Background: The potential for PPAR agonists to positively affect risk of cardiovascular disease in patients with type 2 diabetes (T2DM) is of persistent attention. The PRESS XII study primarily aimed to evaluate the efficacy and safety of saroglitazar (2 mg and 4 mg) as compared to pioglitazone 30 mg on glycemic control in patients with type 2 diabetes mellitus. Methods: In this randomized double-blind study, patients with T2DM [glycosylated hemoglobin (HbA1c) ≥ 7.5%] were enrolled from 39 sites in India. Patients received once-daily doses of either saroglitazar or pioglitazone (1:1:1 allocation ratio) for a total of 24 weeks. Patients were continued in a double blind extension period for an additional 32 weeks. Efficacy evaluations of glycemic parameters [HbA1c (Primary endpoint at week 24), FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B) were conducted at week 12, 24 and 56 and compared to the baseline levels. The efficacy analyses were performed by using paired t-test and ANCOVA model. Results: A total of 1155 patients were enrolled in this study. The baseline characteristics were similar between the three treatment groups. The within group mean (± SD) change in HbA1c (%) from baseline of the saroglitazar (2 mg and 4 mg) and pioglitazone treatment groups at week 24 were: − 1.38 ± 1.99 for saroglitazar 2 mg; − 1.47 ± 1.92 for saroglitazar 4 mg and − 1.41 ± 1.86 for pioglitazone, respectively. Statistically significant reduction from baseline in HbA1c was observed in each treatment group at week 24 with p-value < 0.016. There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016). Most of the AE's were 'mild' to 'moderate' in severity and were resolved by the completion of the study.
Objective: With COVID-19 pandemic severely affecting India and Ahmedabad city being one accounting for half COVID cases, objective was to determine disease course and severity of in patients at a COVID care hospital. Design: A Clinical trial registry of India registered observational study (CTRI/2020/05/025247). Setting: Certified COVID hospital located in Ahmedabad, Gujarat, India. Participants: 549 COVID positive patients hospitalized between 15 th May to 10 th August, 2020 and treated in ICU and non ICU settings. Main Outcome Measure: Comparative analysis of demographic, clinical characteristics, investigations, treatment, complications and outcome of COVID patients in ICU and non ICU settings. Results: Of the 549 hospitalized COVID positive patients, 159 were admitted in ICU during disease course while 390 had ward admissions. Overall median age was 52 (1-86) years. The ICU group was older (>65years), with associated comorbidities like hypertension and diabetes (p<0.001); higher proportion of males (79.25%); with dyspnea as a major clinical characteristic and consolidation in lungs as a major radiological finding as compared to ward patients. C - reactive protein, D-Dimer and Ferritin were higher in ICU patients. Overall 50% females depicted elevated Ferritin levels. Steriods(92.45%)and tocilizumab (69.18%) were more frequently used for ICU patients . Remdesivir was prescribed to both ICU and non ICU patients. Favirapir was also a line of treatment for 25% of ICU patients. Convalescent plasma therapy was given to 7 ICU patients. Complications like acute kidney injury (13.84%), shock (10.69 %), sepsis and encephalopathy were observed in ICU patients. Overall mortality rate was 5.47 % with higher mortality among males in comparison to females (p<0.0001). Conclusion: About 29% of overall patients required ICU admission that was commonly elderly males. Chances of ICU admission were higher with baselines comorbidities (1.5 times) and dyspnea (3.4 times) respectively. A multi-specialty COVID care team and updated treatment protocols improves outcomes.
Background: Epilepsy is a neurological condition characterized by the recurrence of paroxysmal episode of abnormal neuronal function. Epilepsy brings in undesirable social, psychological and economical consequences to its patients. In contrast to early onset of epilepsy in childhood, late onset of epilepsy is usually symptomatic; which usually responds well to antiepileptic drugs. Methods: A prospective study of 75 patients of late onset epilepsy was carried out to ascertain the etiology and to evaluate the usefulness of neuroimaging in late onset epilepsy. Results: We found that majority (72%) of patients of late onset epilepsy were male. About 65% of patients had abnormal CT scan-brain findings. Generalized seizure was the most common seizure type with about 59% cases. Conclusions: Generalized seizures are more common in idiopathic group of epilepsy whereas partial with or without secondary generalized seizures are more common in the symptomatic late onset epilepsy. The new neuroimaging techniques should be an integral part of investigation work up in all cases of epilepsy as they make it possible to find out the etiology in majority of cases. In late onset epilepsy, diagnostic usefulness of EEG is corroborative to CT and MRI.
Background: Pregnant females affected with COVID-19 are reported to have poorer disease outcomes as compared to non-pregnant females of a similar age group. COVID-19 may lead to adverse changes in the placenta, which needs to be studied. Methods: This is a case series of 63 pregnant women hospitalized with COVID-19 from May 2020 to February 2021.The primary outcomes were maternal death or complications. Results: 63 women were studied. 83.3% of women were in the age group of 26 to 35 years. 33% women had associated comorbidities. 68.3% of women tested positive in their third trimester, 15.9% and 11% tested positive in their second and first trimesters respectively. 73% women had mild disease and 27% women required oxygen support. 3/63 women died. One woman in the second and two women in the third trimester died respectively. Histopathological examination in 13 placentae (of 19 placentae examined) were suggestive of maternal and fetal malperfusion. Conclusion: Pregnant COVID-19 women may develop disease-related as well as obstetric complications.
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