Facundo García‐Bournissen
YOU?
Author Swipe
Trimethoprim-Sulfamethoxazole and Acute Respiratory Failure in Adolescents and Young Adults Open
Importance The US Food and Drug Administration (FDA) has issued a warning and a label change regarding a potential association between trimethoprim-sulfamethoxazole (TMP-SMX) and acute respiratory failure in healthy adolescents and young a…
Paroxysmal Nocturnal Hemoglobinuria in Pregnancy Treated With Pegcetacoplan: Case Report and Pharmacokinetic Analysis Open
There is an unmet clinical need for effective treatment of paroxysmal nocturnal hemoglobinuria (PNH) in pregnancy for patients with inadequate response to C5 inhibitors. We report the first case of pegcetacoplan use in pregnancy with accom…
View article: Maternal and fetal pharmacokinetics (PK) of pegcetacoplan in paroxysmal nocturnal hemoglobinuria (PNH): A case report of use in pregnancy
Maternal and fetal pharmacokinetics (PK) of pegcetacoplan in paroxysmal nocturnal hemoglobinuria (PNH): A case report of use in pregnancy Open
Background: PNH is a rare, life-threatening hematologic disorder that poses significant risks in pregnancy. Pegcetacoplan, a first-in-class C3 inhibitor, has superior efficacy in patients with persistent anemia on eculizumab but data in pr…
Intramuscular epinephrine in cardiac arrest: A systematic review Open
A limited number of studies have compared IM epinephrine to IV/IO or no epinephrine in cardiac arrest, including one human trial which showed improved neurological survival for IM epinephrine. Further studies, particularly randomized contr…
View article: Associations between PTSD and pregnancy outcomes: systematic review and Meta- analysis
Associations between PTSD and pregnancy outcomes: systematic review and Meta- analysis Open
Importance Post-Traumatic Stress Disorder (PTSD) is a prevalent and debilitating mental health condition. PTSD may be an important underlying mechanism in pregnancy and obstetric complications as well as adverse neonatal outcomes. Objectiv…
Severe Acute Respiratory Failure Associated With Trimethoprim/Sulfamethoxazole Among Adolescent and Young Adults: An Active Comparator-Restricted Disproportionality Analysis From the FDA Adverse Event Reporting System (FAERS) Database Open
Background: The US Food and Drug Administration (FDA) has raised concerns about a potential link between trimethoprim/sulfamethoxazole (TMP-SMX) and an increased risk of acute respiratory failure/acute respiratory distress syndrome (ARF/AR…
Redefining the treatment of Chagas disease: a review of recent clinical and pharmacological data for a novel formulation of nifurtimox Open
Nifurtimox has been used for over 50 years to treat patients with Chagas disease, a potentially life-threatening neglected tropical disease caused by the protozoan parasite Trypanosoma cruzi . Without effective antitrypanosomal treatment, …
Adverse events associated with benznidazole treatment for Chagas disease in children and adults Open
Aims Chagas disease (ChD) affects approximately 7 million people in Latin America, with benznidazole being the most commonly used treatment. Methods Data from a retrospective cohort study in Argentina, covering January 1980 to July 2019, w…
View article: A phase I study to evaluate the safety, tolerance and pharmacokinetics of anti‐Shiga toxin hyperimmune equine F (ab′)<sub>2</sub> fragments in healthy volunteers
A phase I study to evaluate the safety, tolerance and pharmacokinetics of anti‐Shiga toxin hyperimmune equine F (ab′)<sub>2</sub> fragments in healthy volunteers Open
Aims Shiga toxin‐producing Escherichia coli ‐haemolytic uraemic syndrome (STEC‐HUS) is considered a toxaemic disorder in which early intervention with neutralizing antibodies may have therapeutic benefits. INM004, composed of F (ab′) 2 fra…
Real‐life experience with a generic formulation of lumacaftor‐ivacaftor in patients with cystic fibrosis homozygous for the Phe508del CFTR mutation Open
Introduction Cystic fibrosis (CF) is the most frequent recessive autosomal disorder in the Caucasian population. It is caused by mutations that result in a deficient or dysfunctional cystic fibrosis transmembrane conductance regulator (CFT…
Real-World Evidence of Factors Affecting Cannabidiol Exposure in Children with Drug-Resistant Developmental and Epileptic Encephalopathies Open
The identification of factors that affect cannabidiol (CBD) systemic exposure may aid in optimizing treatment efficacy and safety in clinical practice. In this study, we aimed to correlate CBD plasma concentrations at a steady state to dem…
View article: A Phase I study to evaluate the safety, tolerance and pharmacokinetics of anti-Shiga toxin hyperimmune equine F(ab’)2 fragments in healthy volunteers
A Phase I study to evaluate the safety, tolerance and pharmacokinetics of anti-Shiga toxin hyperimmune equine F(ab’)2 fragments in healthy volunteers Open
Shiga toxin-producing Escherichia coli-associated hemolytic uremic syndrome (STEC-HUS) is considered a toxemic disorder in which early intervention with neutralizing antibodies may have therapeutic benefits. INM004, composed of F(ab’) frag…
View article: Population pharmacokinetics of benznidazole in neonates, infants and children using a new pediatric formulation
Population pharmacokinetics of benznidazole in neonates, infants and children using a new pediatric formulation Open
Background There is a major need for information on pharmacokinetics (PK) of benznidazole (BNZ) in children with Chagas disease (CD). We conducted a multicentre population PK, safety and efficacy study in children, infants and neonates wit…
Prospective Evaluation of Pregnancy Outcomes after Gestational Exposure to Prazosin Open
Introduction: Prazosin is an antihypertensive medication which can be used to help with post-traumatic stress disorder (PTSD) symptoms. Little data is currently available on its safety in pregnancy. Objective: To assess the fetal and pregn…
Long-term cardiology outcomes in children after early treatment for Chagas disease, an observational study Open
Background Parasite persistence after acute infection with Trypanosoma cruzi is an important factor in the development of Chagas disease (CD) cardiomyopathy. Few studies have investigated the clinical effectiveness of CD treatment through …
POPULATION PHARMACOKINETICS OF BENZNIDAZOLE IN NEONATES, INFANTS AND CHILDREN USING A NEW PEDIATRIC FORMULATION Open
Background There is a major need for information on pharmacokinetics (PK) of benznidazole in children with Chagas disease (CD). We present herein the results of a multicentre population PK, safety and efficacy study in children, infants an…
Transforming Possible Risk Into Certain Harm: A Critical Interpretive Synthesis of the Literature on Perinatal Cannabis Use Open
Substance use in pregnancy has been a prominent public health concern for the last several decades. Since the legalization of cannabis in Canada and across several American states, cannabis use during pregnancy has gained considerable publ…
Paediatric and obstetrical pharmacology – Pushing the frontier forward Open
A little over a century ago, at the start of the twentieth century, a child in the United Kingdom faced grim odds over the first 5 years of their life; 20% of children – one in five – died before their fifth birthday, primarily of infectio…
Miltefosine and Benznidazole Combination Improve Anti-Trypanosoma cruzi In Vitro and In Vivo Efficacy Open
Drug repurposing and combination therapy have been proposed as cost-effective strategies to improve Chagas disease treatment. Miltefosine (MLT), a synthetic alkylphospholipid initially developed for breast cancer and repositioned for leish…
Anti-Inflammatory, Antioxidant, and Anti-Atherosclerotic Effects of Natural Supplements on Patients with FMF-Related AA Amyloidosis: A Non-Randomized 24-Week Open-Label Interventional Study Open
We aimed to evaluate the effect of a combination of natural products on parameters related to inflammation, endothelial dysfunction, and oxidative stress in a cohort of familial Mediterranean fever (FMF) patients with Serum Amyloid A amylo…
Drug reaction with eosinophilia and systemic symptoms (DRESS): A tertiary care centre retrospective study Open
Aims Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare, drug‐induced severe adverse reaction that usually occurs 3–6 weeks after initial exposure to certain drugs. It affects mainly adults and children to a lesser ext…
Repurposing alpelisib, an anti-cancer drug, for the treatment of severe TIE2-mutated venous malformations: preliminary pharmacokinetics and pharmacodynamic data Open
Extensive venous malformations (VM) involving limbs severely impact quality of life, mostly due to chronic pain and functional limitations. Patients can also display coagulopathy with associated risks of life-threatening thromboembolism an…
COVID-19 and Chagas Disease in Buenos Aires, Argentina Open
Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2. COVID-19 leads, in most patients, to mild-to-moderate symptoms, but some develop severe disease and succumbed to death. People with medical c…
Systematic Review of Early Phase Pediatric Clinical Pharmacology Trials Open
OBJECTIVE Children have generally been excluded from early-stage clinical trials owing to safety concerns based in social expectations and not data. However, the repositioning of adult therapeutics for pediatric use and the increase in the…
Prevention of congenital Chagas through treatment of girls and women of childbearing age Open
It is currently unknown whether treatment of Chagas disease decreases the risk of congenital transmission from previously treated mothers to their infants. In a cohort of women with Chagas disease previously treated with benznidazole, no c…