European journal of internal medicine
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Eur. J. Intern. Med. · Jan 2025
Randomized Controlled Trial Multicenter StudyAssociation between trajectory of systolic blood pressure and outcomes in heart failure patients with preserved ejection fraction (HFpEF).
The optimal systolic blood pressure (SBP) in heart failure patients with preserved ejection fraction (HFpEF) remains controversial. We aim to assess the SBP trajectory and prognosis in HFpEF. ⋯ The decreasing or increasing SBP trajectory is associated with a high risk of cardiovascular events in HFpEF, suggesting a stable SBP trajectory group (≈130 mmHg) have lower incidence of cardiovascular events and mortality. Trials are necessary to determine the optimal SBP in HFpEF.
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Eur. J. Intern. Med. · Oct 2024
Randomized Controlled Trial Multicenter Study Pragmatic Clinical TrialLong-term inhaled corticosteroid treatment in patients with chronic obstructive pulmonary disease, cardiovascular disease, and a recent hospitalised exacerbation: The ICSLIFE pragmatic, randomised controlled study.
Patients with chronic obstructive pulmonary disease (COPD) frequently have cardiovascular comorbidities, increasing the risk of hospitalised COPD exacerbations (H-ECOPDs) or death. This pragmatic study examined the effects of adding an inhaled corticosteroid (ICS) to long-acting bronchodilator(s) (LABDs) in patients with COPD and cardiac comorbidities who had a recent H-ECOPD. ⋯ Results suggest addition of ICS to LABDs did not reduce the time-to-combined rehospitalisation/death, although it decreased all-cause and cardiovascular mortality. ICS use was not associated with an increased risk of adverse events, particularly pneumonia.
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Eur. J. Intern. Med. · Sep 2024
Randomized Controlled Trial Multicenter StudyLow-dose ondansetron: A candidate prospective precision medicine to treat alcohol use disorder endophenotypes.
Alcohol use disorder (AUD) is among the leading causes of morbidity and mortality worldwide, and over 95 million people live with alcohol dependence globally. The estimated heritability of AUD is 50-60 %, and multiple genes are thought to contribute to various endophenotypes of the disease. Previous clinical trials support a precision medicine approach using ondansetron (AD04, a 5-HT3 antagonist) by segregating AUD populations by the bio-genetic endophenotype of specific serotonergic genotypes and the bio-psychosocial endophenotype of the severity of drinking or both. By targeting the modulation of biogenetic signaling within the biopsychosocial context of AUD, low-dose AD04 holds promise in reducing alcohol consumption among affected individuals while minimizing adverse effects. ⋯ In this Phase 3 clinical trial, AD04 was shown to be a promising treatment for currently drinking heavy drinking individuals with AUD who also possess a specific genotypic profile in the serotonin transporter and serotonin-3AB receptor complex. Using AD04 to reduce the harm of AUD in heavy drinking individuals who are currently drinking, without the necessity of abstinence or detoxification from alcohol use, is an important advance in the field of precision medicine. AD04's adverse events profile, which was like placebo, should enhance accessibility and acceptance of modern medical treatment for AUD by lowering the incorrect but commonly perceived stigma of personal failure.
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Eur. J. Intern. Med. · Sep 2024
Randomized Controlled TrialSafety and compliance of long-term low-dose ondansetron in alcohol use disorder treatment.
The increasing prevalence of alcohol use disorder (AUD) and the parallel surge in alcohol-associated liver disease (ALD) emphasize the urgent need for comprehensive alcohol management strategies. Low-dose ondansetron (AD04, a 5-HT3 antagonist) was shown recently to be a promising treatment for AUD with a specific genotypic profile (5-marker). The liver safety of AD04 has never been evaluated in subjects with AUD. The aim of the present study was to assess the liver safety profile of AD04 compared with placebo in subjects with AUD. ⋯ Low-dose AD04 has the potential to be a safe treatment option for subjects with AUD and ALD, indicating the need for an RCT for this specific cohort. Such a trial would pave the way for the design of a precision treatment for combined AUD with ALD.
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Eur. J. Intern. Med. · Jul 2023
Randomized Controlled TrialThe Influence of baseline glycemic status on the effects of intensive blood pressure lowering: Results from the STEP randomized trial.
Intensive systolic blood pressure (SBP) lowering showed cardiovascular benefits in the Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial. We investigated whether baseline glycemic status influences the effects of intensive SBP lowering on cardiovascular outcomes. ⋯ The effects of intensive SBP lowering on cardiovascular outcomes were consistent among participants with normoglycemia, prediabetes, and diabetes.