The Role of Sodium-Glucose Co-transporter 2 Inhibitors in Patients With Hypomagnesemia: A Systematic Review.

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, initially developed for glycemic control in type 2 diabetes, have demonstrated benefits in reducing heart failure hospitalizations, slowing chronic kidney disease, and decreasing major cardiovascular events. Recent studies have shown that SGLT2 inhibitors can elevate serum magnesium levels in patients with type 2 diabetes, suggesting potential benefits in managing refractory hypomagnesemia. This systematic review analyzed relevant case reports, observational studies, and randomized controlled trials (RCTs) to investigate the association between SGLT2 inhibitors and hypomagnesemia. The review adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and study quality was assessed using the CAse REport (CARE) guidelines. It encompassed four case reports, one retrospective observational study, one post-hoc analysis of 10 RCTs, and one meta-analysis of 18 RCTs, with a total study population of 19,767 patients. The meta-analysis revealed that SGLT2 inhibitors significantly increased serum magnesium levels in patients with type 2 diabetes, with a linear dose-dependent increase noted particularly for canagliflozin. Additionally, the case reports and other studies suggested that SGLT2 inhibitors could exert extraglycemic effects, potentially enhancing magnesium balance beyond their impact on urinary magnesium excretion. This systematic review underscores the effectiveness of SGLT2 inhibitors in addressing refractory hypomagnesemia linked with urinary magnesium wasting. It also suggests promising avenues for the application of these drugs in diverse patient populations.

Causality, Severity, Preventability and Predictability Assessments Scales for Adverse Drug Reactions: A Review.

The pharmacovigilance program of India (PvPI), after its inception, has been reliably acquiring force in bringing issues to light among the masses, healthcare professionals, the pharma industry, and clinical staff at hospitals. Adverse drug reactions are unintended events that occur after exposure to a drug, biological product, or medical device, and they may result in morbidity and mortality. It is critical to monitor the safety of drugs during the post-marketing phase to find long-term and rare ADRs, as well as ADRs in special populations and patients with co-morbidities that are not usually included during clinical trials. The definitive objective of pharmacovigilance is to collate data and analyze it. Assessing the causality between ADRs and drugs is necessary to decrease the occurrence of ADRs and to reduce the risk of drug-related ADRs. ADRs may lead to increased morbidity, increased hospital stays, and increased cost of treatment, resulting in compromised patient safety. Causality assessment is the evaluation of the likelihood that a particular treatment is the cause of an observed adverse event and establishing a causal association between a drug and a drug reaction is necessary to prevent further recurrences. Numerous methods available for establishing a causal association between the drug and adverse events have been broadly classified into clinical judgment or global introspection, algorithms, and probabilistic methods. These include the Swedish method, World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, Naranjo's algorithm, Kramer algorithm, Jones algorithm, Karch algorithm, Bégaud algorithm, Adverse Drug Reactions Advisory Committee guidelines, Bayesian Adverse Reaction Diagnostic Instrument, and so on. Despite various methods available, none of the causality assessment tools have been universally accepted as the gold standard. Naranjo's algorithm and WHO-UMC scales are, however, the most commonly used. Similarly, for preventability and severity assessment of ADRs, the Schumock and Thornton scale and Hartwig and Siegel's scale are most commonly used. Hence, we reviewed different tools and methods available to assess the causality, preventability, and severity of ADRs.

Exploring Therapeutic Digestive Enzyme Landscape in India: Current Evidence, Profit Motives, Regulations, and Future Perspectives.

This analysis critically examines the profit-driven marketing of digestive enzymes as over-the-counter (OTC) supplements in the context of India, expressing ethical concerns regarding pharmaceutical companies prioritizing financial gain over genuine public health needs within the lucrative OTC supplement market. The review delves into various enzymes, their mechanisms of action, uses, adverse drug reactions, and provides evidence from various studies. The research method involves the exploration of profit-driven strategies employed by pharmaceutical companies, addressing regulatory challenges, investigating the gap between dietary supplements and pharmaceutical drugs, and emphasizing the impact of direct-to-consumer advertising on self-diagnosis and overuse. Additionally, the study reviews various e-pharmacy platforms in India, assessing formulations and pricing. Key findings highlight the diverse formulations on these platforms, exposing insights into cost variations and indicating a regulatory gap that necessitates a comprehensive re-evaluation by Indian and international authorities. The analysis emphasizes the influence of direct-to-consumer advertising on behavior and potential health risks, raising ethical concerns about oversimplified health claims that overlook the necessity for individualized treatment plans. In conclusion, the study underscores the ethical complexity of prioritizing profit over public health and advocates for regulatory re-evaluation, exploring broader implications such as cultural influences and alternative therapies. The evolving landscape, featuring plant-based and microbe-derived alternatives, is presented as transformative, particularly in conditions like celiac disease.

Appropriateness of Surgical Antibiotic Prophylaxis in a Tertiary Care Teaching Hospital in Central India: A Retrospective Analysis.

Surgical antibiotic prophylaxis (SAP) has been a boon in the prevention of surgical site infections (SSIs). This study was conducted to assess and evaluate the selection, timing, and duration of administration of SAP and their compliance with national and international guidelines in a tertiary care teaching hospital in India. This retrospective study included the data collected from the central records department in a tertiary care teaching hospital on major surgeries conducted between January 1, 2018, and December 31, 2018, from the departments of ENT, general surgery, orthopedic surgery, and obstetrics and gynecology. The data was analyzed for the appropriateness of their indication for SAP administration, choice, timing, and duration of antibiotics, and compliance with the American Society of Health-System Pharmacists (ASHP) and Indian Council of Medical Research (ICMR) guidelines. Results and interpretation Out of the total 394 case records included, only 2.53% (n = 10) of the cases were given an appropriate antibiotic. The duration of SAP was appropriate only in 6.53% (n = 24), and the timing of SAP administration was appropriate only in 50.76% (n = 204). The most commonly used antibiotic was ceftriaxone (pre-operative 58.12% (n = 229) and post-operative 43.14% (n = 170)). Major inappropriateness was observed in the selection of antibiotics which may be attributed to the non-availability of cefazolin in the institute. The inappropriateness of the duration of the SAP may be attributed to the extra precautions taken by the treating physicians to prevent SSIs. The overall compliance of the surgical cases with respect to the ASHP and ICMR guidelines was less than 1%. Conclusion This study identified the lacuna between the guidelines for SAP and the clinical application of the same. It also identified the areas where quality improvement was needed which can be improved by implementing antimicrobial stewardship, especially the choice and the duration of SAP administration.

Assessment of Reporting Quality of Drug-Related Randomized Controlled Trials Conducted in India and Published in MEDLINE-Indexed Indian Journals Over a Decade: A Systematic Review.

Poorly published trials may result in biased and erroneous healthcare decisions. We conducted this systematic review to evaluate the reporting quality of drug-related randomized controlled trials (RCTs) conducted in India and published in MEDLINE-indexed Indian journals over a decade (between January 1, 2011, and December 31, 2020), as per the Consolidated Standards of Reporting Trials (CONSORT) Checklist 2010. An extensive literature search was conducted using the terms "Randomized controlled trial AND India." The full-length papers were extracted for RCTs related to drugs. Two independent investigators assessed each article against the checklist containing 37 criteria. Each article was scored 1 or 0 against each criterion which was finally summed up and evaluated. None of the articles fulfilled all 37 criteria. A compliance rate of >75% was seen in only 15.5% of articles. More than 75% of articles fulfilled a minimum of 16 criteria. Major checklist points observed to be deficient were "important changes to methods after trial commencement" (7%), "interim analysis and stopping guidelines" (7%), and "description of similarity of interventions while blinding" (4%). There remains ample room for improvement regarding research methodology and manuscript preparation in India. Moreover, journals should stringently implement the CONSORT Checklist 2010 to enhance the standard and quality of publications.