Sourdough Bread with Different Fermentation Times: A Randomized Clinical Trial in Subjects with Metabolic Syndrome.

The Mediterranean diet, featuring sourdough bread, shows promise in managing metabolic syndrome. This study explored the effects of two sourdough breads, with differing fermentation times but similar nutritional profiles, on inflammation, satiety, and gut microbiota composition in adults with metabolic syndrome. In a double-blind clinical trial, participants were randomized to consume either Elias Boulanger long-fermentation (48 h) sourdough bread (EBLong) or Elias Boulanger short-fermentation (2 h) sourdough bread (EBShort) over a two-month period.

The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study).

Background: Severe cases of lymphopenia have been reported during siponimod clinical trials, which may negatively impact its benefit/risk profile.

Objective: We aimed to evaluate the incidence of lymphopenia following the initiation of siponimod treatment in clinical practice. The secondary objectives included the analysis of factors predisposing to and the clinical relevance of lymphopenia events.

Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome. A randomized phase Ib clinical trial (PERSEUS study).

Purpose: Although some caregivers are using epigallocatechin gallate (EGCG) off label in hopes of improving cognition in young adults with Down syndrome (DS), nothing is known about its safety, tolerability, and efficacy in the DS pediatric population. We aimed to evaluate safety and tolerability of a dietary supplement containing EGCG and if EGCG improves cognitive and functional performance.

Methods: A total of 73 children with DS (aged 6-12 years) were randomized.

Efficacy and safety of intermittent repeated levosimendan infusions in advanced heart failure patients: the LAICA study.

Aims: The aim of the LAICA study was to evaluate the long-term effectiveness and safety of intermittent levosimendan infusion in patients with advanced heart failure (AdHF).

Methods And Results: This was a multicentre, randomized, double-blind, placebo-controlled clinical trial of intermittent levosimendan 0.1 μg/kg/min as a continuous 24-h intravenous infusion administered once monthly for 1 year in patients with AdHF.

[Prescription of acetylcholinesterase inhibitors and memantine in the Canary Islands, comparison with the Spanish population.].

Objective: In the Canary Islands the prescriptions billed to the National Health System are registered in a database (FarmaCanarias). The main objective was to estimate the consumption of Acetylcholinesterase inhibitors (IACE) and Memantine in Canary Islands and to compare with a Spanish sample from Pharmacoepidemiological Research Base in Primary Care (PRBPC) which is national in scope. As secondary we determined the percentage in treatment in the Spanish sample.

Alone laser versus bevacizumab plus laser for diffuse diabetic macular edema (ALBA randomized trial).

Purpose: To report the 12-month results of laser (treatment G1) versus intravitreal bevacizumab combined with laser (treatment G2) in patients with diffuse diabetic macular edema (DME).

Methods: In this single-center randomized independent controlled trial, 32 patients were randomized to G1 ( = 15) or G2 ( = 17). In G1, laser was given at baseline and then pro re nata (PRN).

Combination of Tocilizumab and Steroids to Improve Mortality in Patients with Severe COVID-19 Infection: A Spanish, Multicenter, Cohort Study.

Background: We aimed to determine the impact of tocilizumab use on severe COVID-19 (coronavirus disease 19) pneumonia mortality.

Methods: We performed a multicentre retrospective cohort study in 18 tertiary hospitals in Spain from March to April 2020. Consecutive patients admitted with severe COVID-19 treated with tocilizumab were compared to patients not treated with tocilizumab, adjusting by inverse probability of the treatment weights (IPTW).

[Usefulness of the summary of product characteristics as a tool to improve prescription in elderly patients].

Background And Objective: The Drug Technical Data Sheet should contribute to a safe and effective use of medications in the elderly, providing accurate information on the prescription, on the possible benefits or risks of the medications, or failing that, communicating the lack of information on their use in this group. The aim of this article was to quantify the specific information for people over 65 years of age included in the data sheets of the drugs available in Spain, and enables an adequate prescription in this population.

Materials And Methods: A multidisciplinary group reviewed all the Technical Data Sheets of drugs approved by the Spanish Agency for Medicines and Health Devices (AEMPS).

Impact of errors of creatinine and cystatin C equations in the selection of living kidney donors.

Background: Reliable determination of glomerular filtration rate (GFR) is crucial in the evaluation of living kidney donors. Although some guidelines recommend the use of measured GFR (mGFR), many centres still rely on estimated GFR (eGFR) obtained through equations or 24-h creatinine clearance. However, eGFR is neither accurate nor precise in reflecting real renal function.

Generation of the Antioxidant Hydroxytyrosol from Tyrosol Present in Beer and Red Wine in a Randomized Clinical Trial.

Beer and wine contains the simple phenol tyrosol (TYR) which is endogenously converted into hydroxytyrosol (HT), one of the strongest dietary antioxidants, by and polymorphic enzymes. We investigated in humans the rate of this bioconversion after beer and red wine (RW) intake. In a single blind, randomized, crossover, controlled clinical trial ( = 20 healthy subjects), we evaluated TYR absorption and biotransformation into HT following a single dose of (i) RW, (ii) Indian pale ale beer (IPA), (iii) blonde beer, and (iv) non-alcoholic beer (free).

Spanish list of potentially inappropriate drugs in the elderly (ES-PIA project).

Purpose: In the last decades, different criteria have been developed for detecting inappropriate prescription in older patients. In Spain, translations and adaptations of international lists are available but it would be necessary a national list which could cope with the peculiarities of our health system, existing pharmaceutical market, and prescription habits. We propose in this project the creation of a Spanish potentially inappropriate drugs list which could be applicable in our clinical scenario.

Erratum: Impact of errors of creatinine and cystatin C equations in the selection of living kidney donors.

[This corrects the article DOI: 10.1093/ckj/sfz012.].

Chronic kidney disease staging with cystatin C or creatinine-based formulas: flipping the coin.

Background: Chronic kidney disease (CKD) affects 10-13% of the population worldwide. CKD classification stratifies patients in five stages of risk for progressive renal disease based on estimated glomerular filtration rate (eGFR) by formulas and albuminuria. However, the reliability of formulas to reflect real renal function is a matter of debate.

Usefulness of Early Treatment With Melatonin to Reduce Infarct Size in Patients With ST-Segment Elevation Myocardial Infarction Receiving Percutaneous Coronary Intervention (From the Melatonin Adjunct in the Acute Myocardial Infarction Treated With Angioplasty Trial).

Melatonin, an endogenously produced hormone, might potentially limit the ischemia reperfusion injury and improve the efficacy of mechanical reperfusion with primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction (STEMI). This study was aimed to evaluate whether the treatment effect of melatonin therapy in patients with STEMI is influenced by the time to administration. We performed a post hoc analysis of the Melatonin Adjunct in the Acute Myocardial Infarction Treated With Angioplasty trial (NCT00640094), which randomized STEMI patients to melatonin (intravenous and intracoronary bolus) or placebo during pPCI.

Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial.

Purpose: Morphine has been used for several decades in cases of acute pulmonary edema (APE) due to the anxiolytic and vasodilatory properties of the drug. The non-specific depression of the central nervous system is probably the most significant factor for the changes in hemodynamics in APE. Retrospective studies have shown both negative and neutral effects in patients with APE and therefore some authors have suggested benzodiazepines as an alternative treatment.

Effect of intravenous and intracoronary melatonin as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: Results of the Melatonin Adjunct in the acute myocaRdial Infarction treated with Angioplasty trial.

The MARIA randomized trial evaluated the efficacy and safety of melatonin for the reduction of reperfusion injury in patients undergoing revascularization for ST-elevation myocardial infarction (STEMI). This was a prespecified interim analysis. A total of 146 patients presenting with STEMI within 6 hours of chest pain onset were randomized to receive intravenous and intracoronary melatonin (n=73) or placebo (n=73) during primary percutaneous coronary intervention (PPCI).

Definition and risk factors for chronicity following acute idiosyncratic drug-induced liver injury.

Background & Aims: Chronic outcome following acute idiosyncratic drug-induced liver injury (DILI) is not yet defined. This prospective, long-term follow-up study aimed to analyze time to liver enzyme resolutions to establish the best definition and risk factors of DILI chronicity.

Methods: 298 out of 850 patients in the Spanish DILI registry with no pre-existing disease affecting the liver and follow-up to resolution or ⩾1year were analyzed.

Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase(®).

Introduction: In 2008, the US FDA issued an alert about an increased risk of psychiatric events associated with montelukast. Recent national pharmacovigilance analyses in Sweden, France and Spain detected a potential increase in reporting risk of the association.

Aim: Our objective was to analyse spontaneous reports of psychiatric events in children and adolescents worldwide treated with montelukast.

Estimated Glomerular Filtration Rate in Renal Transplantation: The Nephrologist in the Mist.

Background: Formulas do not estimate renal function with acceptable precision and accuracy.

Methods: We compared 51 creatinine-based and/or cystatin c-based formulas with a gold standard (iohexol plasma clearance) in 193 renal transplant recipients using concordance correlation coefficient, total deviation index, coverage probability and the error in chronic kidney disease (CKD) stage classification.

Results: No formula showed a concordance correlation coefficient greater than 0.

Rationale and design of a randomized, double-blind, placebo controlled multicenter trial to study efficacy, security, and long term effects of intermittent repeated levosimendan administration in patients with advanced heart failure: LAICA study.

Background: Advanced heart failure (HF) is associated with high morbidity and mortality; it represents a major burden for the health system. Episodes of acute decompensation requiring frequent and prolonged hospitalizations account for most HF-related expenditure. Inotropic drugs are frequently used during hospitalization, but rarely in out-patients.