Effect of carbamazepine and oxcarbazepine on serum neuron-specific enolase in focal seizures: A randomized controlled trial.

Neuron-specific enolase (NSE) is the most investigated biomarker in the context of epilepsy and brain damage. The present study was conducted to investigate the change in serum NSE in patients with focal seizure and the effect of carbamazepine and oxcarbazepine on serum NSE. The present study is a randomized, open-label, parallel design clinical trial (ClinicalTrials.gov Identifier: NCT02705768) conducted on 60 patients of focal seizure. After recruitment, detailed history, clinical evaluations including Chalfont-National Hospital seizure severity scale (NHS3), Quality of Life in Epilepsy Inventory (QOLIE-31) and serum NSE estimation were done at baseline. Thirty healthy volunteers were recruited for a baseline evaluation of serum NSE. After randomization, one group received tablet oxcarbazepine and another group received tablet carbamazepine. At 4 weeks follow-up, all the parameter were reassessed. Serum NSE level was found to be significantly increased in patients with focal seizure in comparison to healthy volunteers. In both drug groups, serum NSE decreased significantly but the reduction in carbamazepine group (1.43; 95%CI: 0.18-2.67; p=0.025) was significantly higher than oxcarbazepine group.NHS3 score, score in all seven domains of QOLIE-31 and final QOLIE-31 score improved significantly in both the groups. In conclusion, serum NSE increases in the patients with focal seizure within 48h of a seizure episode. Therapy with carbamazepine and oxcarbazepine can decrease serum NSE level but the reduction is significantly higher with carbamazepine. Therapy with both the drugs can decrease the severity of epilepsy and improve the quality of life but adverse events were more with carbamazepine.

Efficacy and Safety of Tazarotene 0.1% Plus Clindamycin 1% Gel Versus Adapalene 0.1% Plus Clindamycin 1% Gel in Facial Acne Vulgaris: A Randomized, Controlled Clinical Trial.

BACKGROUND: Acne vulgaris is a multifactorial disorder which is ideally treated with combination therapy with topical retinoids and antibiotics. OBJECTIVES: The present study was conducted to compare the efficacy and safety of tazarotene plus clindamycin against adapalene plus clindamycin in facial acne vulgaris. METHODS: This study is a randomized, open-label, parallel design clinical trial conducted on 60 patients with facial acne at the outpatient dermatology department in a tertiary healthcare center. The main outcome measures were change in the acne lesion count, Investigator's Static Global Assessment (ISGA) score, Global Acne Grading System (GAGS) score, and Acne-Specific Quality of Life Questionnaire (Acne-QoL) at the end of 4 weeks of therapy. After randomization one group (n = 30) received tazarotene 0.1% plus clindamycin 1% gel and another group (n = 30) received adapalene 0.1% plus clindamycin 1% gel for 1 month. At follow-up, all the parameter were reassessed. RESULT: In both treatment regimens the total number of facial acne lesions decreased significantly. The difference in the change in the total count between the two combination regimens was also significant [6.51, 95% confidence interval (CI) 1.91-11.09, p = 0.007]. A ≥50% reduction in the total lesion count from the baseline levels was achieved by 71% of patients in the tazarotene plus clindamycin group and 22% of patients in the adapalene plus clindamycin group (p = 0.0012). The difference in the change of inflammatory (p = 0.017) and non-inflammatory (p = 0.039) lesion counts in the tazarotene plus clindamycin group were significantly higher than the adapalene plus clindamycin group. The difference in change of the GAGS score was also significantly higher in the tazarotene plus clindamycin group (p = 0.003). The ISGA score improved in 17 patients in the tazarotene plus clindamycin group versusnine patients in the adapalene plus clindamycin group (p = 0.04). The change of total quality-of-life score was found to be significantly (p = 0.027) higher in the tazarotene plus clindamycin group. CONCLUSIONS: Both treatment regimens were efficacious, but tazarotene plus clindamycin was found to be superior to adapalene plus clindamycin. The tolerability profile of both regimens was comparable. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02721173.

Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor in Bipolar Mania: An Exploratory Study.

OBJECTIVE: In bipolar disorder, serum brain-derived neurotrophic factor (BDNF) level decreases leading to dysfunctions of critical neurotrophic, cellular plasticity and neuroprotective processes. The present study was conducted to evaluate the change in serum BDNF level with oxcarbazepine monotherapy in bipolar mania. METHODS: The present study is a prospective, interventional, open label clinical study conducted on 25 patients of bipolar mania and 25 healthy controls. Detailed history, clinical evaluation including Young Mania Rating Scale (YMRS) scoring and serum BDNF were assessed at baseline for all 50 subjects. The bipolar patients were prescribed tablet oxcarbazepine and followed up after 4 weeks for clinical evaluation and re-estimation of serum BDNF and YMRS scoring. RESULTS: The serum BDNF level in bipolar manic patients were compared with healthy controls at baseline and results revealed that there is a significant reduction (p=0.002) in serum BDNF level in bipolar patients. At follow-up after 4 weeks, the mean change in serum BDNF in bipolar group who were on oxcarbazepine monotherapy was found statistically significant (p=0.02) in comparison to healthy controls. In bipolar group, the YMRS score and serum BDNF at baseline have an inverse relation(r=-0.59) whereas change of the YMRS score had a positive correlation (r=0.67) with the change of serum BDNF over 4 weeks. CONCLUSION: In bipolar mania serum BDNF level is low and it is found to be increased with short term monotherapy with oxcarbazepine.

Effect of Atorvastatin on Glycaemic Parameters in Normoglycaemic and Prediabetic Subjects: A Prospective, Panel Study.

INTRODUCTION: Type 2 diabetes is associated with obesity and dyslipidemia, which are risk factor for cardiovascular disease. With recent FDA approved indications for statins being widened because of its lipid lowering and pleiotropic effects, statins are currently amongst the most widely used drugs in patients with or without diabetes. Although cardiovascular risk is reduced by statin therapy, its association with the development of diabetes is disputed. AIM: This study was conducted to evaluate the effect of Atorvastatin on glycaemic status of normoglycaemic and prediabetic individuals. MATERIALS AND METHODS: An observational, prospective panel study was conducted on 75 subjects who were on Atorvastatin therapy. After baseline data collection and investigations, subjects were recruited depending on their glycaemic status into three groups: normoglycaemic, Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT) group. Atorvastatin therapy was continued and the subjects were followed every 6 months up to 18 months. At every follow up all glycaemic parameters were evaluated and subjects were assessed for continuation of statin therapy, dosing schedule and possible adverse drug reactions. RESULT: All three groups as a whole, irrespective of dose of Atrovastatin therapy, showed a statistically significant (p<0.0001) increase in all glycaemic parameters. In normoglycaemic group with low dose Atorvastatin, there was no significant change in 2-hour Post Prandial Blood Sugar (PPBS) but change in HbA1c% (p=0.0004) and FBS (p<0.0001) was significant, whereas, with high dose, changes in 2-hr PPBS and HbA1c % were significant from 6 months onwards. In IFG group, both with low and high dose of Atorvastatin, there was significant change in all glycaemic parameters from 12 months onwards. In case of IGT, especially with high dose Atorvastatin, significant changes were evident from 6 months onwards. CONCLUSION: Atorvastatin therapy especially with higher dose was found to be associated with glucose intolerance in normoglycaemics and also caused progression towards diabetes in prediabetic individuals.