Publications by authors named "Brueckmann M"
Aims: In the EMPACT-MI trial, empagliflozin reduced heart failure (HF) hospitalizations but not mortality in acute myocardial infarction (MI). Contemporary reports of clinical event rates with and without type 2 diabetes mellitus (T2DM) in acute MI trials are sparse. The treatment effect of empagliflozin in those with and without T2DM in acute MI is unknown.
View Article and Find Full Text PDFPatients with chronic kidney disease (CKD) are at risk of progressive loss of kidney function, heart failure, and cardiovascular death despite current proven therapies, including renin-angiotensin system inhibitors (RASi), sodium glucose co-transporter-2 inhibitors (SGLT2i), and statin-based regimens. RASi and SGLT2i reduce risk of CKD progression irrespective of primary cause of kidney disease, suggesting they target final common pathways. Targeting aldosterone overactivity with a nonsteroidal mineralocorticoid receptor antagonist (MRA) also reduces cardiorenal risk in patients with albuminuric diabetic kidney disease already treated with RASi.
View Article and Find Full Text PDFObjective: The objective of this study was to describe the rationale and design of two multinational phase 3 clinical trials of survodutide, an investigational glucagon and glucagon-like peptide-1 receptor dual agonist for the treatment of obesity with or without type 2 diabetes (T2D; SYNCHRONIZE-1 and -2).
Methods: In these ongoing double-blind trials, participants were randomized to once-weekly subcutaneous injections of survodutide or placebo added to lifestyle modification. Survodutide doses are uptitrated to 3.
Long-Term Effects of Empagliflozin in Patients with Chronic Kidney Disease.
N Engl J Med
October 2024
Article Synopsis
- The EMPA-KIDNEY trial examined the effects of empagliflozin, an SGLT2 inhibitor, on patients with chronic kidney disease at risk for progression, assessing outcomes during and after the trial.
- A total of 6609 patients were randomized, with 4891 participating in a follow-up period after the trial where they were observed for an additional 2 years, without trial medication but allowed to use other SGLT2 inhibitors.
- Results showed that fewer primary outcome events (like kidney disease progression or cardiovascular death) occurred in the empagliflozin group (26.2%) compared to the placebo group (30.3%), suggesting lasting benefits of the drug even after the trial ended. *
Article Synopsis
- SGLT2 inhibitors, like empagliflozin, are shown to improve outcomes for heart failure patients and reduce uric acid levels, with a focus on those having heart failure with preserved ejection fraction (HFpEF).
- In a study of patients receiving empagliflozin, about 49% had elevated uric acid levels, which were linked to worse heart failure severity and higher risk of severe outcomes like hospitalization.
- Empagliflozin significantly lowered uric acid levels early on and reduced related clinical events by 38%, with its effectiveness in improving heart failure outcomes not impacted by initial uric acid levels.
Dual agonism of glucagon and glucagon-like peptide-1 (GLP-1) receptors may be more effective than GLP-1 receptor agonism alone in reducing body weight, but the cardiovascular (CV) effects are unknown. The authors describe the rationale and design of SYNCHRONIZE-CVOT, a phase 3, randomized, double-blind, parallel-group, event-driven, CV safety study of survodutide, a dual glucagon and GLP-1 receptor agonist, administered subcutaneously once weekly compared with placebo in adults with a body mass index ≥27 kg/m and established CV disease or chronic kidney disease, and/or at least 2 weight-related complications or risk factors for CV disease. The primary endpoint of SYNCHRONIZE-CVOT is time to first occurrence of the composite adjudicated endpoint of 5-point major adverse CV events.
View Article and Find Full Text PDFAims: Patients hospitalized for acute heart failure (HF) could be enrolled in EMPULSE (NCT04157751) upon haemodynamic stabilization and between 24 h and 5 days after hospital admission. The timing of treatment initiation may influence the efficacy and safety of drugs such as empagliflozin. The aim of this study was to evaluate patient characteristics, clinical events, and treatment effects according to time from admission to randomization.
View Article and Find Full Text PDFAims: The aim of this work is to compare empagliflozin systemic exposure between patients with heart failure (HF) and patients with type 2 diabetes (T2D).
Methods: Analysis of covariance (ANCOVA) compared steady state trough concentrations of empagliflozin 10 mg in EMPEROR-reduced (patients with HF with reduced ejection fraction [HFrEF]) and EMPA-REG OUTCOME (patients with T2D at high cardiovascular risk) after adjusting for eGFR and body weight.
Results: The difference in geometric Mean (gMean) empagliflozin steady state trough concentration of 10 mg empagliflozin between EMPEROR-reduced and EMPA-REG OUTCOME was 1.
Article Synopsis
- Empagliflozin, a medication tested in the EMPACT-MI trial, showed promise in reducing heart failure (HF) hospitalizations but did not impact overall mortality when administered within two weeks post-acute myocardial infarction (AMI).
- In the study of over 6,500 patients, worsening left ventricular ejection fraction (LVEF) and congestion significantly increased the risk of death and HF hospitalizations.
- The drug effectively lowered the risk for HF hospitalizations regardless of the patients' LVEF status or congestion, and its safety profile remained consistent across different patient groups.
Article Synopsis
- Empagliflozin is known to improve cardiovascular outcomes in various patient groups, but its safety and effectiveness in those who have experienced an acute myocardial infarction were previously unclear.
- In a study involving 6522 patients at risk for heart failure after a heart attack, participants were given either empagliflozin or a placebo, with their health monitored over about 18 months.
- The results showed that empagliflozin did not significantly reduce the risk of hospitalization for heart failure or death compared to placebo, though it did show some potential benefits regarding hospitalizations specifically for heart failure.
Article Synopsis
- * In the EMPACT-MI trial, 6,522 patients were randomly assigned to receive either empagliflozin or placebo, with the results showing a significant difference in HF events after a median follow-up of 17.9 months.
- * The study also noted that patients taking empagliflozin required fewer additional heart failure medications after discharge, indicating a broader benefit in managing heart failure risks.
Aim: The EMPULSE (EMPagliflozin in patients hospitalised with acUte heart faiLure who have been StabilizEd) trial showed that, compared to placebo, the sodium-glucose cotransporter 2 inhibitor empagliflozin (10 mg/day) improved clinical outcomes of patients hospitalized for acute heart failure (HF). We investigated whether efficacy and safety of empagliflozin were consistent across the spectrum of left ventricular ejection fraction (LVEF).
Methods And Results: A total of 530 patients hospitalized for acute de novo or decompensated HF were included irrespective of LVEF.
Aims: Both low and high body mass index (BMI) are associated with poor heart failure outcomes. Whether BMI modifies benefits of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in heart failure with preserved ejection fraction (HFpEF) requires further investigation.
Methods And Results: Using EMPEROR-Preserved data, the effects of empagliflozin versus placebo on the risks for the primary outcome (hospitalization for heart failure [HHF] or cardiovascular [CV] death), change in estimated glomerular filtration rate (eGFR) slopes, change in Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS), and secondary outcomes across baseline BMI categories (<25 kg/m, 25 to <30 kg/m, 30 to <35 kg/m, 35 to <40 kg/m and ≥40 kg/m) were examined, and a meta-analysis conducted with DELIVER.
Aim: To assess the effect of empagliflozin on patients with comorbid heart failure (HF) and diabetes with or without baseline insulin, and to study the impact of empagliflozin on insulin requirements over time.
Materials And Methods: We performed a post-hoc analysis of pooled patient-level data from two cardiovascular outcomes trials of empagliflozin in HF (EMPEROR-Reduced and EMPEROR-Preserved trials). We undertook a subgroup analysis stratified by baseline insulin use, including all patients with diabetes.
Background: Congenital heart disease (CHD) is common in children and associated with greater risk of thrombotic complications. Management of these complications with standard-of-care treatment is suboptimal for these children.
Methods And Results: The effectiveness and safety of dabigatran were demonstrated in pivotal pediatric studies for the treatment of acute venous thromboembolism (VTE; NCT01895777) and secondary VTE prevention (NCT02197416).
Aims: Renal function (estimated glomerular filtration rate [eGFR]) changes early after the introduction of empagliflozin have not been described in heart failure with preserved ejection fraction (HFpEF). The aim of this study was to describe early eGFR changes, assess its determinants and its clinical impact on cardiovascular and renal outcomes in patients with HFpEF enrolled in EMPEROR-Preserved.
Methods And Results: Estimated glomerular filtration rate changes (absolute and relative) from randomization to week 4 were calculated and landmark analyses performed.
Background: Numerous studies have demonstrated that low, unstable, or contingent self-esteem negatively affects youth development and is linked to adolescent psychopathology. However, most previous studies have applied variable-oriented approaches, and less is known about the natural combination of self-esteem facets in school-aged adolescents, how parental conditional regard affects self-esteem profiles, and how these profiles relate to self-kindness, self-judgement, and life satisfaction.
Methods: By employing a longitudinal person-oriented approach (i.
Background: The EMPEROR-Reduced (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction) trial established the efficacy of empagliflozin in reducing heart failure (HF) outcomes among patients with heart failure with reduced ejection fraction (HFrEF).
Objectives: The authors examined the outcomes of EMPEROR-Reduced as a function of background diuretic therapy.
Methods: The EMPEROR-Reduced trial was a double-blind, randomized controlled trial of placebo vs empagliflozin 10 mg among 3,730 HFrEF patients.
Background: It is not known whether the benefits of sodium-glucose cotransporter 2 inhibitors in heart failure persist after years of therapy.
Methods: In the EMPEROR-Reduced (Empagliflozin Outcome Trials in Chronic Heart Failure With Reduced Ejection Fraction) and EMPEROR-Preserved (Empagliflozin Outcome Trials in Chronic Heart Failure With Preserved Ejection Fraction) trials, patients with heart failure were randomly assigned (double-blind) to placebo or empagliflozin 10 mg/day for a median of 16 and 26 months, respectively. At the end of the trials, 6799 patients (placebo 3381, empagliflozin 3418) were prospectively withdrawn from treatment in a blinded manner, and, of these, 3981 patients (placebo 2020, empagliflozin 1961) underwent prespecified in-person assessments after ≈30 days off treatment.
Background: The presence of ischemic heart disease impacts prognosis in patients affected by heart failure and reduced ejection fraction (HFrEF). It is not well known how the extent of vascular disease impacts prognoses and responses to therapy in this setting.
Methods: In this post hoc analysis of the EMPEROR-Reduced trial, outcomes and the effects of empagliflozin, were assessed in study participants according to the extent (none vs mono vs poly [≥ 2] vascular bed) of vascular disease.
Aims: In patients hospitalized for acute heart failure (AHF) empagliflozin produced greater clinical benefit than placebo. Many patients with AHF are treated with mineralocorticoid receptor antagonists (MRAs). The interplay between empagliflozin and MRAs in AHF is yet to be explored.
View Article and Find Full Text PDFAim: The prognostic implication of elevated liver tests in heart failure with preserved ejection fraction (HFpEF) is uncertain. This analysis investigates the association of liver markers with hospitalization for heart failure (HHF) and cardiovascular death (CVD), and the treatment effect of empagliflozin across the range of liver marker levels.
Methods And Results: The double-blind, placebo-controlled EMPEROR-Preserved (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure with Preserved Ejection Fraction) enrolled 5988 patients with HFpEF (ejection fraction >40%).
Importance: The diuretic effect of sodium-glucose cotransporter 2 inhibitors may result in interaction with background diuretic therapy in patients with heart failure and preserved ejection fraction (HFpEF).
Objective: To assess the safety and efficacy of empagliflozin in combination with background diuretic therapy and the association of empagliflozin with the need for conventional diuretics.
Design, Setting, And Participants: This was a post hoc analysis of the Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction (EMPEROR-Preserved).
Background: Empagliflozin reduces the risk of major heart failure outcomes in heart failure with reduced or preserved ejection fraction.
Objectives: The goal of this study was to evaluate the effect of empagliflozin across the spectrum of chronic kidney disease in a pooled analysis of EMPEROR-Reduced and EMPEROR-Preserved (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Reduced or Preserved Ejection Fraction, respectively).
Methods: A total of 9,718 patients were grouped into Kidney Disease Improving Global Outcomes (KDIGO) categories based on estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio into low-, moderate-, high-, and very-high-risk categories, comprising 32.