Mean Hb Research Articles

Open-label, phase 2 study of roxadustat for treatment of anemia in patients receiving chemotherapy for non-myeloid malignancies.

12085 Background: Anemia is prevalent in patients (pts) receiving myelosuppressive chemotherapy (> 60%) and exacerbated by repeated treatment cycles due to cytotoxic agent accumulation. Chemotherapy-induced anemia (CIA) management options are suboptimal. We evaluated the efficacy and safety of roxadustat in pts with anemia receiving myelosuppressive chemotherapy. Methods: This open-label, single-arm, proof-of-concept Phase 2 study included pts with mostly advanced, non-myeloid malignancies and CIA (hemoglobin [Hb] ≤10 g/dL) who had not received red blood cell (RBC) transfusion or erythropoietin-stimulating agents within 4 weeks of enrollment. Patients were treated with oral roxadustat for ≤16 weeks. The primary efficacy endpoint was maximum mean change in Hb within 16 weeks of baseline without RBC transfusion in pts who had received ≥1 dose of roxadustat and who had a baseline and ≥1 post-dose Hb assessment. Hb response and safety data were preliminarily assessed in pts receiving a starting dose of 2.0 mg/kg thrice weekly (TIW) for 4 weeks: doses of 100, 150, and 200 mg were given to pts weighing < 70, 70–100, and > 100 kg, respectively. Following a review of data from these pts, dose was increased to 2.5 mg/kg—150, 200, and 250 mg TIW to pts weighing < 70, 70–100, and > 100 kg, respectively—and adjusted every 4 weeks from Week 5 based on Hb response. Results: Patients were assigned to 2.0 mg/kg (n = 31) and 2.5 mg/kg (n = 61) starting doses, and 89 were assessed for efficacy. The maximum mean Hb change from baseline without RBC transfusion was 2.47±1.51 g/dL and 2.52±1.54 g/dL in the 2.0 mg/kg and 2.5 mg/kg cohorts, respectively. Hb increased by ≥1.5 g/dL in 73% of pts and ≥2.0 g/dL in 61% of pts. Median time to ≥2.0 g/dL Hb increase was 71.0 days. Both cohorts had higher proportions of pts with a Hb increase of ≥1, ≥1.5, or ≥2 g/dL at Week 16 compared with baseline. Median time to ≥1 and ≥2 g/dL Hb increase was shorter in pts who started on 2.5 mg/kg compared with 2.0 mg/kg doses (≥1 g/dL: 30 vs 44; ≥2 g/dL 57 vs 105, respectively). Fewer pts required an RBC transfusion (Week 5 to end of treatment) when starting on 2.5 mg/kg compared with 2.0 mg/kg doses (10.2% vs 20.0%). Subgroup analyses based on major tumor and baseline chemotherapy types demonstrated efficacy of roxadustat at both starting doses. The overall safety profile observed was consistent with the patient population under study. Overall, 92% of pts experienced an adverse event (AE). Most AEs were consistent with the underlying malignancies and chemotherapy regimens used. The incidence of deep vein thrombosis was 15.2% (n = 14) and pulmonary embolism was 9.8% (n = 9). There were 17 deaths (18.5%) during the study; none were attributed to roxadustat, and most were associated with disease progression. Conclusions: Roxadustat increased Hb in CIA regardless of tumor type and chemotherapy regimen. These data support additional clinical study. Clinical trial information: NCT04076943.

Risk Factors Leading to Acute Decompensation of Chronic Heart Failure in Patients Presenting to a Tertiary Care Hospital, Islamabad, Pakistan

Objectives: To determine the risk factors leading to acute decompensation of chronic heart failure in patients presenting to a tertiary care hospital, Islamabad, Pakistan Methodology: Study was conducted at Pakistan Institute of Medical Sciences, Cardiology department, Islamabad, Pakistan, 164 chronic heart failure patients aged ≥18 years; diagnosed with CHF from both genders were included. Patients with sudden onset of disease and unstable vital signs, impaired mobility; diagnosis with major depression or those having cognitive functioning disorder were excluded from study.Medical records were analyzed for the patient’s chronic heart failure risk factor profile i.e., history of diabetes, hypertension, hyperlipidemiaand smoking. Details of the coronary angiogram, laboratory investigations, and metabolic and cardiac biomarker were noted. Data was entered and analyzed using statistical package for social sciences (SPSS) version 2.0. P< 0.05 will be considered as significant. Results: In study analysis it was found that out of total 164 participants, study included 78 males (47.6%) and 86 females (52.4%). out of which 157 (95.7%) were having history of hypertension and 85 (51.8%) were found to be having history of diabetes. Participant included in study who used to smoke were 92 (56.1%), patients having dyslipidemia were found to be 85 (51.8%) and 85 (51.8%) were obese. Out of all patients 157 (95.7%) were found to be having a sedentary life, while 19 (8.5%) participants have developed new ischemia. Out of all participants 93 (56.71%) were found to be having ECG changes and 72 (43.9%) were found to have cardiac enzyme changes. Mean age of participant was found to be 59.51±45.54. Mean HB level was found to be 12.8±1.8 and mean respiratory rate was found to be 19.12 ±3.4. Mean pulse was found to be 94.7±3.4. Mean BP was found to be 118.22±10.7.

Prevalence of anemia in pre-school tribal children with reference to parasitic infections and nutritional impact

ObjectivesAnemia is a global health problem and has very high prevalence in developing as well as developed countries, particularly in children and women. The present study evaluates hematological predictors, nutrition deficiency, parasitic infections and their association with the prevalence of anemia. This analysis will help to identify the anemic status of tribal preschool children. MethodsThis was a cross-sectional study conducted in 300 children (age: 6 months to 5 years) in Santrampur village, Gujarat. Blood was collected and used to determine complete blood count (CBC); we also performed ELISA (enzyme-linked immunoassay) for the estimation of ferritin, transferrin, sTfR (soluble transferrin receptor), vitamin B12 and vitamin B9 (folate). Stool samples were also collected and assessed by ELISA for Entamoeba histolytica, Giardia lamblia and Cryptosporidium parvum. Microscopy was used to screen samples for malaria. ResultsOf the 300 children analyzed, 87.7% were anemic, 239 children were mildly anemic, 20 were moderately anemic and 4 were severely anemic. Mean Hb level was 9.49 ± 1.47 g/dL; males and females had an Hb level of 9.39 ± 1.59 g/dL and 9.58 ± 1.34 g/dL, respectively. Twenty-six children had sickle cell anemia and five had thalassemia. Over 50% of the children had vitamin B12 and B9 deficiency and 16% had abnormalities in CRP (C-reactive protein) levels. Parasitic infection by C. parvum was positively associated the anemia followed by the prevalence of G. lamblia and E. histolytica. ConclusionAn increased awareness of parents in the improvement of sanitary facilities and nutritional counselling with regards to iron-rich food consumption is recommended to if we are to prevent anemia among pre-school children. To reduce parasitic infestation, effective periodic deworming measures are also recommended

Risk Factors Leading to ST Elevation Myocardial Infarction in Young Patients Presenting to a Tertiary Care Hospital, Islamabad Pakistan

Objective: To determine the risk factors leading to ST Elevation Myocardial infarction in young patients presenting to a tertiary care hospital,Islamabad Pakistan Methodology: Prospective observational study was conducted at Pakistan Institute of Medical Sciences, Cardiology department, Islamabad, Pakistan for duration of 10 months. Study was conducted on sample size of 164 selected through non-probability consecutive sampling technique. Study included participants with age less than or equals to 45 and participants from both genders.However, participants with Age more than 45and those having non ST myocardial infarction were excluded. findings including Blood pressure, pulse, respiratory rate, cyanosis, S3, Killip class and JVP were noted. Data was entered and analyzed using statistical package for social sciences (SPSS). P value of < 0.05 was considered as significant. Results: Mean age of participant was found to be 25.3±4.3, mean BMI was found to be 25.8 ±0.81. Mean HB level was found to be 12.8±0.8 and mean respiratory rate was found to be 18. Risk factor HTN in association with gender was found to have significant difference between two with p value of 0.01 In study analysis it was seen that risk factor HTN in association with age was found to have significant difference between two with p value of 0.05.Smoking in association with age was found to have shown significant difference between two with p value of 0.02Family history of MI in association with age was found to have shown significant difference between two with p value of 0.04. Conclusion: Risk factors HTN ,Smoking and family history were found to be positively associated with ST elevation myocardial infarctionin young age.

MO526: Renal Function in Patients With Non-Dialysis Kidney Disease Treated With Ferric Carboxymaltose

Abstract BACKGROUND AND AIMS Iron deficiency anemia occurs in most patients with non-dialysis chronic kidney disease (ND-CKD). Several studies have suggested the efficacy and safety of ferric carboxymaltose (FCM) in this group of patients, but none have shown a positive impact on renal function. The aim our study was to investigate the impact of FCM on renal function in ND-CKD patients. METHOD Prospective observational study of ND-CKD stages 3 to 5 patients, with anemia and iron deficiency [ferritin level <100 µg/L or <200 µg/L with transferrin saturation (TSAT) <20%], treated with FCM from 01 January 2019 to 31 June 2021. FCM was administrated as a single IV infusion. Patients were categorized into two cohorts according to the dose of FCM received: 500 mg or 1000 mg. Clinical and analytical data were compared among groups at baseline and 24 weeks after infusion. Renal function was assessed using estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI formula. Statistical analysis was executed using SPSS (Version 23 for Mac OSX). RESULTS The mean age of 140 patients was 77.31 ± 9.68 years, 62 (44.3%) were male, 86 (61.4%) were diabetic, 84 (60%) had congestive heart failure and 121 (86.4%) had hypertension. Thirty-five (25%) patients had CKD stage 3, 74 (52.9%) had stage 4 and 31 (22.1%) had stage 5. Seventy-eight (55.7%) patients were treated with 1000 mg of FCM. There were no gender, comorbidity, CKD etiology or stage differences among groups. Patients treated with 1000 mg were younger (74.36 ± 13.59 versus 78.44 ± 9.28 years, P = .046). At baseline, mean Hb was 10.4 ± 1.35, 10.27 ± 1.47 and 10.54 ± 1.2 g/dL and mean eGFR was 26.18 ± 17.167, 23.55 ± 4.17 and 28.71 ± 19.43 mL/min/1.73 m2 for the whole group, 1000 mg and 500 mg cohorts. At 24 weeks, Hb showed an increase of 1.24 ± 1.78 (P = .001), 1.54 ± 1.99 (P = .001) and 0.86 ± 1.4 g/dL (P = .001), and eGFR an increase of 1.13 ± 6.49 (P = .041) and 1.55 ± 6.87 mL/min/1.73 m2 (P = .049) for the whole group and 1000 mg cohort, but not 500 mg cohort. A Pearson correlation was performed and revealed a positive correlation between the variation of Hb and eGFR during the study follow-up period (r = .283, P = .001 and r = .310, P = .008) in the same groups. CONCLUSION In addition to the effectiveness in correcting iron deficiency anemia in patients with ND-CKD, our results suggest a positive impact on renal function of higher doses of FCM after 6 months of administration.

FC037: A Study to Ascertain the Optimum Starting Dose of Subcutaneous (SC) C.E.R.A. for Maintenance Treatment of Anemia in Pediatric Patients with Chronic Kidney Disease (CKD) on Dialysis or not yet on Dialysis

Abstract BACKGROUND AND AIMS The Phase II study DOLPHIN (NH19707; NCT00717366) demonstrated that pediatric patients with chronic kidney disease (CKD) on hemodialysis can be safely and effectively switched from maintenance treatment with epoetin alfa/beta or darbepoetin alfa to intravenous continuous erythropoietin receptor activator (C.E.R.A.)—methoxy polyethylene glycol-epoetin beta, using defined conversion factors [1]. This study (NH19708; NCT03552393; SKIPPER) was conducted to ascertain the optimum starting dose of C.E.R.A. administered subcutaneously for maintenance treatment of anemia in pediatric patients with CKD on dialysis, or those not yet on dialysis, using the same conversion factors. Methods This Phase II, open-label, single-arm, multicentre study included a 3-week screening period, 16-week dose-titration period, 4-week evaluation period and 24-week optional safety extension (for patients who completed the 20 weeks of treatment with hemoglobin [Hb] within ± 1 g/dL of their baseline Hb and within the target range of 10–12 g/dL). Patients aged 3 months to 17 years with stable chronic renal anemia and a baseline Hb concentration of 10.0–12.0 g/dL were switched from epoetin alfa/beta or darbepoetin to subcutaneous (SC) C.E.R.A. every 4 weeks using the previously determined conversion factors. The primary endpoint was change in Hb concentration (g/dL) between baseline and the evaluation period. Secondary endpoints included the number of patients with a mean Hb concentration within a target range of 10.0–12.0 g/dL and/or ± 1 g/dL of baseline during the evaluation period and change in C.E.R.A. SC dose over time. Safety/tolerability and the pharmacokinetics/pharmacodynamics profile of C.E.R.A. SC were also assessed. RESULTS Forty patients were enrolled, with 38 completing the core study period and 25 entering the safety extension period. Six patients withdrew from the study, mainly due to kidney transplantation (5/6; 83.3%). The mean age of patients was 10 years; 12 (30%) aged <5 years, 11 (27.5%) aged 5–11 years and 17 (42.5%) aged 12–17 years. Eighteen patients (45.0%) were on peritoneal dialysis, 5 (12.5%) were on hemodialysis and 17 (42.5%) were not on dialysis. The mean Hb level at baseline was 11.02 g/dL (range: 10.1–12.2 g/dL). Mean change in Hb between baseline and the evaluation period was 0.48 g/dL (standard deviation: 1.03; 90% confidence interval 0.20–0.76). Results were consistent based on sub-analyses by age groups (<5, 5–11, 12–17 years), dialysis status (no dialysis, hemodialysis or peritoneal dialysis) and previous type of erythropoiesis-stimulating agent treatment. Mean Hb concentration levels were maintained within 10–12 g/dL and within ± 1 g/dL of baseline throughout the entire core period and safety extension period. During the evaluation period, 24/38 patients (63.2%) maintained Hb within 10–12 g/dL, 19 (50%) maintained Hb within 1 g/dL of baseline and 18 (47.4%) fulfilled both criteria. The median ratio of C.E.R.A. dose between Week 1 (median dose of 75 μg) and Week 17 (50 μg) was 1.44, indicating a decrease relative to the initial dose. Safety results were consistent with the known safety profile for C.E.R.A. in adults and pediatric patients aged 6–17 years on hemodialysis and IV administration of C.E.R.A [1], with no unexpected safety signals detected. CONCLUSION In this study, the primary endpoint was met and provided evidence that pediatric patients with CKD on dialysis, or those not yet on dialysis, can be safely and effectively switched from previous treatment with epoetin alfa/beta or darbepoetin to C.E.R.A. SC every 4 weeks for maintenance treatment of anemia.

MO534: Associations of Haemoglobin Values and Rate of Changes With Mace in the ASCEND-D Randomised Clinical Trial

Abstract BACKGROUND AND AIMS Preliminary analyses suggest that absolute haemoglobin (Hb) values and rapid Hb changes may be associated with adverse outcomes in patients with anaemia of chronic kidney disease (CKD) treated with erythropoiesis-stimulating agents (ESAs) [1–3]. In this exploratory post-hoc analysis of the ASCEND-D trial, we investigated the association between absolute Hb values or Hb changes over 4-week periods and the occurrence of the first adjudicated major adverse cardiovascular event (MACE) in patients with CKD on dialysis who were treated with either daprodustat or ESAs. METHOD ASCEND-D was an event-driven cardiovascular outcomes trial conducted in over 30 countries that randomized 2964 CKD patients undergoing dialysis with a baseline Hb of 8.0–11.5 g/dL to receive oral, once-daily daprodustat (1487 patients), or a conventional ESA (epoetin alfa or darbepoetin; 1477 patients). Available doses were daprodustat 1–24 mg once-daily, epoetin alfa 1500–60 000 U total weekly dose, and darbepoetin 20–400 µg total 4-weekly dose. The co-primary endpoints of non-inferiority for first occurrence of adjudicated MACE and mean Hb change from baseline to weeks 28 through 52 were met and have been reported recently [4]. MACE was a composite of death from any cause, non-fatal myocardial infarction or non-fatal stroke. An independent clinical events committee, blind to treatment assignment, adjudicated the events. To examine the association of post-randomization absolute Hb values and Hb changes with first adjudicated MACE, we divided each patient's time in the study before a first MACE or end of follow-up into distinct 4-week intervals. We then calculated a post-randomization mean Hb value and Hb rate of increase or decrease at each 4-week interval. Separately for each treatment arm, we grouped these 4-week periods into quintiles of mean Hb values and Hb rates of increase or decrease (see Table 1), and calculated MACE rates for each quintile. This analysis did not include MACE that occurred before Week 4, as this was the time for the first scheduled post-randomization Hb collection. We used the average of Hb values imputed by the multiple imputation method to impute missing Hb values. RESULTS This analysis included 361 and 389 first MACE in the daprodustat and ESA treatment groups, respectively. When evaluating rates of the first occurrence of adjudicated MACE by absolute Hb value quintiles and irrespective of Hb change (‘All’ column in Figure 1), the MACE rate was higher in the low Hb quintile than in the high Hb quintile across both treatment groups. In the evaluation of rates of the first MACE by Hb change quintile and irrespective of absolute Hb value (‘All’ row in Figure 1), rates of MACE were comparable across Hb change quintiles within each treatment group. When MACE risk was evaluated by both absolute Hb value and Hb change quintiles, the highest MACE rate was observed in the lowest Hb quintile (Q1 row) with the largest positive change (Q5 increase column), and this was more pronounced in the ESA group. CONCLUSION This exploratory analysis suggests a possible association between Hb quintile and MACE outcome for both absolute and fluxes in Hb values. However, this analysis has several limitations including a small number of events in each quintile, possible confounding by severity of disease and the choice of assessment window. Further studies are needed to confirm these findings.

MO797: Roxadustat Decreases Serum Lipids Levels in Hemodialysis Patients

Abstract BACKGROUND AND AIMS The activity of hypoxia-inducible factor (HIF), an oxygen-sensitive transcription factor involved in erythropoiesis, is regulated by HIF-prolyl hydroxylases. With decreased oxygen tension, the activity of these enzymes is suppressed, resulting in increased erythropoiesis [1]. Roxadustat is an oral HIF-prolyl hydroxylase inhibitor (HIF-PHI) developed for dialysis-dependent chronic kidney disease (CKD) anemia. While the impact of HIF-PHI on mean hemoglobin (Hb) change in patients on hemodialysis (HD) has already been investigated [2], its effects on serum lipid levels have yet to be explored. Clarifying such effects is particularly important because chronic HD patients usually have lower plasma high-density lipoprotein (HDL)-cholesterol (C) levels than healthy subjects. The aim of this study is to investigate the effects of roxadustat on serum lipid levels in HD patients. METHOD Study 1: This multicenter observational cohort study investigated the demographic and clinical information of 258 patients on HD (73 women and 185 men) who were being treated for anemia by HIF-PHI between 1 February 2020 and 31 May 2021, at Zenjinkai Group dialysis centers in Japan. Study 2: This study evaluated the efficacy of roxadustat in 24 patients (3 women and 21 men) for HD-dependent CKD anemia and dyslipidemia >24 weeks. RESULTS Study 1: The mean age and HD periods were 71.2 ± 12.2 and 5.5 ± 6.6 years, respectively. The patient's CKDs were diabetic nephropathy (n = 72; 27.9%), chronic glomerular nephritis (CGN) (n = 36; 14%), nephrosclerosis (n = 32; 12.4%) and other pathologies (n = 118; 45.7%). HIF-PH inhibitors used for patients on HD were roxadustat (n = 105), daprodustat (n = 117), vadadustat (n = 14) and enadustat (n = 22). Study 2: The mean age and HD periods were 76.5 ± 7.7 and 5.3 ± 3.9 years, respectively. The patient's CKDs were CGN (n = 6; 25%), nephrosclerosis (n = 6; 25%), diabetic nephropathy (n = 4; 16.7%), unknown pathologies (n = 4; 16.7%) and others (n = 4; 16.7%). Roxadustat treatment did not lead to a significant change in mean Hb values (from 10.4 ± 0.8 to 10.5 ± 0.9 g/dL). There were no significant changes in mean triglycerides (TG), transferrin saturation (TSAT) or ferritin. However, there was a statistically significant decrease (P < .001) in mean total cholesterol (TC) (from 144.0 ± 35.6 to 121.3 ± 38.5 mg/dL), low-density lipoprotein (LDL)-C (from 79.8 ± 26.6 to 62.8 ± 26.2 mg/dL) and HDL-C (from 45.0 ± 12.6 to 38.4 ± 11.9 mg/dL). Furthermore, there were also significant increases in mean serum iron (from 68.1 ± 17.4 to 81.8 ± 31.1 μg/dL; P = .01) and the mean total iron-binding capacity (TIBC) (from 220.0 ± 46.7 to 265.1 ± 54.7 μg/dL; P < .001). Case report: A 56-year-old woman who had undergone HD for 13 years due to CKD due to diabetic nephropathy was hospitalized with cerebral infraction, peripheral arterial disease, heart failure and ischemic heart disease. The patient was treated with percutaneous coronary intervention (PCI) and started on 100 mg of roxadustat 3 times a week. After roxadustat treatment, the following parameters increased: Hb (from 10.7 to 10.8 g/dL), ferritin (from 74 to 103 ng/mL) and TIBC (from 204 to 223 μg/dL). On the other hand, the following parameters decreased: TC (from 325 to 125 mg/dL), TG (from 318 to 165 mg/dL), HDL-C (from 41 to 33 mg/dL) and LDL-C (from 227 to 55 mg/dL). The patient was discharged from the hospital after 3 months. CONCLUSION Roxadustat treatment improves iron metabolism, keeps Hb levels stable and significantly decreases mean LDL-C and HDL-C. Therefore, this drug may have useful effects on dyslipidemia in patients on HD.

MO535: Associations of Haemoglobin Values and Rate of Changes With MACE in the ASCEND-ND Randomised Clinical Trial

Abstract BACKGROUND AND AIMS Rapid changes in haemoglobin (Hb) following treatment with erythropoiesis-stimulating agents (ESAs) in patients with anaemia of chronic kidney disease (CKD) have been suggested to be associated with adverse outcomes [1–3]. This exploratory post-hoc analysis was performed to investigate the association between absolute Hb values or Hb changes over a 4-week period and the occurrence of first adjudicated major adverse cardiovascular event (MACE) in CKD patients not on dialysis who were treated with either daprodustat or darbepoetin. METHOD ASCEND-ND was an event driven, cardiovascular outcomes trial conducted in over 30 countries that randomized 3872 CKD patients not on dialysis with baseline Hb of 8–10 g/dL if not on a prior ESA, or 8–11 g/dL if receiving an ESA, to receive either oral, once-daily daprodustat (1937 patients) or subcutaneous darbepoetin (1935 patients). Available doses were daprodustat 1–24 mg once-daily and darbepoetin 20–400 µg total 4-weekly dose. The study was recently reported to have met the co-primary endpoints of non-inferiority for first occurrence of adjudicated MACE and mean Hb change from baseline to weeks 28 through 52 [4]. MACE was a composite of death from any cause, non-fatal myocardial infarction or non-fatal stroke, and events were adjudicated by an independent clinical events committee blinded to treatment assignment. In this exploratory post-hoc analysis, we examined the associations of post-randomization absolute Hb values and Hb changes categorized into quintiles (see Table 1) with first adjudicated MACE. Each patient's time in the study, prior to a first MACE or end of follow-up, was divided into distinct 4-week intervals, with each interval associated with a particular post-randomization Hb value and rate of change. Separately for each treatment group, these 4-week periods were grouped according to quintiles of Hb values, and MACE rates were calculated for each quintile. This analysis was repeated using quintiles derived from Hb rate of decrease and increase. MACEs that occurred prior to Week 4, the first scheduled post-randomization Hb collection, were not included in the analysis. RESULTS This analysis included 371 and 361 first occurrences of adjudicated MACE (‘first MACE’) in the daprodustat and darbepoetin treatment groups, respectively. When evaluating the rate of first MACE by absolute Hb value quintiles and irrespective of Hb change (‘All’ column in Figure 1), the MACE rate was higher in the low Hb quintile than in the high Hb quintile for both treatment groups (Figure 1). Evaluating the rate of first MACE by Hb change quintile and irrespective of absolute Hb value (‘All’ row in Figure 1), the rates of MACE were comparable across Hb change quintiles within each treatment group. When MACE risk was evaluated by both absolute Hb value and Hb change quintiles, the highest MACE rate was observed in the lowest Hb quintile (Q1 row) with the largest positive change (Q5 increase column), and this was more pronounced in the darbepoetin group. CONCLUSION This exploratory analysis suggests a possible association between Hb quintile and MACE outcome for both absolute and fluxes in Hb values. However, this analysis has several limitations including a small number of events in each quintile, possible confounding by severity of disease, and the choice of assessment window. Further studies will be needed to confirm these findings.

RBC Indices and Morphological Pattern of Anemia in Geriatric Population: A Cross-sectional Study in Eastern India

Background: Geriatric anemia is one of the neglected and undiagnosed health problems throughout the world leading to increased morbidity and mortality among this vulnerable age group. Anemia in elderly is often an indicator of an underlying co-morbid condition. Morphological pattern of anemia may reflect the underlying etiology and thus directs the appropriate way to management of the condition. Aims: To evaluate the severity and morphological pattern of anemia in geriatric age groups. Materials and Methods: Elderly individuals aged 60 years or older of either sex with Hb level <12 gm/dl in women and <13 gm/dl in males were included in this study as geriatric anemic population. Blood samples were analyzed for Hb, hematocrit (Hct), Mean corpuscular volume (MCV), Mean corpuscular haemoglobin (MCH), Mean corpuscular haemoglobin concentration (MCHC) and Red cell distribution width (RDW-CV). Anemia was graded as mild, moderate and severe according to WHO criteria. Morphological classification was done based on RBC indices and peripheral blood smear examination. Statistical analysis was done using SPSS software. Results: Total 277 geriatric anemic subjects were included in this study. Female to male ratio was 1.9:1. Most of the participants (60.29%) were in the age group of 60-69 years. Majority had mild anemia (48.02%). Normocytic-normochromic was the most predominant morphological subtype (74.73%). Mean Hb, MCH and MCHC were found to be significantly lower in geriatric females compared to males (P < 0.05). Conclusion: Normocytic-normochromic anemia of mild degree was the most common type of anemia among geriatric population. Evaluation of morphological pattern of anemia may help in appropriate management of underlying condition.

PD47-03 LOW TESTOSTERONE LEVELS AND THE RISK OF ANEMIA IN MIDDLE-AGED MEN: A PROPENSITY SCORE–MATCHED ANALYSIS

You have accessJournal of UrologyCME1 May 2022PD47-03 LOW TESTOSTERONE LEVELS AND THE RISK OF ANEMIA IN MIDDLE-AGED MEN: A PROPENSITY SCORE–MATCHED ANALYSIS Jun Ho Lee, and Dong-Gi Lee Jun Ho LeeJun Ho Lee More articles by this author , and Dong-Gi LeeDong-Gi Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002615.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Anemia is a common disease, as it affects 12.7% of men in an age-dependent manner. It has been reported that anemia is related to cardiovascular disease and increased mortality. In approximately one-third of anemia cases among older people, the cause of anemia is unexplained. Clinical data that reported that exogenous testosterone replacement in men with testosterone deficiency could induce polycythemia would be indirect evidence that shows low testosterone levels are a risk factor for anemia in men. However, there are few data concerning the endogenous testosterone effect on Hb or hematocrit (Hct) in men. Additionally, scant data are available concerning the relationship between anemia and low testosterone levels. Moreover, the aforementioned clinical data are limited by a cross-sectional study design, including a small number of men with low total testosterone levels, no adjustment for confounding factors, and an inappropriate sampling time of testosterone. Therefore, we conducted the present study to address the aforementioned limitations of previous studies using a large dataset and propensity score matched case-control study method. METHODS: Data from 8727 middle-aged men who had undergone health checkups were analyzed. Hb, Hct, testosterone, basic blood chemistry, blood pressure, and body mass index (BMI) were assessed. We estimated the glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease equation. Of the 8727 men considered, 8368 formed the cohort for propensity score matching, including 966 men with low testosterone (testosterone level <3.5 ng/mL, case) and 7402 men with normal testosterone levels (testosterone level ≥3.5 ng/mL, control); ultimately, however, members of the case and control groups were matched at a 1:2 ratio by propensity score. RESULTS: After matching, the groups were evenly distributed with respect to age, BMI, estimated GFR, hypertension, and diabetes. After matching, the mean Hb and Hct of the case group were significantly lower than those of the control group (15.0±1.1 g/dL vs. 15.3±1.0 g/dL, P <0.001; 43.5±2.9% vs. 44.4±2.8%, P<0.001, respectively). Additionally, the incidence of anemia (Hb <13 g/dL) was significantly greater in the case group (1.2% vs. 3.0%, P=0.001). Finally, the relative risk of anemia in the case was 2.4 compared to the control. CONCLUSIONS: Low testosterone is significantly and independently related to low Hb, low Hct, and anemia in middle-aged men. Our data suggest the need for screening for anemia in middle-aged patients with testosterone deficiency and vice versa. Source of Funding:- © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e794 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jun Ho Lee More articles by this author Dong-Gi Lee More articles by this author Expand All Advertisement PDF DownloadLoading ...

Efficiency of intravenous iron carboxymaltose in patients with iron-deficiency anemia due to heavy menstrual bleeding: a single-center experience.

Heavy menstrual bleeding (HMB) is the most common cause of iron deficiency anemia (IDA) in premenopausal women. Clinical studies have shown that iron carboxymaltose (ICM) is an appropriate, effective, and well-tolerated treatment option for clinical situations associated with iron deficiency (ID). This study took 78 out of 400 consecutive patients diagnosed with IDA due to HMB and intolerant or insufficient response of oral iron. All patients were administered the total calculated dose of ICM separately, based on the body weight and current hemoglobin (Hb) level. All the anemia parameters of the patients were compared before and after treatment. All anemia parameters, including median Hb, ferritin, and transferrin saturation, significantly increased four weeks after treatment. Pre- and post-treatment mean Hb levels were 8.9 (± 1.7) g/dL and 12.3 (± 1.2) g/dL, respectively. The mean ferritin level of the patients before treatment was 3.93 (± 2.7) ng/mL. After treatment, the mean ferritin level was 244 (± 185) ng/mL. The mean transferrin saturation levels before and after treatment were 5.7% (± 5.0) and 43.1% (± 20.9), respectively. Although no serious side effects were observed in all patients, headache was detected in 2 patients (2.6%), urticaria in 3 patients (3.8%), and flushing in 2 patients (2.6%). ICM is an effective and safe treatment option for patients with IDA due to HMB, in which oral iron therapy is insufficient or intolerant. In fact, without waiting for the failure or intolerance of oral iron therapy, moving ICM to the frontline could be cost-effective and more convenient to patients with HMB and health care providers.

THE EFFECTS OF EXENATIDE TREATMENT ON METABOLIC PARAMETERS, GHRELIN, GDF-15 AND FGF-21 IN OBESE TYPE 2 DIABETIC PATIENTS

Objective: Exenatide and similar drugs which have Glucagon Like Peptide-1(GLP-1) like effects have been used frequently in the treatment of diabetes and obesity in recent years. In this study we aimed to investigate the effects of exenatide on ghrelin, FGF-21 and GDF-15 which are known to be associated with appetite and metabolic disorders.Material and Methods: Thirty patients with Type 2 Diabetes Mellitus with a Body Mass Index of 35 kg/m2 and above who are still ongoing treatment for diabetes but not on target (HbA1c&amp;gt;7%) and exenatide treatment was started were included in the study. Venous blood samples were collected for the measurements of complete blood count, biochemical parameters, HbA1c, ghrelin, FGF-21, GDF-15. After 3 months of treatment initial evaluations and biochemical tests were repeated.Results: Mean age of the patients was 50.43±10.35 years. Twenty-one (70%) were female and 9 (30%) were male. Mean Hb A1c of the patients was 9.68±2.02%. After 3 months of exenatide treatment a significant decrease in body weight and body mass index was observed (p&amp;lt;0.001). There was also significant decrease in Ghrelin and GDF-15 levels (p&amp;lt;0.001).Conclusion: Our study is the first study in which these three markers were evaluated together in obese type 2 diabetics. It is thought to be that Ghrelin, FGF-21 and GDF-15 are play role in obesity and type 2 diabetes mellitus pathogenesis together in different ways.

Haematological Changes in Hepatitis C (HCV) Patients

Background: Hepatitis C virus infection victimizes around 200 million people globally. Aim: To evaluate the frequency of haematological abnormalities in HCV infected patients. Study design: Cross Sectional study. Methodology: Present study with chronic HCV infection was carried out in the Department of Pathology, CMH, Multan after the Hospital’s Ethical Committee approval. All patients (n=175) of HCV positive on ELISA were further investigated with hematological parameters. Venous blood was send to laboratory for complete blood count (CBC). The outcome variables i.e. hematological abnormality as (Yes/No), duration or hepatitis C infection, personal data like age, gender, living area and occupation were noted on the Performa. Statistical analysis: SPSS software, version, 26 analyzed the collected data. Results: All patients (n=139) had a mean age of 32.46 ± 7.35years. In frequency of gender of patients there were 101(57.71%) males and 74(42.29%) females. Mean TLC was 11.43±1.33 x 103µL. Mean Hb% was 10.57±3.41 g/dl. Mean platelet count was 154.27± 25.45 x 103 µL. Frequency of haematological abnormalities in HCV infected patients was found in 47 (26.86%) patients. Conclusion: We concluded that the frequency of haematological abnormalities in HCV infected patients is quite high. Keywords: Hepatitis C, Haematological Abnormalities and Thrombocytopenia.

Impact of Fortified Infant Cereals on the Burden of Iron Deficiency Anemia in 6- to 23-Month-Old Indonesian Infants and Young Children: A Health Economic Simulation Model.

Iron deficiency and iron deficiency anemia (IDA) are highly prevalent among Indonesian infants and young children (IYC). Severe IDA hampers mental development in young children and is linked to lower quality of life and lower productivity as adults. The consumption of fortified infant cereals (FIC) increases iron intake during the weaning period, thus reducing the social burden of IDA. In this manuscript, we aimed to assess the impact of FIC on the burden of IDA on IYC in Indonesia. We analyzed data for IYC aged 6–23 months from the fifth wave (2014–2015) of the Indonesia Family Life Survey (IFLS) and the Indonesia Demographic and Health Survey 2017 (IDHS-17). We adapted a health economic simulation model to estimate the impact of FIC that accounted for lifetime health and cost consequences in terms of reduced future income and DALYs. The mean Hb level was 10.5 ± 1.4 g/dL. Consumers of FIC had a reduced burden of disease (43,000 DALYs; USD 171 million) compared with non-consumers. The consumption of fortified infant cereals plays an important role in reducing the burden of IDA, and it might complement the available strategy of nutritional interventions to address this problem in Indonesian IYC.

A Study on Prevalence and Risk Factors of Anaemia among patients at Tertiary Care Hospital

Introduction: The prevalence of anaemia is high in developing countries due to poor economic, malnutrition, heredity diseases and pregnancy and reduced health care utilization. Increased Iron requirement and mal absorption of Iron also cause the Anaemia in chronic blood loss during menstrual periods. Methodology: A randomised, cross sectional study was conducted for 6 months Based on inclusion and exclusion criteria.120 anaemic patients were screened for biochemical tests. Results: Out of 120 patients, 32% were male and 68% were female. Majority of patients fall under the age group of 17 to 30 years. The educational status indicates, 40% were high school and 35% were illiterate. Majority of the patients were ideal body weight in 38% and 34% were under over weight. The severity was analysed based on Hb value and found that, 8% patient were severe, 8% were moderate and 88% were in mild anaemia. The mean Hb value was found that 10.82 mg/dl. Only 40% of patients are taking the daily breakfast regularly and 42% of female patients not consuming red meat, fish and chicken. Serum ferritin value is only 5.8 ng/ml, MCV found that 72.30 fL and Hb is 10.82 g/dl. Conclusion: The health education on healthy diet and creating awareness on risk factors of anaemia helps to avaoid the severity and complications of anaemia. The effective Pharmaceutical care services on anaemic patients are essential to prevent the morbidity and mortality rate.

Effects of Pre-Donated Autologous Blood Transfusion on Peri-Operative Hemoglobin Concentration and Mid-Term Health Outcomes in Primary Total Knee Arthroplasty.

The effects of auto-BT in primary TKA on the perioperative hemoglobin (Hb) concentration and mid-term health outcomes are unknown. This study was performed to analyze the detailed changes in the perioperative Hb concentration before and after the operation (days 0–14 postoperatively), cardiovascular events, and mortality rate within 1 and 5 years postoperatively. One hundred patients undergoing primary TKA with auto-BT using 800 mL of preoperatively collected blood at the authors’ institution were included. The mean Hb concentration before and after autologous blood collection was 12.7 ± 1.1 and 11.7 ± 1.2 g/dL, respectively. After primary TKA with auto-BT, the mean Hb concentration on day 0, 1, 3, 7, and 14 was 10.2 ± 1.2, 9.9 ± 1.2, 10.4 ± 1.3, 10.5 ± 1.3, and 11.0 ± 1.3 g/dL, respectively. Only one (1%) patient required additional allogenic blood transfusion. No patients developed cardiovascular events, and the 1- and 5-year postoperative mortality rate was 1.0% and 2.0%, respectively. Primary TKA with auto-BT showed relatively small perioperative changes in the Hb concentration, a low incidence of cardiovascular events, and a low mortality rate within 1 and 5 years postoperatively. These findings suggest that auto-BT, in which blood is preoperatively collected, is beneficial for patient safety and health, even if its cost-effectiveness may be debatable.

Impact of Anthelmintic Treatment on the Burden of Helminth Infections in Primary Schoolchildren in Biyela Health Zone in Kinshasa, Democratic Republic of the Congo

Background: The study evaluated the impact of anthilminthic treatment, given as non-investigational drugs, on helminth infections, anaemia, and hemoglobin (Hb) level in the context of a malaria clinical trial in which Sulfadoxine Pyrimethamine (SP) and SP+Piperaquine (PQ) were also evaluated as an intermittent preventive treatment strategy in schoolchildren in the Democratic Republic of Congo (DRC). Methods: In a nested cohort study, 616 malaria asymptomatic children attending primary schools of Biyela health area were enrolled and follow-up from November 2012 to November 2013. The control group for the nested study was the negative on helminth infections. They received one dose of PZQ and ALB at baseline and then 2 doses of ALB at 4 months intervals. During the 12-months of follow-up, stool and urine samples were collected for helminth infections and finger prick blood for Hb level. Paired test analyses were used to compare the status before and after treatment, and confounding variables for Hb level were tested by multiple linear regression analysis. Results: At baseline, the prevalence of helminth infections and anaemia were 39.2% (95% CI: 34.7-43.7), and 41.8% (95% CI: 37.3-46.3), respectively. Mean Hb level was 11.6g/dl (SD±1.3). After 12-months post-anthelminthic treatment, the prevalence of helminth infections reduced to 7.2% (p&lt;0.001). There was no change in Hb level and anaemia in the control which received only the anthelminthic drug (p=1.00 and p=0.26, respectively) at 12-months postintervention, compared to those who received active antimalarial SP (p=0.02 and p=0.09, respectively) and PQ (p=0.01 and p&lt;0.001, respectively). Similarly, no difference in Hb level was observed among the infected and uninfected schoolchildren with helminths at 12-months after anthelminthic treatment. Conclusion: These findings suggest that anthelminthic treatment reduces significantly the prevalence of helminth infections. There was no impact on anaemia and Hb level due to the use of anthelmintic drugs.

Testosterone deficiency and the risk of anemia: A propensity score–matched analysis

There are little data on the endogenous testosterone effect on hemoglobin or hematocrit. Moreover, these data are limited by a cross-sectional study design, a small participant number, and no adjustment for confounding factors. Therefore, the present study was conducted to address the aforementioned limitations of previous studies using a large dataset and propensity score matched analysis. Men who underwent health check-up were analyzed. Participants were divided into two groups using the cut-off testosterone value of 3.5 or 3.0ng/ml according to a previous definition of testosterone deficiency. Using the cutoff testosterone value of 3.5ng/ml, 966 cases (testosterone levels <3.5ng/ml) and 7402 controls (testosterone level ≥3.5ng/ml) were included, but following propensity score matching, there were 966 cases and 1932 controls. Using the cutoff testosterone value of 3.0ng/ml, 444 cases (testosterone levels <3.0ng/ml) and 7924 controls (testosterone level ≥3.0ng/ml) were included, but following propensity score matching, there were 444 cases and 888 controls. After matching, the groups were evenly distributed with respect to age, body mass index, estimated glomerular filtration rate, hypertension, and diabetes in both data sets. After matching, the mean Hb and Hct were significantly lower and the incidence of anemia was significantly greater in the case compared to the control in both data sets. The relative risk of anemia in the case was 2.4 compared to the control in both data sets. Screening for anemia in patients with testosterone deficiency would be needed and vice versa.

Comparison of hematological parameters in anemia of chronic disease and chronic periodontitis

Background: Periodontitis is a localized, chronic inflammatory reaction, induced by bacteria, and effect healthy periodontium. The third highest prevalence of periodontal disease in the world is in Asia.6 Infections, malignant cells, and autoimmune dysregulation these all factors lead to the activate the immune system and start production of cytokines. Chronic periodontitis can be a cause of anemia of chronic diseases. Materials and Methods: The study population consisted of 160 individuals between the age groups of 20-70 years, Hemoglobin concentration, Erythrocyte count, Mean corpuscular volume, Mean corpuscular hemoglobin, Mean corpuscular hemoglobin concentration was measured using an automated hematology analyser. ESR was estimated using Westergren’s method. Serum ferritin was measured on ELISA kit by a semi automated analyser on LISA SCAN. Students “t” test was used for comparing the mean Hb, erythrocyte count, MCV, MCH, MCHC, ESR, and ferritin between the two groups. Results: The comparison of blood parameters was done among study and control males. Mean value of hemoglobin, RBC, MCH, MCHC, ESR and Serum Ferritin were statistically significant(P&lt;0.001) whereas mean value of MCV was statistically insignificant. The comparison of blood parameters was done among study and control females.