OBJECTIVE To provide an update on the efficacy and safety of tadalafil, a phosphodiesterase‐5 inhibitor, in the treatment of erectile dysfunction (ED). PATIENTS AND METHODS In all, 2102 men (mean age 56 years) with mild‐to‐severe ED of various causes were randomized to placebo or tadalafil, taken as needed with no food restrictions, at fixed ‘on‐demand’ doses of 10 or 20 mg in 11 randomized, double‐blind, placebo‐controlled trials lasting 12 weeks. The three co‐primary outcomes were changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF) and the proportion of ‘yes’ responses to questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included a Global Assessment Question (GAQ). RESULTS Compared with placebo, tadalafil gave significantly better outcomes. Patients receiving either dose of tadalafil had a significant mean improvement of 6.5 and 8.6, respectively, in the IIEF erectile function domain score from baseline (P < 0.001 vs placebo). At both doses the mean success rate for intercourse attempts (SEP‐Q3) was 58% and 68%, respectively, compared with 31% in the placebo group (P < 0.001), and 71% and 84% reported improved erections at the endpoint (GAQ), vs 33% on placebo (P < 0.001). Tadalafil was effective up to 36 h after dosing and was effective regardless of disease severity and causes, and in patients of all ages. The most frequent adverse events were headache, dyspepsia, back pain and myalgia. CONCLUSION Tadalafil was an effective and well‐tolerated treatment for ED.
Introduction Treatment of erectile dysfunction is based on pharmacotherapy for most patients. Aim To review the current data on pharmacotherapy for erectile dysfunction based on efficacy, psychosocial outcomes, and safety outcomes. Methods A review of the literature was undertaken by the committee members. All related articles were critically analyzed and discussed. Main Outcome Measures Levels of evidence (LEs) and grades of recommendations (GRs) are provided based on a thorough analysis of the literature and committee consensus. Results Ten recommendations are provided. (i) Phosphodiesterase type 5 (PDE5) inhibitors are effective, safe, and well-tolerated therapies for the treatment of men with erectile dysfunction (LE = 1, GR = A). (ii) There are no significant differences in efficacy, safety, and tolerability among PDE5 inhibitors (LE = 1, GR = A). (iii) PDE5 inhibitors are first-line therapy for most men with erectile dysfunction who do not have a specific contraindication to their use (LE = 3, GR = C). (iv) Intracavernosal injection therapy with alprostadil is an effective and well-tolerated treatment for men with erectile dysfunction (LE = 1, GR = A). (v) Intracavernosal injection therapy with alprostadil should be offered to patients as second-line therapy for erectile dysfunction (LE = 3, GR = C). (vi) Intraurethral and topical alprostadil are effective and well-tolerated treatments for men with erectile dysfunction (LE = 1, GR = A). (vii) Intraurethral and topical alprostadil should be considered second-line therapy for erectile dysfunction if available (LE = 3, GR = C). (viii) Dose titration of PDE5 inhibitors to the maximum tolerated dose is strongly recommended because it increases efficacy and satisfaction from treatment (LE = 2, GR = A). (ix) Treatment selection and follow-up should address the psychosocial profile and the needs and expectations of a patient for his sexual life. Shared decision making with the patient (and his partner) is strongly recommended (LE = 2, GR = A). (x) Counterfeit medicines are potentially dangerous. It is strongly recommended that physicians educate their patients to avoid taking any medication from unauthorized sources (LE = 2, GR = A). The first seven recommendations are the same as those from the Third International Consultation for Sexual Medicine and the last three are new recommendations. Conclusion PDE5 inhibitors remain a first-line treatment option because of their excellent efficacy and safety profile. This class of drugs is continually developed with new molecules and new formulations. Intracavernosal injections continue to be an established treatment modality, and intraurethral and topical alprostadil provide an alternative, less invasive treatment option.
Introduction Testosterone deficiency (TD), also known as hypogonadism, is a condition affecting a substantial proportion of men as they age. The diagnosis and management of TD can be challenging and clinicians should be aware of the current literature on this condition. Aim To review the available literature concerning the diagnosis and management of TD and to provide clinically relevant recommendations from the Fourth International Consultation for Sexual Medicine (ICSM) meeting. Methods A literature search was performed using the PubMed database for English-language original and review articles published or e-published up to January 2016. Main Outcome Measures Levels of evidence (LoEs) and grades of recommendations are provided based on a thorough analysis of the literature and committee consensus. Results Recommendations were given for 12 categories of TD: definition, clinical diagnosis, routine measurement, screening questionnaires, laboratory diagnosis, threshold levels for the biochemical diagnosis of TD, prostate cancer, cardiovascular disease, fertility, testosterone (T) formulations, alternatives to T therapy, and adverse events and monitoring. A total of 42 recommendations were made: of these, 16 were unchanged from the Third ICSM and 26 new recommendations were made during this Fourth ICSM. Most of these recommendations were supported by LoEs 2 and 3. Several key new recommendations include the following: (i) the clinical manifestations of TD occur as a result of decreased serum androgen concentrations or activity, regardless of whether there is an identified underlying etiology [LoE = 1, Grade = A]; (ii) symptomatic men with total T levels lower than 12 nmol/L or 350 ng/dL should be treated with T therapy [LoE = 1, Grade = C]; (iii) a trial of T therapy in symptomatic men with total T levels higher than 12 nmol/L or 350 ng/dL can be considered based on clinical presentation [LoE = 3, Grade = C]; (iv) there is no compelling evidence that T treatment increases the risk of developing prostate cancer or that its use is associated with prostate cancer progression [LoE = 1, Grade = C]; and (v) the weight of evidence indicates that T therapy is not associated with increased cardiovascular risk [LoE = 2, Grade = B]. Conclusion TD is an important condition that can profoundly affect the sexual health of men. We provide guidance regarding its diagnosis and management. Men with TD who receive treatment often experience resolution or improvement in their sexual symptoms and non-sexual health benefits.
Introduction Current physiological measures of sexual arousal are intrusive, hard to compare between genders, and quantitatively problematic. Aim To investigate thermal imaging technology as a means of solving these problems. Methods Twenty-eight healthy men and 30 healthy women viewed a neutral film clip, after which they were randomly assigned to view one of three other video conditions: (i) neutral (N=19); (ii) humor (N=19); and (iii) sexually explicit (N=20). Main Outcome Measures Genital and thigh temperatures were continuously recorded using a TSA ImagIR camera. Subjective measures of sexual arousal, humor, and relaxation were assessed using Likert-style questions prior to showing the baseline video and following each film. Results Statistical (Tukey HSD) post-hoc comparisons (P <0.05) demonstrated that both men and women viewing the sexually arousing video had significantly greater genital temperature (mean=33.89°C, SD=1.00) than those in the humor (mean=32.09°C, SD=0.93) or neutral (mean=32.13°C, SD=1.24) conditions. Men and women in the erotic condition did not differ from each other in time to peak genital temperature (men mean=664.6 seconds, SD=164.99; women mean=743 seconds, SD=137.87). Furthermore, genital temperature was significantly and highly correlated with subjective ratings of sexual arousal (range r =0.51–0.68, P <0.001). There were no significant differences in thigh temperature between groups. Conclusion Thermal imaging is a promising technology for the assessment of physiological sexual arousal in both men and women.
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