Reversal of SARS-CoV2-Induced Hypoxia by Nebulized Sodium Ibuprofenate in a Compassionate Use Program.

INTRODUCTION: Sodium ibuprofenate in hypertonic saline (NaIHS) administered directly to the lungs by nebulization and inhalation has antibacterial and anti-inflammatory effects, with the potential to deliver these benefits to hypoxic patients. We describe a compassionate use program that offered this therapy to hospitalized COVID-19 patients. METHODS: NaIHS (50 mg ibuprofen, tid) was provided in addition to standard of care (SOC) to hospitalized COVID-19 patients until oxygen saturation levels of > 94% were achieved on ambient air. Patients wore a containment hood to diminish aerosolization. Outcome data from participating patients treated at multiple hospitals in Argentina between April 4 and October 31, 2020, are summarized. Results were compared with a retrospective contemporaneous control (CC) group of hospitalized COVID-19 patients with SOC alone during the same time frame from a subset of participating hospitals from Córdoba and Buenos Aires. RESULTS: The evolution of 383 patients treated with SOC + NaIHS [56 on mechanical ventilation (MV) at baseline] and 195 CC (21 on MV at baseline) are summarized. At baseline, NaIHS-treated patients had basal oxygen saturation of 90.7 ± 0.2% (74.3% were on supplemental oxygen at baseline) and a basal respiratory rate of 22.7 ± 0.3 breath/min. In the CC group, basal oxygen saturation was 92.6 ± 0.4% (52.1% were on oxygen supplementation at baseline) and respiratory rate was 19.3 ± 0.3 breath/min. Despite greater pulmonary compromise at baseline in the NaIHS-treated group, the length of treatment (LOT) was 9.1 ± 0.2 gs with an average length of stay (ALOS) of 11.5 ± 0.3 days, in comparison with an ALOS of 13.3 ± 0.9 days in the CC group. In patients on MV who received NaIHS, the ALOS was lower than in the CC group. In both NaIHS-treated groups, a rapid reversal of deterioration in oxygenation and NEWS2 scores was observed acutely after initiation of NaIHS therapy. No serious adverse events were considered related to ibuprofen therapy. Mortality was lower in both NaIHS groups compared with CC groups. CONCLUSIONS: Treatment of COVID-19 pneumonitis with inhalational nebulized NaIHS was associated with rapid improvement in hypoxia and vital signs, with no serious adverse events attributed to therapy. Nebulized NaIHS s worthy of further study in randomized, placebo-controlled trials (ClinicalTrials.gov: NCT04382768).

An intensive follow-up in subjects with cardiometabolic high-risk.

BACKGROUND AND AIM: Addressing chronic problems requires a model of care that promotes self-management of the disease and facilitates adherence to treatment. This project was designed to enhance patient's clinical and functional outcomes through a Comprehensive Model to be implemented in our health system and to evaluate the results. METHODS AND RESULTS: Different population stratification tools were tested and designed to classify subjects according to different variables. We have developed a program to detect and screen cardiometabolic risk by integrating most of the Chronic Care Model recommendations through in-house developed management software (MoviHealth®). From the results, 1317 subjects were evaluated (27% of the whole population) during the first year of follow-up which significantly improved for all variables along the follow-up period. The blood pressure of the hypertensive population in 2010 and 2015 showed the importance of enrollment of subjects and the optimization of the blood pressure control. The result of HbA1c observed in 2010 decreased progressively to 7.1 ± 1.4% in 2015, and dyslipidemia levels improved gradually. The number of cardiovascular events requiring hospitalization decreased significantly (48%), from 1.9 events per 100 subjects in 2011 to 0.98 in 2015. CONCLUSION: Our program has combined strategies for the prevention and control of non-communicable diseases, incorporating interventions to control risk factors and to reduce morbidity and mortality. It also had improvements in life quality, accessibility to health-care services, and the promotion of self-care.

Obesidad central, sarcopenia y conductas sedentarias en el riesgo cardiovascular por score Framingham y área total de placa carotídea / Central Obesity, Sarcopenia, and Sedentary Behaviors Related to Cardiovascular Risk by Framingham Score and Total Carotid Plaque Area

Resumen Antecedentes: las enfermedades cardiovasculares son la principal causa de morbimortalidad mundial. La obesidad, sarcopenia, actividad física insuficiente y las conductas sedentarias impactan de manera sinérgica en el riesgo cardiovascular. Objetivo: evaluar el riesgo cardiovascular en relación con la actividad física, las conductas sedentarias y la composición corporal. Materiales y métodos: estudio observacional transversal de 95 personas adultas de ambos sexos. Se determinó el riesgo cardiovascular mediante el score de Framingham y el score de Framingham corregido por área total de placa aterosclerótica; la composición corporal, por antropometría, bioimpedancia y dinamometría como indicador indirecto; y la actividad física y las conductas sedentarias, por cuestionario validado. Se condujeron análisis descriptivos, de correlación y asociación con un 95 % de confianza. Resultados: el 95 % de las mujeres y el 98 % de los varones presentaron riesgo cardiovascular elevado; el 51,5 %, obesidad; el 95,5%, obesidad central; y el 47,3 %, fuerza muscular disminuida. Se observaron asociaciones positivas significativas entre riesgo cardiovascular y circunferencia de cintura (rho=0,26; p=0,024). No hubo asociación significativa entre la fuerza muscular y el riesgo cardiovascular (rho=-0,21; p=0,065). La conducta sedentaria tuvo un efecto promotor del riesgo cardiovascular (OR=3,9; p=0,033). Conclusiones: la obesidad central y permanecer más de 6/h día en posición sedente son factores asociados al riesgo cardiovascular.

Abstract Background: Cardiovascular diseases are the principal cause of morbidity and mortality worldwide. Obesity, sarco-penia, insufficient physical activity, and sedentary behaviors synergistically impact cardiovascular risk. Objective: Evaluate cardiovascular risk in relation to physical activity, sedentary behaviors, and body composition. Materials and Methods: Cross-sectional observational study in 95 total males and females. Cardiovascular risk was determined using the Framingham score, which corrects for total area of atherosclerotic plaque. Risk was also determined using body composition, anthropometry, bioimpedance and dynamometry as indirect indicators, physical activity, sedentary behaviors, and a validated questionnaire. Descriptive, correlation and association analyses were conducted with 95% confidence. Results: 95% of women and 98% of men presented with an elevated cardiovascular risk; 51.5% with obesity, 95.5% central obesity, and 47.3% with diminished muscular strength. Significant positive associations were observed between cardiovascular risk and waist circumference (rho=0.26; p=0.024). There was no significant association between muscle strength and cardiovascular risk (rho=-0.21, p=0.065). Sedentary behavior increased cardiovascular risk (OR=3.9; p=0.033). Conclusions: Central obesity and staying more than six hours per day in a sitting position are factors associated with cardiovascular risk.

Increased carotid plaque burden in patients with family medical history of premature cardiovascular events in the absence of classical risk factors.

INTRODUCTION: The hypothesis that relates atherosclerosis to traditional risk factors (TRF) seems to be not as adequate as previously thought; other risk factors (RF) need to be considered to prevent atherosclerosis progression. Although a family medical history of premature cardiovascular events (FHx) has been considered the putative RF for decades, it has not been incorporated routinely into cardiovascular risk evaluation along with another RF. The objective of this study was to investigate whether FHx is associated with a higher atherosclerotic burden, measured as carotid total plaque area (TPA) in a population having no traditional RF. MATERIAL AND METHODS: The study included 4,351 primary care patients in Argentina. After excluding a personal history of cardiovascular disease (CVD) and TRF: hypertension, diabetes mellitus, hypercholesterolemia, smoking history, and body mass index (BMI) > 25 kg/cm2, 34 patients with FHx were identified. Compared to 56 matched controls TPA was 86% higher in FHx patients (p < 0.05). A second analysis performed in hypertensive patients but no other TRF; 32 patients with FHx were identified. RESULTS: Compared with 44 matched controls, TPA was 77% higher in FHx patients (p < 0.05). A final analysis using a generalized linear model with TPA progression as the response variable suggests that TPA progresses more rapidly in FHx patients compared to controls. CONCLUSIONS: The FHx was associated with increased TPA burden and progression in the absence of other TRF. This supports ultrasound screening in FHx patients in order to detect high-risk patients who may benefit from early intervention.

Adding carotid total plaque area to the Framingham risk score improves cardiovascular risk classification.

INTRODUCTION: Cardiovascular events (CE) due to atherosclerosis are preventable. Identification of high-risk patients helps to focus resources on those most likely to benefit from expensive therapy. Atherosclerosis is not considered for patient risk categorization, even though a fraction of CE are predicted by Framingham risk factors. Our objective was to assess the incremental value of combining total plaque area (TPA) with the Framingham risk score (FramSc) using post-test probability (Ptp) in order to categorize risk in patients without CE and identify those at high risk and requiring intensive treatment. MATERIAL AND METHODS: A descriptive cross-sectional study was performed in the primary care setting in an Argentine population aged 22-90 years without CE. Both FramSc based on body mass index and Ptp-TPA were employed in 2035 patients for risk stratification and the resulting reclassification was compared. Total plaque area was measured with a high-resolution duplex ultrasound scanner. RESULTS: 57% male, 35% hypertensive, 27% hypercholesterolemia, 14% diabetes. 20.1% were low, 28.5% moderate, and 51.5% high risk. When patients were reclassified, 36% of them changed status; 24.1% migrated to a higher and 13.6% to a lower risk level (κ index = 0.360, SE κ = 0.16, p < 0.05, FramSc vs. Ptp-TPA). With this reclassification, 19.3% were low, 18.9% moderate and 61.8% high risk. CONCLUSIONS: Quantification of Ptp-TPA leads to higher risk estimation than FramSc, suggesting that Ptp-TPA may be more sensitive than FramSc as a screening tool. If our observation is confirmed with a prospective study, this reclassification would improve the long-term benefits related to CE prevention.

Risk of vascular disease in premenopausal women with diabetes mellitus.

PURPOSE: The aims of this study were (1) to estimate the prevalence of cardiovascular disease risk factors among premenopausal and menopausal Argentinean women with and without type 2 diabetes mellitus and (2) to assess the contribution of total plaque area (TPA) to risk stratification when added to Framingham risk scores. METHODS: A descriptive cross-sectional study in primary prevention in 1257 women (ages 19-84 years) from Argentina. TPA was measured by ultrasonography. Framingham sex-specific risk equations were used to predict the risk of developing cardiovascular disease, coronary heart disease, and stroke during the next 10 years. Patients were divided into diabetic (n = 293) and control groups (n = 964), and then each group was divided according to age (>40, 40-49, 50-59, and ≥60 years). FINDINGS: No difference was observed between diabetic and control groups in the incidence of smoking or the presence of early family cardiovascular event. Overall, diabetic patients had higher body mass index, blood pressure, and TPA versus the control group. The Framingham risk score was higher in the diabetic group in all age groups. The mean (SD) coronary heart disease scores for the diabetic group at <40, 40 to 49, 50 to 59, and ≥60 were 6% (1.7%), 19% (2.5%), 38% (2.0%), and 60% (1.5%), respectively, whereas the scores in the control group 3% (0.8%), 7% (0.9%), 17% (0.9%), and 40% (0.9%), respectively. The stroke score was also enhanced in diabetic women, independent of their age. These data indicate that diabetic women in the premenopausal age or the early years of menopause age (40-50 years) are at intermediate or higher risk of developing a cardiovascular event. IMPLICATIONS: Premenopausal diabetic women should be considered at possibly high risk of cardiovascular events compared with nondiabetic women. Direct assessment of atherosclerotic burden, such as TPA, should be used early in this population instead of relying on traditional risk scores.

[Risk factors associated to upper gastrointestinal bleeding in non intensive care units]. / Factores de riesgo asociados a hemorragia digestiva alta, en sala común.

UNLABELLED: Upper gastrointestinal bleeding--UGB-, as a complication, is well studied at intensive care units (ICU), but is less known in non ICU settings. OBJECTIVES: To determine incidence and risk factors of this entity at clinical hospitalization. MATERIALS AND METHODS: A case-control study of patients with gastric ulcer disease diagnosed by endoscopy who presented with melena and hematemesis. Ten controls were taken for each case, matching sex, age and prophylaxis for gastric hemorrhage. Demographic data and other know risks factors were analyzed. RESULT: We found ten bleeding case among 35070 discharges (incidence: 2.8/10000 discharges). Mortality was not increased but the number of transfusion was higher in the bleeding group. We found an assocciation betwen UGB and systemic inflammatory response syndrome--SIRS-(OR: 9.22 IC 95% 2.98-28.17) and diabetes (OR: 7.8 IC 95% 2.3-26.8). The rest of the factors studied did not rich a statistical significance. CONCLUSIONS: UGB during clinical hospitalization is a rare complication that requires an increased staying at hospital and a great number of transfusions. It may be probably associated in a positive way with diabetes and SIRS.

Factores de riesgo asociados a hemorragia digestiva alta, en sala común. / [Risk factors associated to upper gastrointestinal bleeding in non intensive care units]

Upper gastrointestinal bleeding--UGB-, as a complication, is well studied at intensive care units (ICU), but is less known in non ICU settings. Objectives: To determine incidence and risk factors of this entity at clinical hospitalization. MATERIALS AND METHODS: A case-control study of patients with gastric ulcer disease diagnosed by endoscopy who presented with melena and hematemesis. Ten controls were taken for each case, matching sex, age and prophylaxis for gastric hemorrhage. Demographic data and other know risks factors were analyzed. RESULT: We found ten bleeding case among 35070 discharges (incidence: 2.8/10000 discharges). Mortality was not increased but the number of transfusion was higher in the bleeding group. We found an assocciation betwen UGB and systemic inflammatory response syndrome--SIRS-(OR: 9.22 IC 95

2.98-28.17) and diabetes (OR: 7.8 IC 95

2.3-26.8). The rest of the factors studied did not rich a statistical significance. CONCLUSIONS: UGB during clinical hospitalization is a rare complication that requires an increased staying at hospital and a great number of transfusions. It may be probably associated in a positive way with diabetes and SIRS.