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Aim: To evaluate the long‐term safety and efficacy of enavogliflozin 0.3 mg/day added to metformin in patients with type 2 diabetes mellitus. Materials and Methods: After 24 weeks of a randomized, double‐blind treatment period with enavogliflozin 0.3 mg/day (n = 101) or dapagliflozin 10 mg/day (n = 99) added to metformin, all patients received enavogliflozin 0.3 mg/day plus metformin for an additional 28 weeks during the open‐label extension period. Results: Eighty‐two patients continued enavogliflozin (maintenance group), and 77 were switched from dapagliflozin to enavogliflozin (switch group). All adverse drug reactions (ADR) were mild in severity. In the maintenance group, ADRs (cystitis and vaginal infection) were reported in two patients (2.44%) during 52 weeks. In the switch group, ADR (hypoglycaemia) was reported in one patient (1.30%) during a 28‐week open‐label extension period. At week 52, glycated haemoglobin and fasting plasma glucose were significantly lower than at the baseline, by 0.85% and 29.08 mg/dl, respectively, in the maintenance group (p <.0001 for both), and by 0.81% and 32.77 mg/dl, respectively, in the switch group (p <.0001 for both). At week 52, 68.92% of patients from the maintenance group and 64.29% from the switch group achieved glycated haemoglobin <7%. A significant increase in the urine glucose‐creatinine ratio was observed at week 52, by 58.81 g/g and 63.77 g/g in the maintenance and switch groups, respectively (p <.0001). Conclusions: Enavogliflozin added to metformin was tolerated well for up to 52 weeks and provided continual glycaemic control in type 2 diabetes mellitus, along with a significant increase in the urine glucose‐creatinine ratio. [ABSTRACT FROM AUTHOR]

Aims: The study aimed to evaluate and compare the efficacy and safety of enavogliflozin, a newly developed sodium‐glucose cotransporter 2 inhibitor, with placebo in Korean patients with type 2 diabetes mellitus. Materials and Methods: Patients with glycated haemoglobin (HbA1c) of 7.0‐10.0%, entered a 2‐week placebo run‐in period, and were randomized to receive once‐daily enavogliflozin (0.1, 0.3 or 0.5 mg) or placebo for 12 weeks. The primary efficacy endpoint was the change in HbA1c from baseline at week 12. Results: Overall, 194 patients were included in the full analysis set [placebo, n = 46; enavogliflozin (0.1 mg, n = 49; 0.3 mg, n = 50; 0.5 mg, n = 49)]. Patients receiving 0.1, 0.3 and 0.5 mg enavogliflozin showed significantly reduced HbA1c compared with those receiving placebo at week 12 (−0.79%, −0.89%, −0.92% and −0.08%, respectively; p <.001 vs. placebo). Mean changes in fasting plasma glucose from baseline at week 12 were −30.5, −31.1, −35.0 and 4.9 mg/dl in patients receiving enavogliflozin doses and placebo, respectively. The proportion of patients achieving HbA1c <7.0% at week 12 was significantly higher in the three enavogliflozin groups than in the placebo group (42.9%, 44.0%, 61.2% and 17.4%, respectively). A higher proportion of patients showed HbA1c reduction by >0.5% after receiving enavogliflozin doses than those receiving placebo (61.2%, 72.0%, 65.3% and 26.1%, respectively). There were no significant differences in incidences of adverse events of hypoglycaemia and genital infection between the groups. Conclusions: Once‐daily enavogliflozin monotherapy for 12 weeks is an effective, safe, and well‐tolerated treatment for Korean patients with type 2 diabetes mellitus. [ABSTRACT FROM AUTHOR]

Urea and N[H.sub.4]HC[O.sub.3] were used to control the emission of NO and S[O.sub.2] from the combustion of coke at high-temperature and low oxygen concentration. Urea and N[H.sub.4]HC[O.sub.3] could control NO emission only under 1100 [degrees]C. Their effects disappeared above 1100 [degrees]C even though the increase of urea and N[H.sub.4]HC[O.sub.3] content from 10 to 50 wt %. However, they showed good desulfurization effect on the emission of S[O.sub.2] at all combustion temperatures and their effects showed remarkable results even at 1500 [degrees]C. Only 10 wt % of urea or N[H.sub.4]HC[O.sub.3] could control the emission of S[O.sub.2] effectively at 1400 and 1500 [degrees]C. This effect was caused by * NH and * N[H.sub.2] from the thermal decomposition of reducing agents at high temperature. Low [O.sub.2] concentration showed little effect on the removal of S[O.sub.2]. Ammonia slip from the thermal decomposition of reducing chemical was not a considerable level. DOI: 10.1061/(ASCE)0733-9372(2005)131:2(190) CE Database subject headings: Emission control; Temperature; Combustion; Fossil fuels; Pollutants; Air pollution.

Objective: To evaluate the effectiveness of poloxamer‐based thermo‐sensitive sol–gel instillation, after transurethral resection of the prostate (TURP), for preventing urethral stricture. Patients and Methods: In all, 198 patients underwent TURP for benign prostatic hyperplasia. Recruited patients were randomly divided into two groups: groups A and B. Patients in Group A (100 patients, experimental group) received poloxamer‐based thermo‐sensitive sol–gel instillation and patients in the Group B (98 patients, control group) received lubricant instillation after TURP. Each patient was evaluated at 4 (V1), 12 (V2), and 24 weeks (V3) after TURP. The effectiveness of poloxamer‐based thermo‐sensitive sol–gel instillation was evaluated based on the International Prostate Symptom Score (IPSS), IPSS‐Quality of Life (QoL), Overactive bladder questionnaire (OAB‐q), maximum urinary flow rate (Qmax), post‐void residual urine volume (PVR), and cystoscopy. Results: Amongst the initial 198 participants, 80 patients in Group A and 83 in Group B completed the study. There were no significant differences in IPSS‐QoL and OAB‐q between the groups. However, Qmax was significantly different between groups A and B, at a mean (SD) of 18.92 (9.98) vs 15.58 (9.24) mL/s (P = 0.028) at 24 weeks after TURP. On cystoscopic examination, urethral stricture after TURP was found in two of the 80 patients in Group A and 10 of 83 in Group B (P = 0.023). Conclusions: Poloxamer‐based thermo‐sensitive sol–gel instillation after TURP lowered the incidence of urethral stricture. [ABSTRACT FROM AUTHOR]

Aims: DWP16001 is a novel sodium-glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes with selective and sustained sodium-glucose cotransporter 2 inhibition. We aimed to evaluate whether the coadministration of DWP16001 and metformin causes any changes in pharmacokinetics (PK) or pharmacodynamics (PD)., Methods: A randomized, open-label, single- and multiple-dose, 2-sequence, crossover study was conducted in healthy male subjects. Subjects received the following treatments: a single oral dose of DWP16001 (DWP) 2 mg, metformin immediate release 1000 mg (MET) twice daily for 7 days and a single oral dose of DWP and MET at steady-state for metformin (DWP+MET). Serial blood and interval urine were collected for PK and PD analyses. Safety and tolerability profiles were assessed throughout the study., Results: DWP+MET displayed increased peak concentration and area under the concentration-time curve from time 0 to time of the last quantifiable concentration compared with DWP (per standard bioequivalence boundaries, 0.8-1.25); the geometric mean ratios (GMRs) and their 90% confidence intervals (CIs) were 1.22 (1.13-1.31) and 1.09 (1.05-1.14), respectively. DWP+MET and MET showed similar peak concentration and area under the concentration-time curve within a dosing interval at steady state for metformin; the GMRs and 90% CIs were 0.98 (0.90-1.06) and 1.05 (0.98-1.13), respectively. The amount of urinary glucose excretion from time 0 to 144 h was also comparable between DWP+MET and DWP (GMR and 90% CI; 0.99, 0.94-1.05)., Conclusion: The results suggest that DWP16001 and metformin could be coadministered without clinically relevant PK and PD interactions., (© 2022 British Pharmacological Society.)