Diacon Hospital

In India, the increasing prevalence of diabetes and obesity poses a significant threat towards a surge in the incidence of metabolic dysfunction‐associated steatotic liver disease (MASLD), formerly known as non‐alcoholic fatty liver disease (NAFLD). Concomitant with the evolving guidelines, there is a need to direct and spread awareness among practicing diabetologists to identify and screen high‐risk individuals for MASLD for timely management. Its asymptomatic nature and the evolving guidelines on diagnosis have hindered the precise estimates of MASLD in the high‐risk group of individuals in a clinical setting. Therefore, an expert panel of diabetologists from India convened to review, discuss and document the approach towards screening, diagnosis and management of MASLD. Serum biomarkers, simple non‐invasive tools and imaging techniques could direct the risk stratification of the patients. Early lifestyle interventions including weight loss and exercise are beneficial. The pharmacological landscape of drugs directed to insulin resistance, lipid metabolism, oxidative stress, inflammation, apoptosis and fibrogenesis pathways for the management of MASLD is expanding. In summary, the consensus statements are expected to serve as a useful guide in the screening and management of MASLD in the region and to direct a well‐planned study design that could enhance the scientific value of these statements.

The morbidity of type 2 diabetes mellitus (T2DM) is rising dramatically both at the national and international levels. In recent years, many novel medications are developed or in development for better management of hyperglycemia in people with T2DM. Focusing on the new promising molecules, here we aim to present the opinion of experts and their consensus on the use of imeglimin for the treatment of T2DM in India. Multiple advisory board meetings were conducted with six leading key opinion leaders (KOLs) in endocrinology and diabetes specialty across India to share their experiences, understand and discuss the real-world imeglimin treatment strategies, its effectiveness and safety in patients with T2DM. A novel oral antidiabetic drug (ADD), imeglimin, a tetrahydrotriazine compound of the "glimin" family, is currently being used in the treatment of T2DM. Its mode of action is unique when compared to other types of ADDs as it has a dual mode of action, which includes (1) improving the action of insulin and (2) reversing pancreatic β-cell dysfunction. Additionally, imeglimin has been associated with reduced hepatic steatosis, protection from β-cell apoptosis and stimulation of skeletal muscle glucose absorption. Efficacy and safety of imeglimin as a monotherapy is well demonstrated in treatment-naive patients when metformin is contraindicated or in patients who are intolerant to metformin, metformin failure, or as an add-on/combination with other oral antidiabetic drugs (OADs), mainly DPP4i, SGLT2i or insulin. The clinical efficacy of imeglimin is dose dependent, and it is observed that the efficacy of imeglimin 1,000 mg BID is >500 mg BID. This consensus paper presents the experts' opinion of their real-world clinical experiences on imeglimin treatment, its clinical efficacy, safety and their recommendations for better management of T2DM.

The study aimed at evaluating efficacy and safety of Remogliflozin etabonate and Vildagliptin fixed dose combination (FDC) compared to currently approved FDC of Empagliflozin and Linagliptin. A randomized, double-dummy, double-blind, active-controlled, parallel-group, two-arm, multi-center study was conducted at 26 sites across India. Type-2 diabetes mellitus (T2DM) patients aged between 18-65 years on metformin ≥1500 mg were randomized to receive either Remogliflozin Etabonate and Vildagliptin (RV) or Empagliflozin and Linagliptin (EL) with matched placebo. Results: A total of 400 study participants with T2DM who had inadequate glycemic control with stable metformin dose as monotherapy were enrolled. At end of study duration i.e. week 16, there was a statistically significant change from baseline in HbA1c levels in both the groups i.e. -1.38% in the RV group and -1.46% in the EL group (p <0.001). The difference between the RV group and EL group was -0.08% (90% CI difference: -0.28, 0.13). Similarly, statistically significant changes from baseline to week 16 in fasting plasma glucose (FPG) and post prandial glucose (PPG) levels were seen in RV group and EL group (p <0.001) with no statistically significant differences seen between the groups. The safety profile of both the FDC's were comparable. The FDC of Remogliflozin and Vildagliptin was found to be non-inferior to FDC of Empagliflozin and Linagliptin in terms of efficacy and safety. This FDC of Remogliflozin and Vildagliptin provides an alternative to the management of Indian T2DM patients requiring SGLT2 inhibitor and DPP4 inhibitor combination.

Abstract Festivals are integral to our cultural tapestry, uniting communities in celebration. However, for individuals living with diabetes, these vibrant occasions can present challenges to glycemic control. This review explores the intricate relationship between festivals and diabetes management. It highlights the need for awareness and knowledge dissemination to empower individuals with diabetes to partake in festivities without compromising their health. By striking a harmonious balance between cultural traditions and health-conscious practices, the article advocates for a joyful yet responsible approach to celebrating festivals for those with diabetes.

Hypertension is one of the common medical complications of pregnancy and contributes significantly to maternal and perinatal morbidity and mortality. Once the hypertension is diagnosed starting with antihypertensive therapy help to manage the outcomes of pregnancy, for both mother and baby. The main objective of the study is to assess prescribing patterns of antihypertensive drugs in pregnant women. It was a prospective observational study that was conducted for 4 months from November 2021 to February 2022. A total of 120 prescriptions were analyzed. Through the current study, we could assess the utilization of antihypertensive drugs in pregnant women. The study reveals that most of the patients having PIH were from Primi gravida in the age group 25-28 years old. The study also shows that Labetalol an alpha-beta blocker is mostly prescribed as monotherapy followed by Nifedipine a calcium channel blocker, or a combination of Labetalol with Nifedipine. Also according to the study, 12% of patients showed co-morbidities and the other 88% were without co-morbidities. Other than antihypertensive prescribed to maximum patients were a combination of several supplements that are protein powders, iron-calcium supplements (Protex powder, Anaport powder, LG-9 sachet, bio folate, calcium supplements, Hbcare, cc250, RG-9 sachet). The current study assessed that most of the patients showed mild to moderate preeclampsia that is blood pressure between 140-160 mmHg. It will help the prescriber to pay more attention to the outcomes of B.P. during pregnancy. If PIH can be treated rationally the complication of pregnancy that affect the mother and baby can be overcome and there would be a significant reduction in maternal and perinatal morbidity and mortality.

COVID-19 has created enormous health crisis in India due to limited available treatments. Majority of the physicians use sepsis as a prototype to understand the pathophysiology of COVID-19 as there are similarities. Heat-killed Mycobacterium w (Mw) (Inj. Mw®) is a known immunomodulator, which is approved for the treatment of gram-negative sepsis. This observational study was aimed to evaluate the role of Mw along with standard of care (SOC) in critically ill COVID-19 patients. Total 448 patients' data (intervention group: 298 in Mw plus SOC vs 150 in SOC alone) with reverse transcriptase-polymerase chain reaction (RT-PCR) confirmed critically ill COVID-19 patients who were admitted at five tertiary care centers were evaluated. They were observed for changes in laboratory [C-reactive protein (CRP), D-dimer, ferritin, lactate dehydrogenase (LDH), and interleukin-6 (IL-6)] parameters, hospital stay, intensive care unit (ICU) stay, and discharge status after giving 0.3 mL intradermal Mw for 3 consecutive days along with SOC during hospitalization. Standard of care included injectable steroids, remdesivir, and heparin. Data were analyzed using STATA 14.2 (StataCorp., College Station, Texas, USA). In baseline characteristics, Mw plus SOC arm had more critically ill patients as seen by higher high-resolution computed tomography (HRCT) score, higher lab values [CRP, ferritin, D-dimer, LDH, creatinine, alanine aminotransferase (ALT)], and more oxygen requirement as compared to SOC alone. Mycobacterium w arm had significantly higher mortality rate in ICU and hospital. Both hospital stay and ICU stay were longer in Mw arm. However, subgroup analysis found that early initiation of Mw (&lt;3 days vs &gt;3 days) was associated with significantly lesser odds of mortality and lesser odds of intubation requirement. Early initiation of Mw (&lt;3 days vs &gt;3 days) also resulted in significantly lesser duration of stay in the ICU along with reduction of CRP, D-dimer, and LDH. Moreover, further analysis of early initiation of Mw (&lt;3 days vs control) resulted in significant reduction in lab values (procalcitonin, CRP, ferritin, LDH, and D-dimer). Mw when added to SOC was found to associate with significantly increased risk of mortality and increased length of hospital stay. However, time since admission to administration of Mw was a significant predictor of in-ICU deaths in multivariate analysis. Early initiation of Mw (&lt;3 days) was observed to be a protective factor against ICU deaths from the multivariate logistic regression model. However, large randomized controlled trials are required to support the same.

IntroductionWe compared the efficacy, safety, and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (70% intermediate SAR341402 protamine and 30% rapid SAR341402 solution) (SARAsp-Mix) with its originator NovoMix 30 insulin aspart mix (NN-Mix) in adults with type 1 or type 2 diabetes switching from different premix insulin analogs.MethodsThis phase 3, randomized, open-label, multinational, 26-week trial (GEMELLI M) enrolled 402 participants with type 1 or type 2 diabetes. At randomization, participants switched from their prestudy premix insulin NovoMix 30 (n = 341) or Humalog Mix 25/Liprolog Mix 25 (n = 61) to equivalent (1:1) doses of either SARAsp-Mix or NN-Mix at least twice daily (1:1 randomization). In this subgroup analysis, efficacy measures [change in hemoglobin A1c (HbA1c), daily insulin dose], and safety outcomes [hypoglycemia incidence, adverse events (including hypersensitivity and injection site reactions), anti-insulin aspart antibodies] of SARAsp-Mix were compared with those of NN-Mix separately according to the participants’ prestudy premix insulin.ResultsAt week 26, change from baseline in HbA1c (primary efficacy endpoint) was similar between SARAsp-Mix and NN-Mix in those participants pretreated with NovoMix 30 [least squares (LS) mean difference 0.05%, 95% confidence interval (CI) −0.195% to 0.289%] or Humalog Mix 25/Liprolog Mix 25 (LS mean difference 0.28%, 95% CI −0.279% to 0.830%) (P value for treatment-by-subgroup interaction = 0.46). In both subgroups, safety outcomes, including immunogenicity, and changes in daily insulin doses were similar between treatments over 26 weeks.ConclusionsEfficacy, safety, and immunogenicity profiles of SARAsp-Mix are similar to NN-Mix over 26 weeks in adults with diabetes irrespective of prior type of premix insulin.Trial RegistrationEudraCT number 2017-000092-84.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01279-z.

IntroductionThis study compared the efficacy, safety, and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (SARAsp-Mix) with European-approved insulin aspart mix 70/30 − NovoMix® 30 (NN-Mix) in people with type 1 (T1D) or type 2 diabetes (T2D).MethodsThis 26-week, open-label, phase 3 trial enrolled 402 people with T1D (n = 105) or T2D (n = 297) previously treated with premix insulin, who were randomized (1:1) to SARAsp-Mix (n = 204) or NN-Mix (n = 198).ResultsAfter 26 weeks, the least squares (LS) mean [median] change in HbA1c from baseline was similar in both treatment groups (SARAsp-Mix − 0.55% [− 0.60%]; NN-Mix − 0.64% [− 0.60%]). The LS mean difference for SARAsp-Mix versus NN-Mix was 0.08%, with the upper bound of the two-sided 95% confidence interval (− 0.139 to 0.303) slightly above the prespecified noninferiority margin of 0.3%. Noninferiority of SARAsp-Mix over NN-Mix was not demonstrated in the primary intent-to-treat analysis, primarily because of one extreme outlying value impacted by the COVID-19 pandemic in the SARAsp-Mix group. Noninferiority was achieved in all secondary analyses, including prespecified per-protocol supportive and COVID-19 sensitivity analyses, as well as post hoc sensitivity analyses. Other efficacy endpoints, insulin dosages, anti-insulin aspart antibody response, hypoglycemia, and adverse events were similar between groups.ConclusionsThe totality of evidence indicates that SARAsp-Mix provides effective glycemic control with a similar safety and immunogenicity profile to NN-Mix in people with diabetes treated for 26 weeks.Trial RegistrationEudraCT number 2017-000092-84.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01255-7.

Introduction: From the moment of conception the human being is predisposed to undergo changes in fetal and neonatal development due to various external factors that occur throughout life and can in the long term influence the phenotypic expression of the new being. Objective: The objective of this work is to determine the relationship between the environment, nutrition, genetics, epigenetics and microbiota with neonatal fetus development and how they influence the phenotypic expression of the new being. Methods: A non-systematic search was performed in electronic databases such as COCHRANE, PUBMED, MEDLINE, etc. The bibliographic research was carried out in the period between October 2019 and January 2020. The studies carried out from 2007 to 2019, in the languages of Spanish and English, were included. Results: We found 51 bibliographic sources related to the subject, of which by means of a last simplification, 30 scientific articles were used that provided important information on the subject, and 21 articles were excluded. Conclusion: Research on methods to detect these interactions and to understand the mechanisms of these interactions is just beginning. However, there is evidence that they play an important role in human development. Keywords: neonatal development, epigenetics, microbiota, fetal development, nutrition. RESUMEN Introducción: Desde el momento de la concepción el ser humano está predispuesto a sufrir cambios en el desarrollo fetal y neonatal debido a diversos factores externos que se presentan a lo largo de la vida y pueden a largo plazo influir en la expresión fenotípica del nuevo ser. Objetivo: El objetivo del presente trabajo es determinar la relación que existe entre el medio ambiente, nutrición, genética, epigenética y microbiota con el desarrollo feto neonatal y como los mismos influyen en la expresión fenotípica del nuevo ser. Métodos: Se realizó una búsqueda no sistemática en bases de datos electrónicas como COCHRANE, PUBMED, MEDLINE, etc. La investigación bibliográfica se realizó en el periodo comprendido entre octubre 2019 y enero 2020. Se incluyeron estudios realizados desde el año 2007 hasta el año 2019, en los idiomas de español e inglés. Resultados: Se encontraron 51 fuentes bibliográficas referentes al tema, de los cuales mediante una última simplificación se utilizaron 30 artículos científicos que aportaron información importante del tema y se excluyeron 21 artículos. Conclusiones: La investigación sobre métodos para detectar estas interacciones y para comprender los mecanismos de estas interacciones apenas está comenzando. Sin embargo, hay evidencia de que estas juegan un papel importante en el desarrollo humano. Palabras clave: desarrollo neonatal, epigenética, microbiota, desarrollo fetal, nutrición.