e., an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter [5.3
mmol per liter]) were randomly assigned to usual prenatal care (control group) or dietary intervention, self-monitoring of blood glucose, and insulin therapy, if necessary (treatment group). The primary outcome was a composite of stillbirth or perinatal death and neonatal complications, including hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and birth trauma.
Results: A total of 958 women were randomly assigned to a study group — 485 to the treatment group and 473 to the control group. We observed no significant difference between groups in the frequency of the composite outcome (32.4% and 37.0% in the treatment and control groups, respectively; P=0.14). Selleck Dasatinib There were no perinatal deaths. However, there were significant reductions with treatment as compared with usual care in several prespecified secondary outcomes, including mean birth weight AZD0156 nmr (3302 vs. 3408 g), neonatal fat mass (427 vs. 464 g), the frequency
of large-for-gestational-age infants (7.1% vs. 14.5%), birth weight greater than 4000 g (5.9% vs. 14.3%), shoulder dystocia (1.5% vs. 4.0%), and cesarean delivery (26.9% vs. 33.8%). Treatment of gestational diabetes mellitus, as compared with usual care, was also associated with reduced rates of preeclampsia and gestational hypertension (combined rates for the two conditions, 8.6% vs. 13.6%; P=0.01).
Conclusions: Although treatment of mild gestational diabetes mellitus did not significantly reduce the frequency of a composite outcome that included stillbirth or perinatal death and several neonatal complications, it did reduce the risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders. (ClinicalTrials.gov number, NCT00069576.)
N Engl J Med 2009;361:1339-48.”
“Purpose: We evaluated the efficacy and safety of silodosin for treatment of benign prostatic hyperplasia symptoms in 2 randomized,
placebo controlled, phase 3 studies.
Materials and Methods: Men 50 years or older with an International Prostate Symptom Score of 13 or greater and peak urinary flow rate of 4 to 15 ml per second received placebo or 8 mg silodosin daily with breakfast PI3K inhibitor for 12 weeks. The primary end point was International Prostate Symptom Score change from baseline to last observation. Change in peak urinary flow rate was a secondary end point. Differences in treatment efficacy were assessed by ANCOVA.
Results: Of 923 patients (mean age 65 years) 466 received silodosin and 457 placebo. After 0.5 week (range 3 to 4 days) of treatment patients receiving silodosin vs placebo achieved significant improvement in total International Prostate Symptom Score (difference -1.9, p <0.0001) and irritative (-0.5, p = 0.0002) and obstructive (-1.4, p <0.0001) subscores. The mean +/- SD change from baseline in total International Prostate Symptom Score was -4.2 +/- 5.