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Safety of sodium-glucose cotransporter 2 inhibitors (SGLT2i) during the month of Ramadan in patients with type 2 diabetes mellitus in Pakistani population-an observational study from a tertiary care center in Karachi.
Sheikh, A, Das, B, Sattar, S, Islam, N
Endocrine. 2023;(1):64-70
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BACKGROUND AND AIMS Primary aim was to assess the safety of SGLT2-i in patients with Type 2 Diabetes Mellitus (T2D) in a real-life scenario during Ramadan by finding the frequency and severity of hypoglycemic/hyperglycemic events, dehydration, and Diabetic ketoacidosis (DKA). Secondary aim was to assess changes in glycated hemoglobin (HbA1c), weight and creatinine levels. METHODS This prospective, observational, controlled cohort study was conducted at Aga Khan University Hospital, Karachi, Pakistan from March 15 to June 30, 2021. Participants were over 21 years of age, on stable doses of SGLT2-I, which was started at least 2 months before Ramadan. Endpoint assessments were done 1 month before and within 6 weeks after Ramadan. RESULTS Of 102 participants enrolled, 82 completed the study. Most (52%) were males, with mean age 52.2 ± 9.5 years and average duration of T2D 11.2 ± 6.5 years. 63% were on Empagliflozin (mean dose; 14.8 ± 7.2 mg/day) whereas 37% were on Dapagliflozin (mean dose; 8.2 ± 2.7 mg/day). Six (7.3%) documented symptoms of hypoglycemia. However, no episode of severe hypoglycemia, hyperglycemia, dehydration, DKA, hospitalization or discontinuation of SGLT2i was reported. HbA1c changes were (7.7 ± 1.2% from 7.9 ± 2.3%, p 0.34), weight (78.4 ± 12.9 kgs from 78.9 ± 13.3, p 0.23) and eGFR (87.8 ± 27.9 from 94.3 ± 37.6, p < 0.001). The reasons of study participants drop outs were: six did not keep any fasts; four discontinued study participation for personal reasons; three were out of city and missed post Ramadan follow-up, two protocol violation and five could not be contacted for post-Ramadan follow up during the third wave of COVID-19. CONCLUSION Results showed the safety of SGLT2i agents during Ramadan in the Pakistani population recommending it as a treatment option in adults with T2D, without any additional adverse events.
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Prolonged body weight gain, lifestyle changes and health-related quality of life in children during the COVID-19 pandemic lockdown: A follow-up study.
Azrak, MÁ, Fasano, MV, Avico, AJ, Sala, M, Casado, C, Padula, M, Kruger, AL, Malpeli, A, Andreoli, MF
European journal of clinical nutrition. 2023;(4):460-467
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BACKGROUND Further investigation is needed to define the impact of long-term pandemic lockdown in children. OBJECTIVES To examine changes in body mass index z-score (zBMI), lifestyle, Health-Related Quality of Life and proportion of overweight or obesity (OW/OB) in 6- to 9-year-old children in Argentina. METHODS Observational study with baseline measurements prior to lockdown and follow-up after eight months of strict restrictive measures (November 2020, first visit, n = 144) and after ten months of partial reopening (September 2021, second visit, n = 108). Anthropometric changes from baseline to first visit in lockdown group (LG) were compared with a historical control group (HCG, n = 134). Follow-up visits included anthropometric measures, lifestyle questionnaire and Pediatric Quality of Life Inventory. RESULTS Change in zBMI was higher in LG [median, IQR: 0.46 (-0.00; 0.83)] vs HCG [median, IQR: 0.02 (-0.31; 0.27)]; p < 0.001, particularly in children with pre-existing OW/OB. In LG, zBMI was higher at first and second visit vs baseline (p < 0.001) and in second visit vs first visit for boys (p = 0.037) but not for girls. The proportion of children with OW/OB increased from baseline (43.5%) to first (56.5%) and second visit (58.3%) (p = 0.029). Unlike girls, the proportion of boys with OW/OB increased from baseline to first and second visit (p = 0.045). Change in zBMI was higher in children with less healthy habits (p < 0.001). CONCLUSIONS Weight gain continued to increase in boys when lockdown measurements were eased, although sedentary behaviors decreased and quality of life improved, indicating that the effects of pandemic lockdown could be difficult to reverse.
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Impact of the COVID-19 pandemic on the glycemic control, eating habits, and body compositions of people with diabetes mellitus: A retrospective longitudinal observational study.
Sawada, M, Ohkuma, K, Aihara, M, Doi, S, Sekine, R, Kaneko, T, Iimuro, S, Ichi, I, Usami, S, Ohe, K, et al
Journal of diabetes investigation. 2023;14(2):321-328
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Several systematic reviews and meta-analyses conducted to evaluate the prognosis of coronavirus disease-2019 (COVID-19) in people with diabetes mellitus have reported an approximately two- to three-fold higher risk of mortality from COVID-19 in people with diabetes mellitus compared with those without diabetes mellitus. The aim of this study was to investigate the impact of the COVID-19 pandemic and the state of emergency on the glycaemic control, eating habits, and body composition of people with diabetes mellitus. This study is a retrospective, longitudinal observational study in outpatients with diabetes mellitus. A total of 408 participants were included in this study, including 239 men (58.6%) and 169 women (41.4%). People with type 2 diabetes mellitus were predominant in this study (96.8%). Results show that: - there was a significant increase of the haemoglobin A1c level in people with diabetes mellitus during the COVID-19 pandemic. - there was an increase in the changes in body weight and percent fat (increased) and skeletal muscle masses (decreased). Authors conclude that the COVID-19 pandemic caused a negative impact on the glycaemic control and body composition in people with diabetes mellitus. Furthermore, the increase of body weight and fat mass and the decrease of the skeletal muscle mass during the pandemic were associated with poor glycaemic control, independent of the age and sex, in people with diabetes mellitus.
Abstract
AIMS/INTRODUCTION To evaluate the impact of the COVID-19 pandemic on the glycemic control, eating habits, and body composition of people with diabetes mellitus; to identify the determinants of worsening glycemic control in people with diabetes mellitus. MATERIALS AND METHODS This retrospective, longitudinal observational study was performed in outpatients with diabetes mellitus who visited our hospital between April 2019 and March 2020 (pre-COVID-19 period) and continued for follow up from April 2020 to March 2021 (COVID-19 period). We compared the glycemic control, nutritional intakes, and body composition of people with diabetes mellitus between the two periods. The changes in the HbA1c values (ΔHbA1c) and other study variables were compared between the two periods. Logistic regression analysis was performed to identify the factors associated with the increase of HbA1c levels. RESULTS A significant increase of HbA1c was observed during the COVID-19 period. The percent fat mass (FM) also increased, while the percent skeletal muscle mass (SMM) decreased during the COVID-19 period. After adjustments for age and sex, the ΔBMI (OR:2.33), ΔFM (OR:1.45), and ΔSMM (OR:0.51) were identified as being associated with elevated levels of HbA1c. CONCLUSIONS The COVID-19 pandemic had a negative impact on the glycemic control and body composition of people with diabetes mellitus. The increased body weight and FM and decreased SMM observed during the pandemic were associated with poor glycemic control in people with diabetes mellitus.
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Use of Intravenous Vitamin C in Critically Ill Patients With COVID-19 Infection.
Li, M, Ching, TH, Hipple, C, Lopez, R, Sahibzada, A, Rahman, H
Journal of pharmacy practice. 2023;(1):60-66
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INTRODUCTION The pathophysiology for Coronavirus Disease 2019 (COVID-19) infection is characterized by cytokine oxidative stress and endothelial dysfunction. Intravenous (IV) vitamin C has been utilized as adjuvant therapy in critically ill patients with sepsis for its protective effects against reactive oxygen species and immunomodulatory effects. The primary objective of this study was to evaluate the effects of IV vitamin C in critically ill patients with COVID-19 infection. METHODS Retrospective observational cohort study with propensity score matching of intensive care unit (ICU) patients who received 1.5 grams IV vitamin C every 6 hours for up to 4 days for COVID-19 infection. The primary study outcome was in-hospital mortality. Secondary outcomes included vasopressor requirements in norepinephrine equivalents, ICU length of stay, and change in Sequential Organ Failure Assessment (SOFA) score. RESULTS Eight patients received IV vitamin C and were matched to 24 patients. Patients in the IV vitamin C group had higher rates of hospital mortality [7 (88%) vs. 19 (79%), P = 0.049]. There was no difference in the daily vasopressor requirement in the treatment group or between the 2 groups. The mean SOFA scores post-treatment was higher in the IV vitamin C group (12.4 ± 2.8 vs. 8.1 ± 3.5, P < 0.005). There was no difference in ICU length of stay between the treatment and control groups. CONCLUSION Adjunctive IV vitamin C for the management of COVID-19 infection in critically ill patients may not decrease the incidence of mortality, vasopressor requirements, SOFA scores, or ventilator settings.
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Relationship between hyponatremia at hospital admission and cardiopulmonary profile at follow-up in patients with SARS-CoV-2 (COVID-19) infection.
Malandrino, D, Berni, A, Fibbi, B, Borellini, B, Cozzi, D, Norello, D, Fattirolli, F, Lavorini, F, Olivotto, I, Fumagalli, C, et al
Journal of endocrinological investigation. 2023;(3):577-586
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PURPOSE Hyponatremia occurs in about 30% of patients with pneumonia, including those with SARS-CoV-2 (COVID-19) infection. Hyponatremia predicts a worse outcome in several pathologic conditions and in COVID-19 has been associated with a higher risk of non-invasive ventilation, ICU transfer and death. The main objective of this study was to determine whether early hyponatremia is also a predictor of long-term sequelae at follow-up. METHODS In this observational study, we collected 6-month follow-up data from 189 laboratory-confirmed COVID-19 patients previously admitted to a University Hospital. About 25% of the patients (n = 47) had hyponatremia at the time of hospital admission. RESULTS Serum [Na+] was significantly increased in the whole group of 189 patients at 6 months, compared to the value at hospital admission (141.4 ± 2.2 vs 137 ± 3.5 mEq/L, p < 0.001). In addition, IL-6 levels decreased and the PaO2/FiO2 increased. Accordingly, pulmonary involvement, evaluated at the chest X-ray by the RALE score, decreased. However, in patients with hyponatremia at hospital admission, higher levels of LDH, fibrinogen, troponin T and NT-ProBNP were detected at follow-up, compared to patients with normonatremia at admission. In addition, hyponatremia at admission was associated with worse echocardiography parameters related to right ventricular function, together with a higher RALE score. CONCLUSION These results suggest that early hyponatremia in COVID-19 patients is associated with the presence of laboratory and imaging parameters indicating a greater pulmonary and right-sided heart involvement at follow-up.
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Statin therapy may protect against acute kidney injury in patients hospitalized for interstitial SARS-CoV2 pneumonia.
Piani, F, Di Salvo, E, Landolfo, M, Saracino, IM, Agnoletti, D, Borghi, C, Fiorini, G
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2023;(1):227-231
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BACKGROUND AND AIMS COVID-19-associated acute kidney injury (AKI) represents an independent risk factor for all-cause in-hospital death in patients with COVID-19. Chronic statin therapy use is highly prevalent in individuals at risk for severe COVID-19. Our aim is to assess whether patients under treatment with statins have a lower risk of AKI and in-hospital mortality during hospitalization for interstitial SARS-CoV2 pneumonia. METHODS AND RESULTS Our study is a prospective observational study on 269 consecutive patients admitted for COVID-19 pneumonia at the Internal Medicine Unit of IRCCS Sant'Orsola Hospital in Bologna, Italy. We compared the clinical characteristics between patients receiving statin therapy (n = 65) and patients not treated with statins and we assessed if chronic statin use was associated with a reduced risk for AKI, all-cause mortality, admission to ICU, and disease severity. Statin use was associated with a significant reduction in the risk of developing AKI (OR 0.47, IC 0.23 to 0.95, p 0.036) after adjustment for age, sex, BMI, hypertension, diabetes, and chronic kidney disease (CKD). Additionally, statin use was associated with reduced C-reactive protein (CRP) levels (p 0.048) at hospital admission. No significant impact in risk of all-cause mortality (HR 1.98, IC 0.71 to 5.50, p 0.191) and ICU admission (HR 0.93, IC 0.52 to 1.65, p 0.801) was observed with statin use, after adjustment for age, sex, BMI, hypertension, diabetes, and CKD. CONCLUSION The present study shows a potential beneficial effect of statins in COVID-19-associated AKI. Furthermore, patients treated with statins before hospital admission for COVID-19 may have lower systemic inflammation levels.
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Real-World Evidence of Neutralizing Monoclonal Antibodies for Preventing Hospitalization and Mortality in COVID-19 Outpatients.
Wynia, MK, Beaty, LE, Bennett, TD, Carlson, NE, Davis, CB, Kwan, BM, Mayer, DA, Ong, TC, Russell, S, Steele, JD, et al
Chest. 2023;(5):1061-1070
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BACKGROUND Neutralizing monoclonal antibodies (mAbs) were authorized for the treatment of COVID-19 outpatients based on clinical trials completed early in the pandemic, which were underpowered for mortality and subgroup analyses. Real-world data studies are promising for further assessing rapidly deployed therapeutics. RESEARCH QUESTION Did mAb treatment prevent progression to severe disease and death across pandemic phases and based on risk factors, including prior vaccination status? STUDY DESIGN AND METHODS This observational cohort study included nonhospitalized adult patients with SARS-CoV-2 infection from November 2020 to October 2021 using electronic health records from a statewide health system plus state-level vaccine and mortality data. Using propensity matching, we selected approximately 2.5 patients not receiving mAbs for each patient who received mAb treatment under emergency use authorization. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and hospitalization severity. RESULTS Of 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 patients not receiving mAbs. Compared with mAb-untreated patients, mAb-treated patients had lower all-cause hospitalization (4.0% vs 7.7%; adjusted OR, 0.48; 95% CI, 0.38-0.60) and all-cause mortality (0.1% vs 0.9%; adjusted OR, 0.11; 95% CI, 0.03-0.29) to day 28; differences persisted to day 90. Among hospitalized patients, mAb-treated patients had shorter hospital length of stay (5.8 vs 8.5 days) and lower risk of mechanical ventilation (4.6% vs 16.6%). Results were similar for preventing hospitalizations during the Delta variant phase (adjusted OR, 0.35; 95% CI, 0.25-0.50) and across subgroups. Number-needed-to-treat (NNT) to prevent hospitalization was lower for subgroups with higher baseline risk of hospitalization; for example, multiple comorbidities (NNT = 17) and not fully vaccinated (NNT = 24) vs no comorbidities (NNT = 88) and fully vaccinated (NNT = 81). INTERPRETATION Real-world data revealed a strong association between receipt of mAbs and reduced hospitalization and deaths among COVID-19 outpatients across pandemic phases. Real-world data studies should be used to guide practice and policy decisions, including allocation of scarce resources.
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A combined role for low vitamin D and low albumin circulating levels as strong predictors of worse outcome in COVID-19 patients.
Sanson, G, De Nicolò, A, Zerbato, V, Segat, L, Koncan, R, Di Bella, S, Cusato, J, di Masi, A, Palermo, A, Caironi, P, et al
Irish journal of medical science. 2023;(1):423-430
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PURPOSE We aimed to assess the combined role of vitamin D and albumin serum levels as predictors of COVID-19 disease progression. METHODS We conducted a prospective observational study on adult patients hospitalized for SARS-CoV-2 pneumonia (March-September 2020). Vitamin D and albumin serum levels were measured on admission. These variables were categorized in albumin < 3.5 or ≥ 3.5 g/dL and vitamin D < 30 ng/mL or ≥ 30 ng/mL. We excluded patients with known bone diseases, renal failure, hypercalcemia and/or treated with antiepileptic drugs and steroids, and patients who received previous vitamin D supplementation. A composite outcome including any ventilatory support, PaO2/FiO2 ratio, and 60-day mortality was defined. RESULTS Sixty-nine patients were enrolled, of whom 50% received non-invasive (NIV) or invasive mechanical ventilation (IMV), 10% died, whereas 89% and 66% presented low albumin and low vitamin D serum levels, respectively. No correlation between vitamin D and albumin levels was found. In multivariable logistic regression analyses adjusted for sex and age-corrected comorbidities, patients having albumin < 3.5 g/dL and vitamin D < 30 ng/mL showed a significant increased risk for all study outcomes, namely NIV/IMV (OR 3.815; 95% CI 1.122-12.966; p = 0.032), NIV/IMV or death (OR 3.173; 95% CI 1.002-10.043; p = 0.049) and PaO2/FIO2 ≤ 100 (OR 3.410; 95% CI 1.138-10.219; p = 0.029). CONCLUSION The measurement of both vitamin D and serum albumin levels on COVID-19 patients' admission, and their combined evaluation, provides a simple prognostic tool that could be employed to guide prompt clinical decisions.
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IMPACT study: Impact of adherence to anti-VEGF intravitreal injections for macular disease during COVID 19-related confinement in France.
Hurand, V, Ducloyer, JB, Baudin, F, Aho, S, Weber, M, Kodjikian, L, Devin, F, Gabrielle, PH, Creuzot-Garcher, C, Massin, P, et al
Acta ophthalmologica. 2023;(1):91-99
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PURPOSE The aim of this study was to evaluate the impact of adherence to French coronavirus disease 2019 (COVID 19)-related guidelines for intravitreal injection (IVI) practice on the visual outcomes of patients treated with anti-vascular endothelial growth factor (VEGF) agents for macular diseases during the first lockdown period. METHODS Observational multicentre study including all patients from 18 centres with an IVI initially planned during the lockdown. Visual acuity (VA, ETDRS) was recorded at 1 and 4 months after lockdown. French COVID 19-related guidelines recommended maintaining IVI practice. We defined three groups of patients: A, adherent to guidelines; NA+, non-adherent with delayed IVIs; and NA-, non-adherent without IVIs performed during the lockdown. Risk factors for non-adherence and visual loss were studied. RESULTS A total of 3020 eyes of 3020 patients, aged 77.8 ± 11.6 years, 59.8% women, were included. 59.3% were non-adherent(46.7% NA+, 12.6% NA-). A smaller decrease in VA at 4 months was observed in the A group than the NA+ and NA- group (-0.2 ± 6.7, -0.3 ± 6.9 and -1.5 ± 6.9, respectively [p < 0.001]). Factors associated with non-adherence were in multivariable analysis, older age, hospital practice, low-density population areas, high viral incidence areas, longer intervals between injection and treat and extent protocol. Factors associated with visual loss at 4 months in multivariable analysis were, being in the NA- group, older age, T&E and fixed regimens. CONCLUSION Strict adherence to guidelines was associated with better visual outcome, although most of our patients did not attend as planned. Identification of patients at risk could help in the future in case of a new pandemic lockdown.
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Acute Muscle Mass Loss Predicts Long-Term Fatigue, Myalgia, and Health Care Costs in COVID-19 Survivors.
Gil, S, de Oliveira Júnior, GN, Sarti, FM, Filho, WJ, Longobardi, I, Turri, JAO, Shinjo, SK, Ferriolli, E, Avelino-Silva, TJ, Busse, AL, et al
Journal of the American Medical Directors Association. 2023;(1):10-16
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OBJECTIVE We examined the impact of loss of skeletal muscle mass in post-acute sequelae of SARS-CoV-2 infection, hospital readmission rate, self-perception of health, and health care costs in a cohort of COVID-19 survivors. DESIGN Prospective observational study. SETTING AND PARTICIPANTS Tertiary Clinical Hospital. Eighty COVID-19 survivors age 59 ± 14 years were prospectively assessed. METHODS Handgrip strength and vastus lateralis muscle cross-sectional area were evaluated at hospital admission, discharge, and 6 months after discharge. Post-acute sequelae of SARS-CoV-2 were evaluated 6 months after discharge (main outcome). Also, health care costs, hospital readmission rate, and self-perception of health were evaluated 2 and 6 months after hospital discharge. To examine whether the magnitude of muscle mass loss impacts the outcomes, we ranked patients according to relative vastus lateralis muscle cross-sectional area reduction during hospital stay into either "high muscle loss" (-18 ± 11%) or "low muscle loss" (-4 ± 2%) group, based on median values. RESULTS High muscle loss group showed greater prevalence of fatigue (76% vs 46%, P = .0337) and myalgia (66% vs 36%, P = .0388), and lower muscle mass (-8% vs 3%, P < .0001) than low muscle loss group 6 months after discharge. No between-group difference was observed for hospital readmission and self-perceived health (P > .05). High muscle loss group demonstrated greater total COVID-19-related health care costs 2 ($77,283.87 vs. $3057.14, P = .0223, respectively) and 6 months ($90,001.35 vs $12, 913.27, P = .0210, respectively) after discharge vs low muscle loss group. Muscle mass loss was shown to be a predictor of total COVID-19-related health care costs at 2 (adjusted β = $10, 070.81, P < .0001) and 6 months after discharge (adjusted β = $9885.63, P < .0001). CONCLUSIONS AND IMPLICATIONS COVID-19 survivors experiencing high muscle mass loss during hospital stay fail to fully recover muscle health. In addition, greater muscle loss was associated with a higher frequency of post-acute sequelae of SARS-CoV-2 and greater total COVID-19-related health care costs 2 and 6 months after discharge. Altogether, these data suggest that the loss of muscle mass resulting from COVID-19 hospitalization may incur in an economical burden to health care systems.
