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Samavat J.,University of Florence | Natali I.,Seminology Laboratory | Degl'Innocenti S.,University of Florence | Filimberti E.,University of Florence | And 8 more authors.
Fertility and Sterility | Year: 2014

Objective: To compare spontaneous (Sp-AR) and P-induced acrosome reaction (AR) in spermatozoa of obese and lean subjects. Setting: Bariatric unit at a university hospital. Design: Prospective, observational study. Patient(s): Twenty-three obese (mean ± SD body mass index [BMI], 44.3 ± 5.9 kg/m2) and 25 age-matched lean (BMI, 24.2 ± 3.0 kg/m2) subjects. Intervention(s): None. Main Outcome Measure(s): Spontaneous and P-induced AR in spermatozoa of obese and lean subjects. Result(s): A statistically significant difference was found between obese and lean cohorts in total T and calculated free T, E2, glycated hemoglobin, and high-density lipoproteins, whereas among the routine semen parameters analyzed, only immotile sperm percentage and ejaculate volume differed significantly. Spermatozoa of obese (n = 13) vs. lean men (n = 19) showed a higher Sp-AR (17.9% ± 7.2% vs. 8.3% ± 4.2%), which resulted in a reduced ability to respond to P evaluated as the AR-after-P-challenge parameter (3.5% ± 3.2% vs. 17.6% ± 9.2%). Multivariate analysis adjusted for age revealed a significant correlation between BMI, waist, E2, and glycated hemoglobin with both Sp-AR (age-adjusted r = 0.654, r = 0.711, r = 0.369, and r = 0.644, respectively) and AR-after-P-challenge (age-adjusted r = -0.570, r = -0.635, r = -0.507, and r = -0.563, respectively). A significant difference in sperm cholesterol content was reported between obese and lean men (29.8 ± 19.5 vs. 19.1 ± 14.6 ng/μg of proteins). content was reported between obese and lean men (29.8 ± 19.5 vs. 19.1 ± 14.6 ng/μg of proteins). Conclusion(s): Sperm AR is impaired in obese men, showing reduced response to P and elevated Sp-AR, associated with altered circulating levels of E2 and sperm cholesterol content. ©2014 by American Society for Reproductive Medicine.

Patadia V.K.,Erasmus Medical Center | Patadia V.K.,Astellas Pharma Inc. | Coloma P.,Erasmus Medical Center | Schuemie M.J.,Erasmus Medical Center | And 10 more authors.
Expert Review of Clinical Pharmacology | Year: 2014

A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA's Adverse Event Reporting System and WHO's Vigibase is reported. The study compared drug safety signals found in the EU-ADR and SRS databases. The potential for signal detection in the EU-ADR system was found to be dependent on frequency of the event and utilization of drugs in the general population. The EU-ADR system may have a greater potential for detecting signals for events occurring at higher frequency in general population and those that are commonly not considered as potentially a drug-induced event. Factors influencing various differences between the datasets are discussed along with potential limitations and applications to pharmacovigilance practice. © 2015 Informa UK, Ltd.

Seghieri G.,Agenzia Regionale Sanita Toscana | Policardo L.,Agenzia Regionale Sanita Toscana | Profili F.,Agenzia Regionale Sanita Toscana | Francesconi P.,Agenzia Regionale Sanita Toscana | And 2 more authors.
Journal of Diabetes and its Complications | Year: 2015

Aims: To identify incidental previously unrecognized diabetes (IPUD) among hospitalized patients and corresponding mortality risk in comparison with individuals with known diabetes (KDM). Methods: Out of 214,991 individuals discharged in year 2011 from all hospitals of Tuscany, Italy we retrospectively identified IPUD as individuals with no known diabetes and/or previous antidiabetic medication, receiving at least two prescriptions of glucose-lowering-drugs over the next 6. months after discharge. Two-year (2012-2013) adjusted mortality risk was tested by a Cox-regression-analysis, comparing IPUD and KDM patients with at least one hospital admission in 2011. Results: 974 patients with IPUD (375.6. ×. 100,000 hospitalized people) have been identified. IPUD risk was associated with aging, male gender and greater burden of co-morbidities, was higher in migrants of non-Italian ancestry and was reduced among patients of family physicians adhering to guidelines resulting in a proactive model of care delivery. In IPUD patients alive at 1st January 2012, (n = 865) the adjusted risk of two-year mortality was similar to that of KDM subjects (HR = 1.08; 95% CI: 0.92-1.26; p = NS). Conclusions: IPUD occurs more commonly in older male subjects, migrants of non-Italian ancestry, and among patients of physicians non-adhering to a shared diabetes care model. People with IPUD have similar two-year-mortality risk compared with KDM individuals. © 2015 Elsevier Inc.

Policardo L.,Agenzia Regionale Sanita Toscana | Seghieri G.,Agenzia Regionale Sanita Toscana | Francesconi P.,Agenzia Regionale Sanita Toscana | Franconi F.,University of Sassari | And 3 more authors.
Journal of Diabetes and its Complications | Year: 2015

Objective To evaluate the effect of diabetes by gender on the peak-risk of first-ever-ischemic stroke and its recurrence. Methods Administrative datasets including all hospital discharges for ischemic stroke (N = 43,332) in the diabetic (N = 207,568) and non-diabetic (N = 2,808,554) population of the Tuscany region, Italy were used to calculate Hazard ratios (HR) after Cox-regression, of first-ever and recurrent ischemic strokes, between 2005 and 2011. Results Overall, diabetes increased the HR of first-ever ischemic stroke by about 50% in both genders. However, this risk significantly declined with age and was higher in women aged 55-74 yr than in men of the same age (HR; 95% CI: 1.392; 1.228-1.579 in age-class 55-64 yr and 1.203; 1.110-1.304 in age class 65-74 yr; p < 0.001). Diabetes also increased the adjusted risk of three-year-stroke recurrence (N = 5,998) in women, independently of age, whereas this was the case in men < 70 yr. Conclusions Diabetes is associated with increased risk of ischemic stroke although it declines with age though at lower rate among women than men. Moreover, diabetic women have greater risk of recurrence than in men > 70 yrs old, supporting a high-risk "time-window" in postmenopausal-elderly diabetic women. © 2015 Elsevier Inc.

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