Patients with hyperkalemia who received ZS-9, as compared with those who received placebo, had a significant reduction in potassium levels at 48 hours, with normokalemia maintained during 12 days of maintenance therapy. (Funded by ZS Pharma; ClinicalTrials.gov number, NCT01737697.).

Clinical trials registry: ClinicalTrials.gov Trial identifier number: NCT00171496DIRECT (Diabetes Incidence after Renal Transplantation: Neoral C 2 Monitoring Versus Tacrolimus) was a 6-month, open-label, randomized, multicenter study which used American Diabetes Association/World Health Organization criteria to define glucose abnormalities. De novo renal transplant patients were randomized to cyclosporine microemulsion (CsA-ME, using C 2 monitoring) or tacrolimus, with mycophenolic acid, steroids and basiliximab. The intent-to-treat population comprised 682 patients (336 CsA-ME, 346 tacrolimus): 567 were nondiabetic at baseline. Demographics, diabetes risk factors and steroid doses were similar between treatment groups. The primary safety endpoint, new-onset diabetes after transplant (NO-DAT) or impaired fasting glucose (IFG) at 6 months, occurred in 73 CsA-ME patients (26.0%) and 96 tacrolimus patients (33.6%, p = 0.046). The primary efficacy endpoint, biopsy-proven acute rejection, graft loss or death at 6 months, occurred in 43 CsA-ME patients (12.8%) and 34 tacrolimus patients (9.8%, p = 0.211). Mean glomerular filtration rate (Cockcroft-Gault) was 63.6 ± 20.7 mL/min/1.73 m 2 in the CsA-ME cohort and 65.9 ± 23.1 mL/min/1.73 m 2 with tacrolimus (p = 0.285); mean serum creatinine was 139 ± 58 and 133 ± 57 lmol/L, respectively (p = 0.005). Blood pressure was similar between treatment groups at month 6, but total cholesterol, LDL-cholesterol and triglyceride levels were significantly higher with CsA than with tacrolimus (total cholesterol:HDL remained unchanged). The profile and incidence of adverse events were similar between treatments. The incidence of NODAT or IFG at 6 months post-transplant is significantly lower with CsA-ME than with tacrolimus without a significant difference in short-term outcome.

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Background: Dexmedetomidine (DEX) is a highly selective a 2 -adrenoceptor agonist that has been used increasingly in children. However, the effect of caudal DEX has not been evaluated before in children. This prospective randomized double-blinded study was designed to evaluate the analgesic efficacy of caudal DEX with bupivacaine in providing pain relief over a 24-h period. Methods: Sixty children (ASA status I) aged 1-6 years undergoing unilateral inguinal hernia repair/orchidopexy were allocated randomly to two groups (n 5 30 each). Group B received a caudal injection of bupivacaine 2.5 mg/ml, 1 ml/kg; Group BD received the same dose of bupivacaine mixed with DEX 1 mg/kg during sevoflurane anesthesia. Processed electroencephalogram (bispectral index score), heart rate, blood pressure, pulse oximetry and end-tidal sevoflurane were recorded every 5 min. The characteristics of emergence, objective pain score, sedation score and quality of sleep were recorded post-operatively. Duration of analgesia and requirement for additional analgesics were noted.

BackgroundCurrent anemia therapies for patients with non–dialysis-dependent CKD may require injection and medical visits. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates erythropoiesis and improves iron homeostasis.MethodsIn this double-blind phase 3 study, we randomized patients with non–dialysis-dependent CKD stages 3–5 and hemoglobin <10.0 g/dl (1:1) to thrice-weekly 70-mg oral roxadustat or placebo. Doses were titrated throughout the study based on hemoglobin levels. The primary efficacy end point was mean change from baseline in hemoglobin averaged over weeks 28–52 versus placebo, irrespective of rescue therapy use. We assessed patients for adverse events.ResultsThe study included 2781 patients, 1393 who received roxadustat and 1388 who received placebo. Mean baseline hemoglobin was 9.1 g/dl for both groups. The mean change in hemoglobin from baseline was 1.75 g/dl (95% confidence interval [95% CI], 1.68 to 1.81) with roxadustat versus 0.40 g/dl (95% CI, 0.33 to 0.47) with placebo, (P<0.001). Among 411 patients with baseline elevated high-sensitivity C-reactive protein, mean change in hemoglobin from baseline was 1.75 g/dl (95% CI, 1.58 to 1.92) with roxadustat versus 0.62 g/dl (95% CI, 0.44 to 0.80) with placebo, (P<0.001). Roxadustat reduced the risk of red blood cell transfusion by 63% (hazard ratio, 0.37; 95% CI, 0.30 to 0.44). The most common adverse events with roxadustat and placebo, respectively, were ESKD (21.0% versus 20.5%), urinary tract infection (12.8% versus 8.0%), pneumonia (11.9% versus 9.4%), and hypertension (11.5% versus 9.1%).ConclusionsRoxadustat effectively increased hemoglobin in patients with non–dialysis-dependent CKD and reduced the need for red blood cell transfusion, with an adverse event profile comparable to that of placebo.Clinical Trial registry name and registration number:Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With CKD, Not on Dialysis, NCT02174627