3 +/- 4.4 for placebo. Differences.(silodosin vs placebo) in International Prostate Symptom Score and subscores increased by week 12 (p <0.0001). Mean change from baseline in peak urinary flow rate (ml per second) 2 to 6 hours after initial dose was greater (p <0.0001) with silodosin (2.8 +/- 3.4) than placebo (1.5 +/- 3.8). Differences remained significant (p <0.001) through
week 12. The most common treatment emergent adverse event was (mostly mild) retrograde ejaculation (silodosin 28.1% of patients, placebo 0.9%). Few patients receiving silodosin (2.8%) discontinued because of retrograde ejaculation. Proportions of patients with treatment emergent orthostatic hypotension were similar for silodosin (2.6%) and placebo (1.5%).
Conclusions: Treatment with silodosin produced rapid improvement
in urinary symptoms that was sustained for see more 12 weeks. Silodosin was well tolerated with a low incidence of orthostatic hypotension.”
“Background: Whether hypothermic therapy improves neurodevelopmental outcomes in newborn infants with asphyxial encephalopathy is uncertain.
Methods: We performed a randomized trial of infants who were less than 6 hours of age and had a gestational age of at least 36 weeks and perinatal asphyxial encephalopathy. We compared intensive care plus cooling of the body to 33.5 degreesC for 72 hours and intensive care alone. The primary outcome was death or severe disability at 18 months of age. Prespecified secondary outcomes included 12 neurologic outcomes and 14 other adverse outcomes.
Results: Of 325 selleck infants enrolled, 163 underwent intensive care with cooling, and 162 underwent intensive care alone. In the cooled group, 42 infants died and 32 survived but had severe neurodevelopmental disability, whereas in the noncooled group, 44 infants died and 42 had severe disability (relative risk for either outcome, 0.86; 95% confidence interval [CI], 0.68 to 1.07; P=0.17). Infants in the cooled group CP673451 nmr had an increased rate of survival without neurologic abnormality (relative risk, 1.57; 95% CI, 1.16 to 2.12; P=0.003). Among
survivors, cooling resulted in reduced risks of cerebral palsy (relative risk, 0.67; 95% CI, 0.47 to 0.96; P=0.03) and improved scores on the Mental Developmental Index and Psychomotor Developmental Index of the Bayley Scales of Infant Development II (P=0.03 for each) and the Gross Motor Function Classification System (P=0.01). Improvements in other neurologic outcomes in the cooled group were not significant. Adverse events were mostly minor and not associated with cooling.
Conclusions: Induction of moderate hypothermia for 72 hours in infants who had perinatal asphyxia did not significantly reduce the combined rate of death or severe disability but resulted in improved neurologic outcomes in survivors. (Current Controlled Trials number, ISRCTN89547571.)
N Engl J Med 2009;361:1349-58.