Real-world evidence for improved outcomes with histamine antagonists and aspirin in 22,560 COVID-19 patients.
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ABSTRACT:
SUBMITTER: Mura C
PROVIDER: S-EPMC8278809 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Biliary tract cancers are rare cancers with poor prognosis due to a lack of therapeutic options, especially after the failure of first-line systemic treatment. Targeted treatments for this clinical situation are promising and have entered clinical practice. We aimed to describe the overall survival of matched targeted treatment after first-line treatment in patients with biliary tract cancers in an Austrian real-world multicenter cohort. We performed a multicenter retrospective chart review of patients with biliary tract cancer between September 2015 and January 2022. Data, including comprehensive molecular characteristics-next generation sequencing (NGS) and immunohistochemistry (IHC), clinical history, surgical procedures, ablative treatments, patient history, and systemic chemotherapy, were extracted from the records of the participating institutions. Targeted treatment was matched according to the ESMO scale for the clinical actionability of molecular targets (ESCAT). We identified 159 patients with the available molecular characteristics. A total of 79 patients underwent second-line treatment. Of these, 36 patients received matched targeted treatment beyond the first-line and were compared with 43 patients treated with cytotoxic chemotherapy in terms of efficacy outcomes. For Tier I/II alterations, we observed a progression free survival ratio (PFStargeted/PFSpre-chemotherapy) of 1.86, p = 0.059. The overall survival for patients receiving at least two lines of systemic treatment significantly favored the targeted approach, with an overall survival of 22.3 months (95% CI 14.7-29.3) vs. 17.5 months (95% CI 1.7-19.8; p = 0.048). Our results underscore the value of targeted treatment approaches based on extended molecular characterization of biliary tract cancer to improve clinical outcomes.
| S-EPMC10507096 | biostudies-literature
Project description:Cord blood (CB) transplantation is hampered by low cell dose and high nonrelapse mortality (NRM). A phase 1-2 trial of UM171-expanded CB transplants demonstrated safety and favorable preliminary efficacy. The aim of the current analysis was to retrospectively compare results of the phase 1-2 trial with those after unmanipulated CB and matched-unrelated donor (MUD) transplants. Data from recipients of CB and MUD transplants were obtained from the Center for International Blood and Marrow Transplant Research (CIBMTR) database. Patients were directly matched for the number of previous allogeneic hematopoietic stem cell transplants (alloHCT), disease and refined Disease Risk Index. Patients were further matched by propensity score for age, comorbidity index, and performance status. Primary end points included NRM, progression-free survival (PFS), overall survival (OS), and graft-versus-host disease (GVHD)-free relapse-free survival (GRFS) at 1 and 2 years after alloHCT. Overall, 137 patients from CIBMTR (67 CB, 70 MUD) and 22 with UM171-expanded CB were included. NRM at 1 and 2 years was lower, PFS and GRFS at 2 years and OS at 1 year were improved for UM171-expanded CBs compared with CB controls. Compared with MUD controls, UM171 recipients had lower 1- and 2-year NRM, higher 2-year PFS, and higher 1- and 2-year GRFS. Furthermore, UM171-expanded CB recipients experienced less grades 3-4 acute GVHD and chronic GVHD compared with MUD graft recipients. Compared with real-world evidence with CB and MUD alloHCT, this study suggests that UM171-expanded CB recipients may benefit from lower NRM and higher GRFS. This trial was registered at www.clinicaltrials.gov as #NCT02668315.
| S-EPMC10539875 | biostudies-literature
Project description:Background: The COVID-19 pandemic forced health-related organizations to rapidly launch country-wide procedures that were easy to use and inexpensive. Body temperature measurement with non-contact infrared thermometers (NCITs) is among the most common procedures, both in hospital settings and in many other entities. However, practical hospital experiences have raised great doubts about the procedure's validity. Aim: This study aimed to evaluate the validity of the body temperature measured using NCITs among oncological and transplant patients who took the polymerase chain reaction test for SARS-Cov-2 PCR+ and PCR- in a Romanian Hospital. Methods: Body temperature was measured for 5,231 inpatients using NCITs. The cutoff point for fever was equal to or above 37.3°C. Patients then completed a questionnaire about their symptoms, contact, and travel history. Findings: Fever was detected in five of 53 persons with PCR+, resulting in a sensitivity of 9.43% (95% CI, 3.13-20.66%). No fever was verified in 5,131 of 5,171 persons with PCR-, resulting in a specificity of 99.15% (95% CI, 98.86-99.38%). A defensive vision of NCIT procedure (maximum standard error only in favor) had a sensitivity of 15.09% (95% CI, 6.75-27.59%). Conclusions: The use of NCITs in a triage provides little value for detection of COVID-19. Moreover, it provides a false sense of protection against the disease while possibly discriminating individuals that could present fever due to other reasons, such as oncologic treatments, where fever is a common therapeutical consequence. The consumption of qualified human resources should be considered, especially in the context of the shortage of healthcare professionals worldwide.
| S-EPMC8277959 | biostudies-literature
Project description:BackgroundMineralocorticoid receptor antagonists (MRAs) were shown to delay chronic kidney disease (CKD) progression in patients with hypertension and/or heart failure (HF) and proteinuria.ObjectiveWe conducted a systematic literature review on real-world evidence to identify the literature gaps related to the efficacy and safety outcomes of MRAs administered to CKD patients.ResultsA total of 751 records were identified of which, 23 studies (26 publications) were analyzed. Studies included heterogeneous populations, including the overall CKD, CKD and diabetes, CKD and HF, and CKD and a history of cardiovascular disease. Most of the studies were small and non-rigorous, resulting in a notable lack of evidence in these populations. In the overall CKD population, steroidal MRAs resulted in a significant or sustained eGFR reduction but no efficacy in delaying progression to end-stage kidney disease. No cardiovascular protection was found. Results for all-cause mortality and hospitalization for HF were inconsistent; however, the longest follow-up studies indicate similar or lower incidence for spironolactone non-users. Most results consistently reported a higher incidence of hyperkalemia among patients on steroidal MRAs in all CKD stages, and side effects led to high discontinuation rates in the real-world setting.ConclusionsDespite the limited availability of evidence on the effectiveness and safety of steroidal MRAs in CKD patients and subgroups with diabetes, HF or history of cardiovascular disease, MRAs were shown to have a limited effect on renal and cardiovascular outcomes. Gaps in the evidence regarding the efficacy and safety of MRAs are particularly relevant in diabetic CKD patients; therefore, further research is warranted.
| S-EPMC10227157 | biostudies-literature
Project description:ObjectivesPrevious studies ruled out the benefits of azithromycin for treatment of patients with COVID-19 who are hospitalized. However, the effects of azithromycin for treatment of patients with positive SARS-CoV-2 test results in the community remains a matter of debate. This study aimed to assess whether azithromycin, when used in subjects with positive test results for SARS-CoV-2, is associated with a reduced risk of hospitalization, in-hospital COVID-19 outcomes, and death.MethodsTwo study cohorts were selected. Cohort A included subjects with positive test results for SARS-CoV-2 between February 20, 2020 and December 10, 2020; cohort B included subjects infected with SARS-CoV-2 and hospitalized between February 20, 2020 and December 31, 2020. We compared the risk of hospitalization, intensive care unit access, need for mechanical ventilation, and death in azithromycin users versus nonusers. A clustered Fine-Gray analysis was employed to assess the risk of hospitalization; logistic and Cox regressions were performed to assess the risk of intensive care unit access, mechanical ventilation, and death.ResultsIn cohort A, among 4861 azithromycin users and 4861 propensity-matched nonusers, azithromycin use was associated with higher risk of hospitalization (hazard ratio [HR] 1.59, 95% confidence interval [CI] 1.45-1.75) compared with nonuse. In cohort B, among 997 subjects selected in both groups, azithromycin use was not significantly associated with intensive care unit access (odds ratio [OR] 1.22, 95% CI 0.93-1.56), mechanical ventilation (OR 1.30, 95% CI 0.99-1.70), 14-day mortality (HR0.88, 95% CI 0.74-1.05), or 30-day mortality (HR 0.89, 95% CI 0.77-1.03).ConclusionOur findings confirm the lack of benefits of azithromycin treatment among community patients infected with SARS-CoV-2, raising concern on potential risks associated with its inappropriate use.
| S-EPMC9458549 | biostudies-literature
Project description:BackgroundThere is still a lack of consensus on the efficacy of convalescent plasma (CP) treatment in COVID-19 patients. We performed a systematic review and meta-analysis to investigate the efficacy of CP vs standard treatment/non-CP on clinical outcomes in COVID-19 patients.MethodsCochrane Library, PubMed, EMBASE and ClinicalTrials.gov were searched from December 2019 to 16 July 2021, for data from clinical trials and observational studies. The primary outcome was all-cause mortality. Risk estimates were pooled using a random-effect model. Risk of bias was assessed by Cochrane Risk of Bias tool for clinical trials and Newcastle-Ottawa Scale for observational studies.ResultsIn total, 18 peer-reviewed clinical trials, 3 preprints and 26 observational studies met the inclusion criteria. In the meta-analysis of 18 peer-reviewed trials, CP use had a 31% reduced risk of all-cause mortality compared with standard treatment use (pooled risk ratio [RR] = 0.69, 95% confidence interval [CI]: 0.56-0.86, P = .001, I2 = 50.1%). Based on severity and region, CP treatment significantly reduced risk of all-cause mortality in patients with severe and critical disease and studies conducted in Asia, pooled RR = 0.61, 95% CI: 0.47-0.81, P = .001, I2 = 0.0%; pooled RR = 0.67, 95% CI: 0.49-0.92, P = .013, I2 = 0.0%; and pooled RR = 0.62, 95% CI: 0.48-0.80, P < .001, I2 = 20.3%, respectively. The meta-analysis of observational studies showed the similar results to the clinical trials.ConclusionsConvalescent plasma use was associated with reduced risk of all-cause mortality in severe or critical COVID-19 patients. However, the findings were limited with a moderate degree of heterogeneity. Further studies with well-designed and larger sample size are needed.
| S-EPMC8420367 | biostudies-literature
Project description:The purpose of this study was to examine the clinical effectiveness of aldosterone antagonists in older patients with heart failure and preserved ejection fraction (HF-PEF).Aldosterone antagonists improve outcomes in HF and reduced EF. However, their role in HF-PEF remains unclear.Of the 10,570 hospitalized older (65 years of age) HF-PEF (EF 40%) patients in the Medicare-linked OPTIMIZE-HF(Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure) trial, 8,013 patients had no prior aldosterone antagonist use and no current contraindications; 492 (6% of these 8,013) patients received new prescriptions for aldosterone antagonists. We assembled a matched cohort of 487 pairs of patients receiving and not receiving aldosterone antagonists, who had a similar propensity to receive these drugs and were balanced on 116 baseline characteristics.Patients had a mean age of 80 years old, a mean EF of 54%, 59% were women, and 8% were African American. During 2.4 year of mean follow-up (through December 2008), the primary composite endpoint of all-cause mortality or HF hospitalization occurred in 392 (81%) and 393 (81%) patients receiving and not receiving aldosterone antagonists, respectively (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.84 to 1.11; p = 0.628). Aldosterone antagonists had no association with all-cause mortality (HR: 1.03; 95% CI: 0.89 to 1.20; p = 0.693) or HF hospitalization (HR: 0.88; 95% CI: 0.73 to 1.07; p = 0.188). Among 8013 prematched patients, multivariable-adjusted HR for the primary composite endpoint associated with aldosterone antagonist use was 0.93 (95% CI: 0.83 to 1.03; p = 0.144).In older HF-PEF patients, aldosterone antagonists had no association with clinical outcomes. Findings from the ongoing randomized controlled TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial will provide further insights into their effect in HF-PEF.
| S-EPMC3694622 | biostudies-other
Project description:BackgroundNeutralizing 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 questionDid mAb treatment prevent progression to severe disease and death across pandemic phases and based on risk factors, including prior vaccination status?Study design and methodsThis 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.ResultsOf 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).InterpretationReal-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.
| S-EPMC9613796 | biostudies-literature
Project description:ObjectiveRandomized trials provide evidence that intensive lifestyle interventions leading to dietary and physical activity change can delay or prevent Type 2 diabetes. Translational studies have assessed the impact of interventions based on, but less intensive than, trial protocols delivered in community settings with high-risk populations. The aim of this review was to synthesize evidence from translational studies of any design to assess the impact of interventions delivered outside large randomized trials.MethodsMedical and scientific databases were searched using specified inclusion and exclusion criteria. Studies were included that used a tested diabetes preventive study protocol with an adult population at risk from Type 2 diabetes. Included papers were quality assessed and data extracted using recommended methods.ResultsFrom an initial 793 papers, 19 papers reporting 17 studies were included. Translational studies from a range of settings utilized a variety of methods. All were based on the US Diabetes Prevention Programme protocol or the Finnish Diabetes Prevention Study, with modifications that increased feasibility and access. The main outcome that was reported in all studies was weight change. Weight loss, which occurred in all but one study, was greater in intervention arms than in control subjects. No consistent differences were found in blood glucose or waist circumference.ConclusionsTranslational studies based on the intensive diabetes prevention programmes showed that there is potential for less intensive interventions both to be feasible and to have an impact on future progression to diabetes in at-risk individuals.
| S-EPMC3555428 | biostudies-literature
Project description:ImportanceAs the United States continues to accumulate COVID-19 cases and deaths, and disparities persist, defining the impact of risk factors for poor outcomes across patient groups is imperative.ObjectiveOur objective is to use real-world healthcare data to quantify the impact of demographic, clinical, and social determinants associated with adverse COVID-19 outcomes, to identify high-risk scenarios and dynamics of risk among racial and ethnic groups.DesignA retrospective cohort of COVID-19 patients diagnosed between March 1 and August 20, 2020. Fully adjusted logistical regression models for hospitalization, severe disease and mortality outcomes across 1-the entire cohort and 2-within self-reported race/ethnicity groups.SettingThree sites of the NewYork-Presbyterian health care system serving all boroughs of New York City. Data was obtained through automated data abstraction from electronic medical records.ParticipantsDuring the study timeframe, 110,498 individuals were tested for SARS-CoV-2 in the NewYork-Presbyterian health care system; 11,930 patients were confirmed for COVID-19 by RT-PCR or covid-19 clinical diagnosis.Main outcomes and measuresThe predictors of interest were patient race/ethnicity, and covariates included demographics, comorbidities, and census tract neighborhood socio-economic status. The outcomes of interest were COVID-19 hospitalization, severe disease, and death.ResultsOf confirmed COVID-19 patients, 4,895 were hospitalized, 1,070 developed severe disease and 1,654 suffered COVID-19 related death. Clinical factors had stronger impacts than social determinants and several showed race-group specificities, which varied among outcomes. The most significant factors in our all-patients models included: age over 80 (OR=5.78, p= 2.29×10 -24 ) and hypertension (OR=1.89, p=1.26×10 -10 ) having the highest impact on hospitalization, while Type 2 Diabetes was associated with all three outcomes (hospitalization: OR=1.48, p=1.39×10 -04 ; severe disease: OR=1.46, p=4.47×10 -09 ; mortality: OR=1.27, p=0.001). In race-specific models, COPD increased risk of hospitalization only in Non-Hispanics (NH)-Whites (OR=2.70, p=0.009). Obesity (BMI 30+) showed race-specific risk with severe disease NH-Whites (OR=1.48, p=0.038) and NH-Blacks (OR=1.77, p=0.025). For mortality, Cancer was the only risk factor in Hispanics (OR=1.97, p=0.043), and heart failure was only a risk in NH-Asians (OR=2.62, p=0.001).Conclusions and relevanceComorbidities were more influential on COVID-19 outcomes than social determinants, suggesting clinical factors are more predictive of adverse trajectory than social factors.Key pointsQUESTION: What is the impact of patient self-reported race, ethnicity, socioeconomic status, and clinical profile on COVID-19 hospitalizations, severity, and mortality?FINDINGS: In patients diagnosed with COVID-19, being over 50 years of age, having type 2 diabetes and hypertension were the most important risk factors for hospitalization and severe outcomes regardless of patient race or socioeconomic status.MEANING: In this large sample pf patients diagnosed with COVID-19 in New York City, we found that clinical comorbidity, more so than social determinants of health, was associated with important patient outcomes.
| S-EPMC8043490 | biostudies-literature