Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: Analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies
Porst H.,Private Practice |
Roehrborn C.G.,University of Texas Southwestern Medical Center |
Secrest R.J.,Eli Lilly and Company |
Esler A.,Statistics |
Viktrup L.,Eli Lilly and Company
Journal of Sexual Medicine | Year: 2013
Introduction: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are common in aging males and frequently occur together. Tadalafil has demonstrated efficacy in treating both conditions. Aim: The study aims to evaluate the efficacy and safety of tadalafil 5mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men. We also assessed relationships of baseline disease severity and prostate specific antigen (PSA) to outcomes. Methods: Data were pooled from four multinational, randomized studies of men ≥45 years with LUTS/BPH, with analyses restricted to sexually active men with ED. Randomization (baseline) followed a 4-week placebo run-in; changes from baseline were assessed vs. placebo using analysis of covariance. Main Outcome Measures: International Prostate Symptom Score (IPSS), IPSS subscores, Quality-of-Life Index (IPSS-QoL), BPH Impact Index (BII), and International Index of Erectile Function-Erectile Function (IIEF-EF) Domain score were used in this study. Results: Tadalafil (N=505) significantly improved total IPSS vs. placebo (N=521); mean changes from baseline were -6.0 and -3.6, respectively (P<0.001). Improvements in IIEF-EF Domain score (tadalafil, 6.4; placebo, 1.4) were also significant vs. placebo, as were the IPSS storage and voiding subscores, IPSS-QoL, and BII (all P<0.001). No significant impact of baseline ED severity or PSA category on IPSS response was observed (interaction P values, 0.463 and 0.149, respectively). Similarly, improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category (interaction P values, 0.926 and 0.230, respectively). Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated (r=-0.229). Treatment-emergent adverse events were consistent with previous reports. Conclusions: Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions. Improvements in both conditions were significant regardless of baseline severity. Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated. © 2013 International Society for Sexual Medicine.
Hughes G.,Public Health England |
Alexander S.,Sexually Transmitted Bacteria Reference Unit STBRU |
Simms I.,Public Health England |
Conti S.,Statistics |
And 3 more authors.
Sexually Transmitted Infections | Year: 2013
Objectives To investigate the drivers behind the epidemic expansion of lymphogranuloma venereum (LGV) cases in late 2009 to help inform infection control. Methods An epidemic curve of all LGV diagnoses between 2003 and mid-2012 was plotted and divided into the initial detection period, and endemic, growth and hyperendemic phases. Detailed clinical and behavioural data were collected and logistic regression was used to compare the characteristics of diagnoses made during the growth and endemic phases. Results Between April 2003 and June 2012, 2138 cases of LGV were diagnosed. Enhanced surveillance data were available for 1370 of whom 1353 were men who have sex with men (MSM). 98% of MSM presented with proctitis, 82% were HIV positive, 20% were hepatitis C virus (HCV) antibody positive, and 67% lived in London. Growth phase cases (n=488) were more likely to report meeting sexual contacts at sex parties (11% vs 6%, p=0.014), unprotected receptive or insertive oral intercourse (93% vs 86%, p=0.001; 92% vs 85%, p=0.001) and sharing sex toys (8% vs 4%; p=0.011), and to be diagnosed HIV positive (86% vs 80%; p=0.014), than endemic phase cases (n=423). Unprotected receptive anal intercourse was equally likely to be reported in both phases (71% vs 73%). After adjustment, cases in the growth phase were more likely to meet new contacts at sex parties ( p=0.031) and be HIV positive (p=0.045). Conclusions Rapid epidemic growth coincided with an intensification of unprotected sexual activity among a core population of HIV-positive MSM. Efforts to develop innovative interventions for this hard-to-reach population are needed.
Kristensen P.,University of Oslo |
Heir T.,University of Oslo |
Langsrud O.,Statistics |
Weisaeth L.,University of Oslo
Journal of Nervous and Mental Disease | Year: 2012
We prospectively studied parental mental health after suddenly losing a son in a military training accident. Parents (N = 32) were interviewed at 1, 2 and 23 years after the death of their son. The General Health Questionnaire and Expanded Texas Inventory of Grief were self-reported at 1, 2, 5, and 23 years; the Inventory of Complicated Grief was self-reported at 23 years. We observed a high prevalence of psychiatric disorders at 1- and 2-year follow-ups (57% and 45%, respectively), particularly major depression (43% and 31%, respectively). Only one mental disorder was diagnosed at the 23-year follow-up. Grief and psychological distress were highest at 1- and 2-year follow-ups. Spouses exhibited a high concordance of psychological distress. Mothers reported more intense grief reactions than did fathers. The loss of a son during military service may have a substantial impact on parental mental health particularly during the first 2 years after death. Spouses' grief can be interrelated and may contribute to their psychological distress. © 2012 Lippincott Williams & Wilkins, Inc.
Kishore J.,Maulana Azad Medical College |
Jena P.K.,STEPS |
Bandyopadhyay C.,Statistics |
Swain M.,Medical |
And 2 more authors.
Asian Pacific Journal of Cancer Prevention | Year: 2013
Background: Hardcore smoking is represented by a subset of daily smokers with high nicotine dependence, inability to quit and unwillingness to quit. Estimating the related burden could help us in identifying a high risk population prone to tobacco induced diseases and improve cessation planning for them. This study assessed the prevalence and associated factors of hardcore smoking in three South-East Asian countries and discussed its implication for smoking cessation intervention in this region. Materials and Methods: Global Adult Tobacco Survey (GATS) data of India, Bangladesh and Thailand were analyzed to quantify the hardcore smoking prevalence in the region. On the basis of review, an operational definition of hardcore smoking was adopted that includes (1) current daily smoker, (2) no quit attempt in the past 12 months of survey or last quit attempt of less than 24 hours duration, (3) no intention to quit in next 12 months or not interested in quitting, (4) time to first smoke within 30 minutes of waking up, and (5) knowledge of smoking hazards. Logistic regression analysis was carried out using hardcore smoking status as response variable and gender, type of residence, occupation, education, wealth index and age-group as possible predictors. Results: There were 31.3 million hardcore smokers in the three Asian countries. The adult prevalence of hardcore smoking in these countries ranges between 3.1% in India to 6% in Thailand. These hardcore smokers constitute 18.3-29.7% of daily smokers. The logistic regression model indicated that age, gender, occupation and wealth index are the major predictors of hardcore smoking with varied influence across countries. Conclusions: Presence of a higher number of hardcore smoking populations in Asia is a major public health challenge for tobacco control and cancer prevention. There is need of intensive cessation interventions with due consideration of contextual predictors.
Vermeire S.,University Hospital Gasthuisberg |
Schreiber S.,University of Kiel |
Sandborn W.J.,Mayo Medical School |
Dubois C.,Statistics |
Rutgeerts P.,University Hospital Gasthuisberg
Clinical Gastroenterology and Hepatology | Year: 2010
Background & Aims: Clinical trials of Crohn's disease generally use the Crohn's Disease Activity Index to assess disease activity; these calculations are complex, time-consuming, and impracticable. We investigated whether a simpler tool, the Harvey-Bradshaw Index, was equally effective in assessing disease severity. Methods: Crohn's Disease Activity and Harvey-Bradshaw Index scores were collected from 2 large multicenter Crohn's disease studies. The PEGylated antibody fragment evaluation in Crohn's disease: safety and efficacy (PRECiSE) 1 and 2 trials assessed efficacy and tolerability of certolizumab pegol (PEGylated, humanized, Fab' fragment of an antitumor necrosis factor α antibody). PRECiSE 1 and 2 data were analyzed to determine if results from the Crohn's Disease Activity Index correlated with those from the Harvey-Bradshaw Index criteria for defining response and remission. Results: Analysis of almost 1000 data pairs showed a positive correlation between scores. The correlation between the indices for pooled data from PRECiSE 1 and PRECiSE 2 was 0.800 (Spearman correlation coefficient). The correlations between indices for the PRECiSE 1 or PRECiSE 2 were 20.698 and 0.716, respectively (Kronecker product variance). A 3-point change in the Harvey-Bradshaw Index score corresponded to a 100-point change in the Crohn's Disease Activity Index (clinical response); scores ≤4 points corresponded to a Crohn's Disease Activity Index score ≤150 points (clinical remission). Conclusions: Results from the Crohn's Disease Activity Index correlate with those from the Harvey-Bradshaw Index; use of the Harvey-Bradshaw Index might permit simpler Crohn's disease activity assessment in long-term clinical trials, and facilitate standardized disease activity measurements and cross-center comparisons. © 2010 AGA Institute.