Baseline Characteristics Of Study Population Research Articles

#2897 Urinary CD44 levels in chronic kidney disease: a validation study

Abstract Background and Aims Proteinuria is the one of the main cause of kidney failure progression. There is inadequate data about protein components in urine and CKD severity. Our recent urinary proteomics study demonstrated the higher expression of CD44 in the urine proteome of healthy participants compared to CKD patients, arguing the protective role of CD44 in kidney health. However, the validation study needed to proof those differences in CD44 levels by ELISA tests in healthy participants and CKD patients. Therefore, we aimed to investigate urinary CD44 levels in our previously studied cohort of healthy controls and CKD patients using ELISA test. Method This study included 49 healthy participants and 88 early-stage CKD patients. Along with routine laboratory tests, 24 h collected urine samples were investigated using liquid chromatography-mass spectrometry (HPLC-MS) for proteomic analysis. Exponentially Modified Protein Abundance Index (emPAI) was used to estimate peptide count of proteins. Additionally, urinary CD44 levels were measured using ELISA kit to validate findings from proteomic study. Results A brief baseline characteristics of study population presented in Table 1. CKD group represented with lower eGFR, increased creatinine and higher proteinuria compared to healthy controls. Urinary CD44 levels were significantly higher in CKD group compared to healthy controls. Both CD44 levels measured by HPLC-MS and ELISA methods significantly positively correlated with eGFR levels (Table 2). Conclusion In this validation study, we compared the levels of CD44 measured by HPLC-MS and ELISA in healthy controls and CKD patients. We demonstrated that CD44 is overexpressed in urine samples of healthy people compared to CKD patients and may play a protective role in the kidney health. Further investigations needed to explain this finding in a different cohort and large number of CKD patients.

Assessment of Imatinib as a Primary Treatment of Chronic Myeloid Leukemia in Chronic Phase: a Cohort Study.

The study aimed to assess the effectiveness of Imatinib in chronic myeloid leukaemia (CML) in our hospital population. In addition to identify which brand of imatinib (Gleevec/Veenat) is cost effective for CML patients and to assess the possible adverse drug reactions during the treatment for chronic myeloid leukaemia. A non-interventional (observational), both retrospective and prospective study was carried out in the department of Medical Oncology and Haematology of our hospital. A total of 152 patients were enrolled in the study. Patients who satisfied the inclusion and exclusion criteria were selected for the study. Evaluation of baseline characteristics of study population (n = 152) showed predominance of males (65.1%). The mean age was 49.80 ± 16.561 years. The overall clinical outcome of the sample population, BCR ABL value responses during 3,6 and 12 months are the main indicators for the prediction of outcome in CML -CP patients. Using Independent sample t test, it was found that the difference in response to Imatinib therapy during 3,6 & 12 months were statistically significant and showed a statistically significant difference between the good and adverse outcome (p < 0.001). Our study concluded that Imatinib showed a benefit in treating the condition without any life-threatening adverse events and also the drug exhibits a complete haematological and optimal response based on European Leukaemia Net criteria during the period of study. From which, it can be concluded that imatinib appears to be a safe and well-tolerated treatment for the chronic-phase chronic myeloid leukaemia population.

The Indian Chronic Kidney Disease (ICKD) study: baseline characteristics.

ABSTRACTBackgroundChronic kidney disease (CKD) is an important cause of morbidity and mortality worldwide. There is a lack of information on epidemiology and progression of CKD in low–middle income countries. The Indian Chronic Kidney Disease (ICKD) study aims to identify factors that associate with CKD progression, and development of kidney failure and cardiovascular disease (CVD) in Indian patients with CKD.MethodsICKD study is prospective, multicentric cohort study enrolling patients with estimated glomerular filtration rate (eGFR) 15–60 mL/min/1.73 m2, or >60 mL/min/1.73 m2 with proteinuria. Clinical details and biological samples are collected at annual visits. We analysed the baseline characteristics including socio-demographic details, risk factors, disease characteristics and laboratory measurements. In addition, we compared characteristics between urban and rural participants.ResultsA total of 4056 patients have been enrolled up to 31 March 2020. The mean ± SD age was 50.3 ± 11.8 years, 67.2% were males, two-thirds of patients lived in rural areas and the median eGFR was 40 mL/min/1.73 m2. About 87% were hypertensive, 37% had diabetes, 22% had CVD, 6.7% had past history of acute kidney injury and 23% reported prior use of alternative drugs. Diabetic kidney disease, chronic interstitial nephritis (CIN) and CKD-cause unknown (CKDu) were the leading causes. Rural participants had more occupational exposure and tobacco use but lower educational status and income. CIN and unknown categories were leading causes in rural participants.ConclusionsThe ICKD study is the only large cohort study of patients with mild-to-moderate CKD in a lower middle income country. Baseline characteristics of study population reveal differences as compared with other cohorts from high-income countries.

POS0675 THE COMPARATIVE 3-YEAR RETENTION RATE OF TARGETED-SYNTHETIC AND BIOLOGIC DRUGS FOR RHEUMATOID ARTHRITIS: REAL-LIFE DATA FROM THE ITALIAN GISEA REGISTRY

Background:Long-term observational data on the real-life use of JAK inhibitors (JAKis) for rheumatoid arthritis (RA) and their comparison with biological drugs are still very limited. Large population-based registries have been increasingly used to investigate the performance of targeted drugs in a real-life setting.Objectives:The aim of this study is to evaluate and compare the 3-year retention rate of JAKis, TNF inhibitors (TNFis) and biologic drugs with other mechanisms of action (OMAs) in the large cohort of RA patients included in the Italian national GISEA registry.Methods:Data of all RA patients treated with targeted synthetic or biologic drugs were prospectively collected in the Italian multicentric GISEA registry. The analysis was limited to patients who started a first- or second-line targeted drug in the period after the first JAKi was marketed in Italy (1st December 2017). The 3-year retention rate was calculated by the Kaplan-Meier method and compared between different drug classes by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 1027 RA patients (79.8% females, mean age [±SD] 56.9 [±13.5] years, mean disease duration 9.8 [±9] years, mean baseline SDAI 17.5 [±11.9], ACPA positive 67.4%, RF positive 62.7%) who received JAKis (baricitinib or tofacitinib, n=297), TNFis (n=365), or OMAs (n=365) as first or second targeted drug. Main baseline characteristics of study population were overall well balanced between treatment groups. Retention rate was numerically but not statistically higher (p=0.18) in patients treated with JAKis compared with TNFis or OMAs (80.6, 78.9 and 76.4% at 1 year and 73, 56.8 and 63.8% at 3 years, respectively) (Figure 1). Drug survival was significantly higher in patients receiving concomitant methotrexate (MTX) compared with monotherapy only in TNFis (66.8 vs 47.1%, p=0.04) but not in JAKis (76.1 vs 70.1%, p=0.54) and OMAs (66.1 vs 61.9%, p=0.41) group. Therapy was discontinued in a total of 211 patients because of ineffectiveness (n=107), adverse events (n=88), or compliance/other reasons (n=16). The most frequent reason for treatment withdrawal was ineffectiveness in both JAKis (n=30 out of 56) and TNFis (n=45 out of 74) groups, whereas OMAs were discontinued more frequently because of adverse events (n=41 out of 81).Conclusion:Our data confirmed in a real-life setting a favorable 3-year retention rate of all available targeted mechanisms of action for RA therapy. As expected, concomitant MTX significantly impacted persistence on therapy of TNFis only. Discontinuations of JAKis for adverse events were infrequent overall, confirming the safety profile observed in randomized clinical trials.Figure 1.Three-year retention rate by treatment groupDisclosure of Interests:None declared

Association of Omentin-1 and Central Obesity with Coronary Heart Disease

Background: Omentin-1 is a novel adipocytokine expressed from visceral adipose tissues and is closely associated with obesity, inflammation and coronary artery disease. Central or abdominal obesity has a dynamic role in the development of coronary heart disease by enviably effecting conventional risk factors. Waist circumference is a sensitive, reliable and specific anthropometrical indicator of central obesity. Thus, the present study aimed to evaluate the correlation between central obesity measured by waist circumference and plasma omentin-1 in patients with coronary heart disease. Methods: The study was performed in cardiac unit of Civil Hospital Karachi and Karachi Institute of Heart Diseases (KIHD), Pakistan from January 2016-August 2016. A total of 250 patients (92 females, 158 males) with coronary artery disease were evaluated. Waist circumference was measured at the level of umbilicus. Determination of Omentin-1 was done by an enzyme-linked immunosorbent assay (ELISA). Data was evaluated by SPSS and one way ANOVA was performed to determine the baseline characteristics of study population. Pearson’s correlation was used for association between waist circumference and plasma omentin-1. Results: There was a negative association between waist circumference and plasma omentin-1 (R = -0.68, p &lt; 0.01) in males and (R= – 0.50, p &lt; 0.01) in female patients of coronary heart disease. Waist circumference was found an independent determinant of circulating omentin-1 while performing multivariate logistic regression analysis, after adjusting cardio-metabolic risk factors like age, body mass index, lipid profile, blood sugar levels and smoking. Conclusion: There was a negative correlation of plasma omentin-1 and central obesity in coronary heart disease. Keywords: Central Obesity; Coronary Heart Disease; Omentin-1; Waist Circumference.

S0667 Sweet Syndrome in Inflammatory Bowel Disease in the U.S.

INTRODUCTION: Sweet Syndrome (SS) or (acute febrile neutrophilic dermatosis) is a rare entity which manifests as painful, and edematous inflammatory skin lesions associated with fever and leukocytosis. Inflammatory bowel disease (IBD) has been linked to the classical form of SS in many reports. However, as SS is a rare condition, limited epidemiologic data is available in the literature. Utilizing large population database, we aim to describe the epidemiology of SS in IBD patients in the US. METHODS: Using Explorys Inc, which is a Large population-based database uses an aggregate of electronic health records data from different US healthcare systems throughout the US, we searched all the active records between 2015 and 2020. After excluding patients with history of malignancy and pregnant patients, a cohort of patients with a Systematized Nomenclature of Medicine-Clinical Terms (SNOMED) of Ulcerative Colitis (UC) and Crohn's Disease (CD) were identified. Age, race, gender, and the different categories of IBD medications were identified. Statistical multivariate model was performed using Statistical Package for Social Sciences (SPSS version 25, IBM Corp). We reported the epidemiologic predictors of SS in IBD. For all analyses, a 2-sided P value < 0.05 was considered statistically significant. RESULTS: We included 335,920 IBD patients,154,500 with UC and 181,420 with CD; Prevalence of SS in patients with UC was 39 per 100.000 and 33 per 100.000 in patients with CD. Using a multivariate analysis model, patients with IBD were more likely to develop SS compared to patients with no IBD, (OR:5.696, CI 95% 4.677—6.936, P < 0.0001, OR: 5.286, CI 95% 4.720—5.919, P < 0.0001 in UC and CD respectively). Prevalence's of SS in the different age groups of both UC and CD are shown in Figure 1. Demographic predictors of SS are presented in Table 2. CONCLUSION: In this large population-based study, we confirm the strong association between IBD and SS. Female gender and old age groups were a predictor of the disease in both UC and CD. Unlike UC, Caucasian race was a strong predictor of SS in CD.Figure 1Table 1Table 2.: Baseline Characteristics of Study Population

Association of Green Tea Consumption and Coronary Arterial Disease Risk in a Chinese Population in Guangzhou.

To explore the association between green tea consumption and coronary arterial disease (CAD) in the Chinese population of Guangzhou. Design, location, subjects: A retrospective study at the Sun Yat-sen Memorial Hospital in Guangzhou, China. Consecutive patients were enrolled between January 2013 and August 2014. A total of 539 patients were included. Two hundred sixty-seven of them are CAD patients and 272 of them are non-CAD patients. The CAD patients were diagnosed according to international diagnostic criteria. Using data from the questionnaires and clinical laboratories, we attempted to elucidate the association between green tea and CAD. Baseline characteristics of study population, CAD-related biomarkers, amount, frequency and duration of green tea consumption, and CAD risk analysis. The results showed that among males, those who drank green tea did not have a reduced risk of CAD (odds ratio; OR = 1.58, 95% CI: 0.96-2.59, p > 0.05). However, women in the study who drank green tea had a reduced risk of CAD (OR = 0.13, 95% CI: 0.07-0.23, p < 0.01). The females who consumed ≤1 cup/day green tea had lower CAD risk (OR = 0.12, 95% CI: 0.07-0.23, p < 0.01). The frequency of 3-5 days/week (OR = 0.14, 95% CI: 0.07-0.29, p < 0.01) and >5 days/week (OR = 0.24, 95% CI: 0.08-0.69, p < 0.01) were both beneficial in preventing CAD. Those who had been drinking green tea for 0-10 years (OR = 0.11, 95% CI: 0.04-0.30), 10-20 years (OR = 0.22, 95% CI: 0.11-0.46), or >20 years (OR = 0.37, 95% CI: 0.12-0.96) had a reduced risk of CAD. Through the analysis of green tea consumption and CAD-related biomarkers, we concluded that a small amount of high-frequency green tea consumption was associated with a reduced risk of CAD in female populations in Guangzhou, China, and the association might be partly due to altered CAD-related biomarkers.

Sickle cell disease complicating pregnancy: A retrospective study

Introduction: Sickle cell disease is an uncommon cause of anemia and jaundice during pregnancy. Sickle cell crisis may lead to several maternal and fetal complications. Aims: To study maternal and fetal complications in pregnant patients with sickle cell disease. Settings and Design: Retrospective study was carried out from case records at Mamata Medical College over a period of five years from July 2011 to June 2016. Patients and Methods: Among 17 pregnancies in 12 cases, we studied the baseline characteristics of study population, frequency of sickle hemoglobin variants, and complications to mother and baby. Statistical Analysis Used: Compiled data was analyzed by simple descriptive statistics and frequency tables. Results: Most cases were primigravida (58.3%). Most common presenting features were anemia and jaundice (hemolytic crisis, 70.58%) and bone and joint pains (painful crises, 41.17%). Acute chest syndrome was seen in 5.88% of the patients. Pregnancies were complicated by severe anemia (Hb Discussion: Because of hematological changes, extra demands, and sickle crisis, complications to both mother and fetus are more common in sickle cell anemia during pregnancy than in non-pregnant state. Conclusions: Although sickle cell anemia during pregnancy is usually associated with complications, prompt recognition and careful management reduces morbidity and mortality associated with them.

Serum Concentrations of Heme Oxigenase-1 are Reduced in Patients with Acute Heart Failure and Preserved Ejection Fraction

Heme oxygenase-1 (HO1) has been characterized as one of the most important cardioprotective proteins. The benefits of HO1 overexpression has been demonstrated mainly in animal models related to the protection of ischemic reperfusion injury, improved survival in chronic heart failure and improvement of type 1 cardiorenal syndrome through modulation of oxidative stress and inflammatory pathways. HO1 has been shown to increase with age. The objective of this study was to measure the concentration of HO-1 in patients with acute heart failure (AHF) with reduced (AHF rEF) and preserved ejection fraction (AHF pEF). A total of 25 subjects were included in this study under an approved IRB protocol with signed informed consent form. We studied 21 patients admitted with a diagnosis of acute decompensated heart failure and 4 healthy subjects used as controls. Serum was collected and stored at -80C. Samples were then analyzed for Heme Oxigenase-1 using an ELISA kit from NeoBiolab©. Results were standardized and compared to patient’s clinical characteristics. P-values <0.05 were considered significant. Baseline characteristics of study population are shown in the table. The majority of patients were male (57%), had a history of CAD (62%) and hypertension. Patients with AHF pEF were older than those with AHF rEF. Heme oxigenase-1 concentration was similar in patients with AHF rEF (257 ± 162 mg/ml) and controls (292± 74 mg/ml) p-value= 0.71, but it was significantly decreased in patients with AHF pEF (139 ± 73 mg/ml) compared to controls (p-value= 0.004) and patients with AHF rEF (p-value= 0.04). In spite of being older, patients with acute heart failure with preserved ejection fraction had significant reduced levels of Heme oxigenase-1. This may render HFpEF patients susceptible to increased oxidative stress and inflammation. The importance of these findings requires further investigation.Table 1Patient characteristicsAcute HF with rEF (n=9)Acute HF with pEF (n=12)p-valueAge (yrs.)62740.04Sex (% female)4 (44)5 (41)1.0CAD (%)6 (66)7 (58)1.0Diabetes Mellitus (%)6 (66)5 (41)0.3Hypertension (%)9 (100)11 (91)1.0Atrial Fibrillation (%)1 (11)6 (50)0.08Systolic Blood Pressure (mmHg)124 ± 23139 ± 330.29HR (bpm)84 ± 1972 ± 130.13LVEF (%)28 ± 959 ± 6<0.0001Creatinine (mg/ml)1.4 ± 0.71.4 ± 0.70.78Sodium (meq/L)141 ± 3.3140 ± 2.30.58BNP (pg/ml)849 ± 618501 ± 4740.20Hs-TnT (ug/L)0.070.050.61Heme oxygenase-1 (mg/ml)257 ± 162139 ± 730.04 Open table in a new tab

The impact of interventions by pharmacists in community pharmacies on control of hypertension: a systematic review and meta-analysis of randomized controlled trials.

To undertake a systematic review and meta-analysis of randomized controlled trials concerned with the impact of community pharmacist-led interventions on blood pressure control in patients with hypertension. Eight electronic databases were searched up to 30 November 2013, with no start date (Web of Science, Embase, The Cochrane Library, Medline Ovid, Biomed Central, Biosis Citation Index, CINAHL, PsycINFO). All studies included were randomized controlled trials involving patients with hypertension, with or without cardiovascular-related co-morbidities, with difference in blood pressure as an outcome. Data collected included the study design, baseline characteristics of study populations, types of interventions and outcomes. The Cochrane tool was used to assess risk of bias. From 340 articles identified on initial searching, 16 randomized controlled trials (3032 patients) were included. Pharmacist-led interventions were patient education on hypertension, management of prescribing and safety problems associated with medication, and advice on lifestyle. These interventions were associated with significant reductions in systolic [11 studies (2240 patients); -6.1 mmHg (95% confidence interval, -3.8 to -8.4 mmHg); P < 0.00001] and diastolic blood pressure [11 studies (2246 patients); -2.5 mmHg (95% confidence interval, -1.5 to -3.4 mmHg); P < 0.00001]. Community pharmacist-led interventions can significantly reduce systolic and diastolic blood pressure. These interventions could be useful for improving clinical management of hypertension.

O-080 Elevated Soluble Thrombomodulin Is Associated With Increased Mortality Among Children With Indirect Acute Respiratory Distress Syndrome (ards)

Background Inflammation and endothelial damage accelerate cleavage of endothelium bound Thrombomodulin (TM). Elevated soluble TM (sTM) in plasma is associated with adverse outcomes in sepsis and DIC in adults, but this has not been studied among children with ARDS. Objective Test the relationship of plasma sTM with clinical outcomes in paediatric ARDS. Design/methods We measured sTM in plasma collected within 24 h of onset of ARDS (diagnosed by Berlin criteria) in an ongoing multi-centre observational cohort. We used non-parametric Mann-Whitney and trend tests, and regression models. Results Baseline characteristics of study population are shown in Table. Among children with indirect lung injury, mean sTM levels were higher in non-survivors [241 ng/mL (102–134)] compared to survivors [118 ng/mL (107–374)] (p = 0.004). Mortality and Paediatric Logistic Organ Dysfunction (PELOD) score increased stepwise by tertile of plasma sTM (figure). On logistic regression, the odds of death increased by 4.5 for every log increase in plasma sTM and the association was independent of age, race, gender and severity of illness. No such relationship existed for direct ARDS. Conclusions Higher plasma sTM is associated with increased mortality and organ failure in children with indirect ARDS. This supports the importance of endothelial injury and TM in pathobiology of indirect ARDS and suggests that early elevation in plasma sTM is an independent risk factor for mortality.

Lower plasma nutrient levels in people with mild Alzheimer's disease compared with healthy volunteers

memory performance in drug-na€ive mild AD patients (MMSE 20-26 and MMSE 20), indicating that Souvenaid is efficacious in the early phases of AD. The ’LipiDiDiet’ study 2 is one of the first RCTs in prodromal AD, investigating the effects of Souvenaid on cognition.Methods: The LipiDiDiet study is an ongoing 24-month, double-blind, parallel-group RCT investigating the effects of Souvenaid in 300 prodromal AD subjects (criteria Dubois, 2007). Subjects are randomly assigned to Souvenaid or an iso-caloric control product. Primary outcome measure is cognitive functioning, assessed by a modified version of the Neuropsychological Test Battery (Harrison, 2007). Secondary outcome measures include progression to AD, cognitive performance, functional abilities (ADCS-ADL), depression (MADRS), MRI atrophy rate, plasma and CSF biomarkers, safety, tolerance and nutritional parameters. Main study outcomes are assessed at baseline and after 6, 12 and 24 months of intervention. Baseline characteristics of the study population are analyzed.Results: Preliminary analysis of baseline data from 213 randomized subjects (47.9% male, enrolled until July 2012) showed that subjects had a mean age of 71.866.9 years, MMSE score of 26.662.0 and ADAS-cog score of 19.767.8. Baseline biomarker data from a subsample of subjects (n1⁄422) showed a CSF b-amyloid 1-42/ 1-40x10 ratio of 1.8960.71, CSF total tau of 465.56269.6 pg/ml, CSF phosphorylated tau of 74.5635.6 pg/ml and MTA score of 1.6461.00 (MRI evidence for medial temporal lobe atrophy). Last subject randomized in the study is expected early 2013. Therefore, baseline characteristics of the total study population will be presented at the conference. Conclusions: Baseline characteristics of the study population included in the LipiDiDiet study so far are as expected for subjects with prodromal AD.