Efficacy and Safety of Teneligliptin in Indian Patients with Inadequately Controlled Type 2 Diabetes Mellitus: A Randomized, Double-blind Study.

AIMS: This study evaluated the efficacy and safety of teneligliptin in patients with inadequately controlled type 2 diabetes mellitus (T2DM). SETTINGS AND DESIGN: This was a randomized, doubleblind, placebocontrolled, parallelgroup, multicenter, Phase III study. SUBJECTS AND METHODS: Patients with T2DM and inadequate glycemic control (glycosylated hemoglobin [HbA1c]: >7.0-≤8.5%) were enrolled. Patients were randomly assigned (ratio: 2:1) to receive teneligliptin 20 mg (Glenmark) or placebo. The primary efficacy variable was change from baseline in HbA1c at week 16. Additional analyses included the proportion of patients who achieved target of HbA1c ≤7.0%, changes in fasting plasma glucose (FPG), and postprandial glucose (PPG). STATISTICAL ANALYSIS: Mean change in HbA1c was analyzed using an analysis of covariance model, least square (LS) means, 95% confidence intervals (CIs), and P values were calculated. RESULTS: Overall, 237 patients were included. Patients of the teneligliptin group showed reduced HbA1c levels (LS mean difference = -0.304% for intent-to-treat [ITT]; -0.291% for per-protocol (PP) populations) after 16 weeks of treatment, and a statistically significant difference was observed between the ITT (LS mean difference = 0.555; 95% CI: 0.176-0.934; P = 0.0043) and PP populations (LS mean difference = 0.642; 95% CI: 0.233-1.052; P = 0.0023). Target HbA1c level was achieved by a greater proportion of teneligliptin group patients (ITT, 43.4%; PP, 43.6%) than placebo group patients (ITT, 27.3%; PP, 26.6%). Reduction in FPG levels was observed in ITT (LS mean difference: 8.829; 95% CI: -4.357-22.016; P = 0.1883) and PP populations (LS mean difference: 11.710 mg/dL; 95% CI: -2.893-26.312; P = 0.1154). Reduction in PPG levels was higher in teneligliptin group than placebo group in both ITT (LS mean difference = 25.849 mg/dL; 95% CI: 7.143-44.556; P = 0.0070) and PP populations (LS mean difference = 25.683 mg/dL; 95% CI: 5.830-45.536; P = 0.0115). Overall, 44 patients (18.6%) experienced at least one adverse event. Three or more hypoglycemic events were experienced by 2.5% patients of teneligliptin group and none in placebo group. CONCLUSION: Treatment with once-daily teneligliptin led to statistically significant and clinically meaningful reductions in HbA1c and PPG, and was well tolerated in Indian patients with T2DM.

Mural adenomatoid odontogenic tumour as anterior mandibular swelling: a diagnostic challenge.

Adenomatoid odontogenic tumour is an uncommon, benign, hamartomatous lesion that commonly affects the anterior maxilla and has two radiographic variants, follicular and extrafollicular where the former is more common than the latter. Here, we report a case of 15-year-old female with midline swelling of the mandible. Radiographically, impacted right permanent mandibular canine was associated with the radiolucent lesion. Dentigerous cyst was given as provisional diagnosis. However, histologically the lesion represented the features of cystic variant of Adenomatoid odontogenic tumour.

Post-marketing study of clinical experience of atorvastatin 80 mg vs 40 mg in Indian patients with acute coronary syndrome- a randomized, multi-centre study (CURE-ACS).

OBJECTIVE: To generate comparative clinical data in Indian patients with acute coronary syndrome (ACS) in terms of safety and efficacy of atorvastatin 80 mg vis-à-vis atorvastatin 40 mg MATERIALS AND METHODS: A total of 236 patients with diagnosed ACS (with TIMI Risk score > or = 3) within preceding 10 days were randomized to receive either atorvastatin 80 mg or atorvastatin 40 mg once daily for 12 weeks. Out of 236 patients, data for 173 was analyzed who had both baseline and post-baseline lipid assessment. The primary end point of the trial was percentage change in LDL-C at the end of treatment from baseline. Other end points were change in high sensitivity C reactive protein, incidence of increase in liver enzymes > or = 3 times upper limit of normal and incidence of myotoxicity (with or without elevation of creatinine phosphokinase) at the end of treatment. RESULTS: A dose-dependent response was observed with greater reduction of LDL -C in atorvastatin 80 mg (27.5% vs 19.04%) than that of atorvastatin 40 mg group. Both the treatment groups had a significant reduction (p < 0.001) in LDL-C at the end of 6 and 12 weeks in comparison to baseline. hs-CRP was also significantly reduced (p < 0.001) in both the treatment groups i.e. atorvastatin 80 mg (76.15%) and atorvastatin 40 mg (84.4%) from baseline at the end of 12 weeks. Both doses of atorvastatin were well tolerated. No patient had elevation of (> or = 3 times of upper limit of normal) liver enzymes or creatinine phosphokinase. One patient on atorvastatin 80 mg complained of myalgia. There were no dose-related differences in incidence of adverse events between two treatment groups. CONCLUSION: The CURE-ACS trial indicated that atorvastatin 80 mg was more effective than atorvastatin 40 mg in terms of reduction in LDL cholesterol and was as safe and well tolerated as 40 mg dose in Indian patients with ACS.

Ameloblastic fibroma in six-year-old male: Hamartoma or a true neoplasm.

Ameloblastic fibroma (AF) is an uncommon true mixed odontogenic tumor with a relative frequency between 1.5% and 4.5%. Recently, it has been proposed that two subtypes of AF exist: A neoplasm and a hamartomatous lesion. We report a case of AF in left mandibular posterior region in a 6-year-old male patient. The tumor showed unusual and aggressive features that suggested it was a true neoplasm.