Gastrostomy Tubes Placed in Children With Neurologic Impairment: Associated Morbidity and Mortality

Background: Gastrostomy tube (G-tube) placement for children with neurologic impairment with dysphagia has been suggested for pneumonia prevention. However, prior studies demonstrated an association between G-tube placement and increased risk of pneumonia. We evaluate the association between timing of G-tube placement and death or severe pneumonia in children with neurologic impairment. Methods: We included all children enrolled in California Children’s Services between July 1, 2009, and June 30, 2014, with neurologic impairment and 1 pneumonia hospitalization. Prior to analysis, children with new G-tubes and those without were 1:2 propensity score matched on sociodemographics, medical complexity, and severity of index hospitalization. We used a time-varying Cox proportional hazard model for subsequent death or composite outcome of death or severe pneumonia to compare those with new G-tubes vs those without, adjusting for covariates described above. Results: A total of 2490 children met eligibility criteria, of whom 219 (9%) died and 789 (32%) had severe pneumonia. Compared to children without G-tubes, children with new G-tubes had decreased risk of death (hazard ratio [HR] 0.47, 95% confidence interval [CI] 0.39-0.55) but increased risk of the composite outcome (HR 1.21, CI 1.14-1.27). Sensitivity analyses using varied time criteria for definitions of G-tube and outcome found that more recent G-tube placement had greater associated risk reduction for death but increased risk of severe pneumonia. Conclusion: Recent G-tube placement is associated with reduced risk of death but increased risk of severe pneumonia. Decisions to place G-tubes for pulmonary indications in children with neurologic impairment should weigh the impact of severe pneumonia on quality of life.

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Impact of old and very old age on outcomes in patients with acute ischemic stroke undergoing endovascular therapy

European Heart Journal ◽

10.1093/ehjci/ehaa946.3243 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

M Proietti ◽

A.P Mascolo ◽

F Maramma ◽

D Morosetti ◽

V Da Ros ◽

...

Keyword(s):

Ischemic Stroke ◽

Elderly Patients ◽

Acute Ischemic Stroke ◽

Age Groups ◽

Sensitivity Analyses ◽

Composite Outcome ◽

Very Elderly ◽

Risk Of Death ◽

Increased Risk

Abstract Background and purpose Only a restricted number of elderly patients has been included in the majority of recent endovascular stroke trials. We provided an analysis about differences in outcomes after mechanical thrombectomy (MT) according to age. Methods A retrospective analysis of an observational registry of patients with anterior large vessel acute ischemic stroke was performed. Main analysis was performed comparing patients <80 vs. ≥80 years old. A sensitivity analysis was performed comparing 3 age groups: i) <80 years; ii) 80–84 years; iii) ≥85 years. Outcomes were: i) any hemorrhagic infarction; ii) alive with disability; iii) death; iv) a composite outcome of alive with disability/death. Results 615 patients were identified. 227 (36.9%) patients were ≥80 years old, with 115 (18.5%) ≥85 years old. Elderly (≥80 years) patients showed a higher modified Rankin Scale (mRS) at discharge and 3-months follow-up (F=9.819, p=0.001) [Figure 1]. Comparing the three groups (<80 years, 80–84 years, ≥85 years) a progressively higher mRS was found at discharge and 3 months follow-up (F=4.899, p=0.008). A progressively higher rate of death and composite outcome between the age groups was found, both in the main and sensitivity analyses. In the logistic regression analysis age ≥80 years was found associated with an increased risk of death (odds ratio [OR]: 2.25, 95% confidence interval [CI]: 1.27–4.00) and showed a trend in higher risk for composite outcome (OR: 1.61, 95% CI: 0.92–2.281). No difference was found between 80–84 years and <80 years patients, while very elderly (≥85 years) had an increased risk of death (OR: 2.85, 95% CI: 1.60–5.10) and composite outcome (OR: 2.37, 95% CI: 1.30–4.33). Conclusions In our analysis elderly patients have an increased risk of death and composite outcome of disability and death. In particular, this risk appears to be significantly higher in very elderly patients (≥85 years old). Figure 1. mRS according to main analysis Funding Acknowledgement Type of funding source: None

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Association between Intraoperative Blood Transfusion and Mortality and Morbidity in Patients Undergoing Noncardiac Surgery

Anesthesiology ◽

10.1097/aln.0b013e3182054d06 ◽

2011 ◽

Vol 114 (2) ◽

pp. 283-292 ◽

Cited By ~ 312

Author(s):

Laurent G. Glance ◽

Andrew W. Dick ◽

Dana B. Mukamel ◽

Fergal J. Fleming ◽

Raymond A. Zollo ◽

...

Keyword(s):

Blood Transfusion ◽

Noncardiac Surgery ◽

Pulmonary Complications ◽

Wound Complications ◽

Severe Anemia ◽

Thromboembolic Complications ◽

Mortality And Morbidity ◽

Risk Of Death ◽

Increased Risk ◽

The Impact

Background The impact of intraoperative erythrocyte transfusion on outcomes of anemic patients undergoing noncardiac surgery has not been well characterized. The objective of this study was to examine the association between blood transfusion and mortality and morbidity in patients with severe anemia (hematocrit less than 30%) who are exposed to one or two units of erythrocytes intraoperatively. Methods This was a retrospective analysis of the association of blood transfusion and 30-day mortality and 30-day morbidity in 10,100 patients undergoing general, vascular, or orthopedic surgery. We estimated separate multivariate logistic regression models for 30-day mortality and for 30-day complications. Results Intraoperative blood transfusion was associated with an increased risk of death (odds ratio [OR], 1.29; 95% CI, 1.03-1.62). Patients receiving an intraoperative transfusion were more likely to have pulmonary, septic, wound, or thromboembolic complications, compared with patients not receiving an intraoperative transfusion. Compared with patients who were not transfused, patients receiving one or two units of erythrocytes were more likely to have pulmonary complications (OR, 1.76; 95% CI, 1.48-2.09), sepsis (OR, 1.43; 95% CI, 1.21-1.68), thromboembolic complications (OR, 1.77; 95% CI, 1.32-2.38), and wound complications (OR, 1.87; 95% CI, 1.47-2.37). Conclusions Intraoperative blood transfusion is associated with a higher risk of mortality and morbidity in surgical patients with severe anemia. It is unknown whether this association is due to the adverse effects of blood transfusion or is, instead, the result of increased blood loss in the patients receiving blood.

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Body mass index and risk of all-cause mortality in normotensive and hypertensive adults: The Rural Chinese Cohort Study

Public Health Nutrition ◽

10.1017/s1368980021001592 ◽

2021 ◽

pp. 1-25

Author(s):

Qionggui Zhou ◽

Xuejiao Liu ◽

Yang Zhao ◽

Pei Qin ◽

Yongcheng Ren ◽

...

Keyword(s):

Cohort Study ◽

Population Based ◽

Normal Weight ◽

Sensitivity Analyses ◽

Hypertension Status ◽

Moderation Effect ◽

Increased Risk ◽

All Cause Mortality ◽

Chinese Cohort ◽

The Impact

Abstract Objective: The impact of baseline hypertension status on the BMI–mortality association is still unclear. We aimed to examine the moderation effect of hypertension on the BMI–mortality association using a rural Chinese cohort. Design: In this cohort study, we investigated the incident of mortality according to different BMI categories by hypertension status. Setting: Longitudinal population-based cohort Participants: 17,262 adults ≥18 years were recruited from July to August of 2013 and July to August of 2014 from a rural area in China. Results: During a median 6-year follow-up, we recorded 1109 deaths (610 with and 499 without hypertension). In adjusted models, as compared with BMI 22-24 kg/m2, with BMI ≤18, 18-20, 20-22, 24-26, 26-28, 28-30 and >30 kg/m2, the HRs (95% CI) for mortality in normotensive participants were 1.92 (1.23-3.00), 1.44 (1.01-2.05), 1.14 (0.82-1.58), 0.96 (0.70-1.31), 0.96 (0.65-1.43), 1.32 (0.81-2.14), and 1.32 (0.74-2.35) respectively, and in hypertensive participants were 1.85 (1.08-3.17), 1.67 (1.17-2.39), 1.29 (0.95-1.75), 1.20 (0.91-1.58), 1.10 (0.83-1.46), 1.10 (0.80-1.52), and 0.61 (0.40-0.94) respectively. The risk of mortality was lower in individuals with hypertension with overweight or obesity versus normal weight, especially in older hypertensives (≥60 years old). Sensitivity analyses gave consistent results for both normotensive and hypertensive participants. Conclusions: Low BMI was significantly associated with increased risk of all-cause mortality regardless of hypertension status in rural Chinese adults, but high BMI decreased the mortality risk among individuals with hypertension, especially in older hypertensives.

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FRI0421 RATES OF PROGRESSION DIFFER BETWEEN STRUCTURAL PHENOTYPES OF KNEE OSTEOARTHRITIS: A SECONDARY ANALYSIS FROM THE FNIH COHORT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1802 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 808.1-809

Author(s):

F. Roemer ◽

J. Collins ◽

T. Neogi ◽

M. Crema ◽

A. Guermazi

Keyword(s):

Subchondral Bone ◽

Radiographic Progression ◽

Conditional Logistic Regression ◽

Secondary Analysis ◽

Sensitivity Analyses ◽

Case Group ◽

Composite Outcome ◽

Bone Phenotype ◽

Increased Risk ◽

Inflammatory Phenotype

Background:Imaging plays an important role in determining structural disease severity and potential suitability of patients recruited to disease-modifying osteoarthritis drug (DMOAD) trials. It has been suggested that there may be three main structural phenotypes in OA, i.e., inflammation, meniscus/cartilage and subchondral bone. These may progress differently and may represent distinct tissue targets for DMOAD approaches.Objectives:To stratify the Foundation for National Institutes of Health Osteoarthritis Biomarkers Consortium (FNIH) cohort, a well-defined subsample of the larger Osteoarthritis Initiative (OAI) study, into distinct structural phenotypes based on semiquantitative MRI assessment and to determine their risk for progression over 48 months.Methods:The FNIH was designed as a case-control study with knees showing either 1) radiographic and pain progression (i.e., “composite” cases), 2) radiographic progression only (“JSL”), 3) pain progression only, and 4) neither radiographic nor pain progression. MRI of both knees was performed on 3 T systems at the four OAI clinical sites. Two musculoskeletal radiologists read the baseline MRIs according to the MOAKS scoring system. Knees were stratified into subchondral bone, meniscus/cartilage and inflammatory phenotypes1. A secondary, less stringent definition for inflammatory and meniscus/cartilage phenotype was used for sensitivity analyses. The relation of each phenotype to risk of being in the JSL or composite case group compared to those not having that phenotype was determined using conditional logistic regression. Only KL2 and 3 and those without root tears were included.Results:485 knees were included. 362 (75%) did not have any phenotype, while 95 (20%) had the bone phenotype, 22 (5%) the cartilage/meniscus phenotype and 19 (4%) the inflammatory phenotype. The bone phenotype was associated with a higher risk of the JSL and composite outcome (OR 1.81;[95%CI 1.14,2.85] and 1.65; 95%CI [1.04,2.61]) while the inflammatory (OR 0.96 [95%CI 0.38,2.42] and 1.25; 95%CI [0.48,3.25]) and the meniscus/cartilage phenotypes were not (OR 1.30 95%CI [0.55,3.07] and 0.99; 95%CI [0.40,2,49]).In sensitivity analyses, the bone phenotype and having two phenotypes (vs. none) were both associated with increased risk of experiencing the composite outcome (bone: OR 1.65; 95% CI 1.04, 2.61; 2 phenotypes: OR 1.87; 95% CI 1.11, 3.16.Conclusion:The bone phenotype was associated with increased risk of having both radiographic and pain progression together, or radiographic progression alone, whereas the inflammatory phenotype or meniscus/cartilage phenotype each individually were not associated with either outcome. Phenotypic stratification appears to provide insights into risk for structural or composite structure plus pain progression, and therefore may be useful to consider when selecting patients for inclusion in clinical trials.References:[1]Roemer FW, Collins J, Kwoh CK, et al. MRI-based screening for structural definition of eligibility in clinical DMOAD trials: Rapid OsteoArthritis MRI Eligibility Score (ROAMES). Osteoarthritis Cartilage 2020;28(1):71-81Disclosure of Interests:Frank Roemer: None declared, Jamie Collins Consultant of: Boston Imaging Core Lab (BICL), LLC., Tuhina Neogi Grant/research support from: Pfizer/Lilly, Consultant of: Pfizer/Lilly, EMD-Merck Serono, Novartis, Michel Crema: None declared, Ali Guermazi Consultant of: AventisGalapagos, Pfizer, Roche, AstraZeneca, Merck Serono, and TissuGene

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Routine use of immunosuppressants is associated with mortality in hospitalised patients with COVID-19

Therapeutic Advances in Drug Safety ◽

10.1177/2042098620985690 ◽

2021 ◽

Vol 12 ◽

pp. 204209862098569

Author(s):

Phyo K. Myint ◽

Ben Carter ◽

Fenella Barlow-Pay ◽

Roxanna Short ◽

Alice G. Einarsson ◽

...

Keyword(s):

Medical Attention ◽

Close Monitoring ◽

Plain Language ◽

Discharge Data ◽

Specific Patient ◽

Risk Of Death ◽

Hospitalised Patients ◽

Increased Risk ◽

The Uk ◽

The Impact

Background: Whilst there is literature on the impact of SARS viruses in the severely immunosuppressed, less is known about the link between routine immunosuppressant use and outcome in COVID-19. Consequently, guidelines on their use vary depending on specific patient populations. Methods: The study population was drawn from the COPE Study (COVID-19 in Older People), a multicentre observational cohort study, across the UK and Italy. Data were collected between 27 February and 28 April 2020 by trained data-collectors and included all unselected consecutive admissions with COVID-19. Load (name/number of medications) and dosage of immunosuppressant were collected along with other covariate data. Primary outcome was time-to-mortality from the date of admission (or) date of diagnosis, if diagnosis was five or more days after admission. Secondary outcomes were Day-14 mortality and time-to-discharge. Data were analysed with mixed-effects, Cox proportional hazards and logistic regression models using non-users of immunosuppressants as the reference group. Results: In total 1184 patients were eligible for inclusion. The median (IQR) age was 74 (62–83), 676 (57%) were male, and 299 (25.3%) died in hospital (total person follow-up 15,540 days). Most patients exhibited at least one comorbidity, and 113 (~10%) were on immunosuppressants. Any immunosuppressant use was associated with increased mortality: aHR 1.87, 95% CI: 1.30, 2.69 (time to mortality) and aOR 1.71, 95% CI: 1.01–2.88 (14-day mortality). There also appeared to be a dose–response relationship. Conclusion: Despite possible indication bias, until further evidence emerges we recommend adhering to public health measures, a low threshold to seek medical advice and close monitoring of symptoms in those who take immunosuppressants routinely regardless of their indication. However, it should be noted that the inability to control for the underlying condition requiring immunosuppressants is a major limitation, and hence caution should be exercised in interpretation of the results. Plain Language Summary Regular Use of Immune Suppressing Drugs is Associated with Increased Risk of Death in Hospitalised Patients with COVID-19 Background: We do not have much information on how the COVID-19 virus affects patients who use immunosuppressants, drugs which inhibit or reduce the activity of the immune system. There are various conflicting views on whether immune-suppressing drugs are beneficial or detrimental in patients with the disease. Methods: This study collected data from 10 hospitals in the UK and one in Italy between February and April 2020 in order to identify any association between the regular use of immunosuppressant medicines and survival in patients who were admitted to hospital with COVID-19. Results: 1184 patients were included in the study, and 10% of them were using immunosuppressants. Any immunosuppressant use was associated with increased risk of death, and the risk appeared to increase if the dose of the medicine was higher. Conclusion: We therefore recommend that patients who take immunosuppressant medicines routinely should carefully adhere to social distancing measures, and seek medical attention early during the COVID-19 pandemic.

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Survival in elderly glioblastoma patients treated with bevacizumab-based regimens in the United States

Neuro-Oncology Practice ◽

10.1093/nop/npy001 ◽

2018 ◽

Vol 5 (4) ◽

pp. 251-261 ◽

Cited By ~ 2

Author(s):

Jessica Davies ◽

Irmarie Reyes-Rivera ◽

Thirupathi Pattipaka ◽

Stephen Skirboll ◽

Beatrice Ugiliweneza ◽

...

Keyword(s):

Elderly Patients ◽

Lower Risk ◽

Karnofsky Performance Status ◽

The United States ◽

Cox Proportional Hazards Model ◽

Sensitivity Analyses ◽

Primary Analysis ◽

Risk Of Death ◽

Initial Surgery ◽

The Impact

AbstractBackgroundThe efficacy of bevacizumab (BEV) in elderly patients with glioblastoma remains unclear. We evaluated the effect of BEV on survival in this patient population using the Survival, Epidemiology, and End Results (SEER)-Medicare database.MethodsThis retrospective, cohort study analyzed SEER-Medicare data for patients (aged ≥66 years) diagnosed with glioblastoma from 2006 to 2011. Two cohorts were constructed: one comprised patients who had received BEV (BEV cohort); the other comprised patients who had received any anticancer treatment other than BEV (NBEV cohort). The primary analysis used a multivariate Cox proportional hazards model to compare overall survival in the BEV and NBEV cohorts with initiation of BEV as a time-dependent variable, adjusting for potential confounders (age, gender, Charlson comorbidity index, region, race, radiotherapy after initial surgery, and diagnosis of coronary artery disease). Sensitivity analyses were conducted using landmark survival, propensity score modeling, and the impact of poor Karnofsky Performance Status.ResultsWe identified 2603 patients (BEV, n = 597; NBEV, n = 2006). In the BEV cohort, most patients were Caucasian males and were younger with fewer comorbidities and more initial resections. In the primary analysis, the BEV cohort showed a lower risk of death compared with the NBEV cohort (hazard ratio, 0.80; 95% confidence interval, 0.72–0.89; P < .01). The survival benefit of BEV appeared independent of the number of temozolomide cycles or frontline treatment with radiotherapy and temozolomide.ConclusionBEV exposure was associated with a lower risk of death, providing evidence that there might be a potential benefit of BEV in elderly patients with glioblastoma.

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Association of Dementia-Related Psychosis With Long-term Care Use and Death

Neurology ◽

10.1212/wnl.0000000000011632 ◽

2021 ◽

Vol 96 (12) ◽

pp. e1620-e1631

Author(s):

James B. Wetmore ◽

Yi Peng ◽

Heng Yan ◽

Suying Li ◽

Muna Irfan ◽

...

Keyword(s):

Long Term Care ◽

Fold Increase ◽

Proportional Hazard ◽

Comorbid Conditions ◽

Term Care ◽

Risk Of Death ◽

Cox Proportional Hazard ◽

Increased Risk ◽

Cox Proportional Hazard Regression

ObjectiveTo determine the association of dementia-related psychosis (DRP) with death and use of long-term care (LTC); we hypothesized that DRP would be associated with increased risk of death and use of LTC in patients with dementia.MethodsA retrospective cohort study was performed. Medicare claims from 2008 to 2016 were used to define cohorts of patients with dementia and DRP. Outcomes were LTC, defined as nursing home stays of >100 consecutive days, and death. Patients with DRP were directly matched to patients with dementia without psychosis by age, sex, race, number of comorbid conditions, and dementia index year. Association of DRP with outcomes was evaluated using a Cox proportional hazard regression model.ResultsWe identified 256,408 patients with dementia. Within 2 years after the dementia index date, 13.9% of patients developed DRP and 31.9% had died. Corresponding estimates at 5 years were 25.5% and 64.0%. Mean age differed little between those who developed DRP (83.8 ± 7.9 years) and those who did not (83.1 ± 8.7 years). Patients with DRP were slightly more likely to be female (71.0% vs 68.3%) and white (85.7% vs 82.0%). Within 2 years of developing DRP, 16.1% entered LTC and 52.0% died; corresponding percentages for patients without DRP were 8.4% and 30.0%, respectively. In the matched cohort, DRP was associated with greater risk of LTC (hazard ratio [HR] 2.36, 2.29–2.44) and death (HR 2.06, 2.02–2.10).ConclusionsDRP was associated with a more than doubling in the risk of death and a nearly 2.5-fold increase in risk of the need for LTC.

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Impact of Medicaid expansion on two-year mortality among stage IV breast cancer (BC) patients according to race.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.6525 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 6525-6525

Author(s):

Catalina Malinowski ◽

Xiudong Lei ◽

Hui Zhao ◽

Sharon H. Giordano ◽

Mariana Chavez Mac Gregor

Keyword(s):

Breast Cancer ◽

Low Income ◽

Stage Iv ◽

Medicaid Expansion ◽

Risk Of Death ◽

Stage Iv Breast Cancer ◽

Increased Risk ◽

The Impact ◽

Expansion Period ◽

White Patients

6525 Background: Inadequate access to healthcare services is associated with worse outcomes. Disparities in access to cancer care are more frequently seen among racial/ethnic minorities, uninsured patients, and those with low socioeconomic status. A provision in the Affordable Care Act called for expansion of Medicaid eligibility in order to cover more low-income Americans. In this study, we evaluate the impact of Medicaid expansion in 2-year mortality among metastatic BC patients according to race. Methods: Women (aged 40-64) diagnosed with metastatic BC (stage IV de novo) between 01/01/2010 and 12/31/2015 and residing in states that underwent Medicaid expansion in 01/2014 were identified in the National Cancer Database. For comparison purposes, 2010-2013 was considered the pre-expansion period and 2014-2015 the post-expansion period. We calculated 2-year mortality difference-in-difference (DID) estimates between White and non-White patients using multivariable linear regression models. Results are presented as adjusted differences (in % points) between groups in the pre- and post-expansion periods and as adjusted DID with 95%CI. Covariates included age, comorbidity, BC subtype, insurance type, transfer of care, distance to hospital, region, residence area, education, income quartile, facility type and facility volume. In addition, overall survival (OS) was evaluated in pre- and post-expansion periods via Kaplan-Meier method and Cox proportional hazards models; results are presented as 2-year OS estimates, hazard ratios (HRs), and 95% CIs. Results: Among 7,675 patients included, 4,942 were diagnosed in the pre- and 2,733 in the post-expansion period. We observed a reduction in 2-year mortality rates in both groups according to Medicaid expansion. Among Whites 2-year mortality decreased from 42.5% to 38.7% and among non-Whites from 45.4% to 36.4%, resulting in an adjusted DID of -5.2% (95%CI -9.8 to -0.6, p = 0.027). A greater reduction in 2-year mortality was observed among non-Whites in a sub-analysis of patients who resided in the poorest quartile (n = 1372), with an adjusted DID of -14.6% (95%CI -24.8 to -4.4, p = 0.005). In the multivariable Cox model, during the pre-expansion period there was an increased risk of death for non-Whites compared to Whites (HR 1.14, 95% CI 1.03 to 1.26, P = 0.04), however no differences were seen in the post-expansion period between the two groups (HR 0.93, 95% CI 0.80 to 1.07, P = 0.31). Conclusions: Medicaid expansion reduced racial disparities by decreasing the 2-year mortality of non-White patients with metastatic breast cancer and reducing the gap when compared to Whites. These results highlight the positive impact of policies aimed at improving equity and increasing access to health care.

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Real-world evidence on sodium-glucose cotransporter-2 inhibitor use and risk of Fournier’s gangrene

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2019-000985 ◽

2020 ◽

Vol 8 (1) ◽

pp. e000985 ◽

Cited By ~ 3

Author(s):

Jeff Yufeng Yang ◽

Tiansheng Wang ◽

Virginia Pate ◽

John B Buse ◽

Til Stürmer

Keyword(s):

Real World ◽

Fournier’S Gangrene ◽

Sensitivity Analyses ◽

Standardized Mortality Ratio ◽

Fournier's Gangrene ◽

Diagnosis Codes ◽

Sodium Glucose Cotransporter ◽

Real World Evidence ◽

Increased Risk ◽

The Impact

BackgroundSodium-glucose cotransporter-2 inhibitors (SGLT2i) have been associated with increased occurrence of Fournier’s gangrene (FG), a rare but serious form of necrotizing fasciitis, leading to a warning from the Food and Drug Administration. Real-world evidence on FG is needed to validate this warning.MethodsWe used data from IBM MarketScan (2013–2017) to compare the incidence of FG among adult patients who initiated either SGLT2i, a dipeptidyl peptidase-4 inhibitor (DPP4i), or any non-SGLT2i antihyperglycemic medication. FG was defined using inpatient International Classification of Diseases, Ninth Edition and Tenth Edition diagnosis codes 608.83 and N49.3, respectively, combined with procedure codes for debridement, surgery, or systemic antibiotics. We estimated crude incidence rates (IRs) using Poisson regression, and crude and adjusted HRs (aHR) and 95% CIs using standardized mortality ratio-weighted Cox proportional hazards models. Sensitivity analyses examined the impact of alternative outcome definitions.ResultsWe identified 211 671 initiators of SGLT2i (n=93 197) and DPP4i (n=118 474), and 305 329 initiators of SGLT2i (n=32 868) and non-SGLT2i (n=272 461). Crude FG IR ranged from 3.2 to 3.8 cases per 100 000 person-years during a median follow-up of 0.51–0.58 years. Compared with DPP4i, SGLT2i initiation was not associated with increased risk of FG for any outcome definition, with aHR estimates ranging from 0.25 (0.04–1.74) to 1.14 (0.86–1.51). In the non-SGLT2i comparison, we observed an increased risk of FG for SGLT2i initiators when using FG diagnosis codes alone, using all diagnosis settings (aHR 1.80; 0.53–6.11) and inpatient diagnoses only (aHR 4.58; 0.99–21.21).ConclusionsNo evidence of increased risk of FG associated with SGLT2i was observed compared with DPP4i, arguably the most relevant clinical comparison. However, uncertainty remains based on potentially higher risk in the broader comparison with all non-SGLT2i antihyperglycemic agents and the rarity of FG.Trial registration numberEUPAS Register Number 30018.

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The Effect of Anakinra in Hospitalized Patients with COVID-19: An Updated Systematic Review and Meta-Analysis

Journal of Clinical Medicine ◽

10.3390/jcm10194462 ◽

2021 ◽

Vol 10 (19) ◽

pp. 4462

Author(s):

Konstantinos G. Kyriakoulis ◽

Anastasios Kollias ◽

Garyphallia Poulakou ◽

Ioannis G. Kyriakoulis ◽

Ioannis P. Trontzas ◽

...

Keyword(s):

Systematic Review ◽

Meta Analysis ◽

Interleukin 1 ◽

Severe Pneumonia ◽

Hospitalized Patients ◽

Current Evidence ◽

Adjusted Risk ◽

Risk Of Death ◽

The Impact

The role of immunomodulatory agents in the treatment of hospitalized patients with COVID-19 has been of increasing interest. Anakinra, an interleukin-1 inhibitor, has been shown to offer significant clinical benefits in patients with COVID-19 and hyperinflammation. An updated systematic review and meta-analysis regarding the impact of anakinra on the outcomes of hospitalized patients with COVID-19 was conducted. Studies, randomized or non-randomized with adjustment for confounders, reporting on the adjusted risk of death in patients treated with anakinra versus those not treated with anakinra were deemed eligible. A search was performed in PubMed/EMBASE databases, as well as in relevant websites, until 1 August 2021. The meta-analysis of six studies that fulfilled the inclusion criteria (n = 1553 patients with moderate to severe pneumonia, weighted age 64 years, men 66%, treated with anakinra 50%, intubated 3%) showed a pooled hazard ratio for death in patients treated with anakinra at 0.47 (95% confidence intervals 0.34, 0.65). A meta-regression analysis did not reveal any significant associations between the mean age, percentage of males, mean baseline C-reactive protein levels, mean time of administration since symptoms onset among the included studies and the hazard ratios for death. All studies were considered as low risk of bias. The current evidence, although derived mainly from observational studies, supports a beneficial role of anakinra in the treatment of selected patients with COVID-19.

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