Retrospective Observational Study on Assessing Sitagliptin and Dapagliflozin as a Fixed-Dose Combination in the Indian Population With Type 2 Diabetes Mellitus: The SIDAXA Study.

Introduction Type 2 diabetes mellitus (T2DM), a prevalent chronic metabolic disorder, necessitates multifaceted treatment approaches. Emerging studies highlight the cardiovascular advantages of sodium-glucose transport protein 2 (SGLT2) and dipeptidyl peptidase 4 (DPP-4) inhibitors in T2DM. This investigation delves into the synergistic effects of the fixed-dose combination (FDC) of sitagliptin and dapagliflozin, offering insights into its safety and efficacy for the Indian population. Methods This real-world, retrospective, observational study spanned 328 cases across 111 Indian centres, evaluating the safety, efficacy, and clinical utilization of the sitagliptin and dapagliflozin FDC in T2DM patients after obtaining ethical approval. Assessments at baseline, week four, and week 12 encompassed hemoglobin A1C (HbA1C), fasting plasma glucose (FPG), postprandial blood glucose (PPBG), low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), and weight change. The statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 29.0.1.0(171) (IBM Corp., Armonk, NY, USA) with a significance level p<0.05. Results Study participants [mean age: 51.14±5.55 years, 77.74% (n=255) males, 22.26% (n=73) females] exhibited prevalent risk factors like sedentary lifestyle (n=167, 50.91%) and smoking (n=147, 44.82%). Comorbidities included hypertension (n=235, 71.65%) and dyslipidaemia (n=139, 42.38%). Metformin (n=282, 85.98%) and sulfonylurea (n=134, 40.85%) were commonly prescribed concomitant oral antidiabetic agents (OADs). FDC administration significantly reduced HbA1c by 1.05 ± 0.83% (p < 0.0001) at week 12. FPG and PPBG showed significant reductions of 22.98 ± 22.23 mg/dL (p < 0.0001), 165.50 ± 37.02 mg/dL and 40.94 ± 36.04 mg/dL (p < 0.0001) at four weeks respectively. By week 12, significant reductions were noted in SBP (14.61±13.98mmHg reduction, p-value <0.0001), DBP (7.80±8.45mmHg reduction, p-value <0.0001), and LDL-C levels (18.14±23.95 mg/dL reduction, p-value <0.0001). In patients with established cardiovascular disease, there was reduction in HbA1c levels by 1.02 ± 0.63% after 12 weeks, with FPG decreasing by 54.52 ± 32.67 mg/dL and PPBG decreasing by 88.73 ± 44.90 mg/dL. Treatment-emergent adverse events included headache, changes in micturition, genital mycotic infection, and nausea and diarrhoea which were mild, transient, and necessitated no treatment discontinuation. Conclusion The FDC of sitagliptin and dapagliflozin significantly improved glycaemic control and lipid profiles in T2DM patients, particularly those with coronary artery disease. It demonstrated a favourable safety profile in the Indian population, signifying its potential as an effective and well-tolerated therapeutic option in patients with established cardiovascular disease.

Real-World Assessment of Personalized Approach With Voglibose Fixed-Dose Combination in Type 2 Diabetes Mellitus.

BACKGROUND: Post-prandial hyperglycemia (PPHG) remains a complex aspect in the management of type 2 diabetes mellitus (T2DM) in the Indian population due to uncertainty in the optimal utilization of alpha-glucosidase inhibitors (AGIs) either as standalone therapy or in combination, whether initiated initially or as a sequential therapy. METHODS: This was a post-approval, observational, multicentric clinical study conducted at 50 centers according to principles of the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki and local ethics approval. Descriptive and analytical statistics were applied for conclusion and categorical variables using SPSS version 29.0.1.0 (171) (Armonk, NY: IBM Corp.). RESULTS: Protocol analyses of 515 cases revealed baseline demographics as follows: age 57.35±10.04 years, weight 72.86±10.92 kg, and BMI 28.33±6.07 kg/m2. Comorbidities included hypertension (N=169, 32.82%), thyroid disorders (N=99, 19.22%), and heart failure (N=92, 17.86%). Concomitant oral antidiabetics (OADs) prescribed as DPP4i (9.50%), SGLT2i (19.20%), and DPP4i+SGLT2i (7.20%). Study drug reduced glycosylated hemoglobin (HbA1c) by 13.77% (1.25% mean change, p<0.01), fasting blood glucose (FBG) by 23.69% (44.61 mg/dL mean change, p<0.01), post-prandial blood glucose (PPBG) by 24.57% (70.46 mg/dL mean change, p<0.01), and body weight by 4.43% (3.21 kg mean change, p<0.01) over 12 weeks. A total of 161 patients accomplished targeted PPBG of <180 mg/dL (119.13 mg/dL mean change, p<0.01). Regression analysis considering PPBG and HbA1c ≤7.5% showed a weak correlation between them (R-value=0.13, R-squared value=0.02), whereas between PPBG and HbA1c ≤9% yielded moderate positive correlation (R-value=0.53, R-squared value=0.28). There were no adverse events reported or analyzed during the observation period. CONCLUSION: Voglibose fixed-dose combination (FDC) demonstrates significant effectiveness at the initial dosage when started early in the management of T2DM and high PPBG levels. Moreover, it exhibits good tolerability, thereby contributing to higher compliance among Indian patients who consume a high-carbohydrate diet.

Mannose-binding lectin gene 2 variant DD (rs 5030737) is associated with susceptibility to COVID-19 infection in the urban population of Patna City (India).

The study aimed to measure plasma levels of Mannose-Binding Lectin (MBL) and MBL-associated serine protease-2 (MASP-2) and their polymorphisms in COVID-19 patients and controls to detect association. As MBL is a protein of immunological importance, it may contribute to the first-line host defence against SARS-CoV-2. MBL initiates the lectin pathway of complement activation with help of MASP-1 and MASP-2. Hence, appropriate serum levels of MBL and MASPs are crucial in getting protection from the disease. The polymorphisms of MBL and MASP genes affect their plasma levels, impacting their protective function and thus may manifest susceptibility, extreme variability in the clinical symptoms and progression of COVID-19 disease. The present study was conducted to find plasma levels and genetic variations in MBL and MASP-2 in COVID-19 patients and controls using PCR-RFLP and ELISA, respectively.The present study was conducted to find plasma levels and genetic variations in MBL and MASP-2 in COVID-19 patients and controls using PCR-RFLP and ELISA, respectively. Our results indicate that median serum levels of MBL and MASP-2 were significantly low in diseased cases but attained normal levels on recovery. Only genotype DD was found to be associated with COVID-19 cases in the urban population of Patna city.

Predictors of Mortality among Patients Hospitalized with COVID-19 during the First Wave in India: A Multisite Case-Control Study.

Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused more than 6 million deaths globally. Understanding predictors of mortality will help in prioritizing patient care and preventive approaches. This was a multicentric, unmatched, hospital-based case-control study conducted in nine teaching hospitals in India. Cases were microbiologically confirmed COVID-19 patients who died in the hospital during the period of study and controls were microbiologically confirmed COVID-19 patients who were discharged from the same hospital after recovery. Cases were recruited sequentially from March 2020 until December-March 2021. All information regarding cases and controls was extracted retrospectively from the medical records of patients by trained physicians. Univariable and multivariable logistic regression was done to assess the association between various predictor variables and deaths due to COVID-19. A total of 2,431 patients (1,137 cases and 1,294 controls) were included in the study. The mean age of patients was 52.8 years (SD: 16.5 years), and 32.1% were females. Breathlessness was the most common symptom at the time of admission (53.2%). Increasing age (adjusted odds ratio [aOR]: 46-59 years, 3.4 [95% CI: 1.5-7.7]; 60-74 years, 4.1 [95% CI: 1.7-9.5]; and ≥ 75 years, 11.0 [95% CI: 4.0-30.6]); preexisting diabetes mellitus (aOR: 1.9 [95% CI: 1.2-2.9]); malignancy (aOR: 3.1 [95% CI: 1.3-7.8]); pulmonary tuberculosis (aOR: 3.3 [95% CI: 1.2-8.8]); breathlessness at the time of admission (aOR: 2.2 [95% CI: 1.4-3.5]); high quick Sequential Organ Failure Assessment score at the time of admission (aOR: 5.6 [95% CI: 2.7-11.4]); and oxygen saturation < 94% at the time of admission (aOR: 2.5 [95% CI: 1.6-3.9]) were associated with mortality due to COVID-19. These results can be used to prioritize patients who are at increased risk of death and to rationalize therapy to reduce mortality due to COVID-19.

Evaluation of C4b as an adjunct marker in symptomatic RT-PCR negative Covid-19 cases.

Introduction: Detecting low viral load has been a challenge in this pandemic, which has led to its escalated transmission. Complement activation has been implicated in pathogenesis of Covid-19 infection. Thus, evaluation of complement activation in suspected Covid-19 infection may help to detect infection and limit false negative cases thus limiting transmission of infection. We speculate that measuring C4b, produced from an activated complement system due to the presence of Covid-19 may help in its detection, even when the viral titers are low. Methods: Plasma C4b levels of symptomatic RT-PCR positive patients (cases, n = 40); symptomatic RT-PCR negative patients (n = 35) and asymptomatic RT-PCR negative controls (n = 40) were evaluated. Plasma C5b-9, IL-6, D-dimer and C1-Inhibitor (C1-INH) were also measured in cases and controls. ELISA kits were used for all measurements. Statistical analyses were carried out using Stata, version 12 (Stata Corp., Texas, USA). Results: C4b levels were found to be significantly increased in RT-PCR positive patients as compared to asymptomatic RT-PCR negative controls. RT-PCR negative but symptomatic patients still showed increased C4b levels. The significantly higher levels of C4b in cases with a cut-off value of ≥ 116 ng/ml with optimum sensitivity and specificity of 80% and 52% respectively is indicative of its possible use as an adjunct marker. Increased levels of D-dimer, IL6, along with decreased levels of C1-INH were found in cases compared to controls. Whereas, C5b-9 levels were not significantly raised in cases. Conclusions: The results of our study suggests that plasma C4b may help to detect infection in false negative cases of RT-PCR that escape detection owing to low viral load. However, to confirm it a large-scale study is needed. Supplementary Information: The online version contains supplementary material available at 10.1007/s12291-022-01033-z.

Lived Experience of Nurses in COVID-19 Units - A Phenomenological Study from Eastern India.

Introduction: Nurses are the frontline workers who had to play multiple functions like in acute care, community, etc. but, it was stated that COVID-19 has caused immense trauma to nurses globally. Methods: A descriptive phenomenological study to explore the lived experience of nurses working in COVID-19 units was conducted among nine senior nursing officers recruited by purposive homogenous sampling and interviewed with an open-ended interview guide by ensuring data saturation. COREQ guideline were adopted for this qualitative study. Results: Qualitative data were analysed using Giorgi's framework, and themes and sub-themes were derived. The major themes that emerged in the present study were "Reactions and preparation", "Feelings and satisfaction in active duty", "Role of a helping hand", "Working experience in PPE", and "Pandemic and socialization". Each theme had further sub-themes to classify the verbatims. Conclusion: Most of the nurses had anxiety and prepared themselves to play with fire, had unrealistic hope, and mixed emotions, kept their family away and intentionally concealed information to reduce family's fear, were satisfied with training and preparation, and had unpleasant experiences with PPE, had to restrict their social activities and felt social stigma. It also concludes with the recommendation that warrants the need to improve their professional quality of life and working conditions by safeguarding nurses' physical and mental health.

Early Determinants of Length of Hospital Stay: A Case Control Survival Analysis among COVID-19 Patients admitted in a Tertiary Healthcare Facility of East India.

BACKGROUND: Length of hospital stay (LOS) for a disease is a vital estimate for healthcare logistics planning. The study aimed to illustrate the effect of factors elicited on arrival on LOS of the COVID-19 patients. MATERIALS AND METHODS: It was a retrospective, record based, unmatched, case control study using hospital records of 334 COVID-19 patients admitted in an East Indian tertiary healthcare facility during May to October 2020. Discharge from the hospital (cases/survivors) was considered as an event while death (control/non-survivors) as right censoring in the case-control survival analysis using cox proportional hazard model. RESULTS: Overall, we found the median LOS for the survivors to be 8 days [interquartile range (IQR): 7-10 days] while the same for the non-survivors was 6 days [IQR: 2-11 days]. In the multivariable cox-proportional hazard model; travel distance (>16 km) [adjusted hazard ratio (aHR): 0.69, 95% CI: (0.50-0.95)], mode of transport to the hospital (ambulance) [aHR: 0.62, 95% CI: (0.45-0.85)], breathlessness (yes) [aHR: 0.56, 95% CI: (0.40-0.77)], number of co-morbidities (1-2) [aHR: 0.66, 95% CI: (0.47-0.93)] (≥3) [aHR: 0.16, 95% CI: (0.04-0.65)], COPD/asthma (yes) [ [aHR: 0.11, 95% CI: (0.01-0.79)], DBP (<60/≥90) [aHR: 0.55, 95% CI: (0.35-0.86)] and qSOFA score (≥2) [aHR: 0.33, 95% CI: (0.12-0.92)] were the significant attributes affecting LOS of the COVID-19 patients. CONCLUSION: Factors elicited on arrival were found to be significantly associated with LOS. A scoring system inculcating these factors may be developed to predict LOS of the COVID-19 patients.

Co-teaching: Exploring an Alternative for Integrated Curriculum.

PURPOSE: Currently, the curriculum of medical education is compartmentalized which makes achieving the expected outcome, a real challenge. Co-teaching, an existing concept in education, however, may be used in medical education for integrating the applied component while basic concepts are being taught. The hypothesis, "can co-teaching be an alternate for an integrated curriculum?" was explored in this study. Therefore, the present study was designed to compare the outcomes of co-teaching with the existing teaching methodology owing to the absence of integrated curriculum. METHODS: Co-teaching and conventional modules of topics Diabetes mellitus (DM) and Alcohol and liver disease (AL), were prepared and validated. 100 under graduate medical students were randomly assigned to groups A and B. Group A was taught DM by Conventional teaching (CT) and AL by Integrated Co-teaching (ICT) and Group B was taught DM by ICT and AL by CT. A knowledge assessment tool of 20 multiple choice items was administered to assess the pre, post and retention knowledge scores. Change between knowledge scores was analyzed using inferential statistics. RESULTS: Both conventional and co-teaching were significantly effective in increasing the knowledge scores (p = 0.0001) with no significant difference in learning outcomes (p = 0.59) between the two. However, co-teaching showed better knowledge retention compared to conventional teaching (p = 0.008). CONCLUSIONS: Co-teaching could be considered as a substitute for integrated curriculum as it enabled comparatively better retention of knowledge as revealed by the findings.

Anxiety Among Cancer Patients at Selected Hospital of Haryana.

The experience of being diagnosed with and treated for cancer is extremely stressful for most individuals involving a series of threats during diagnosis and treatment. The purpose of the study was to explore the anxiety among cancer patients. The study involved 100 cancer patients. Data was collected by using standardised tool i.e. state-trait anxiety inventory (STAI). Participants reported moderate low state-trait anxiety (36% and 34% of cancer patients were in moderate low anxiety level in state-trait anxiety inventory. respectively). The mean score for state-trait anxiety inventory was 92.74 with S.D ± 29.94 and mean percent as 57.96. The state anxiety was found associated with demographic variables that were: religious. activities (34.15) and importance of religious activities (21.33) and clinical variables were found to be associated with duration of diagnosis (26.23) and stage of disease (27.02) at 0.05 level of signficance. The trait anxiety was found associated with demographic variables (14.13), marital status (10.90); clinical variables were found to be associated with diagnosis (42.89), duration of diagnosis (27.64) and stage of disease (32.61) at 0.05 level of significance. So, it can be concluded that as duration and stage of disease increases stress level decreases and it was also affected by gender, marital status, diagnosis, duration and stage of disease.

Vitamin D: The "sunshine" vitamin.

Vitamin D insufficiency affects almost 50% of the population worldwide. An estimated 1 billion people worldwide, across all ethnicities and age groups, have a vitamin D deficiency (VDD). This pandemic of hypovitaminosis D can mainly be attributed to lifestyle (for example, reduced outdoor activities) and environmental (for example, air pollution) factors that reduce exposure to sunlight, which is required for ultraviolet-B (UVB)-induced vitamin D production in the skin. High prevalence of vitamin D insufficiency is a particularly important public health issue because hypovitaminosis D is an independent risk factor for total mortality in the general population. Current studies suggest that we may need more vitamin D than presently recommended to prevent chronic disease. As the number of people with VDD continues to increase, the importance of this hormone in overall health and the prevention of chronic diseases are at the forefront of research. VDD is very common in all age groups. As few foods contain vitamin D, guidelines recommended supplementation at suggested daily intake and tolerable upper limit levels. It is also suggested to measure the serum 25-hydroxyvitamin D level as the initial diagnostic test in patients at risk for deficiency. Treatment with either vitamin D2 or vitamin D3 is recommended for deficient patients. A meta-analysis published in 2007 showed that vitamin D supplementation was associated with significantly reduced mortality. In this review, we will summarize the mechanisms that are presumed to underlie the relationship between vitamin D and understand its biology and clinical implications.

In-vitro antimicrobial activity of Psidium guajava l. leaf extracts against clinically important pathogenic microbial strains

The methanol, acetone and N, N-dimethylformamide (DMF) fractions of leaves of Psidium guajava L. were evaluated for antibacterial and antifungal activity. Piperacillin and gentamicin were used as standards for antibacterial assay, while nystatin and flucanazole were used as standards for antifungal assay. 91 clinically important strains were used for the study which were both clinical isolates as well as identified strains. The antibacterial activity was more pronounced against gram-positive bacterial and fungal strains. Moderate activity was shown against the gram-negative bacterial strains studied.

Os extratos de folhas de Psidium guajava L. preparados com metanol, acetona e N,N-formamida foram avaliados quanto a sua atividade antibacteriana e antifúngica. Piperacilina e gentamicina foram empregadas como padrões de atividade antibacteriana e nistatina e fluoconazol com padrões de atividade antifúngica. O estudo foi desenvolvido com noventa e uma cepas de importância clínica, incluindo isolados clínicos e cepas identificadas. A atividade antibacteriana foi mais intensa contra as cepas de bactérias Gram positivas e de fungos. A atividade contra bactérias Gram negativas foi moderada.

Antibacterial activity of some plant extracts used in folk medicine.

In the present work, selected plants were screened for their potential antibacterial activity. For evaluating antibacterial activity, both aqueous and organic solvent methanol was used. The plants screened were Ocimum sanctum, Jatropha gossypifolia, Boerhavia diffusa, Azadirachta indica, Solidago virgaurea, and Commelina benghalensis. The antibacterial activity was assessed against six bacterial strains--Pseudomonas testosteroni, Staphylococcus epidermidis, Klebsiella pneumoniae, Bacillus subtilis, Proteus morganii, Micrococcus flavus. Agar disc diffusion method and Agar ditch diffusion method were used to study the antibacterial activity of all these plants. Ps. testosteroni and K. pneumoniae were the most resistant bacterial strains. A. indica showed strong activity against tested bacterial strains. Therefore, we conclude that A. indica may prove to be a promising agent, and further exploration into this compound should be performed to determine its full therapeutic potential. In addition, its leaf extract can also be used as a lead molecule in combating the diseases caused by the studied bacterial strains.