Evaluation of safety and efficacy of zonisamide in adult patients with partial, generalized, and combined seizures: an open labeled, noncomparative, observational Indian study.

A prospective, multicentric, noncomparative open-label observational study was conducted to evaluate the safety and efficacy zonisamide in Indian adult patients for the treatment of partial, generalized, or combined seizures. A total of 655 adult patients with partial, generalized, or combined seizures from 30 centers across India were recruited after initial screening. Patients received 100 mg zonisamide as initiating dose as monotherapy/adjunctive therapy for 24 weeks, with titration of 100 mg every 2 weeks if required. Adverse events, responder rates, and seizure freedom were observed every 4 weeks. Efficacy and safety were also assessed using Clinicians Global Assessment of Response to Therapy and Patients Global Assessment of Tolerability to Therapy, respectively. Follow-up was conducted for a period of 24 weeks after treatment initiation. A total of 655 patients were enrolled and received the treatment and 563 completed the evaluation phase. A total of 20.92% of patients received zonisamide as monotherapy or alternative monotherapy and 59.85% patients received zonisamide as first adjunctive therapy. Compared with baseline, 41.22% of patients achieved seizure freedom and 78.6% as responder rate at the end of 24 week study. Most commonly reported adverse events were loss of appetite, weight loss, sedation, and dizziness, but discontinuation due to adverse events of drug was seen in 0.92% of patients. This open label real-world study suggests that zonisamide is an effective and well-tolerated antiepileptic drug in Indian adults for treatment of partial, generalized as well as combined seizures type. No new safety signals were observed.

Reduction of post-prandial hyperglycemia by mulberry tea in type-2 diabetes patients.

AIM: The dietary contents have a very important role in the management of metabolic syndrome along with type 2 diabetes mellitus (T2DM). Indian diet contains a large amount of carbohydrates that set off unpredictable blood sugar fluctuations and leads to increased risk of diabetic complications. The aim of the present study was to identify the effect of mulberry tea in the reduction of abnormally high postprandial blood glucose (PPG) levels in T2DM patients. METHODS: The study design was follow-up T2DM, 20 diabetic patients were given plain tea (control) and 28 diabetic patients were given mulberry tea (test subject) to measure the effect of mulberry tea on fasting blood glucose and PPG levels. Fasting blood glucose samples were collected after a standard breakfast. The PPG levels were recorded after the consumption of 70 ml tea along with 1 teaspoon of sugar after 90 min in all 48 patients. RESULTS: Fasting blood glucose levels in control and test group samples were found to be 178.55 ± 35.61 and 153.50 ± 48.10, respectively. After the consumption of plain tea and mulberry tea, the PPG values were recorded as 287.20 ± 56.37 and 210.21 ± 58.73, respectively. A highly significant (p < 0.001) change in the PPG level was observed in response to mulberry tea in all the test patients compared with control. Moreover, the effect size was also found to be very large (1.31). CONCLUSION: Mulberry tea suppresses postprandial rise of blood glucose levels after 90 min of its consumption.

Correlation of Toll-like receptor 4, interleukin-18, transaminases, and uric acid in patients with chronic periodontitis and healthy adults.

BACKGROUND: Because of the potential association between periodontal disease and inflammation, the purpose of the present study is to examine the level of Toll-like receptor 4 (TLR-4), interleukin-18 (IL-18), and uric acid as markers of the inflammatory host response in the plasma and saliva of healthy individuals and patients with periodontitis. In addition, routine biochemical parameters such as fasting glucose, insulin, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, alanine transaminase (ALT), and aspartate transaminase (AST) were measured. The authors also wanted to check whether patients with chronic periodontitis (CP) exhibit different modulations in salivary and/or plasma concentrations of these parameters compared with clinically healthy individuals. METHODS: Saliva and plasma samples were collected from 40 patients with CP and 20 healthy individuals. TLR-4 and IL-18 measurements were done using commercially available enzyme-linked immunosorbent assay kits. Total, HDL, and LDL cholesterol; triglycerides; fasting glucose; AST; and ALT levels were analyzed on a biochemistry analysis system using specific kits. Non-parametric tests were used for certain parameters in the statistical analyses because the data did not follow Gaussian distribution. RESULTS: Significant differences were observed in plasma and salivary TLR-4 and IL-18 levels, along with clinical measurements such as plaque index and probing depth, in patients with CP (P < 0.001). The plasma level of TLR-4 was found to be increased from 0.99 to 3.28 ng/mL in patients with CP. Salivary TLR-4 levels also showed a slightly higher increase in the diseased state (12.44 to 29.97 ng/mL). A significant increase of ≈ 46% was recorded in the plasma IL-18 level. However, salivary IL-18 levels rose up to > 5-fold in the patients with CP compared with healthy individuals. The level of plasma uric acid was found to be highly significantly increased compared with control individuals. HDL cholesterol and triglyceride also showed significant differences (P < 0.02 and P < 0.03, respectively). Plasma glucose, total cholesterol, LDL cholesterol, and insulin levels did not show any significant difference. There was only a slight increase in plasma AST and ALT levels between diseased and healthy states (22.55 versus 25.50 IU/L and 12.35 versus 15.95 IU/L, respectively). However, salivary AST and ALT levels showed a ≈ 6-fold rise in the patients with CP compared with the healthy individuals. Cross-correlation analysis in the periodontitis disease group showed a significant association of plasma AST, salivary AST, and salivary ALT with uric acid level. CONCLUSIONS: Based on this study, the authors believe that TLR-4, IL-18, and uric acid could have a role in the inflammatory pathology of periodontitis. These parameters are suggested to be useful in the prognosis and diagnosis of CP. However, the mechanistic association of these parameters with inflammatory pathology of patients with periodontitis needs to be further elucidated in a higher number of samples.

Comparative study of non-high density lipoproteins cholesterol level and lipid profile in pre-diabetic and diabetic patients.

OBJECTIVES: The present study compares the role and significance of non-high density lipoproteins (non-HDL) cholesterol level in pre-diabetic and diabetic patients. This study also compares non-HDL cholesterol level between males and females and with different age groups as well. METHODS: An observational study was conducted among 3830 randomly selected individuals to envisage the association of non-HDL cholesterol and other lipid parameters with age, gender, and diabetic status. On the basis of health status, the subjects were classified as diabetic, pre-diabetic and normal. Fasting blood samples were collected and analyzed on Roche p-800 modular system. Total cholesterol, high density lipoproteins (HDL), low density lipoproteins (LDL) and fasting triglycerides were also measured. From the above mentioned parameters, the level of non-HDL cholesterol level was also calculated. RESULTS: Significant association was observed with non-HDL cholesterol level and all other studied lipid parameters (total cholesterol, HDL, LDL and triglycerides) compared with age and gender of the subjects studied. Moreover, the calculated non-HDL level, total cholesterol and triglycerides were found to be significantly co-related with diabetic status of the patients involved in the study. However, HDL and LDL values did not show any significant association with diabetic status of the patients. CONCLUSION: In this study, we found that age and gender of the studied subjects are associated with non-HDL cholesterol. Moreover, our data clearly indicates the positive association of non-HDL cholesterol level with pre-diabetic and diabetic status of the patients. Based on our study, we recommend estimation of non-HDL level in routine clinical practice to differentiate pre-diabetic and diabetic patients.