Ertugliflozin 5mg tablets

Selective sodium-glucose cotransporter-2 (SGLT2) inhibitors act only at the renal level, promoting glucose excretion. Their glucose-independent mechanism makes them effective in advanced type 2 diabetes mellitus, when pancreatic β-cell reserves are permanently reduced. In addition to glucosuria, SGLT2 inhibition induces natriuresis, contributing to negative salt and water balance. The aim of this study is to evaluate the efficacy and safety of SGLT2 inhibitors in patients with type 2 diabetes mellitus through a systematic review of scientific publications, examining clinical trials with this class of glucose-lowering medicinal products. We performed a literature search in MEDLINE, the Central Library of Medicine, and peer-reviewed journals for the period January 2004 to December 2024. The systematic review is conducted in accordance with the PRISMA standard and the PICOS tool. The results of the PICOS analysis show that the most significant reduction in HbA1c level is observed after administration of Ertugliflozin 15 mg (−0.90%) and Ipragliflozin 50 mg (−0.88%). The body weight reduction is the most significant after administration of Ertugliflozin 15 mg, by 2.93 kg. Common adverse drug reactions include urinary tract infections and genital mycotic infections. The results of the conducted PICOS analysis prove the high efficacy of SGLT2 inhibitors in terms of their cardiovascular safety and cardio-renal benefits. In addition to their glucose-lowering properties, they are associated with a very low risk of hypoglycemia.

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Background: In patients with type 2 diabetes (T2D) and a history of heart failure (HF), sodium-glucose cotransporter-2 inhibitors (SGLT2is) have demonstrated cardiovascular (CV) benefits. However, the comparative efficacy of individual SGLT2is remains uncertain. This network meta-analysis (NMA) compared the efficacy and safety of five SGLT2is (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, and sotagliflozin) on CV outcomes in these patients. Materials and methods: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched up to September 23, 2022, to identify all randomized controlled trials (RCTs) comparing SGLT2is to placebo in T2D patients with HF. The main outcomes included composite CV death/heart failure hospitalization (HFH), HFH, CV death, all-cause mortality, and adverse events. Pairwise and NMA approaches were applied. Results: Our analysis included 11 RCTs with a total of 20,438 patients with T2D and HF. All SGLT2is significantly reduced HFH compared to standard of care (SoC) alone. "Add-on" SGLT2is, except ertugliflozin, significantly reduced composite CV death/HFH relative to SoC alone. Moreover, canagliflozin had lower composite CV death/HFH compared to dapagliflozin. Based on the surface under the cumulative ranking curve (SUCRA), the top-ranked SGLT2is for reducing HFH were canagliflozin (95.5%), sotagliflozin (66.0%), and empagliflozin (57.2%). Head-to-head comparisons found no significant differences between individual SGLT2is in reducing CV death. "Add-on" SGLT2is reduced all-cause mortality compared with SoC alone, although only dapagliflozin was statistically significant. No SGLT2is were significantly associated with serious adverse events. A sensitivity analysis focusing on HF-specific trials found that dapagliflozin, empagliflozin, and sotagliflozin significantly reduced composite CV death/HFH, consistent with the main analysis. However, no significant differences were identified from their head-to-head comparisons in the NMA. The SUCRA indicated that sotagliflozin had the highest probability of reducing composite CV death/HFH (97.6%), followed by empagliflozin (58.4%) and dapagliflozin (44.0%). Conclusion: SGLT2is significantly reduce the composite CV death/HFH outcome. Among them, canagliflozin may be considered the preferred treatment for patients with diabetes and a history of heart failure, but it may also be associated with an increased risk of any adverse events compared to other SGLT2is. However, a sensitivity analysis focusing on HF-specific trials identified sotagliflozin as the most likely agent to reduce CV death/HFH, followed by empagliflozin and dapagliflozin. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42022353754.

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BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease associated with liver inflammation, fibrosis, and cirrhosis and is associated with a greater risk of hepatocarcinoma. Nonalcoholic steatohepatitis (NASH) is a persistent and progressive form of NAFLD. Recent evidence suggested that ertugliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2), suppresses NAFLD development in patients with type 2 diabetes mellitus (T2DM). The objective of this study was to determine the impact of ertugliflozin on improving NAFLD in patients with T2DM and the function of liver enzymes. METHODS: This prospective, randomized, double-blind, placebo-controlled, interventional study aimed to determine the effectiveness of 15 mg of ertugliflozin versus 30 mg of the standard therapy pioglitazone versus placebo in NAFLD patients with T2DM. The study was established based on patient randomization in three groups: ertugliflozin, pioglitazone, and a placebo. This study was registered under the Australian New Zealand Clinical Trial Registry (Trial ID: ACTRN12624000032550). RESULTS: The impact of therapy was determined in the treatment groups by utilizing liver ultrasonography and biochemical parameters. After 24 weeks of clinical study, the results revealed significant improvement in the grades of fatty liver, especially in the ertugliflozin group. The number of patients with hepatic steatosis significantly decreased among the respective groups classified according to fatty liver grade. Among patients in the ertugliflozin and pioglitazone groups, 45% to 23.4% and 41.7% to 26.6%, respectively, decreased in the Grade 2 group. The aspartate aminotransferase and alanine aminotransferase levels were significantly lower in all the study groups, especially in the ertugliflozin group (P ≤ .001). CONCLUSION: The present study revealed that the concomitant use of ertugliflozin has favorable effects on liver enzymes, as it decreases liver fat intake and reduces complications in patients with NAFLD-associated T2DM. However, more in-depth studies will be required to observe every aspect of ertugliflozin.

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Chronic kidney disease (CKD) is a progressive condition affecting millions worldwide, leading to substantial morbidity, mortality, and healthcare burden. While traditional treatments such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) have been the cornerstone of CKD management, newer therapeutic approaches are needed to slow disease progression and improve outcomes. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, initially developed as antihyperglycemic agents, have demonstrated significant renoprotective and cardioprotective effects beyond glucose control. This review aims to evaluate the current evidence on the efficacy, safety, and clinical implications of SGLT2 inhibitors in CKD, highlighting their mechanisms of action, benefits, limitations, and future research directions. A comprehensive literature search was conducted in PubMed, Google Scholar, and Medline using keywords related to SGLT2 inhibitors, CKD, and renal outcomes with no time limit. Studies included randomized controlled trials, cohort studies, and case-control studies examining the effects of SGLT2 inhibitors on renal and cardiovascular outcomes in CKD patients. The risk of bias was assessed using standard tools such as the Newcastle-Ottawa Scale and the Cochrane Risk of Bias Tool. Clinical trials have demonstrated that SGLT2 inhibitors, including empagliflozin, canagliflozin, dapagliflozin, and ertugliflozin, significantly reduce CKD progression, lower albuminuria, and decrease the risk of cardiovascular events and all-cause mortality. These effects are observed in both diabetic and non-diabetic populations. Additionally, SGLT2 inhibitors exhibit renoprotective mechanisms such as reducing glomerular hyperfiltration, modulating tubuloglomerular feedback, and exerting anti-inflammatory and antifibrotic properties. However, potential adverse effects, including an initial decline in estimated glomerular filtration rate (eGFR), an increased risk of euglycemic diabetic ketoacidosis, and urinary tract infections, necessitate careful patient selection and monitoring. Emerging studies also explore the role of machine learning in optimizing SGLT2 inhibitor use for personalized treatment approaches. SGLT2 inhibitors have emerged as a transformative addition to CKD management, offering substantial renal and cardiovascular benefits. Despite safety concerns, their advantages outweigh the risks, warranting broader clinical implementation. Future research should focus on refining patient selection, optimizing treatment combinations, and leveraging data science to enhance therapeutic outcomes in CKD patients. • This paper analyzes SGLT2 inhibitors’ efficacy and safety in managing chronic kidney disease (CKD). • Highlights dual benefits of SGLT2 inhibitors in slowing CKD and improving cardiovascular outcomes. • Discusses SGLT2 inhibitors’ renoprotective effects, including reduced hyperfiltration and inflammation. • Examines risks like initial eGFR decline, diabetic ketoacidosis, and urinary tract infections. • Explores machine learning to optimize SGLT2 inhibitor use through personalized treatment and drug discovery.

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BACKGROUND: The co-occurrence of tuberculosis (TB) and diabetes mellitus (DM) presents a growing public global health concern. Managing DM during anti-TB therapy is challenging due to potential drug-drug interactions, especially with rifamycin (RIF). RESEARCH QUESTION: Assess the effects of anti-TB drugs on the pharmacokinetics and pharmacodynamics of novel antidiabetic agents, including DPP-4 inhibitors (DPP4i), SGLT-2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1a). STUDY DESIGN AND METHODS: A PRISMA-ScR-based scoping review was conducted among four databases. RESULTS: Ten studies involving 307 participants were included. RIF significantly reduced the plasma exposure of DPP4i (saxagliptin, gemigliptin, evogliptin) and canagliflozin, while other SGLT2i (dapagliflozin, empagliflozin, ertugliflozin) were minimally affected. No direct data was available for GLP-1a. Adverse events were rare in healthy participants but more frequent in elderly patients with poorly controlled DM. Linezolid and dapagliflozin co-administration may lead to severe pancytopenia. DISCUSSION: RIF co-administration with gemigliptin, evogliptin and canagliflozin requires caution and potential requiring dose adjustments, while saxagliptin, dapagliflozin, ertugliflozin and empagliflozin appear safer alternatives. Haematologic monitoring is recommended when combining linezolid and dapagliflozin. However, current evidence remains limited by small sample sizes, single-dose designs, inclusion of mainly healthy participants, and lack of data on GLP-1a or other anti-TB agents. The limited inclusion of DM patients with TB, restricted to one study with latent TB infection, further reduces generalisability. We developed a clinical decision algorithm to support co-treatment in TB - DM cases, but further dedicated studies are warranted to guide optimal co-treatment.

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