Efficacy, safety, and treatment satisfaction of tadalafil versus placebo in patients with erectile dysfunction evaluated at tertiary-care academic centers.
ABSTRACT To determine the efficacy, safety, and treatment satisfaction of tadalafil 20 mg for erectile dysfunction (ED) in patients evaluated at tertiary-care academic centers.
In this randomized, double-blind, placebo-controlled trial, patients were randomly allocated to receive fixed-dose tadalafil 20 mg (n = 146) or placebo (n = 49) for 12 weeks. Efficacy was assessed by the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ); patient and partner treatment satisfaction by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and SEP; and safety by adverse events, laboratory values, and vital signs.
Mean baseline IIEF erectile function (EF) domain was 12.98. Fifty-one percent of enrolled patients had severe baseline ED, and 82% had organic ED. Pre-existing, ED-associated comorbid conditions were common. When compared with patients treated with placebo, those receiving tadalafil reported significant improvement from baseline in the IIEF EF domain (P <0.001), successful penetration attempts (SEP question 2; P <0.001), successful intercourse (SEP question 3; P <0.001), and all secondary efficacy outcomes (P <0.001). Patients and their sexual partners were also significantly more satisfied with tadalafil treatment (P <0.001), including overall satisfaction (P <0.001) and length of time the treatment worked (P <0.001). Mild or moderate headache, dyspepsia, and myalgia were the most frequent treatment-emergent adverse events reported.
Tadalafil significantly improved erectile function and patient and partner satisfaction and was well tolerated. These results were observed in a tertiary-care, academic center population with a high incidence of severe, organic ED, and comorbid medical conditions, factors known to compromise erectile function and treatment outcome.
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ABSTRACT: Introduction Over the past 15 years, the discovery and development of oral medications that selectively inhibit the enzyme phosphodiesterase type 5 (PDE5) have revolutionised the treatment of erectile dysfunction (ED). Currently, three PDE5 inhibitors are widely available clinically, i.e., sildenafil, vardenafil and tadalafil. New PDE5 inhibitors, including avanafil and udenafil, are now in clinical use in a few countries, and other compounds are under development. Methods We describe the current use and future direction of PDE5 inhibitors in the treatment of ED. Results and conclusion Each PDE5 inhibitor has an excellent and comparable efficacy and tolerability. These drugs are highly effective for ED of various causes, and are effective in preventing ED after radical prostatectomy. However, whilst being at least 60% effective, PDE5 inhibitors are still ineffective in at least 30% of patients, prompting current research into other pharmacological targets for ED.Arab Journal of Urology. 09/2013; 11(3):222–229.
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ABSTRACT: To develop and validate a new functional assessment of chronic illness therapy (FACIT) measure of satisfaction with treatment for chronic illnesses such as cancer and HIV/AIDS. To define domains and generate items, a literature review informed creation of semi-structured interview guides for patients and an international expert panel of clinicians and researchers. Patients and experts also rated 15 areas of satisfaction for relevance. The final list of items underwent further refinement by the original expert panel and a new group of clinical experts. Items were tested in four studies (primarily lung cancer) and data were pooled for analysis. Exploratory and confirmatory factor analyses (CFA), and item response theory modeling were conducted to evaluate dimensionality. Internal consistency reliability and test-retest reliability were both evaluated. Validity was evaluated by correlating the FACIT subscale scores and measures of comparable concepts and by testing the scales' ability to distinguish people according to their overall treatment satisfaction. Two instruments were created: the FACIT TS-general (G), an overall evaluation of current treatment, and the FACIT TS-patient satisfaction (PS), a measure of patient satisfaction. CFA results were not optimal for a five-factor solution for PS. Internal consistency reliability met psychometric standards (≥0.70) for all PS subscales. Construct validity was established for the PS subscales: Physician Communication, Treatment Staff Communication, Technical Competence, Confidence and Trust, and Nurse Communication. The two instruments generated here offer a new way to assess several key dimensions of patient satisfaction with treatment, especially for people with lung cancer.Quality of Life Research 09/2013; · 2.86 Impact Factor
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ABSTRACT: IntroductionErectile dysfunction (ED) is a worldwide health problem with an ever increasing prevalence, affecting the quality of life of many patients.Objective The aim of this study was to describe treatment effectiveness and patient satisfaction with ED treatment in the Spanish cohort of the EDOS study.Material and methodsThis observational, pan-European study, assessed treatment effectiveness and patient satisfaction with ED treatment under routine clinical settings, using standard questionnaires. Men ≥18 years about to initiate or change ED treatment were enrolled. Patients were assessed at baseline, 3 and 6 months.ResultsA total of 1,029 patients were analyzed (12.8% of the total European sample). In general, the Spanish population characteristics are consistent with the overall population. At baseline 56.6% of patients received tadalafilo, 16.6% sildenafilo, 19.6% vardenafilo, and 7.2% received other treatments. At 3 months, a higher proportion of patients on tadalafil reported improved erections (GAQ 1: 96.5% tadalafil, 85.7% sildenafil and 87.2% vardenafil), satisfaction with treatment (EDITS: 84.2% tadalafil, 75.0% sildenafil and 76.0% vardenafil), and sexual self confidence (SF-PAIRS: 2.73 tadalafil, 2.39 sildenafil and 2.55 vardenafil), in comparison with sildenafil and vardenafil. At 6 months, differences between treatments were not significant. The mean±SD time elapsed from drug intake to sexual intercourse was higher for patients on tadalafil (18.6±26.4 h) compared to sildenafil (3.6±7.5) and vardenafil (8.6±19.4).Conclusion The longer duration of action for tadalafil, and thus, the longer period of time between dosing and sexual intercourse may contribute to enhance sexual spontaneity, patient satisfaction with the treatment and greater self-confidence.Actas urologicas españolas 04/2010; 34(4):356–364. · 1.15 Impact Factor