Background Metformin is the first-line treatment for type 2 diabetes mellitus (T2DM), but many patients either cannot tolerate it or cannot achieve glycemic control with metformin alone, so treatment with other glucose-lowering agents in combination with metformin is frequently required. Remogliflozin etabonate, a novel agent, is an orally bioavailable prodrug of remogliflozin, which is a potent and selective sodium-glucose co-transporter-2 inhibitor. Objective Our objective was to evaluate the efficacy and safety of remogliflozin etabonate compared with dapagliflozin in subjects with T2DM in whom a stable dose of metformin as monotherapy was providing inadequate glycemic control. Methods A 24-week randomized, double-blind, double-dummy, active-controlled, three-arm, parallel-group, multicenter, phase III study was conducted in India. Patients aged ≥ 18 and ≤ 65 years diagnosed with T2DM, receiving metformin ≥ 1500 mg/day, and with glycated hemoglobin (HbA1c) levels ≥ 7 to ≤ 10% at screening were randomized into three groups. Every patient received metformin ≥ 1500 mg and either remogliflozin etabonate 100 mg twice daily (BID) (group 1, n = 225) or remogliflozin etabonate 250 mg BID (group 2, n = 241) or dapagliflozin 10 mg once daily (QD) in the morning and placebo QD in the evening (group 3, n = 146). The patients were followed-up at weeks 1 and 4 and at 4-week intervals thereafter until week 24. The endpoints included mean change in HbA1c (primary endpoint, noninferiority margin = 0.35), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), bodyweight, blood pressure, and fasting lipids. Treatmentemergent adverse events (TEAEs), safety laboratory values, electrocardiogram, and vital signs were evaluated. Results Of 612 randomized patients, 167 (group 1), 175 (group 2), and 103 (group 3) patients with comparable baseline characteristics completed the study. Mean change ± standard error (SE) in HbA1c from baseline to week 24 was − 0.72 ± 0.09, − 0.77 ± 0.09, and − 0.58 ± 0.12% in groups 1, 2, and 3, respectively. The difference in mean HbA1c of group 1 versus group 3 (− 0.14%, 90% confidence interval [CI] − 0.38 to 0.10) and group 2 versus group 3 (− 0.19%; 90% CI − 0.42 to 0.05) was noninferior to that in group 3 (p < 0.001). No significant difference was found between group 1 or group 2 and group 3 in change in FPG, PPG, and bodyweight. The overall incidence of TEAEs was comparable across study groups (group 1 = 32.6%, group 2 = 34.4%, group 3 = 29.5%), including adverse events (AEs) of special interest (hypoglycemic events, urinary tract infection, genital fungal infection). Most TEAEs were mild to moderate in intensity, and no severe AEs were reported. Conclusion This study demonstrated the noninferiority of remogliflozin etabonate 100 and 250 mg compared with dapagliflozin, from the first analysis of an initial 612 patients. Remogliflozin etabonate therefore may be considered an effective and well-tolerated alternative treatment option for glycemic control in T2DM. Trial Registration CTRI/2017/07...
Aims:The aim of the present study was to evaluate the accuracy of Cone Beam Computed Tomography (CBCT) measurements of alveolar bone defects caused due to periodontal disease, by comparing it with actual surgical measurements which is the gold standard.Materials and Methods:Hundred periodontal bone defects in fifteen patients suffering from periodontitis and scheduled for flap surgery were included in the study. On the day of surgery prior to anesthesia, CBCT of the quadrant to be operated was taken. After reflection of the flap, clinical measurements of periodontal defect were made using a reamer and digital vernier caliper. The measurements taken during surgery were then compared to the measurements done with CBCT and subjected to statistical analysis using the Pearson's correlation test.Results:Overall there was a very high correlation of 0.988 between the surgical and CBCT measurements. In case of type of defects the correlation was higher in horizontal defects as compared to vertical defects.Conclusions:CBCT is highly accurate in measurement of periodontal defects and proves to be a very useful tool in periodontal diagnosis and treatment assessment.
Background: Outbreak of novel corona virus has led World Health Organization (WHO) to come up with healthcare guidelines which includes wearing of N95 mask. The aim of this study was to evaluate whether blood oxygen saturation level is affected by wearing of N95 mask for the duration of 4 hours. Materials and Methods: A total of 90 exam going students were included in this study, who were instructed to wear N95 mask. Blood oxygen saturation level (SpO2) was checked both before and after wearing of N95 mask for a period of 4 hours. Results: It was observed that, before wearing N95 mask at 9 am, SpO2 values were 96.64±0.196 while at 1 pm after removing N95 mask, the saturation values were 95.68±0.235 (p=0.000) among all the students. There was a statistically highly significant difference seen for the values between the time intervals (p<0.01) with higher values at 9 am and lesser at 1pm. On comparing the SpO2 levels among males and females, a statistically nonsignificant difference was seen. Thus, reduction in blood oxygen saturation level can be a major parameter to evaluate the respiratory consequences of N95 mask. Conclusion: Various adverse effects of N95 mask were quoted in literature but respiratory consequences due to reduction in blood oxygen saturation level can be harmful. Thus, to avoid such consequences, precautionary measures are advised to be taken. Key words: N95 mask, SpO2, Blood oxygen saturation, COVID-19.
Context: Ultrasonic scaling is a routinely performed procedure in dental practice. During ultrasonic scaling, sensitivity of teeth is a common occurrence. The sensitivity of teeth causes discomfort and pain to many patients. The potassium nitrate is an antihypersensitivity agent used effectively in dentifrices. Aims: The aim of the study is to evaluate the efficacy of 5% potassium nitrate gel application on the reduction of sensitivity during ultrasonic scaling. Settings and Design: This study is a randomized controlled trial with a split-mouth design. A total of 100 patients were recruited in the study after informed consent. Subjects and Methods: Mandibular anterior teeth were selected as the area for study. About 5% potassium nitrate gel was applied to the left or right side of the teeth. After 5 min, ultrasonic scaling was performed for both test and control sides. Visual analog scale (VAS) and patient satisfaction were recorded for both the groups. Statistical Analysis Used: An unpaired t-test was used to analyze the mean VAS scores with the area treated with or without application of 5% potassium gel during ultrasonic scaling. Chi-square test was used to analyze the satisfaction level with the test and control group. Results: The mean VAS scores and patient satisfaction for the test group were (P < 0.001) statistically significant as compared to the control group. Conclusions: Potassium nitrate gel can be effectively used before ultrasonic scaling to reduce sensitivity.
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