Publications by authors named "Amy Meadowcroft"

Article Synopsis
  • OptiBreech Care is a care pathway designed for breech births at term, focusing on safe and proficient vaginal deliveries with trained professionals.
  • The study assessed the feasibility of implementing this care pathway across 13 NHS sites in England and Wales, evaluating factors like training, cost, safety, and recruitment.
  • Results indicated successful training implementation, with a high percentage of vaginal births attended by qualified staff and relatively low neonatal admission rates, supporting the potential for a future pilot trial.
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  • Hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) affects 10-15% of chronic dialysis patients, and a study compared the investigational drug daprodustat with standard ESA treatment to understand the characteristics and predictors of this issue.
  • The study recruited 2,964 ESA-treated chronic dialysis patients and defined ESA hyporesponsiveness using specific criteria, finding that about 12% of participants were hyporesponsive.
  • Key predictors included geographic region (especially Latin America), lower body mass index, younger age, and certain blood levels, along with additional factors like female sex and a history of heart failure; notably, the geographic finding suggests a need for further research.
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  • The ASCEND-ND trial raised concerns about daprodustat having a higher risk of cancer-related adverse events compared to darbepoetin in patients with anemia due to chronic kidney disease (CKD), but this was not seen in the dialysis-focused ASCEND-D trial.* -
  • Both trials involved randomizing patients to receive either daprodustat or various types of erythropoiesis-stimulating agents (ESAs), with different dosing schedules, and used statistical models to analyze the safety of the treatments.* -
  • The findings indicated that the perceived increased risk of cancer-related adverse events for daprodustat in ASCEND-ND may have been biased due to under-counting of events in the darbepo
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The coronavirus disease 2019 pandemic has had an unprecedented effect on health and health care and posed challenges to the conduct of clinical trials.Targeted mitigating strategies, on the basis of early and continued data collection from site surveys, limited disruption to the ASCEND trials.Flexibly allowing hemoglobin assessment at local laboratories to inform randomized treatment dosing was key to limiting the discontinuation of treatment.

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  • Daprodustat is being tested as an oral alternative to traditional ESAs for treating anemia in patients with chronic kidney disease starting dialysis, with limited past studies on this topic.
  • The clinical trial involved a randomized, open-label design across 90 centers in 14 countries, focusing on patients who were either set to begin dialysis soon or had started within the last 90 days.
  • The main goal was to compare the effectiveness and safety of daprodustat to darbepoetin alfa by assessing changes in hemoglobin levels and monitoring adverse events over a treatment period of 28 to 52 weeks.
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  • Anaemia is a common issue for patients with chronic kidney disease (CKD), and it's crucial to evaluate new treatments like daprodustat compared to the existing drug, darbepoetin alfa.
  • The ASCEND-ND trial involved 3,872 adult participants across 39 countries, focusing on those with specific hemoglobin levels and assessing various health characteristics related to CKD.
  • The study aims to determine the effectiveness and safety of daprodustat in treating CKD-related anaemia in patients not on dialysis, providing important insights into managing this condition.
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  • Daprodustat, a new oral treatment for anemia in chronic kidney disease (CKD) patients not on dialysis, was compared to the standard treatment darbepoetin alfa in a phase 3 clinical trial to evaluate effectiveness and safety.* -
  • The study included 3872 participants, revealing that daprodustat resulted in a slightly higher increase in hemoglobin levels (0.74 g/dL) compared to darbepoetin alfa (0.66 g/dL), meeting noninferiority benchmarks for effectiveness.* -
  • Cardiovascular safety outcomes showed daprodustat was also noninferior to darbepoetin alfa, with similar rates of major adverse cardiovascular events (19.5% vs. 19
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  • A phase 3 trial compared the effectiveness of an oral drug called daprodustat to injectable erythropoiesis-stimulating agents (ESAs) in increasing hemoglobin levels in CKD patients on dialysis with low hemoglobin.
  • Results showed that daprodustat increased hemoglobin by an average of 0.28 g/dL, while the ESA group had an increase of 0.10 g/dL, indicating that daprodustat was noninferior to ESAs.
  • Cardiovascular events were similar in both groups, with 25.2% of daprodustat patients and 26.7% of ESA patients experiencing major adverse events, confirming dap
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  • The ASCEND-D trial aims to compare the effectiveness and cardiovascular safety of the prolyl hydroxylase inhibitor daprodustat against traditional treatments (epoetin alfa and darbepoetin alfa) in patients with anemia related to chronic kidney disease (CKD).
  • Over 2,900 patients were randomly assigned to this study, with a focus on demographic and clinical characteristics, and the group showed a median age of 58 years, predominantly male, and high rates of diabetes and cardiovascular history.
  • The results of the trial will help determine whether daprodustat is a viable alternative for managing anemia in CKD patients, contributing to the broader understanding of treatment options in this population.
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Article Synopsis
  • - This study examined the effects of daprodustat, a new oral medication for anemia in chronic kidney disease, focusing on its impact on hemoglobin levels and safety compared to traditional treatments like erythropoietin (rhEPO).
  • - Participants (216) on hemodialysis were switched from rhEPO to daprodustat at varying doses and their hemoglobin levels were monitored over 24 weeks, with initial results showing significant hemoglobin increases in the daprodustat group during the first 4 weeks.
  • - While both treatment groups showed similar hemoglobin levels after 24 weeks, daprodustat's safety profile was consistent with patients on hemodialysis, suggesting it could be a viable
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  • - The study evaluated the safety and effectiveness of daprodustat, a new oral medication, for treating anemia in patients with chronic kidney disease (CKD) not on dialysis over a 24-week period.
  • - In the trial involving 252 patients, those taking daprodustat achieved average hemoglobin levels similar to those receiving standard care with rhEPO, and maintained target hemoglobin levels better than the control group for a majority of the study period.
  • - Overall, daprodustat was found to be a viable option for managing anemia in CKD patients, showing effectiveness and a safety profile in line with expectations for this population.
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  • Hypoxia-inducible factor prolyl hydroxylase inhibitors, like GSK1278863, help stabilize hypoxia-inducible factor levels which boost the production of erythropoietin and other genes related to low oxygen levels.
  • Two phase 2a studies were conducted to assess how different dosages of GSK1278863 affected hemoglobin levels in patients with anemia of chronic kidney disease (CKD), both those not on dialysis and those undergoing hemodialysis.
  • Results showed that higher doses of GSK1278863 increased hemoglobin in nondialysis patients and maintained levels in hemodialysis patients switching from erythropoietin, with the treatment being generally safe and well
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Limited information is available on the epidemiology of hypertriglyceridemia (HTG; 150-499 mg/dL) and severe HTG (SHTG; >500 mg/dL) in children. This study estimates the prevalence of HTG and SHTG, evaluates factors that may be associated with these conditions, and describes the use of dyslipidemic agents in children. The sample included children 12 to 19 years old who participated in National Health and Nutrition Examination Survey (NHANES) 2001-2008 (n = 3248) and children 5 to 19 years of age who were part of a large managed-care claims database in the United States (n = 65 258).

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Objective: Assess the long-term efficacy and safety of prescription omega-3-acid ethyl esters (P-OM3) coadministered with simvastatin in an extension of the Combination of Prescription Omega-3 Plus Simvastatin (COMBOS) trial.

Methods: COMBOS included hypertriglyceridemic patients (triglyceride [TG] >or=200 mg/dL and <500 mg/dL or >or=2.26 mmol/L and <5.

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