena-fil in the treatment of ED. In comparison studies, tadalafil is preferred to sildenafil (50/100mg) by men with ED, possibly because of its longer duration of action. Of the phosphodiesterase inhibitors, tadalafil may displace sild-enafil as the drug of choice among men with ED.
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Drug category:Sexual stimulants
 Cialis scientific update
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