Semaglutide and the risk of adverse liver outcomes in patients with nonalcoholic fatty liver disease and type 2 diabetes: a multi-institutional cohort study
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Semaglutide
Liver disease
Liver diseases in Australia are estimated to affect 6 million people with a societal cost of $51 billion annually. Information about utilisation of specialist hepatology care is critical in informing policy makers about the requirements for delivery of hepatology-related healthcare.This study examined the aetiology and severity of liver disease seen in a tertiary hospital hepatology clinic, as well as the resource utilisation patterns.A longitudinal cohort study included consecutive patients booked in hepatology outpatient clinics during a 3-month period. Subsequent outpatient appointments for these patients over the following 12 months were then recorded.During the initial 3-month period, 1471 appointments were scheduled with a hepatologist, 1136 of which were attended. Twenty-one per cent of patients were 'new cases'. Hepatitis B virus (HBV) was the most common disease aetiology for new cases (37%). Advanced disease at presentation varied between aetiology; only 5% of HBV cases had advanced liver disease at presentation, in contrast with HCV, NAFLD and ALD, in which advanced disease was identified at presentation in 31%, 46% and 72% of cases, respectively. Most patients (83%) attended multiple hepatology appointments, and a range of referral patterns for procedures, investigations and other specialty assessments were observed.There is a high prevalence of HBV in new case referrals. Patients with HCV infection, NAFLD and ALD have a high prevalence of advanced liver disease at referral, requiring ongoing surveillance for development of decompensated liver disease and liver cancer. These findings that describe the patterns of health service utilisation among patients with liver disease provide useful information for planning sustainable health service provision for this clinical population.
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Semaglutide is a GLP1-RA for the treatment of type 2 diabetes. Treatment with semaglutide led to significant reductions in HbA1c and body weight vs. all comparators across the SUSTAIN phase 3a clinical trial programme. In SUSTAIN 6, subjects with T2D and established cardiovascular disease or high CV risk were randomised to subcutaneous semaglutide or placebo, added to standard of care; the median duration of follow-up was 2.1 years. Semaglutide-treated patients had a significant 26% lower risk of major adverse CV events vs. those receiving placebo over 2 years.
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Abstract Glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) are recommended for glycaemic management in patients with type 2 diabetes (T2D). Oral semaglutide, the first oral GLP‐1RA, has recently been approved for clinical use, based on the results of the randomized, Phase 3a Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) clinical trials. The PIONEER programme tested oral semaglutide in patients with T2D of duration ranging from 3.5 to 15 years, from monotherapy through to insulin add‐on, in global populations and two trials dedicated to Japanese patients. Outcomes (glycated haemoglobin [HbA1c] and body weight reduction, plus other relevant efficacy and safety endpoints) were tested against both placebo and active standard‐of‐care medications. A separate trial evaluated the cardiovascular safety of oral semaglutide in patients with T2D at high cardiovascular risk. Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA1c and body weight across the spectrum of T2D, and improved other diabetes‐related endpoints, such as fasting plasma glucose. Oral semaglutide provided significantly better efficacy than placebo and commonly used glucose‐lowering medications from the dipeptidyl peptidase‐4 inhibitor (sitagliptin) and sodium‐glucose co‐transporter‐2 inhibitor (empagliflozin) classes, as well as the subcutaneous GLP‐1RAs liraglutide and dulaglutide. Oral semaglutide was well tolerated in line with the known safety profile of GLP‐1RAs, with transient gastrointestinal events being the most common side effects reported. Cardiovascular safety was demonstrated for oral semaglutide in patients with cardiovascular disease or high cardiovascular risk. The results of the PIONEER programme suggest that oral semaglutide is efficacious and well tolerated for glycaemic control of T2D. The availability of oral semaglutide may help to broaden treatment choice and facilitate adoption of earlier GLP‐1RA treatment in the paradigm of T2D management.
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Summary Semaglutide is a glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) with a long elimination half‐life, allowing subcutaneous (sc) administration once per week. Both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) recently approved once‐weekly sc semaglutide for the treatment of type 2 diabetes mellitus (T2DM). The weight loss efficacy of once‐weekly sc semaglutide appears to be superior compared with the other once‐weekly GLP‐1 RAs in patients with T2DM. Semaglutide was recently evaluated as an antiobesity drug in a phase II dose‐finding trial, which demonstrated superior weight loss efficacy of once daily sc semaglutide compared with both placebo and once daily 3.0 mg liraglutide in patients with obesity but without T2DM. The magnitude of semaglutide‐induced weight loss in this study exceeded the criteria of both the EMA and FDA for antiobesity drugs, and there were no safety concerns, indicating the eligibility of once daily sc semaglutide as a future antiobesity drug.
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ENWEndNote BIBJabRef, Mendeley RISPapers, Reference Manager, RefWorks, Zotero AMA Augustyn M, Grys I, Kukla M. Small intestinal bacterial overgrowth and nonalcoholic fatty liver disease. Clinical and Experimental Hepatology. 2019;5(1):1-10. doi:10.5114/ceh.2019.83151. APA Augustyn, M., Grys, I., & Kukla, M. (2019). Small intestinal bacterial overgrowth and nonalcoholic fatty liver disease. Clinical and Experimental Hepatology, 5(1), 1-10. https://doi.org/10.5114/ceh.2019.83151 Chicago Augustyn, Monika, Iwon Grys, and Michał Kukla. 2019. "Small intestinal bacterial overgrowth and nonalcoholic fatty liver disease". Clinical and Experimental Hepatology 5 (1): 1-10. doi:10.5114/ceh.2019.83151. Harvard Augustyn, M., Grys, I., and Kukla, M. (2019). Small intestinal bacterial overgrowth and nonalcoholic fatty liver disease. Clinical and Experimental Hepatology, 5(1), pp.1-10. https://doi.org/10.5114/ceh.2019.83151 MLA Augustyn, Monika et al. "Small intestinal bacterial overgrowth and nonalcoholic fatty liver disease." Clinical and Experimental Hepatology, vol. 5, no. 1, 2019, pp. 1-10. doi:10.5114/ceh.2019.83151. Vancouver Augustyn M, Grys I, Kukla M. Small intestinal bacterial overgrowth and nonalcoholic fatty liver disease. Clinical and Experimental Hepatology. 2019;5(1):1-10. doi:10.5114/ceh.2019.83151.
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Semaglutide is a glucagon-like peptide-1 receptor-agonist (GLP-1 RA), which is injected subcutaneously once a week for treatment of Type 2 diabetes. In this review, the present results of semaglutide treatment are presented. Semaglutide has been evaluated in more than 8,000 patients across the spectrum of Type 2 diabetes. Trials with semaglutide have demonstrated superiority with sustained improved glycaemic control and weight loss compared to oral antidiabetic agents, other GLP-1 RAs and basalinsulin. In addition, semaglutide significantly decreased the occurrence of cardiovascular events compared with standard pharmacological diabetic treatment combined with placebo.
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Introduction: The 'glutides,' which stimulate the glucagon-like peptide 1 (GLP-1) receptor to stimulate insulin secretion, are used in the treatment of type 2 diabetes. Semaglutide is the first glutide to be developed in an oral form. The PIONEER series of clinical trials (Peptide Innovation for Early Diabetes Treatment) were undertaken to establish a clinical role for oral semaglutide.Areas covered: This evaluation is of PIONEER 6 in a non-inferiority phase 3a trial. In PIONEER 6, the primary outcome was the time from randomization to first occurrence of a major adverse cardiovascular event and this was non-inferior with oral semaglutide, compared to placebo.Expert opinion: In my opinion, there are several reasons why once-daily oral semaglutide may not replace once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes. Most importantly, subcutaneous semaglutide has already been shown to be superior to placebo in reducing cardiovascular risk, whereas the study of this with oral semaglutide will not be completed until 2024. Secondly, it is debatable whether subjects will find the daily protocol for taking oral semaglutide more convenient than that for the weekly subcutaneous formulation.
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Semaglutide
Dulaglutide
Empagliflozin
Sitagliptin Phosphate
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Background: Once weekly (OW) semaglutide 0.5-1.0 mg is a glucagon-like type-1 receptor agonist (GLR-1 RA) approved for treatment of type 2 diabetes and is currently under evaluation for treatment of obesity at a higher dose of 2.4 mg OW. Objective: to provide an appraisal of WO semaglutide 2.4 mg for treatment of obesity. Methods: Pubmed research up to March 22. Randomized trials, pertinent animal studies, and reviews are included. Search terms were glucagon-like type 1 receptor agonists, weight loss, obesity, semaglutide, safety, efficacy. Results: WO semaglutide 2.4 mg was evaluated as a weight loss agent in 3 well-designed clinical trials of 68 week-duration. In one trial including patients with type 2 diabetes, the difference in weight loss from baseline to week 68 between OW semaglutide and placebo was - 6.2 percentage points (95% CI, -7.3 to -5.2; P<0.0001). In the other 2 studies that excluded patients with diabetes, the difference in weight loss between OW semaglutide and placebo ranged between -10.3% and -12.4%. A significantly higher proportion of participants in the semaglutide groups vs placebo groups achieved at least 5% of weight loss. The most common adverse effects of semaglutide were related to the gastrointestinal (GI) system. Across these 3 trials, premature discontinuation of OW semaglutide occurred in 6-7% vs 3% in placebo groups. Conclusions: OW semaglutide may be a promising agent for treatment of obesity irrespective of presence of type 2 diabetes. Further studies are needed to establish its long-term safety and efficacy.
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