Biomedical subjects

Dimitrios Hatzichristou

Publications and source records attributed to Dimitrios Hatzichristou.

At least 19 recordsLinked to original sources

PubMed2006

Phosphodiesterase type 5 inhibitors: the day after.

OBJECTIVE: Review the literature on phosphodiesterase type 5 inhibitors (PDE5-Is), addressing critical issues in their current and future use, assessing unanswered questions, and identifying research needs. METHODS: A MEDLINE search was conducted on PDE5-Is, with emphasis on clinical trials and experience, for interpretation and analysis of their present and future role. RESULTS: Although approximately 40 million patients with erectile dysfunction have been treated successfully worldwide with the three available PDE5-Is, inappropriate instructions, lack of follow-up, and lack of patient-centered care models are the main reasons for "non-response," leading to drop-out rates of >50%. Patients with severe neurologic damage, diabetes mellitus, or severe vascular disease may be resistant to PDE5-Is. Preservation of corporal smooth muscle with chronic administration of PDE5-Is has been reported and substantial evidence indicates that these drugs have beneficial effects on endothelium and cardiovascular function; sildenafil has been approved for the treatment of idiopathic pulmonary hypertension. Improvement of lower urinary tract symptoms in men with benign prostatic hyperplasia after PDE5-I administration has been also suggested. CONCLUSIONS: The data indicate the necessity for (1) exploration of the pharmacologic characteristics of the three PDE5-Is; (2) research on their pharmacologic differences because some actions seems to be drug-specific; (3) development of alternative management strategies, such as chronic, low, everyday doses of PDE5-Is, if the monthly cost is affordable; and (4) clinical trials on use of PDE5-Is to treat other chronic conditions. The door for innovative therapeutic approaches will open, specifically for cross-risk factor treatment with PDE5-Is or their use in combination treatments or new multimodal pills that take advantage of drugs that exert pleiotropic vascular actions.

Animals↗

PubMed2006

Terazosin modifies the content of glycosaminoglycans and the activity of matrix metalloproteinase 2 in the rat ventral prostate.

OBJECTIVES: We have investigated the effects of terazosin on the content of glycosaminoglycans (GAGs), the activity of matrix metalloproteinase 2 (MMP-2) and MMP-9, and the content of tissue inhibitors of MMP (TIMP) in the ventral prostate of Wistar rats. METHODS: Rats were treated with terazosin (0.12, 1.2mg/kg orally every second day) for 120 d. GAGs were isolated and purified from ventral prostate homogenates by lipid extraction, ethanol precipitation, and extensive digestion with pronase and DNAse, separated by electrophoresis, and characterised using specific enzymes. The activity of MMP-2 and MMP-9 was estimated using gelatin zymography and TIMP-1 and TIMP-2 were measured by enzyme-linked immunosorbent assay. RESULTS: Terazosin treatment did not affect the weight of the ventral prostate gland. The prostate contains hyaluronic acid, chondroitin sulfate (CS), dermatan sulfate (DS), and heparan sulfate (HS), MMP-2, TIMP-1, and TIMP-2, but not MMP-9. Terazosin caused a significant increase in the relative content of DS and a significant decrease in the relative content of CS and to a lesser extent of HS. Terazosin evoked a significant increase in the activity of proMMP-2 and MMP-2 but did not affect TIMP. CONCLUSIONS: The differential effect of terazosin treatment in GAG molecules of the rat prostate may be beneficial because CS is known to induce and DS to inhibit cell proliferation. The effect of terazosin on GAGs and MMP-2 may contribute in the molecular mechanisms of terazosin-induced apoptosis because HS and CS have a proapoptotic effect, whereas DS and MMP-2 are antiapoptotic.

Adrenergic alpha-Antagonists↗

PubMed2006

Treatment strategy for "non-responders" to tadalafil and vardenafil: a real-life study.

OBJECTIVES: To develop and test step-wise treatment strategy for erectile dysfunction "non-responders" to tadalafil and vardenafil. MATERIAL AND METHODS: Two groups [tadalafil-treated (TG); vardenafil-treated (VG)] of 100 consecutive patients complaining of non-response to treatments were enrolled in three-phase study. Phase 1: inadequate use was identified and patients were rechallenged, after receiving detailed usage information. Phase 2: true non-responders were given new instructions based on drugs' pharmacologic profiles: TGs were dosed at least 2 h before intercourse; VGs were dosed only in fasted state. Remaining non-responders entered phase 3: continuous administration of 20 mg tadalafil every other day, or 20 mg vardenafil every day for 2 weeks. Efficacy was based on positive (yes) response to two questions: "Were your erections rigid, and did they last long enough to have successful intercourse?" and "Do you want to repeat your prescription?" RESULTS: Tadalafil group: Inappropriate use was recognized in 32 patients; 14 (43.75%) responded after adequate instruction. Phase 2: 32 of 86 (37.2%) had intercourse at least 2 h after dose intake. Phase 3: 6 of 86 (11.1%) responded to continuous administration. Overall salvage rate was 52 of 100 (52%). Vardenafil group: Inappropriate use was recognized in 38 patients; 12 (31.58%) responded after adequate instruction. Phase 2, 22 of 88 (25%) responded to dosing in a fasted state. Phase 3: 12 of 66 (18.2%) responded to daily dosing. Overall salvage rate was 46 of 100 (46%). CONCLUSIONS: Following proposed treatment strategy may maximize response rate to phosphodiesterase 5 inhibitors; appropriate usage instructions may play significant role in response rate.

Adult↗

PubMed2006

EAU Guidelines on erectile dysfunction: an update.

The introduction of new oral therapies has completely changed the diagnostic and therapeutic approach to erectile dysfunction. A panel of experts in this field has developed guidelines for the clinical evaluation and treatment based on the review of available scientific information.

Erectile Dysfunction↗

PubMed2006

A prospective study of the beneficial effects of dose optimization and customized instructions on patient satisfaction with sildenafil citrate (Viagra) for erectile dysfunction.

Our objective was to assess the effects of customized instructions and dose optimization on treatment satisfaction and improvement in erectile function (EF) with sildenafil citrate in men with erectile dysfunction (ED) who had not been previously treated with a phosphodiesterase-5 inhibitor. This 8-week, multicenter, open-label, flexible-dose (25, 50, or 100 mg sildenafil) study included 2 phases. During phase 1, patients took 50 mg sildenafil and followed the sildenafil sample package instructions. In phase 2, sildenafil dose could be adjusted on the basis of efficacy and tolerability, and investigators provided additional customized instructions. The primary efficacy variable was the satisfaction rate (defined as patients responding "very" or "somewhat" satisfied to the Erectile Dysfunction Inventory of Treatment Satisfaction [EDITS] Question 1). Other efficacy assessments included the International Index of Erectile Function (IIEF) and the percentage of successful sexual intercourse attempts. Of 1109 men (mean age, 54+/-13 years) treated, 867 completed the study. In phase 1, 75% of patients were very or somewhat satisfied with treatment. Mean EF domain score on the IIEF increased from 14.3 at baseline to 23.5, and 79% of sexual intercourse attempts were successful. In phase 2, 53% of patients increased their sildenafil dose to 100 mg and 2% decreased to 25 mg. Satisfaction with sildenafil increased to 86%, 91% of sexual intercourse attempts were successful, and mean IIEF EF domain score increased to 25.7. Of the 196 men who were not initially satisfied at the end of phase 1, 64% became very or somewhat satisfied with treatment by the end of phase 2. Initially high levels of efficacy and satisfaction with sildenafil were achieved when patients were provided with only the sample package instructions and the recommended 50-mg starting dose. These results were enhanced with dose optimization, individual patient counseling, and customized instructions.

Adult↗

PubMed2006

Moderate and severe erectile dysfunction equally affects life satisfaction.

PURPOSE: To explore the life satisfaction of patients with erectile dysfunction (ED) and to examine the relation between severity of ED and life satisfaction. MATERIALS AND METHODS: The study sample was recruited from patients who presented in an andrologic outpatient clinic complaining of ED. All patients underwent the basic clinical evaluation and were assessed by the International Index of Erectile Dysfunction (IIEF) and the Life Satisfaction Inventory (LSI). RESULTS: The study included 69 patients with ED (age range 22-71 years, mean 49.5, SD 13.7). The LSI appeared to have satisfactory internal consistency (Cronbach's alpha = 0.82). Men with ED had significantly lower satisfaction with their sexual life (t = -13.756, d.f. = 68, P = 0.000), but also significantly lower total score of satisfaction with their life (t = -2.793, d.f. = 68, P = 0.007) compared with available normative data from healthy population. However, when compared with controls, men with ED showed significantly higher satisfaction scores on their financial status (t = 5.075, d.f. = 68, P = 0.000) and on their leisure time activities (t = 4.029, d.f. = 68, P = 0.000). Regarding ED severity, mild ED affects patients' satisfaction with sexual life less than do moderate and severe ED. Interestingly, no difference was identified between moderate and severe ED groups. CONCLUSIONS: Men who seek help for ED have lower satisfaction with sexual life and lower satisfaction with their overall life compared with healthy people. Severity of ED seems to be an important factor, as men with moderate ED perceive the impact of ED on their life satisfaction equally with those with severe ED. ED patients gain more satisfaction from other domains of their life, provided they adopt coping behaviors that help compensate for their low overall life satisfaction. Furthermore, as ED patients do not differ from healthy people in their expressed subjective rating of quality of life (QoL), life satisfaction may be more sensitive than QoL assessment in the evaluation of the impact of ED on our patients' life.

Adult↗

PubMed2006

Educating physicians to treat erectile dysfunction patients: development and evaluation of a course on communication and management strategies.

PURPOSE: To describe the development and assess the outcome of a workshop on erectile dysfunction (ED) management based on participating physicians evaluations. METHOD: The study involved physicians who attended a workshop offered throughout the country, during a 3-year period. The workshop included tutorials, video-based dramatizations, and role-play sessions. A pilot study investigated the workshop's impact on physicians' attitudes toward patient-centeredness and sexual behavior issues; Patient-Practitioner Orientation Scale (PPOS) and Cross Cultural Attitude Scale (CCAS) were administered before and after the course. New knowledge acquisition, quality of presentation, and workshop's usefulness in their clinical practice were the dimensions used for workshop's evaluation. Analysis used quantitative and qualitative methods. RESULTS: A total of 194 questionnaires were administered during the pilot study and the response rate was 53.6%. A shift in attitudes toward patient-centeredness and less judgmental attitude toward patients' sexual attitudes were revealed (total PPOS score and Sharing subscale: P < 0.05, CCAS: P < 0.001). Six hundred physicians were asked to evaluate the workshops and the response rate was 62.3%. The tutorial session for "medical treatment of ED" (P < 0.001) and the role-play on sexual history taking (P < 0.05) received higher evaluation scores. Qualitative analysis showed that the most frequently reported category referred to the appropriateness of role-play as a teaching and awareness-raising technique (31.25%); a need for changes in clinical practice and communication patterns was identified by 20% of the participants who stressed the necessity for multidisciplinary approach, as well as the adoption of a nonjudgmental attitude toward patients. CONCLUSION: Training courses on ED management, using a combination of tutorial and interactive sessions, constitute an effective way of providing knowledge, enhancing physicians' communication skills with ED patients, and influencing attitudes toward patient-centeredness in sexual issues. Such results strongly support the establishment of sexual medicine courses at continuing medical education curricula.

Adult↗

PubMed2006

Treatment-seeking behavior of erectile dysfunction patients in Europe: Results of the Erectile Dysfunction Observational Study.

INTRODUCTION: The Erectile Dysfunction Observational Study (EDOS) is a 6-month, pan-European prospective, observational study of health outcomes designed to assess patients' profiles and characteristics and the effectiveness of erectile dysfunction (ED) treatment in routine clinical practice. AIM: To present baseline characteristics and treatment-seeking behavior of a large sample of ED patients recruited in real-life clinical settings. METHODS: Men aged 18 years and older who visited a physician to initiate or change any ED treatment were enrolled in EDOS. They were assessed at baseline, 3 months, and 6 months as part of their normal course of care in nine European countries. MAIN OUTCOME MEASURES: Sexual health outcomes using the short form of the Psychological and Interpersonal Relationship Scales. Treatment effectiveness and satisfaction were assessed using the International Index of Erectile Function questionnaire, Global Assessment Questions, and further single-item questions. RESULTS: Of the 8,186 patients enrolled by 904 investigators (69% general practitioners [GPs]) across nine European countries, 8,055 patients were eligible for analysis at baseline; 63.9% were ED treatment-naive. Of the total patient population, mean age was 56.5 years, mean body mass index (BMI) was 27.2 kg/m2, 18.3% were obese (BMI > 30 kg/m2), 42.5% had severe ED, and there was a high frequency of comorbidities and concomitant medication use. A similar proportion of the treatment-naive patients were seen by GPs (62.9%) and specialists (65.8%). In the treatment-naive group, there was a higher frequency of severe ED among ex-smokers, obese patients, and in those who drank no alcohol or excessive amounts of alcohol. CONCLUSIONS: Unmet need of treatment in ED is high; 66% of patients had experienced ED symptoms for 1 year or longer when they were looking for treatment. Severity seems to be related to treatment seeking.

Adult↗

PubMed2006

Efficacy of tadalafil in men with erectile dysfunction naïve to phosphodiesterase 5 inhibitor therapy compared with prior responders to sildenafil citrate.

INTRODUCTION: Tadalafil, an inhibitor of phosphodiesterase 5 (PDE5), is indicated for treatment of erectile dysfunction. Most tadalafil clinical trials excluded patients with unsuccessful prior treatment with sildenafil citrate (sildenafil). AIM: This retrospective analysis of pooled data from 14 tadalafil clinical trials examines the effect of this exclusion by comparing efficacy results in 1,349 patients without prior sildenafil use (naïve, presumably a mixture of potential responders and nonresponders) with efficacy results in 1,440 patients previously responsive to sildenafil (prior responders). MAIN OUTCOME MEASURES: Efficacy measures included the International Index of Erectile Function (IIEF) erectile function (EF) domain, overall satisfaction (OS), and intercourse satisfaction (IS) domain scores; Sexual Encounter Profile (SEP) diary questions 2 through 5 (SEP2 [successful penetration], SEP3 [successful intercourse], SEP4 (satisfaction with hardness of erection), and SEP5 [overall satisfaction with the sexual experience]); and a Global Assessment Question (GAQ1) (13/14 trials) about erection improvement. Efficacy was compared using analysis of covariance (IIEF and SEP) and logistic regression (GAQ1) models. METHODS: After a 4-week, treatment-free, run-in period, patients in 14 double-blind, placebo-controlled, parallel-group trials were treated with tadalafil 10 mg, tadalafil 20 mg, or placebo for 12 weeks (dosed as needed before sexual activity, no more than once daily). RESULTS: Tadalafil improved erectile function compared with placebo (P < 0.001) in naïve patients and sildenafil prior responders for all efficacy measures. For most efficacy outcomes, responses in the naïve group (probable mix of responders and nonresponders) were not statistically different from responses in the prior-responder group (P >or= 0.10). CONCLUSIONS: The similar responses of these two patient groups observed in this post hoc analysis suggest, but do not confirm, that exclusion of sildenafil nonresponders in previously reported tadalafil clinical trials may not have substantially affected efficacy outcomes. Tadalafil improved erectile function in patients naïve to PDE5 inhibitor therapy and in patients who previously responded to sildenafil therapy.

3',5'-Cyclic-GMP Phosphodiesterases↗

PubMed2005

Erectile dysfunction and premature ejaculation are the most frequently self-reported sexual concerns: profiles of 9,536 men calling a helpline.

OBJECTIVES: To describe the range of sexual problems, as reported by men calling a help-line and to investigate factors associated with help seeking behaviour. METHODS: The study included all calls between 1999 and 2004. The information used for analysis comprised caller's demographic characteristics, the sexual problem reported, previous doctor contacts, coexisting physical and mental health problems. RESULTS: Erectile dysfunction (ED) and premature ejaculation (PE) were the most frequently reported problems (57 and 19.2% respectively). ED-reporting callers were older (OR 0.63 for the ages of 50-59 yrs), with co-morbidities (OR 1.75) and in stable relationship (OR 0.46), while PE-reporting callers were younger (OR 5.83 for the ages of 20-29 yrs), relatively healthy and more likely single (OR 2.62 and OR 2.92 respectively). Type and duration of sexual concern, age, coexisting health problems and marital status relate significantly (p<0.01) with willingness to seek medical help. CONCLUSIONS: The study demonstrates that ED and PE are men's major sexual concerns with personal and interpersonal factors influencing their help-seeking behaviour. Help-lines can serve as a link between health services and callers, while provide useful information for policy formation and improvement of support services.

Adult↗

PubMed2005

Prevention and management of cardiovascular disease and erectile dysfunction: toward a common patient-centered, care model.

Erectile dysfunction (ED) is highly prevalent in men with cardiovascular disease (CVD), yet it is frequently underrecognized and underdiagnosed in clinical practice. Even among clinicians who acknowledge the relevance of addressing sexual issues in their patients, there is a general lack of awareness of the optimal approach for sexual problem identification and management. Additionally, cardiac rehabilitation programs typically neglect the role of sexual function. The trajectory of CVD and ED may necessitate continuous adjustment by both patients and their partners as they adapt to the chronicity of heart disease and the changing reality of their sexual lives. Health professionals typically approach management of these disorders from a disease-centered perspective, which often fails to incorporate the patient's needs and perspectives. In turn, patients frequently complain of a lack of sensitivity or awareness on the part of their physicians. From a patient-centered perspective, greater emphasis is placed on life satisfaction and quality of life as primary outcomes of treatment. Finally, a patient-centered framework is relevant for both treatment and prevention of cardiac risk in men with ED, in addition to ED management in patients with or without overt CVD.

Cardiovascular Diseases↗

PubMed2005

Sildenafil failures may be due to inadequate patient instructions and follow-up: a study on 100 non-responders.

OBJECTIVE: The objective of this study was to identify factors that affect efficacy response rate to sildenafil in the clinical practice. MATERIAL AND METHOD: The study comprised 100 consecutive sildenafil non-responders. Mean patient age was 59+/-14.4 years and mean duration of ED 5.5+/-6.4 years. All patients underwent detailed medical and sexual history and completed the IIEF and a questionnaire regarding the previous use of sildenafil. When inadequate instructions were reported, information on the appropriate use of sildenafil was given and patients were asked to use at least 4 tablets at home. Pharmacologic efficacy was re-evaluated in a scheduled follow-up visit. RESULTS: Mean Erectile Function Domain (ED) of the IIEF score was 14+/-9.9. In 56 patients inappropriate use of sildenafil was recognized; 45 had never used the highest recommended dose (100 mg), 32 had taken the pill with a full stomach right after a meal, 22 had taken the pill just before the initiation of sexual activity and 12 were not aware that sexual stimulation was mandatory to achieve an erection. Furthermore, 8 patients had tried the 100mg dose, despite the presence of factors associated with sildenafil clearance reduction (renal insufficiency, cimetidine treatment). Only 34 patients reported that their physician had scheduled a follow-up visit. Following adequate dose titration and time adjustment, 31 patients responded to sildenafil; 10 patients used the 50 mg dose and 21 the 100 mg. Second and third-line treatment options were offered to the rest of the patients. CONCLUSIONS: ED patients may receive inadequate instructions with their prescriptions. Response rate to sildenafil may be maximized after receiving appropriate dose titration and instructions on administration. ED should be treated in the same way as other chronic conditions; follow-up is necessary to evaluate the appropriate application and pharmacologic efficacy of the proposed treatment.

Adult↗

PubMed2005

Psychiatric morbidity is frequently undetected in patients with erectile dysfunction.

PURPOSE: We investigated the prevalence of psychiatric morbidity in patients with erectile dysfunction (ED). MATERIALS AND METHODS: Consecutive patients who attended an andrology outpatient clinic complaining of ED were recruited for study purposes. ED severity was evaluated by the International Index of Erectile Function erectile function domain score. The psychiatric diagnosis was established by a semistructured clinical interview as well as by the Mini International Neuropsychiatric Interview 5 Diagnostic and Statistical Manual of Mental Disorders-IV. The Beck Depression Inventory was also incorporated as a complementary tool to assess depressive symptom severity. RESULTS: The study included 103 patients 20 to 76 years old (mean age +/- SD 47.06 +/- 14.78) with ED. Most patients were classified with moderate and severe ED (26.2% and 44.7%, respectively). A detectable psychiatric condition was present in 63.1% of the patients, including depressive disorders in 25.2%, anxiety disorders in 11.7%, depression-anxiety comorbidity in 6.8% and personality disorders in 5.8%. A positive psychiatric anamnesis was identified in 41 cases, while 24 were newly diagnosed. No significant association was found between the duration and severity of ED, and psychiatric morbidity or the severity of depressive symptoms (p > 0.05). A positive association was found between the severity of depressive symptoms and the patient tendency to discuss the problem with their partner (p < 0.01). CONCLUSIONS: Psychiatric morbidity is highly prevalent in patients with ED, potentially affecting treatment outcome. Because lifetime psychological problems were reported by more than half of the patients, a psychosocial history seems mandatory. Partner support appeared to have a significant role in the patient psychological state.

Adult↗

PubMed2005

Women's sexual concerns: data analysis from a help-line.

PURPOSE: To report female sexual problems and concerns, as presented by women calling a help-line, and to evaluate women's help-seeking behavior regarding sexual matters. MATERIALS AND METHODS: The study included all telephone calls from women who called for sexual concerns to a help-line dedicated to sexual problems during a 5-year period. During the call, the counselor addresses demographic characteristics of the caller, the sexual problem reported, their sexual function, any previous doctor contacts, coexisting physical and mental health problems, couple's relationship, and lifestyle factors that may influence sexual function. Data processing employed descriptive statistics and logistic regression analysis in order to detect possible associations between categorical variables. RESULTS: Of a total of 3,523 calls made by women, 2,287 full forms were analyzed, reflecting a response rate of 64.9%. Most women (46.6%) called for problems encountered by their partners, 45.1% called for their own sexual problems, while 5.9% were calling for their children. Only 34.3% of them had already consulted a doctor. The most frequently reported difficulties were achieving orgasm (25.6%), reduced sexual desire (16.9%), and pain during intercourse (6.1%). Women in the 40-49 age group had the higher odds ratios for the sexual problems reported (reduced sexual desire: odds ratio [OR] 5.0; difficulties achieving orgasm: OR 6.3; pain during intercourse: OR 5.8). Both married and single women had high risk of experiencing low levels of sexual desire (40% and 30%, respectively). CONCLUSIONS: Women's sexual concerns are not devoted to their sexual problems, but also their partner's and children's problems. Most frequently reported sexual problems are difficulties in reaching orgasm and reduced sexual desire. However, women are reluctant to seek medical advice on their sexual concerns. There is a need for general practitioners and family doctors to become aware of the possibility of a sexual problem and to be trained on how to manage this at a primary care level.

Adult↗

PubMed2005

Vardenafil improves satisfaction rates, depressive symptomatology, and self-confidence in a broad population of men with erectile dysfunction.

INTRODUCTION: Vardenafil is a potent and selective phosphodiesterase 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction (ED). Fixed-dose and flexible-dose studies have previously established the efficacy and tolerability of vardenafil. AIM: To assess, besides the usual measures of efficacy, the quality of erection, satisfaction with the sexual experience, symptoms of depression, and overall confidence. METHODS: This 12-week double-blind, placebo-controlled flexible-dose study assessed patients from the general ED population. Patients underwent a 4-week treatment-free period before randomization to vardenafil or matching placebo. Initial dosage was vardenafil 10 mg for 4 weeks. At 4 weeks, patients could switch to 5 or 20 mg (or corresponding placebo), or remain on 10 mg for an additional 4 weeks; dose switching was also optional for the last 4 weeks. This paper describes per-patient success in satisfaction with hardness of erection, satisfaction with overall sexual experience, effect on overall self-confidence, and an assessment of symptoms of depression using the Center for Epidemiologic Studies Depression Scale. RESULTS: Mean per-patient satisfaction rates with erection hardness increased after vardenafil treatment to 43%, 59%, and 63% at weeks 4, 8, and 12, respectively, compared to placebo with 10%, 21%, and 23% (all P < 0.005 vs. placebo). Vardenafil also improved mean per-patient overall satisfaction 50-65% over the 4-12 week study period compared with 17-28% for placebo (P < 0.005). Symptoms of depression were statistically significantly reduced compared to placebo (P = 0.02); the effect was observed particularly in patients who were depressed at baseline (P = 0.01). Significantly more patients in the vardenafil treatment group reported improved self-confidence than those who received placebo (P < 0.005). CONCLUSIONS: A flexible-dose regimen of vardenafil improved satisfaction rates, symptoms of depression, and self-confidence, providing patients with an effective ED therapy that contributes to overall improvements in sexual function and confidence.

Analysis of Variance↗

PubMed2004

The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men.

BACKGROUND: In fixed-dose studies, vardenafil 5, 10, and 20mg improves erectile function in men with erectile dysfunction (ED). Here, the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed. METHODS: In this multicenter trial, 323 patients randomly received vardenafil 10mg or placebo. After 4 weeks, patients could switch to 5 or 20mg (or corresponding placebo), or remain on 10mg for an additional 4 weeks; dose-switching was optional for the last 4 weeks. Efficacy variables included the IIEF-EF domain score, GAQ, and percentage of positive responses to SEP2/SEP3 questions. RESULTS: The IIEF-EF domain score significantly improved from a baseline of moderate ED (12.6-13.1) to mild ED in men on vardenafil (21.0-24.2) compared with placebo (13.7-15.6) at weeks 4, 8, 12, and last observation carried forward (LOCF) (p<0.005 vs. placebo). A significantly greater proportion of men receiving vardenafil at weeks 4, 8, 12, and LOCF reported improved erections (80-86% vs. 21-36% for placebo, p<0.005). Successful SEP2 rates increased after vardenafil, reaching 84% at weeks 8 and 12 vs. 49-53% receiving placebo (p<0.005 vs. placebo). Vardenafil improved successful SEP3 rates ranging from 58% to 74% compared to 22-34% for placebo. The most common adverse events, flushing and headache, were generally mild and transient. CONCLUSION: In this flexible dose study, vardenafil was well-tolerated, and produced clinically relevant improvements in erectile function in men with ED.

Erectile Dysfunction↗

PubMed2004

Summary of the recommendations on sexual dysfunctions in men.

INTRODUCTION: There are few published guidelines for the management of sexual dysfunctions in men and women, despite the prevalence and lack of attention to these problems. Disorders of sexual function in men include erectile dysfunction, orgasm/ejaculation disorders, priapism, and Peyronie's disease. AIM: To provide evidence-based and expert-opinion consensus guidelines for the clinical management of men's sexual dysfunctions. METHODS: An International Consultation in collaboration with major urological and sexual medicine societies assembled over 200 multidisciplinary experts from 60 countries into 17 consultation committees. Committee members established the scope and objectives for each chapter. Following intensive review of available data and publications, committees developed evidence-based guidelines in each area. MAIN OUTCOME MEASURE: New algorithms and guidelines for assessment and treatment of men's sexual dysfunction were developed. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of the medical literature, in addition to cultural and ethical considerations. RESULTS: Recommendations and guidelines for men's sexual dysfunction are presented. These guidelines were developed as evidence-based, patient-centered, and multidisciplinary in focus. For the clinical assessment and diagnosis of ED, a basic evaluation was recommended for all patients, with optional and specialized testing reserved for special cases. A new treatment algorithm is proposed. This algorithm provides a clinically relevant guideline for managing ED in the large majority of men. New treatment guidelines and algorithms are provided for men's orgasm and ejaculation disorders, including premature ejaculation, retrograde and delayed ejaculation. Finally, expert opinion-based guidelines for the clinical management of priapism and Peyronie's disease are provided. CONCLUSIONS: Additional research is needed to validate and extend these guidelines. Nonetheless, this summary encompasses the recommendations concerning men's sexual dysfunctions presented at the 2nd International Consultation on Sexual Medicine in Paris, France, June 28-July 1, 2003.

Algorithms↗

PubMed2004

Clinical evaluation and management strategy for sexual dysfunction in men and women.

INTRODUCTION: The optimal approach for identification and evaluation of the sexual problems in men and women in primary care or general medicine practice has not been consensed. AIM: To provide recommendations/guidelines concerning state-of-the-art knowledge for clinical evaluation and management strategies in the evaluation and treatment of sexual dysfunction in men and women, emphasizing evidence-based medicine and a patient-centered framework. METHODS: An International Consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. Concerning the Clinical Evaluation and Management Strategies Committee, there were 12 experts from five countries. MAIN OUTCOME MEASURE: Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. RESULTS: Three concepts underlie sexual medicine management: (i) adoption of a patient-centered framework for evaluation and treatment; (ii) application of the principles of evidence-based medicine in diagnostic and treatment planning; and (iii) use of a unified management approach in men and women. When taken together, these three principles provide a balanced and integrated approach to sexual dysfunction management. Common algorithms for diagnosis and management of men and women with sexual dysfunction, brief sexual symptom checklists, basics in history and physical examination, indications for specialized referral and development of a follow-up strategy are presented. CONCLUSIONS: More research is needed in understanding the role of evidence-based and patient-centered medicine in the clinical evaluation and management strategies of men and women with sexual dysfunction.

Algorithms↗