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1.
Br J Clin Pharmacol ; 90(4): 1142-1151, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38288879

RESUMEN

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 fragments from equine immunoglobulins, neutralizes Stx1/Stx2, potentially preventing the onset of HUS. METHODS: A single-centre, randomized, phase 1, single-blind, placebo-controlled clinical trial to evaluate INM004 safety, tolerance and pharmacokinetics (PK) in healthy adult volunteers, was conducted; in stage I, eight subjects were divided in two cohorts (n = 4) to receive a single INM004 dose of 2 or 4 mg kg-1, or placebo (INM004:placebo ratio of 3:1). In stage II, six subjects received three INM004 doses of 4 mg kg-1 repeated every 24 h, or placebo (INM004:placebo ratio of 5:1). RESULTS: Eight subjects (57.1%) experienced mild treatment-emergent adverse events (TEAEs); most frequent were rhinitis, headache and flushing, resolved within 24 h without changes in treatment or additional intervention. No serious AEs were reported. Peak concentrations of INM004 occurred within 2 h after infusion, with median Cmax values of 45.1 and 77.7 µg mL-1 for 2 and 4 mg kg-1, respectively. The serum concentration of INM004 declined in a biphasic manner (t1/2 range 30.7-52.9 h). Systemic exposures increased with each subsequent dose in a dose-proportional manner, exhibiting accumulation. Geometric median Cmax and AUC values were 149 and 10 300 µg h mL-1, respectively, in the repeated dose regimen. Additionally, samples from subjects that received INM004 at 2 mg kg-1 showed neutralizing capacity against Stx1 and Stx2 in in vitro assays. CONCLUSIONS: The results obtained in this first-in-human study support progression into the phase 2 trial in children with HUS.


Asunto(s)
Síndrome Hemolítico-Urémico , Toxina Shiga II , Niño , Adulto , Humanos , Animales , Caballos , Toxina Shiga I , Voluntarios Sanos , Método Simple Ciego
2.
Pharmacoepidemiol Drug Saf ; 33(2): e5747, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38126218

RESUMEN

PURPOSE: Antipsychotic agents, which may increase the risk of infection through dopaminergic dysregulation, are prescribed to a fraction of patients following critical illness. We compared the rate of recurrent sepsis among patients who filled a prescription for antipsychotics with high- or low-D2 affinity. METHODS: Population-based cohort with active comparator design. We included sepsis survivors older than 65 years with intensive care unit admission and new prescription of antipsychotics in Ontario 2008-2019. The primary outcome were recurrent sepsis episodes within 1 year of follow-up. Patients who filled a prescription within 30 days of hospital discharge for high-D2 affinity antipsychotics (e.g., haloperidol) were compared with patients who filled a prescription within 30 days of hospital discharge for low-D2 affinity antipsychotics (e.g., quetiapine). Multivariable zero-inflated Poisson regression models with robust standard errors adjusting for confounding at baseline were used to estimate incidence rate ratios (IRR) and 95% confidence intervals (CI). RESULTS: Overall, 1879 patients filled a prescription for a high-D2, and 1446 patients filled a prescription for a low-D2 affinity antipsychotic. Patients who filled a prescription for a high-D2 affinity antipsychotic did not present a higher rate of recurrent sepsis during 1 year of follow-up, compared with patients who filled a prescription for a low-D2 affinity antipsychotic (IRR: 1.12; 95% CI: 0.94, 1.35). CONCLUSIONS: We did not find conclusive evidence of a higher rate of recurrent sepsis associated with the prescription of high-D2 affinity antipsychotics (compared with low-D2 affinity antipsychotics) by 1 year of follow-up in adult sepsis survivors with intensive care unit admission.


Asunto(s)
Antipsicóticos , Sepsis , Adulto , Humanos , Antipsicóticos/efectos adversos , Estudios de Cohortes , Reinfección , Prescripciones , Sepsis/tratamiento farmacológico , Sepsis/epidemiología
3.
J Med Virol ; 95(5): e28786, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-37212340

RESUMEN

The aim of this study was to analyze whether the coronavirus disease 2019 (COVID-19) vaccine reduces mortality in patients with moderate or severe COVID-19 disease requiring oxygen therapy. A retrospective cohort study, with data from 148 hospitals in both Spain (111 hospitals) and Argentina (37 hospitals), was conducted. We evaluated hospitalized patients for COVID-19 older than 18 years with oxygen requirements. Vaccine protection against death was assessed through a multivariable logistic regression and propensity score matching. We also performed a subgroup analysis according to vaccine type. The adjusted model was used to determine the population attributable risk. Between January 2020 and May 2022, we evaluated 21,479 COVID-19 hospitalized patients with oxygen requirements. Of these, 338 (1.5%) patients received a single dose of the COVID-19 vaccine and 379 (1.8%) were fully vaccinated. In vaccinated patients, mortality was 20.9% (95% confidence interval [CI]: 17.9-24), compared to 19.5% (95% CI: 19-20) in unvaccinated patients, resulting in a crude odds ratio (OR) of 1.07 (95% CI: 0.89-1.29; p = 0.41). However, after considering the multiple comorbidities in the vaccinated group, the adjusted OR was 0.73 (95% CI: 0.56-0.95; p = 0.02) with a population attributable risk reduction of 4.3% (95% CI: 1-5). The higher risk reduction for mortality was with messenger RNA (mRNA) BNT162b2 (Pfizer) (OR 0.37; 95% CI: 0.23-0.59; p < 0.01), ChAdOx1 nCoV-19 (AstraZeneca) (OR 0.42; 95% CI: 0.20-0.86; p = 0.02), and mRNA-1273 (Moderna) (OR 0.68; 95% CI: 0.41-1.12; p = 0.13), and lower with Gam-COVID-Vac (Sputnik) (OR 0.93; 95% CI: 0.6-1.45; p = 0.76). COVID-19 vaccines significantly reduce the probability of death in patients suffering from a moderate or severe disease (oxygen therapy).


Asunto(s)
COVID-19 , Vacunas , Humanos , Vacunas contra la COVID-19 , Oxígeno , ChAdOx1 nCoV-19 , Vacuna BNT162 , Estudios de Cohortes , Estudios Retrospectivos , COVID-19/prevención & control , ARN Mensajero
4.
J Clin Psychopharmacol ; 37(4): 405-411, 2017 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-28622161

RESUMEN

BACKGROUND: Treatment with antipsychotic (AP) agents is associated with incident thromboembolic events. However, the underpinnings of this association remain unknown. We sought to evaluate the effect of AP agents-categorized by their metabolic/sedative and hyperprolactinemia adverse effect profile-on the risk of venous thromboembolic disease during long-term follow-up. METHODS: A retrospective cohort study of adult patients initiating AP treatment for the first time was conducted. Primary outcome was defined as the time to venous thromboembolism (VTE) (either deep venous thrombosis or acute pulmonary embolism). Antipsychotic agents were categorized by their risk (high vs low) of either drug-induced (a) sedation/metabolic adverse event or (b) hyperprolactinemia. We used a propensity score-adjusted Cox proportional hazards model to control for confounding. FINDINGS: One thousand eight patients (mean age, 72.4 y) were followed for a median of 36 months. Incident VTE occurred in 6.25% of patients, corresponding to an incidence rate of 184 cases per 10,000 person-years. We found no difference in the hazard of VTE during follow-up between high- and low-risk groups (hazard ratio, 1.23 [95% confidence interval, 0.74-2.04] for drug-induced sedation/metabolic adverse event risk categories, and hazard ratio 0.81 [95% confidence interval, 0.50-1.35] for high versus low hyperprolactinemia risk). CONCLUSIONS: These results suggest that the risk of thromboembolic events in older adults who started AP treatment for the first time does not seem to be related to these drugs' risk of either sedation/metabolic adverse events or hyperprolactinemia. However, VTE remains a common problem in this subgroup of patients.


Asunto(s)
Atención Ambulatoria/tendencias , Antipsicóticos/uso terapéutico , Pacientes Ambulatorios , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Atención Ambulatoria/métodos , Antipsicóticos/efectos adversos , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tromboembolia Venosa/inducido químicamente
5.
Eur J Intern Med ; 99: 82-88, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35288031

RESUMEN

IMPORTANCE: The actual risk of thrombotic events after Covid-19 vaccination is unknown. OBJECTIVE: To evaluate the risk of thrombotic events after Covid-19 vaccination. DESIGN: Retrospective cohort study which included consecutive adult patients vaccinated with the first dose of Covid-19 vaccine between January 1 and May 30, 2021, and a historic control group, defined as consecutive patients vaccinated with influenza vaccine between March 1 and July 30, 2019. SETTING: Hospital Italiano de Buenos Aires, a tertiary hospital in Argentina. PARTICIPANTS: Non-Hospitalized Adults vaccinated with the first dose of a Covid-19 vaccine. EXPOSURE: Vaccination with Covid-19 vaccines available during the study period: Gam-COVID-Vac (Sputnik), ChAdOx1 nCoV-19 (AstraZeneca/Oxford or Covishield), BBIBP-CorV (Beijing Institute of Biological Products) (Sinopharm). Active comparator group exposure was Influenza vaccine. MAIN OUTCOME: Primary endpoint was cumulative incidence of any symptomatic thrombotic event at 30 days, defined as the occurrence of at least one of the following: symptomatic acute deep venous thrombosis (DVT); symptomatic acute pulmonary embolism (PE); acute ischemic stroke (AIS); acute coronary syndrome (ACS) or arterial thrombosis. RESULTS: From a total of 29,985 adult patients who received at least a first dose of Covid-19 vaccine during study period and 24,777 who received Influenza vaccine in 2019, we excluded those who were vaccinated during hospitalization. We finally included 29,918 and 24,753 patients respectively. Median age was 73 years old (IQR 75-81) and 67% were females in both groups. Thirty six subjects in the Covid-19 vaccination group (36/29,918) and 15 patients in the Influenza vaccination group (15/24,753) presented at least one thrombotic event. The cumulative incidence of any thrombotic event at 30 days was 12 per 10,000 (95%CI 9-17) for Covid-19 group and 6 per 10,000 (95%CI 4-10) for Influenza group (p-value=0.022). CONCLUSIONS AND RELEVANCE: This study shows a significant increase in thrombotic events in subjects vaccinated with Covid-19 vaccines in comparison to a control group. The clinical implication of these findings should be interpreted with caution, in light of the high effectiveness of vaccination and the inherent risk of thrombosis from Covid-19 infection itself.


Asunto(s)
COVID-19 , Vacunas contra la Influenza , Gripe Humana , Accidente Cerebrovascular Isquémico , Trombosis , Adulto , Anciano , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , ChAdOx1 nCoV-19 , Femenino , Humanos , Vacunas contra la Influenza/efectos adversos , Gripe Humana/epidemiología , Gripe Humana/prevención & control , Masculino , Estudios Retrospectivos , Trombosis/epidemiología , Trombosis/etiología
6.
Medicina (B Aires) ; 82(2): 172-180, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35417379

RESUMEN

We conducted a retrospective cohort study to report the clinical characteristics, incidence and outcomes of patients with severe COVID-19 with acute kidney injury (AKI). One-hundred and sixtytwo intensive care unit (ICU) admitted patients in a tertiary level hospital in the city of Buenos Aires with COVID-19 diagnosis were included. We hypothesized that COVID-19 related AKI would develop in the period of more severe hypoxemia as an early event and late AKI would be more probably related to intensive care unit complications. For this purpose, we divided subjects into two groups: those with early AKI and late AKI, before and after day 14 from symptom onset, respectively. A stepwise multivariate analysis was conducted to find possible AKI predictors. AKI incidence was 43.2% (n = 70) of the total patients admitted into ICU with severe COVID-19, 11.1% (n = 18) required renal replacement therapy. In-hospital mortality was higher (58.6%) for the AKI group. AKI occurred on a median time of 10 (IQR 5.5-17.5) days from symptom onset. A history of hypertension or heart failure, age and invasive mechanical ventilation (IMV) requirement were identified as risk factors. Late AKI (n = 25, 35.7%) was associated with sepsis and nephrotoxic exposure, whereas early AKI occurred closer to the timing of IMV initiation and was more likely to have an unknown origin. In conclusion, AKI is frequent among critically ill patients with severe COVID-19 and it is associated with higher in-hospital mortality.


Llevamos a cabo un estudio retrospectivo con el objetivo de describir las características clínicas, incidencia y desenlaces de los pacientes con injuria renal aguda (IRA) asociada a la COVID-19. Se incluyeron 162 pacientes con diagnóstico de COVID-19 admitidos en una unidad de cuidados intensivos en un hospital de tercer nivel en la Ciudad de Buenos Aires. Nuestra hipótesis consistió en que la IRA asociada a COVID-19 sería un evento temprano asociado a la gravedad de la hipoxemia y la IRA tardía se relacionaría con complicaciones propias de la UCI. Por ello se clasificó la IRA en temprana y tardía, según sucediera antes o después de los 14 días desde el inicio de síntomas. Se realizó un análisis multivariado mediante regresión logística escalonada para evaluar posibles factores de riesgo. La incidencia de IRA fue de 43.2% (n = 70), 11.1% (n = 18) requirieron terapia de reemplazo renal. La mortalidad intrahospitalaria fue mayor (58.6%) en el grupo con IRA. El diagnóstico de IRA se realizó en una mediana de 10 (IQR = 5.5-17.5) días desde el inicio de los síntomas. El antecedente de hipertensión e insuficiencia cardíaca, la edad y el requerimiento de ventilación mecánica invasiva (VMI) fueron identificados como factores de riesgo para IRA. La IRA tardía (n = 25, 35.7%) estuvo asociada a sepsis y exposición a nefrotóxicos, mientras que la IRA temprana (n = 45, 64.2%) estuvo temporalmente asociada al inicio de la VMI y en muchos casos no se pudo filiar una etiología. En conclusión, la IRA es una complicación frecuente en pacientes con COVID-19 grave y está asociada a una alta mortalidad intrahospitalaria.


Asunto(s)
Lesión Renal Aguda , COVID-19 , Lesión Renal Aguda/epidemiología , Lesión Renal Aguda/etiología , Adulto , COVID-19/complicaciones , Prueba de COVID-19 , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Terapia de Reemplazo Renal/efectos adversos , Estudios Retrospectivos , Factores de Riesgo
7.
J Clin Psychiatry ; 82(3)2021 04 13.
Artículo en Inglés | MEDLINE | ID: mdl-34000131

RESUMEN

OBJECTIVE: Mounting evidence suggests that antipsychotics may have immunomodulatory effects, but their impact on disseminated infections remains unknown. This study thus sought to estimate the effect of antipsychotic treatment on the occurrence of bloodstream infection during long-term follow-up in adult patients with chronic obstructive pulmonary disease. METHODS: This retrospective cohort study, with new user and active comparator design, included adult patients seen from January 2008 to June 2018 in a tertiary teaching hospital in Buenos Aires, Argentina. New users of antipsychotic drugs were compared to new users of any benzodiazepine. The primary outcome of interest was incident bloodstream infection at 1 year of follow-up. Propensity score methods and a Cox proportional hazards model were used to adjust for baseline confounding. RESULTS: A total of 923 patients were included in the present analysis. Mean (SD) age was 75.0 (9.8) years, and 51.9% of patients were female. The cumulative incidence of bloodstream infections at 1 year was 6.0% and 2.3% in the antipsychotic and benzodiazepine groups, respectively. Antipsychotic use was associated with a higher risk of bloodstream infections during the first year of follow-up (hazard ratio [HR] = 2.41; 95% CI, 1.13 to 5.14) compared to benzodiazepine use. Antipsychotics with high dopamine receptor affinity presented greater risk than less selective agents (HR = 5.20; 95% CI, 1.53 to 17.67). CONCLUSIONS: Antipsychotic use is associated with bloodstream infections during the first year of follow-up in adult patients with chronic obstructive pulmonary disease. Further studies are warranted to confirm our findings and evaluate this effect in a broader population of patients.


Asunto(s)
Antipsicóticos/uso terapéutico , Benzodiazepinas/uso terapéutico , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Sepsis/epidemiología , Anciano , Anciano de 80 o más Años , Antipsicóticos/efectos adversos , Argentina/epidemiología , Benzodiazepinas/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Estudios Retrospectivos
8.
Intern Emerg Med ; 16(3): 711-717, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33001349

RESUMEN

BACKGROUND: Proton pump inhibitors (PPI)-related hypomagnesemia is a potentially life-threatening adverse event first described in 2006. PPIs are widely used in the general population. Information regarding prevalence and risk factors is scarce. We conducted a cross-sectional study in inpatients to evaluate prevalence and associated factors with hypomagnesemia in chronic PPIs users. This is a cross-sectional study of hospitalized adult patients with chronic use of PPIs from January 01, 2012, to December 31, 2018. Chronic use was defined as taking PPIs at least 6 months before hospital admittance. Data were collected from informatized medical records from a University Hospital (Hospital Italiano de Buenos Aires). Hypomagnesemia was defined as a value equal to or less than 1.7 mg/dl. The first hospitalization measurement was retrieved. Thirty-six percent of patients (95% CI 30-43) with chronic PPI use presented hypomagnesemia at admission. Patients with hypomagnesemia presented a higher prevalence of chronic kidney disease (18.6% vs 8%, p < 0.05), more use of oral magnesium supplementation (20.9% vs 8%, p < 0.05), use of corticosteroids (32.6% vs 19.3%, p = 0.06) and calcineurin inhibitors (17.4% vs 6.7%, p < 0.05). Regarding laboratory findings, they presented lower hematocrit (28.7% vs 32.8%, p < 0.05), phosphatemia (3 mg/dl vs 3.4 mg/dl, p < 0.05), natremia (135 mg/dl vs 136 mg/dl, p < 0.05) and albumin levels (2.8 g/dl vs 3.2 g/dl p < 0.05) when compared to those who presented normomagnesemia. Hypocalcemia was more frequent among patients with hypomagnesemia (57% vs 38.7%, p < 0.05). In the multivariate analysis, hyponatremia, decreasing levels of hematocrit (odds ratio, OR 0.93-CI 95% 0.88-0.98) and malignant bone compromise (OR 2.83-CI 95% 1.04-7.7) were associated with hypomagnesemia. Adult patients with long-term use of PPIs have a high prevalence of hypomagnesemia. Increasing age, female sex, concomitant use of drugs that impair tubular function and chronic kidney disease may enhance this phenomenon. Anemia, hyponatremia and malignant bone compromise were associated factors with PPIs-related hypomagnesemia.


Asunto(s)
Magnesio/sangre , Inhibidores de la Bomba de Protones/efectos adversos , Anciano , Anciano de 80 o más Años , Argentina , Estudios Transversales , Femenino , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Factores de Riesgo
9.
Clin Appl Thromb Hemost ; 27: 10760296211051712, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34714177

RESUMEN

BACKGROUND: Since the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pandemic, there have been many reports of increased incidence of venous thromboembolism and arterial events as a complication. OBJECTIVE: To determine the incidence of symptomatic thrombotic events (TEs) in patients hospitalized for SARS-CoV2 disease (coronavirus 19 [Covid-19]). METHODS: A retrospective single-center cohort study with adult patients with a positive reverse transcriptase-polymerase chain reaction (rt-PCR) for SARS-CoV2, included from the date of diagnosis of Covid-19 and followed for 90 days or until death. RESULTS: A total of 1621 patients were included in this study. The median age was 73 years (interquartile range25th-75th [IQR] 53-87 years) and 57% (913) were female. Overall mortality was 21.6% (348). The overall incidence of symptomatic TEs within 90 days of diagnosis was 1.8% (30 of 1621) occurring in 28 patients, including an incidence of pulmonary embolism of 0.9% (15, 95% confidence interval [CI] 0.60%-1.6%), deep venous thrombosis of 0.61% (10, 95% CI 0.2%-1%), ischemic stroke of 0.25% (4, 95% CI 0.09%-0.65%), and ischemic arterial events of 0.06% (1, 95% CI 0.008%-0.43%). No acute coronary syndrome events were recorded. The incidence of symptomatic TEs was significantly lower in the general ward than in intensive care units (1.2% vs 5.7%; p < .001). The median time since positive rt-PCR for SARS-CoV2 to symptomatic TE was 22.5 days (IQR 19-43 days). There was no significant difference in the proportion of patients receiving (53.6%) and not receiving thromboprophylaxis (66.5%) and the development of TEs. CONCLUSION: The overall incidence of symptomatic TEs among these patients was lower than the incidence previously reported.


Asunto(s)
Arteriopatías Oclusivas/epidemiología , COVID-19/epidemiología , Embolia Pulmonar/epidemiología , Tromboembolia/epidemiología , Trombosis de la Vena/epidemiología , Anciano , Anciano de 80 o más Años , Argentina/epidemiología , Arteriopatías Oclusivas/sangre , Arteriopatías Oclusivas/diagnóstico , COVID-19/sangre , COVID-19/diagnóstico , Femenino , Humanos , Incidencia , Accidente Cerebrovascular Isquémico/sangre , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/epidemiología , Masculino , Persona de Mediana Edad , Admisión del Paciente , Embolia Pulmonar/sangre , Embolia Pulmonar/diagnóstico , Estudios Retrospectivos , Tromboembolia/sangre , Tromboembolia/diagnóstico , Factores de Tiempo , Trombosis de la Vena/sangre , Trombosis de la Vena/diagnóstico
10.
PLoS One ; 15(2): e0228486, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32032395

RESUMEN

OBJECTIVE: To report our clinical experience with bevacizumab in a cohort of Hereditary Hemorrhagic Telangiectasia (HHT) patients with severe hepatic involvement and/or refractory anemia. METHODS: Observational, ambispective study of the Institutional Registry of HHT at Hospital Italiano de Buenos Aires. Patients were treated with bevacizumab due to iron deficiency refractory anemia secondary to nasal/gastrointestinal bleeding and/or high output cardiac failure. We describe basal clinical data, bevacizumab schedules, efficacy outcomes and adverse events. Wilcoxon signed ranks test and longitudinal analysis were conducted. RESULTS: Twenty adult patients were included from July 2013 to June 2019. Clinical indications were: 13 for anemia, 4 for heart failure and 3 for both. In the anemia group, median pretreatment hemoglobin was 8.1 g/dl [IQR: 7.2-8.4] and median transfusion requirement was 4 units [2-6]. In heart failure group, pretreatment median cardiac index was 4.5 L/min/m2 [4.1-5.6] and cardiac output was 8.3 L/min [7.5-9.2]. Bevacizumab 5 mg/kg/dose every 2 weeks for 6 applications was scheduled. By the end of induction, median hemoglobin at 3 months was 10.9 g/dl [9.5-12.8] (p = 0.01) and median transfusion requirement 0 units [0-1] (p<0.01), and this effect was more or less sustained during a year. Regarding heart failure group, two patients had complete hemodynamic response and achieved liver transplantation and two had partial response. No serious adverse events were registered. CONCLUSION: Bevacizumab is a promising line of treatment for HHT patients with refractory anemia. For patients with high output cardiac failure, bevacizumab may be useful as bridge therapy awaiting for liver transplantation.


Asunto(s)
Anemia Refractaria/tratamiento farmacológico , Bevacizumab/uso terapéutico , Hepatopatías/tratamiento farmacológico , Telangiectasia Hemorrágica Hereditaria/tratamiento farmacológico , Adulto , Anciano , Anemia Refractaria/etiología , Anemia Refractaria/patología , Argentina , Femenino , Humanos , Hepatopatías/etiología , Hepatopatías/patología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Telangiectasia Hemorrágica Hereditaria/complicaciones , Resultado del Tratamiento
11.
J Clin Psychiatry ; 80(5)2019 08 27.
Artículo en Inglés | MEDLINE | ID: mdl-31509358

RESUMEN

BACKGROUND: Venous thromboembolism (VTE) represents a major cause of morbidity and mortality worldwide. Antipsychotic treatment is associated with an increased risk of thromboembolic disease, an effect that seems to be constant across the spectrum of distinct agents. This study sought to delineate the effect of new antipsychotic use on the risk of recurrent thromboembolic events after a first episode of either deep venous thrombosis or pulmonary embolism. METHODS: This cohort study, conducted between January 2010 and June 2017, was based on a prospectively collected database of adult patients with VTE. The main exposure was the new onset of antipsychotic treatment after having a first episode of venous thromboembolic disease. The primary outcome was defined as recurrent VTE, either deep venous thrombosis or pulmonary embolism, during long-term follow-up. The composite of all-cause mortality and recurrent VTE served as the secondary outcome. An inverse probability weighted multivariable Cox proportional hazards model was fitted to adjust for measured confounding and competing risks. RESULTS: One thousand one hundred three patients were included in the present analysis, of whom 136 were identified as new users of antipsychotic agents. A total of 67% of patients were currently treated with full-dose anticoagulation at baseline. No association was found between the new use of antipsychotic agents and recurrent VTE during follow-up (adjusted hazard ratio (HR) = 1.08; 95% CI, 0.38-3.08). However, the use of these agents was associated with a 63% increased risk of recurrent VTE or all-cause mortality (adjusted HR = 1.63; 95% CI, 1.26-2.10). CONCLUSIONS: The use of antipsychotic agents among patients with a first episode of VTE and full-dose anticoagulation was not associated with an increased risk of recurrent thromboembolic events. However, antipsychotic treatment was associated with a higher risk of both VTE and all-cause mortality. Further studies are warranted to confirm these findings.


Asunto(s)
Antipsicóticos/efectos adversos , Embolia Pulmonar/epidemiología , Sistema de Registros/estadística & datos numéricos , Tromboembolia Venosa/epidemiología , Trombosis de la Vena/epidemiología , Anciano , Argentina/epidemiología , Comorbilidad , Femenino , Humanos , Masculino , Recurrencia , Estudios Retrospectivos , Tromboembolia Venosa/mortalidad
12.
Rev Chilena Infectol ; 35(3): 239-245, 2018.
Artículo en Español | MEDLINE | ID: mdl-30534902

RESUMEN

BACKGROUND: The emergence of colistin resistant carbapenemase-producing Klebsiella represents a therapeutic challenge and a worldwide problem. AIM: To estimate the in-hospital mortality and identify the associated risk factors among patients with colistin-resistant carbapenemase-producing Klebsiella pneumoniae (KPC) that present with a clinical infection. METHODS: We carried a retrospective cohort study, including adult patients infected with colistin-resistant KPC hospitalized at a tertiary teaching hospital in Buenos Aires, Argentina during the year 2016. The main outcome was in-hospital mortality. We used generalized lineal models to evaluate potential predictors of mortality. RESULTS: 18 patients that developed a colistin-resistant KPC clinical infection were identified and included in the final analysis. In-hospital mortality in this cohort was 38.9%. The presence of bacteremia, acute renal injury at the time of diagnosis and septic shock were associated with the main outcome. CONCLUSIONS: Infections due to colistin-resistant KPC among in-hospital patients was frequent and was associated with high mortality rate. In our cohort, both shock and acute kidney injury were associated with a higher likelihood of poor outcomes. Further studies are warranted to evaluate the role of these and others risk factors so as to aid in the early detection of high risk patients.


Asunto(s)
Antibacterianos/uso terapéutico , Proteínas Bacterianas/metabolismo , Colistina , Mortalidad Hospitalaria , Infecciones por Klebsiella/mortalidad , Klebsiella pneumoniae/efectos de los fármacos , beta-Lactamasas/metabolismo , Adulto , Argentina , Farmacorresistencia Bacteriana , Femenino , Humanos , Infecciones por Klebsiella/tratamiento farmacológico , Infecciones por Klebsiella/enzimología , Infecciones por Klebsiella/microbiología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo
13.
Psychiatry Res ; 265: 82-86, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29702305

RESUMEN

We aimed to compare the mortality risk between patients with affective disorders and dementia under treatment with antipsychotics. To do this, a matched-cohort study based on an electronic database of a tertiary teaching hospital in Argentina was performed. Antipsychotic exposure was defined as any antipsychotic drug initiated by the patient. Primary outcome was defined as all-cause mortality during the 5-year follow-up period. To estimate the association between baseline diagnosis (affective disorders vs. dementia) and all-cause mortality, we used a multivariate generalized linear model with robust standard errors. Of 1008 eligible patients, 114 age-matched pairs were included in the present study. The primary event occurred in 23 patients (20%) and 17 patients (15%) in the dementia and affective disorder group respectively. In the adjusted model, the risk of all cause mortality for the affective disorders group was 0.92 times the risk for the dementia group (95%CI, 0.54-1.59, p = 0.77). In conclusion, older patients with affective disorders starting antipsychotic treatment presented with a similar risk of all-cause mortality during the 5-year follow-up when compared to older patients with dementia who were also initiating either typical or atypical antipsychotic medications. Closer medical attention to older patients with mental conditions under antipsychotic treatment remains warranted.


Asunto(s)
Antipsicóticos/efectos adversos , Demencia/tratamiento farmacológico , Demencia/mortalidad , Trastornos del Humor/tratamiento farmacológico , Trastornos del Humor/mortalidad , Anciano , Anciano de 80 o más Años , Antipsicóticos/uso terapéutico , Argentina/epidemiología , Causas de Muerte/tendencias , Estudios de Cohortes , Bases de Datos Factuales/tendencias , Demencia/psicología , Femenino , Humanos , Masculino , Trastornos del Humor/psicología , Mortalidad/tendencias , Estudios Retrospectivos , Resultado del Tratamiento
14.
Rev. Hosp. Ital. B. Aires (2004) ; 42(1): 29-36, mar. 2022. ilus, tab
Artículo en Español | LILACS, UNISALUD, BINACIS | ID: biblio-1368992

RESUMEN

Introducción: el síndrome de vena cava superior resulta de la obstrucción del flujo sanguíneo a través de este vaso. Casi la totalidad de los casos en la actualidad se asocian con tumores malignos. Existen controversias acerca del manejo apropiado de este cuadro. Actualmente, las terapias endovasculares son consideradas de elección. Materiales y métodos: se recolectaron y describieron, a partir de datos de la historia clínica electrónica, los casos de pacientes mayores de 18 años internados ­de forma consecutiva, que desarrollaron el síndrome­ en el Hospital Italiano de Buenos Aires en 2021. Se constataron las características basales, los tratamientos recibidos y los desenlaces clínicos intrahospitaliarios de cada uno de ellos. Resultados: un total de cinco pacientes fueron incluidos en el presente estudio y seguidos durante su instancia intrahospitalaria. Todos los casos descriptos fueron secundarios a enfermedades oncológicas. La mayoría de los pacientes presentaron un cuadro de moderada gravedad según las escalas utilizadas. En cuatro de cinco pacientes se optó por terapias endovasculares y dos de ellos fallecieron durante la internación. Discusión: existen controversias respecto del tratamiento óptimo del síndrome de vena cava superior, y heterogeneidad en la práctica clínica. Los estudios futuros deberían centrarse en identificar a aquellos pacientes que más probablemente se beneficien de las estrategias terapéuticas endovasculares, anticoagulantes o antiagregantes. (AU)


Introduction: superior vena cava syndrome results from an obstruction of blood flow through this vessel. Currently, almost all cases are associated with malignancies. There are controversies about the optimal management of this syndrome. Endovascular therapies are considered the first-line therapy. Material and methods: we collected clinical, laboratory and pharmacological data from patients admitted at the Hospital Italiano de Buenos Aires, between January 1st and November 1st 2021 with a diagnosis o superior vein cava syndrome. Baseline characteristics, treatment strategies and clinical outcomes were recorded. Results: a total of five patients were included in the present study. All cases were malignancy-related. Most of the patientsdeveloped moderate symptoms. Four out of five patients were treated with endovascular therapies and two patients died during hospitalization. Discussion: controversies regarding optimal management of the superior vena cava syndrome remain. Future research should focus on identifying those patients who are most likely to benefit from endovascular, anticoagulant or antiplatelet therapeutic strategies. (AU)


Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Síndrome de la Vena Cava Superior/terapia , Procedimientos Endovasculares , Hospitalización , Neoplasias/complicaciones , Síndrome de la Vena Cava Superior/etiología , Síndrome de la Vena Cava Superior/mortalidad , Síndrome de la Vena Cava Superior/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Stents , Registros Electrónicos de Salud , Anticoagulantes/uso terapéutico
15.
Medicina (B.Aires) ; 82(2): 172-180, mayo 2022. graf
Artículo en Inglés | LILACS-Express | LILACS | ID: biblio-1375858

RESUMEN

Abstract We conducted a retrospective cohort study to report the clinical characteristics, incidence and out-comes of patients with severe COVID-19 with acute kidney injury (AKI). One-hundred and sixtytwo intensive care unit (ICU) admitted patients in a tertiary level hospital in the city of Buenos Aires with COVID-19 diagnosis were included. We hypothesized that COVID-19 related AKI would develop in the period of more severe hypoxemia as an early event and late AKI would be more probably related to intensive care unit complications. For this purpose, we divided subjects into two groups: those with early AKI and late AKI, before and after day 14 from symptom onset, respectively. A stepwise multivariate analysis was conducted to find possible AKI predictors. AKI incidence was 43.2% (n = 70) of the total patients admitted into ICU with severe COVID-19, 11.1% (n = 18) required renal replacement therapy. In-hospital mortality was higher (58.6%) for the AKI group. AKI occurred on a median time of 10 (IQR 5.5-17.5) days from symptom onset. A history of hypertension or heart failure, age and invasive mechanical ventilation (IMV) requirement were identified as risk factors. Late AKI (n = 25, 35.7%) was associated with sepsis and nephrotoxic exposure, whereas early AKI occurred closer to the timing of IMV initiation and was more likely to have an unknown origin. In conclusion, AKI is frequent among critically ill patients with severe COVID-19 and it is associated with higher in-hospital mortality.


Resumen Llevamos a cabo un estudio retrospectivo con el objetivo de describir las características clínicas, incidencia y desenlaces de los pacientes con injuria renal aguda (IRA) asociada a la COVID-19. Se incluyeron 162 pacientes con diagnóstico de COVID-19 admitidos en una unidad de cuidados intensivos en un hospital de tercer nivel en la Ciudad de Buenos Aires. Nuestra hipótesis consistió en que la IRA asociada a COVID-19 sería un evento temprano asociado a la gravedad de la hipoxemia y la IRA tardía se relacionaría con complicaciones propias de la UCI. Por ello se clasificó la IRA en temprana y tardía, según sucediera antes o después de los 14 días desde el inicio de síntomas. Se realizó un análisis multivariado mediante regresión logística escalonada para evaluar posibles factores de riesgo. La incidencia de IRA fue de 43.2% (n = 70), 11.1% (n = 18) requirieron terapia de reemplazo renal. La mortalidad intrahospitalaria fue mayor (58.6%) en el grupo con IRA. El diagnóstico de IRA se realizó en una mediana de 10 (IQR = 5.5-17.5) días desde el inicio de los síntomas. El antecedente de hipertensión e insuficiencia cardíaca, la edad y el requerimiento de ventilación mecánica invasiva (VMI) fueron identificados como factores de riesgo para IRA. La IRA tardía (n = 25, 35.7%) estuvo asociada a sepsis y expo sición a nefrotóxicos, mientras que la IRA temprana (n = 45, 64.2%) estuvo temporalmente asociada al inicio de la VMI y en muchos casos no se pudo filiar una etiología. En conclusión, la IRA es una complicación frecuente en pacientes con COVID-19 grave y está asociada a una alta mortalidad intrahospitalaria.

17.
Rev. chil. infectol ; 35(3): 239-245, 2018. tab, graf
Artículo en Español | LILACS | ID: biblio-959437

RESUMEN

Resumen Introducción: La emergencia de Klebsiella productora de carbapenemasas resistente a colistín representa un desafío clínico y un problema emergente. Objetivo: Evaluar la mortalidad intrahospitalaria y sus potenciales factores de riesgo en pacientes internados con infecciones clínicas por Klebsiella pneumoniae productora de carbapenemasas (KPC) resistente a colistín. Material y Método: Realizamos un estudio de cohorte retrospectivo, incluyendo pacientes adultos admitidos a un hospital universitario de tercer nivel en Buenos Aires, infectados por KPC resistente a colistín. El evento primario considerado fue la mortalidad intrahospitalaria. Se utilizaron modelos generalizados lineales para evaluar potenciales predictores de dicho evento. Resultados: En total, se identificaron 18 pacientes hospitalizados que presentaron una infección clínica por esta bacteria durante el año 2016 y que fueron incluidos en el análisis final. La mortalidad intrahospitalaria en esta cohorte fue de 38,9%. La presencia de bacteriemia, la injuria renal aguda al momento del diagnóstico y la presencia de shock séptico se asociaron a la ocurrencia del evento primario. Conclusión: El desarrollo de infecciones clínicamente relevantes por KPC resistente a colistín en pacientes internados es frecuente y presenta una elevada mortalidad. En nuestra cohorte, la presencia de shock e injuria renal aguda al momento del diagnóstico se asociaron a un incrementado riesgo de mortalidad intrahospitalaria. Futuras investigaciones deberían corroborar estos hallazgos e investigar factores adicionales que permitan identificar tempranamente a aquellos pacientes que presentarán eventos desfavorables.


ABSTRACT Background: The emergence of colistin resistant carbapenemase-producing Klebsiella represents a therapeutic challenge and a worldwide problem. Aim: To estimate the in-hospital mortality and identify the associated risk factors among patients with colistin-resistant carbapenemase-producing Klebsiella pneumoniae (KPC) that present with a clinical infection. Methods: We carried a retrospective cohort study, including adult patients infected with colistin-resistant KPC hospitalized at a tertiary teaching hospital in Buenos Aires, Argentina during the year 2016. The main outcome was in-hospital mortality. We used generalized lineal models to evaluate potential predictors of mortality. Results: 18 patients that developed a colistin-resistant KPC clinical infection were identified and included in the final analysis. In-hospital mortality in this cohort was 38.9%. The presence of bacteremia, acute renal injury at the time of diagnosis and septic shock were associated with the main outcome. Conclusions: Infections due to colistin-resistant KPC among in-hospital patients was frequent and was associated with high mortality rate. In our cohort, both shock and acute kidney injury were associated with a higher likelihood of poor outcomes. Further studies are warranted to evaluate the role of these and others risk factors so as to aid in the early detection of high risk patients.


Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Proteínas Bacterianas/metabolismo , beta-Lactamasas/metabolismo , Infecciones por Klebsiella/mortalidad , Mortalidad Hospitalaria , Colistina , Klebsiella pneumoniae/efectos de los fármacos , Antibacterianos/uso terapéutico , Argentina , Infecciones por Klebsiella/enzimología , Infecciones por Klebsiella/microbiología , Infecciones por Klebsiella/tratamiento farmacológico , Estudios Retrospectivos , Factores de Riesgo , Farmacorresistencia Bacteriana
18.
Rev. Hosp. Ital. B. Aires (2004) ; 37(4): 129-135, dic. 2017. graf, tab
Artículo en Español | LILACS | ID: biblio-1095384

RESUMEN

Introducción: comprender los factores que condicionan el uso off-label de los agentes monoclonales es crucial para su utilización racional. El objetivo de nuestro estudio fue describir la prevalencia de uso off-label de rituximab y los factores médicos, clínicos y socioeconómicos que se vinculan con dicha práctica. Métodos: estudio de corte transversal retrospectivo. Incluimos pacientes adultos con una primera indicación de rituximab entre 2010 y 2016. La exposición primaria fue definida como el momento de la pérdida de patente de rituximab. Otros factores considerados fueron el diagnóstico de base y las comorbilidades, así como también datos referentes a los médicos tratantes. El evento primario fue la prevalencia de prescripción off-label de rituximab. Utilizamos un modelo de regresión logística para estimar la asociación entre el tiempo y el evento primario. Resultados: de 160 pacientes adultos que iniciaron tratamiento con rituximab y fueron potencialmente elegibles se tomó una muestra aleatoria; 22 de ellos fueron incluidos en el análisis final. La prevalencia de uso off-label fue del 30,4% (IC 95%, 13,9 a 54,9%). No evidenciamos un cambio en el patrón de prescripción de rituximab asociado al tiempo de caída de la patente. El único factor predictor de dicho uso fueron las internaciones previas (7 vs. 1, p = 0,04). Conclusión: el uso off-label de rituximab es frecuente en nuestra población. Futuros estudios deberían estar dirigidos a determinar los factores asociados a esta práctica, así como a estimar el impacto en términos de eficacia y potencial toxicidad en esta población. (AU)


Background: the description of those characteristics that are associated with the off-label use of monoclonal antibodies remains paramount if we are to maximize the rational use of available resources. Our main objective was to describe the prevalence of off-label use of Rituximab, in addition to its associated factors (for example, prescribing physician and patient´s clinical and socioeconomic characteristics). Methods: we designed a retrospective cross-sectional study which included patients starting treatment with Rituximab between 2010 and 2016. Our main exposure was the time when Rituximab´s patent expired. Other potential factors associated with the off-label prescription pattern were baseline diagnosis and comorbidities in addition to the main characteristics of the prescribing physician. The main outcome was the prevalence of off-label use of Rituximab. We used a multivariate logistic regression model in order to estimate the association between time and our main endpoint. Results: out of 160 eligible patients that started treatment with Rituximab we included 22 adult patients in our main analysis by conducting a random sampling procedure. The prevalence of off-label use was 30.4% (95% CI, 13.9 to 54.9%). We did not find a change in the prescription pattern of Rituximab with regards to time and patent expiration. The only factor associated with off-label use were previous hospitalizations (7 vs. 1, p = 0.04). Conclusions: the off-label use of Rituximab is common in our population. Future studies evaluating distinct factors associated with such use as well as its impact in both potential efficacy and toxicity are warranted. (AU)


Asunto(s)
Humanos , Masculino , Femenino , Adolescente , Adulto , Persona de Mediana Edad , Adulto Joven , Uso Fuera de lo Indicado/estadística & datos numéricos , Rituximab/administración & dosificación , Prescripciones de Medicamentos/estadística & datos numéricos , Factores Socioeconómicos , Factores Epidemiológicos , Estudios Transversales , Factores de Riesgo , Razón de Prevalencias , Propiedad Intelectual de Productos y Procesos Farmacéuticos , Rituximab/efectos adversos , Rituximab/toxicidad , Rituximab/uso terapéutico , Anticuerpos Monoclonales/administración & dosificación
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