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Background: Post-COVID syndromes are the most abundant sequel of coronavirus disease of 2019 (COVID-19) infection, which affects millions of people around the whole world. There is a significant difference observed during the acute phase as well as during the post-COVID period between patients hospitalized with (alpha, delta, or omicron) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant. In the present scenario, when most people are vaccinated, COVID-19 disease is less likely, but the remnants of previous COVID-19 infections are still a vast health burden. Materials and methods: This prospective, observational, comparative, and analytical study included a total of 3,840 COVID-19-infected patients who visited the hospital. We included 1,150 patients of alpha variants, 1,845 patients of delta variants, and 815 patients of omicron variants, from June 2020 to November 2020, March 2021 to July 2021, and January 2022 to May 2022, respectively. All medical data of the study population, including hospital stay and vaccination status, were collected, and all patients were followed up for 6 months of duration. All collected data were compiled and analyzed to compare the post-COVID thrombotic and other events among different variants of COVID-19. Results: Patients infected during the delta variant are the most symptomatic at onset (higher prevalence of fever, dyspnea, cough, myalgia, headache, or gastrointestinal problems) than those infected with the alpha or omicron variant (p < 0.01). A total of 2,830 patients (7.48%) [1,520 (82.38%) of delta variant, 598 (73.37%) of omicron variant, and 712 (60.34%) of omicron variant] developed post-COVID syndrome during their follow-up period out of 3,220 enrolled patients and the difference was statistically significant when compared among variants (p < 0.05). In this study, the highly prevalent post-COVID syndrome was mucormycosis (11.41%), followed by new-onset diabetes (9.89%), pulmonary fibrosis (7.67%), ischemic heart disease (6.46%), brain stroke (3.29%), and other thromboembolic disorders (2.37%). Conclusion: COVID-19-associated onset symptoms during the delta variant were more severe and highly prevalent, while neurological symptoms (aguesia and anosmia) were more common during the alpha variant. Patients infected with the delta variant of COVID-19 are more prone to develop post-COVID-associated complications with minimal risk in the omicron variant and intermediate risk in the alpha variant. Long COVID-19 requires specific attention for management, irrespective of the SARS-CoV-2 variant.
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The prevalence of prediabetes, a forerunner of diabetes is very high, and its conversion to diabetes is also more rapid among Asian Indians. Prediabetes also predisposes to the development of macrovascular and to a lesser extent of microvascular complications of diabetes. In a large community-based epidemiological study, the Indian Council of Medical Research–India Diabetes (ICMR–INDIAB), data reported an overall prevalence of prediabetes of 10.3%, derived from 15 Indian states. This shows that the diabetes epidemic is far from over as many of them may soon convert to diabetes. Prediabetes, however, should not be considered a path to diabetes rather it should be a window of opportunity for the prevention of diabetes. This early screening, detection, and treatment of prediabetes should be made a national priority. Several countries have introduced lifestyle programs to prevent diabetes and, when indicated, pharmacological intervention with metformin as well. This consensus statement outlines the approaches to screening and lifestyle and pharmacological management of prediabetes in Asian Indians.
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Lipid-lowering therapy plays a crucial role in reducing adverse cardiovascular (CV) events in patients with established atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia. Lifestyle interventions along with high-intensity statin therapy are the first-line management strategy followed by ezetimibe. Only about 20–30% of patients who are on maximally tolerated statins reach recommended low-density lipoprotein cholesterol (LDL-C) goals. Several factors contribute to the problem, including adherence issues, prescription of less than high-intensity statin therapy, and de-escalation of statin dosages, but in patients with very high baseline LDL-C levels, including those with familial hypercholesterolemia and those who are intolerant to statins, it is critical to expand our arsenal of LDL-C-lowering medications. Moreover, in the extreme risk group of patients with an LDL-C goal of ?30 mg/dL according to the Lipid Association of India (LAI) risk stratification algorithm, there is a significant residual risk requiring the addition of non-statin drugs to achieve LAI recommended targets. This makes bempedoic acid a welcome addition to the existing non-statin therapies such as ezetimibe, bile acid sequestrants, and PCSK9 inhibitors. A low frequency of muscle-related side effects, minimal drug interactions, a significant reduction in high-sensitivity C-reactive protein (hsCRP), and a lower incidence of new-onset or worsening diabetes make it a useful adjunct for LDL-C lowering. However, the CV outcomes trial results are still pending. In this LAI consensus document, we discuss the pharmacology, indications, contraindications, advantages, and evidence-based recommendations for the use of bempedoic acid in clinical practice.
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Introduction: Nonalcoholic fatty liver disease (NAFLD) has become a leading cause of liver disease worldwide. The prevalence of NAFLD varies depending on population studied and type of diagnostic tools used to screen or diagnose the patients. There is a strong relationship between metabolic syndrome components and NAFLD prevalence. This study aims to understand the prevalence of NAFLD along with the associated risk factors and their interaction with other comorbidities among people living with diabetes in Indian context. Materials and methods: It is a retrospective, observational study based on data retrieved from electronic medical records (EMRs) of people living with diabetes from more than 250 individual diabetes centers located in more than 30 cities across 14 states in India. Medical records of 171,996 adults living with diabetes were included in the analysis. The assessment of prevalence of NAFLD in diabetes was done using algorithm based on alanine transaminase (ALT) and aspartate aminotransferase (AST). Results: Overall, 44.48% of people living with diabetes were found to have NAFLD. A significantly higher proportion of males (58.64%) had NAFLD compared to females (36.91%) (p<0.001). Nonalcoholic fatty liver disease prevalence was >50% in seven of the states. People living with diabetes along with dyslipidemia and hypertension had a significantly higher prevalence of NAFLD (p<0.001). Obesity (57.1%), dyslipidemia (59.1%), and hypertriglyceridemia (42.3%) had significantly higher odds of NAFLD among people living with diabetes. Conclusion: This study highlighted high-risk categories for NAFLD in diabetes, like young, obese, hypertriglyceridemia, poor glycemic control, etc. This information will help health care providers in prioritizing screening among high-risk diabetes population.
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Background: The available evidence was systematically reviewed to evaluate the effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors (SGLT2i) on cardiovascular (CV) and renal outcomes in people with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors (MRF), with or without heart failure (HF), and per estimated glomerular filtration rate (eGFR) rate at baseline. Methods: We comprehensively searched three electronic databases to retrieve publications up to 30th November 2019, which were screened for inclusion. The data extracted for the outcomes according to baseline ASCVD, HF, and eGFR levels were meta-analyzed using fixed effects model. Results: Of the 735 screened citations, 15 primary and secondary publications from five CV or renal outcome trials were included. SGLT2is reduced the risk of CV death or hospitalization for HF (HHF), HHF alone, and composite renal-specific outcome, irrespective of ASCVD and HF at baseline. The three-point major adverse cardiovascular events (3P-MACE) risk was reduced by 14% (p<0.001) in patients with ASCVD and by 10% (p = 0.018) in those without baseline HF compared with their counterparts. SGLT2is significantly reduced the risk of MACE (18%) in patients with mild kidney dysfunction (eGFR within the range of 60–<90 mL/min/1.73 m2 and <60 mL/min/1.73 m2 ). Conclusion: SGLT2is are effective for both secondary and primary prevention of composite CV outcomes, and secondary prevention of MACE. The upcoming evidence may strengthen the primary prevention benefits of SGLT2is.
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Heart failure with preserved ejection fraction (HFpEF) accounts for 15–20% of patients with heart failure (HF) in India. Diagnosis is by clinical features supported by biomarkers and echocardiography. Lifestyle modifications, control of risk factors to optimum levels, and treatment of comorbidities are essential in the management of HFpEF. Spironolactone and sacubitril-valsartan [angiotensin receptor neprilysin inhibitor (ARNI)] are beneficial in subsets of HFpEF, especially with lower range of ejection fraction (EF). Sodium-glucose co-transporter-2 inhibitors (SGLT2i)—empagliflozin and dapagliflozin and probably sotagliflozin are the only currently available drugs which have shown benefits in HFpEF, mostly by reducing hospitalizations. The benefit of SGLT2i is evident in both diabetic and nondiabetic subsets. Heart failure with preserved ejection fraction is defined as patients with HF with documented left ventricular ejection fraction (LVEF) equal to or more than 50%.1 Globally, HFpEF accounts for close to 50% of patients presenting with HF. As per the registry data like Trivandrum Heart Failure Registry2 and ASIAN-HF,3 the proportion of HFpEF in our country is approximately 19–25%, which is much lower as compared to that of western population. There is a possibility that many cases go undiagnosed in developing countries like India. The mean age of presentation of patients from India was around 58–68 years, which is about 10 years younger than the data reported from the west. Heart failure with preserved ejection fraction is characterized by elevated left ventricular filling pressures and/or reduced cardiac output either at rest or on exertion. Cardiac output is maintained at the cost of abnormally elevated filling pressure which is responsible for the symptoms and signs. Neurohumoral activation (sympathetic and renin-angiotensin-aldosterone system activation) is present only in a group of HFpEF patients unlike in patients with heart failure with reduced ejection fraction (HfrEF).
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Background: Nimesulide shows preferential inhibition for the cyclooxygenase-2 (COX-2) enzyme, which blocks the formation of prostaglandins critical in pain and inflammatory pathways. Few studies in the past have reported rare and unpredictable hepatic effects with nimesulide. The present study aimed to evaluate the efficacy and safety of nimesulide/paracetamol (100 mg + 325 mg) fixed-dose combination twice a day for 2 weeks in the management of acute pain in Indian population. Materials and methods: This was a multicenter study, performed on 500 patients, by 24 experienced physicians across India. The primary outcome assessed clinical safety at 2 weeks for mild/serious adverse effects (AEs), change in liver function tests (LFTs), serum bilirubin and alkaline phosphatase levels. The secondary outcomes assessed the clinical effectiveness in reduction of pain at rest and at movement. Results: Analysis of LFT at 2 weeks showed a slight increase (mean change) in the aspartate transaminase {-0.73 [95% confidence interval (CI) -1.54, 0.09; p = 0.081]}, alanine transaminase [-1.73 (95% CI -2.82, -0.64; p = 0.002)], serum bilirubin [-0.02 (95% CI -0.04, -0.001; p = 0.018)] and alkaline phosphatase levels [-1.92 (95% CI -5.84, 2; p = 0.336), not exceeding the normal range. Only one in 500 patients reported AEs. The numerical rating scale (NRS) scores for intensity of pain at rest and at movement at 2 weeks, ?7 days and >7 days were 68.38%, 68.44% and 68.39%; and 65.43%, 64.60% and 66.02%, respectively. An improvement of 96.6% was observed in patient global assessment scale (GAS) and 97.2% in physician GAS. Conclusion: Nimesulide/paracetamol combination was safe, effective and well-tolerated in acute pain conditions and did not lead to clinically significant changes in liver parameters indicating hepatic safety.
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Aim: Arterial stiffness, a major marker of vascular impedance, has been identified as a predictor of adverse cardiac outcomes. The present study determined the relationship between blood pressure (BP) and arterial stiffness measured noninvasively using a periscope in hypertensive patients. It has also evaluated the usefulness of indices of arterial stiffness in cardiovascular (CV) risk stratification and the necessity to implement these aortic pressure parameters in clinical practice. Methods: The prospective, observational study involved patients with hypertension between the age of 18 and 80 years. The demographic and anthropometric measurements of all the participants were recorded and various central and peripheral (brachial) arterial pressure parameters were measured using a periscope. The clinical variables were compared separately for different CV risk grades and arterial stiffness index (ASI) using Kruskal–Wallis test for non-normal data and chi-square test for count data. The correlation of different parameters with CV risk grade and ASI were evaluated using Spearmen’s correlation method. The agreement of different ASI indices with CV risk grades was assessed using Kappa method. Results: The study recruited a total of 3,032 patients with hypertension. Classification of the subjects for CV risk grades had demonstrated that major proportion of the patients (n = 713) had moderate and severe CV risks (n = 708). The classification of hypertensive patients for arterial stiffness had shown that 1,037 subjects had severe arterial stiffness. Classification of arterial stiffness based on BP levels had demonstrated that 623 patients with severe arterial stiffness and 315 with borderline arterial stiffness had stage II hypertension, and 480 patients with normal BP had no arterial stiffness. Brachial ASI had a strong correlation with systolic BP (SBP). A very good agreement with K value 0.871 was noted for Kappa agreement of arterial stiffness indices with CV risk. Conclusion: The present study corroborates the use of central BP parameters as indicators of arterial stiffness in hypertensive subjects. Noninvasive measurement of these indices has wider implications in personalized risk assessment of CV risk in subjects with hypertension.
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Non-nutritive sweeteners (NNSs) are used to substitute sugar in the diet and are approved by the regulatory bodies in many countries, including the Food and Agriculture Organization (FAO)/the World Health Organization (WHO). Non-nutritive sweeteners are here to stay, as it is an effective strategy to reduce sugar and caloric intake which is a public health priority today. It is a tool to increase dietary compliance in the management of obesity and diabetes and is a partner for fitness seekers. However, the debate on its safety and efficacy continues, including several myths associated with its usage. This review has evaluated the scientific literature in-depth and concludes that NNSs are safe to use within an acceptable daily intake (ADI). Non-nutritive sweeteners are beneficial for their intended use, including weight management and diabetes control when consumed as a part of a dietary management program. The current data do not provide sufficient evidence that NNSs can affect the gut microbiome, and more research, particularly at relevant doses, is required. We also need more randomized control trials (RCTs) among the Indian population on the impact of sugar reduction with NNSs and its health benefits to strengthen the evidence for its use in medical nutrition management and preventive health, helping the individual make an informed choice.
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Objective: Exercise and physical activity are integral aspects for the effective management of diabetes. Unsupervised home exercise although very accessible is limited by poor adherence, risk of injury, and a higher dropout rate of participants. A fitness assessment by a qualified physiotherapist can help in understanding the baseline fitness of individuals and thus generating appropriate exercise prescriptions. The current study assesses the feasibility of video call-based fitness assessment for people with diabetes. The study also assesses the effect of current physical activity status and pain on performance in physical fitness tests. Methods: One hundred participants with type II diabetes (T2D) underwent 6-minute walk test (6MWT), 1-minute push-up test, wall sit test, 1-minute sit-up test, and V-sit and reach test for measuring different components of physical fitness such as aerobic capacity, upper body strength, lower body strength, core strength, and flexibility, respectively. The performance in physical fitness of participants was analyzed after the video consult along with pain complaints and current exercise status. Results: All the participants underwent the physical fitness test safely based on video call. Out of all the participants, a good range score was achieved by 52% in 6MWT, 17% in push-up test, 1% in wall sit test, 6% in sit-up test, and 9% in V-sit and reach test. Current physical activity status (aerobic exercise for minimum 20 minutes) did not show any association with performance in fitness tests (p = 0.89 for push-up test, p = 0.50 for wall sit test, p = 0.23 for sit-up test, and p = 0.10 for V-sit and reach test). Presence of upper body and lower body pain affected the performance in push-up test and wall sit test with 71.4% and 95.6% of participants achieving scores in poor to below-average range (p-value < 0.001). Conclusion: The study showed the safety and feasibility of conducting video call-based assessment of physical fitness by physiotherapists. The study also highlighted the poor glycemic control, high cardiovascular risk, and poor level of physical fitness in people with diabetes in India. Insights based on physical fitness, current physical activity status, and pain can help in developing personalized exercise plans for people with diabetes.
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Purpose: To evaluate efficacy for an on-demand treatment of acute bleeding events, pharmacokinetics, safety, and tolerability of HemoRel-A® in severe hemophilia A. Methods: A total of 44 male subjects with severe hemophilia A with an annualized bleed rate of 12 while on-demand treatment with factor VIII (FVIII) were enrolled in the study and received HemoRel-A® for bleed treatment. The efficacy of HemoRel-A® was evaluated based on a four-point scale (excellent, good, moderate, or none). Six-point pharmacokinetic (PK) assessment was performed following a single dose of 50 IU/kg in 12 subjects after a 7-day wash-out period. Safety evaluations were performed at each visit and inhibitor testing was performed in all patients at screening and end of study. Results: Forty-four male subjects received at least a single dose of the study medication and were included in the intent-to-treat (ITT) analysis and safety outcome. In 23 (7.52%) out of the 306 bleeding events, HemoRel-A® efficacy was rated as excellent, in 272 (88.89 %) bleeds it was rated as good, and in 11 (3.68%) bleeding events it was rated as moderate. No failure of efficacy was noted in any of the bleeding events. Thus overall out of 306 bleeding events, 295 (96.41%) showed excellent or good efficacy. Pharmacokinetic assessment based on plasma FVIII activity measured by the chromogenic assay in 12 patients showed comparative results similar to FVIII preparations. A total of 12 adverse events (AEs) were reported in this study. There was no inhibitor development in this previously treated patients (PTP) cohort. Conclusion: HemoRel-A® was established to be efficacious and safe in the treatment of acute bleeding events in subjects with severe hemophilia A.
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Biapenem is a novel parenteral broad spectrum carbapenem primarily used for the treatment of complicated infections like sepsis, lower respiratory infections, urinary tract infections, intra-abdominal and genitourinary infections etc. in Japan, Thailand and China since two decades, has been recently approved in India. Biapenem shows good bactericidal activity against Gram-positive bacteria including streptococcus pneumoniae, pyogenes and methicillin-susceptible staphylococcus aureus (MSSA). It also shows antibacterial activities against Gram-negative bacteria including resistant Pseudomonas aeruginosa and Acinetobacter baumannii. Evidence from international studies confirmed that biapenem can be used as effectively and safely as meropenem or imipenem/ cilastatin in the treatment of various infectious diseases. This article summarizes the milestones, unique structure, mechanism of action, pharmacokinetics, special pharmacological properties and spectrum of in vitro activity of biapenem. The results of comparative clinical trials on Biapenem are also described, as is the patient safety and tolerability observed during these studies.
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Rheumatic Fever (RF)/ Rheumatic Heart Disease (RHD) is the result of autoimmune response triggered by group A Beta-haemolytic streptococcal pharyngitis leading to immune-inflammatory injury to cardiac valves. It is practically disappeared in developed countries. However, it continues to be a major cause of disease burden among children, adolescents, and young adults in low-income countries and even in high-income countries with socioeconomic inequalities. For decades, many cases of Acute Rheumatic Fever (ARF) and RHD were missed and were denied the secondary prophylaxis, as a result these patients used to end up with complications and untimely death. Advanced understanding of the echocardiography can prevent both under diagnosis and over diagnosis and thus help in management strategy. Another new advancement in recent past is the mitral valve repair, which is technically demanding, and the results are acceptable in experienced cardiac surgical units. Whenever feasible, valve repair should be preferred over valve replacement since it precludes the need for anticoagulation and future risks of prosthesis dysfunction.
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Introduction: To evaluate the effect of metabolic surgery on microvascular changes associated with diabetic retinopathy (DR) and diabetic kidney disease (DKD) in obese Asian Indians with type 2 diabetes (T2DM), one year after metabolic surgery. Methods: This is a follow up study in 21 obese Asian Indians with T2DM who underwent metabolic surgery (MS). Diabetic microvascular complications were assessed before and one-year post surgery using urinary albumin, protein creatinine ratio, eGFR, retinal colour photography and Optical coherence tomography (OCT). Results: Microalbuminuria (54±26 vs 28±16 vs 21±6 ?g/mg, p<0.001) and protein creatinine ratio (0.4±0.1 vs 0.2±0.03 vs 0.1±0.02, p<0.05) reduced significantly 6 months and one year after Metabolic surgery (MS) respectively compared to baseline values. Estimated Glomerular Filtration (eGFR) rate and creatinine was stable and there was no decline in renal function one year after MS. DR was present in eight individuals at baseline. After metabolic surgery, 12 % of individuals achieved regression of DR and 12% individuals showed a one step regression from severe to moderate non proliferative DR while 12 % individuals progressed from moderate to severe non proliferative DR. Of the 14 (53.8%) individuals who had micro or macroalbuminuria at baseline, 43% individuals reverted back to normoalbuminuria. There was also a reduction in the usage of anti- hypertensive medications after MS. Conclusion: In obese Asian Indians with T2DM, metabolic surgery reduced urinary microalbuminuria and protein creatinine ratios at one-year post MS. MS resulted in stable D. Retionpathy status one-year post surgery. MS may help to improve in stabilisation of the microvascular complications in obese patients with T2DM.