Introduction Intravaginal ejaculation latency time (IELT), defined as the time between the start of vaginal intromission and the start of intravaginal ejaculation, is increasingly used in clinical trials to assess the amount of selective serotonin reuptake inhibitor-induced ejaculation delay in men with premature ejaculation. Prospectively, stopwatch assessment of IELTs has superior accuracy compared with retrospective questionnaire and spontaneous reported latency. However, the IELT distribution in the general male population has not been previously assessed. Aim To determine the stopwatch assessed-IELT distribution in large random male cohorts of different countries. Methods A total of 500 couples were recruited from five countries: the Netherlands, United Kingdom, Spain, Turkey, and the United States. Enrolled men were aged 18 years or older, had a stable heterosexual relationship for at least 6 months, with regular sexual intercourse. The surveyed population were not included or excluded by their ejaculatory status and comorbidities. This survey was performed on a “normal” general population. Sexual events and stopwatch-timed IELTs during a 4-week period were recorded, as well as circumcision status and condom use. Main Outcome Measures The IELT, circumcision status, and condom use. Results The distribution of the IELT in all the five countries was positively skewed, with a median IELT of 5.4 minutes (range, 0.55–44.1 minutes). The median IELT decreased significantly with age, from 6.5 minutes in the 18–30 years group, to 4.3 minutes in the group older than 51 years (P < 0.0001). The median IELT varied between countries, with the median value for Turkey being the lowest, i.e., 3.7 minutes (0.9–30.4 minutes), which was significantly different from each of the other countries. Comparison of circumcised (N = 98) and not-circumcised (N = 261) men in countries excluding Turkey resulted in median IELT values of 6.7 minutes (0.7–44.1 minutes) in circumcised compared with 6.0 minutes (0.5–37.4 minutes) in not-circumcised men (not significant). The median IELT value was not affected by condom use. Conclusion The IELT distribution is positively skewed. The overall median value was 5.4 minutes but with differences between countries. For all five countries, median IELT values were independent of condom usage. In countries excluding Turkey, the median IELT values were independent of circumcision status.
These results show that sildenafil is a well tolerated and effective oral therapy for male erectile dysfunction with no established organic cause and may represent a new class of peripherally acting drug for the treatment of this condition.
The Sexual Quality of Life-Female (SQOL-F) questionnaire has been developed to assess the impact of female sexual dysfunction (FSD) on a woman's sexual quality of life. SQOL-F items were developed through interviews with 82 women. Three data sets from women's health surveys in the United Kingdom and the United States generated data for scale validation. The SQOL-F showed good psychometric properties: convergent validity, discriminant validity, and test-retest reliability. The SQOL-F is a valid instrument for assessing the impact of FSD on quality of life and as an adjunct in evaluating FSD in clinical trials. The SQOL-F sensitivity to changes in sexual function needs confirmation.
Objectives Premature ejaculation (PE) is the most common ejaculatory dysfunction. We assessed the efficacy of sildenafil to increase the time to ejaculation, improve ejaculatory control, and decrease the postejaculatory erectile refractory time in men with PE. Design and Methods The main study was an 8-week, double-blind, placebo-controlled, parallel group study in men between 18 and 65 years of age with diagnosed PE. A substudy was also conducted using a subset of patients (two-way crossover, one center) before entry to the main study. The primary study measured intravaginal ejaculatory latency (IELT) and responses to the Index of Premature Ejaculation (IPE) questionnaire. The substudy measured vibrotactile stimulation ejaculatory latency time (VTS-ELT) and postejaculatory erectile refractory time. Differences between treatment groups were determined by ancova at the 5% level of significance. Results The change in IELT (1.6 ± 6.08 vs. 0.6 ± 2.07 minutes) and VTS-ELT (2.9 ± 0.4 vs. 2.4 ± 0.4 minutes) were higher after taking sildenafil, compared with placebo, but did not reach statistical significance. However, patients who took sildenafil (vs. placebo) reported significantly (P < 0.05) increased ejaculatory control (1.8 ± 0.3 vs. 1.5 ± 0.3), increased ejaculatory confidence (2.2 ± 0.2 vs. 1.9 ± 0.2), and improved overall sexual satisfaction scores (3.1 ± 0.2 vs. 2.8 ± 02) on the IPE, and had a decreased postejaculatory erectile refractory time (3.2 ± 0.7 vs. 6.4 ± 0.7 minutes). The most common adverse events for sildenafil (vs. placebo) were headache (15% vs. 1%), flushing (15% vs. 0%), dyspepsia (5% vs. 1%), abnormal vision (5% vs. 0%), and rhinitis (5% vs. 0%). Conclusions Although IELT and VTS-ELT were not significantly improved, sildenafil increased confidence, the perception of ejaculatory control, and overall sexual satisfaction, and decreased the refractory time to achieve a second erection after ejaculation in men with PE.
BackgroundIt is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance. MethodsIn this double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification. We then followed the patients for a median of 5.0 years for the development of diabetes (6.5 years for vital status). We studied the effects of valsartan on the occurrence of three coprimary outcomes: the development of diabetes; an extended composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, arterial revascularization, or hospitalization for unstable angina; and a core composite outcome that excluded unstable angina and revascularization. ResultsThe cumulative incidence of diabetes was 33.1% in the valsartan group, as compared with 36.8% in the placebo group (hazard ratio in the valsartan group, 0.86; 95% confidence interval [CI], 0.80 to 0.92; P<0.001). Valsartan, as compared with placebo, did not significantly reduce the incidence of either the extended cardiovascular outcome (14.5% vs. 14.8%; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P = 0.43) or the core cardiovascular outcome (8.1% vs. 8.1%; hazard ratio, 0.99; 95% CI, 0.86 to 1.14; P = 0.85). ConclusionsAmong patients with impaired glucose tolerance and cardiovascular disease or risk factors, the use of valsartan for 5 years, along with lifestyle modification, led to a relative reduction of 14% in the incidence of diabetes but did not reduce the rate of cardiovascular events. (ClinicalTrials.gov number, NCT00097786.)Copyright © 2010 Massachusetts Medical Society. All rights reserved.Downloaded from www.nejm.org by JEAN-CHRISTOPHE PHILIPS on May 3, 2010 .T h e ne w e ngl a nd jou r na l o f m e dic i ne n engl j med 362;16 nejm.org april 22, 2010 1478 P atients with impaired glucose tolerance have an increased risk of type 2 diabetes mellitus and cardiovascular disease. [1][2][3] Interventions that might reduce the incidence of diabetes and associated rates of death and complications from cardiovascular causes in such patients are therefore of importance. 3 Several trials have shown that lifestyle modification, including increased physical activity and weight loss, reduces the risk of diabetes, although these trials did not evaluate cardiovascular outcomes. [3][4][5][6][7][8] Certain drugs, including metformin, acarbose, and rosiglitazone, also reduce the incidence of diabetes, although their effect on cardiovascular events is uncertain. 6,9,10 Another pharmacologic approach to reducing the risk of diabetes and cardiovascular disease is inhibition of the renin-angiotensin system. Some studies have shown that angiotensin-convertingenzyme (ACE) inhibitors and ang...
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