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Mean Corpuscular Volume

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61. Classification of Anemias

agent ESRD=end-stage renal dx FeSO4=ferrous sulfate Hct=hematocrit HD-CKD=dialysis-CKD HF=heart failure Hgb=hemoglobin HRQL=health-related QOL ITT=intention to treat LFT=liver function tests LVMI=left ventricular mass index LVVI=left ventricular volume index LVCVI=left ventricular cavity volume index MCV=Mean corpuscular volume MI=myocardial infarction ND-CKD=non-dialysis CKD OL=open label pt=patient QALY=quality-adjusted life year QOL=quality of life RCT=randomized control trial RDW=Red cell (...) , tetracyclines & triamterene. ANEMIA OF CKD: Hemoglobin Control – Landmark Trials Summary Z Dumont BSP, P Ricci, L Gross, B Lang Trials Mean follow-up, n Intervention Population CKD stage, age, etc. Key Baseline Indices (e.g. Iron Studies) Results Comments Charytan et al. 3 43 days; n=96; RCT, OL Oral vs IV iron for ND-CKD FeSO4 325mg po TID x 29 days vs Iron sucrose 200mg IV weekly x 5 doses; assessments made up to 14 days after last dose ND-CKD; Age mean ~61; mostly ?, (71% oral, 60% IV); multi-racial

2014 RxFiles

62. Iron Bisglycinate Chelate and Polymaltose Iron for the Treatment of Iron Deficiency Anemia: A Pilot Randomized Trial. (PubMed)

with FeBC and FeP in anemic children.In this double-blind study, children aged 1 to 13 years who were diagnosed with IDA were randomly divided into two groups: i) FeBC, supplemented with iron bisglycinate chelate, and ii) FeP, supplemented with polymaltose iron (3.0 mg iron/kg body weight/day for 45 days for both groups).Both treatments resulted in significant increases in hemoglobin levels, Mean Corpuscular Volume (MCV) and Cell Distribution Width (RDW) and in a reduction of transferrin levels (...) , relative to initial values. However, only FeBC treatment significantly increased ferritin and Mean Corpuscular Hemoglobin (MCH) levels. A significant negative correlation was observed between the increase in ferritin and initial hemoglobin levels in the FeBC group, indicating that the absorption of FeBC is regulated by the body iron demand.These results provide preliminary evidence to suggest a greater efficacy of FeBC than FeP in increasing iron stores.Copyright© Bentham Science Publishers; For any

2019 Current pediatric reviews

63. Sodium zirconium cyclosilicate (Lokelma) - Hyperkalemia

at a dose volume of 10 ml/kg to rats or dogs. Repeat dose toxicity EMA/93250/2018 Page 20/103 Study ID Species/ Sex/ Number/ Group Dose (mg/kg b.w.)/ Route/ Duration NOAEL (mg/kg/ day) Major findings 2009- 001/ GLP - No Rat (Sprague- Dawley)/ M/5 F/5 0, 500, 1000, 2000 1,2 Oral (gavage) 7 days Treatment with ZS-9 did not result in moribundity or mortality. There was a test article-related increase in plasma mean prothrombin time (PT) in M and F from Group 4 when compared to control Group 1. Treatment (...) weight. A decrease in body weight gain across all dose groups including control compared to pre-trial during the 14-day dosing period was attributed to the volume of the dose formulation. Food Consumption: A reduction in mean daily food consumption was observed for both the 0 mg/kg/dose (Control) group as well as all the groups administered ZS-9. This reduction in food consumption is most likely reflective of animals receiving a 10 mL/kg dose volume, three times a day. Hematology: At Day 15/16

2018 European Medicines Agency - EPARs

64. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

compared to control SHR. Similar to the Sprague Dawley rats, ertugliflozin increased water intake, urine volume, percent of urine volume to water intake, and hematocrit, indicating a diuretic effect. Concurrent with the diuresis, ertugliflozin lowered mean systolic blood pressure by 11%, mean arterial blood pressure by 13%, and heart rate by 15% when compared with vehicle control animals. Ertugliflozin also significantly increased plasma renin activity, serum aldosterone, and plasma and urinary (...) to baseline values), while furosemide did not have any significant effect on body weight. Both compounds lowered mean systolic blood pressure, diastolic blood pressure and mean blood pressure to the same degree (8-10%) as compared to control rats. Although ertugliflozin increased the urine volume to water intake ratio, indicating a diuretic effect, plasma renin activity and urinary and plasma angiotensinogen were not significant altered. Unlike ertugliflozin, furosemide caused a significant increases

2018 European Medicines Agency - EPARs

65. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

in urinary glucose excretion (UGE) and a non-significant decrease in plasma glucose were seen in the pair-fed SHR treated with ertugliflozin concomitant with a 12% loss in body weight from baseline value of 307 ±4 g and 22% reduction in body weight compared to control SHR. Similar to the Sprague Dawley rats, ertugliflozin increased water intake, urine volume, percent of urine volume to water intake, and hematocrit, indicating a diuretic effect. Concurrent with the diuresis, ertugliflozin lowered mean (...) . Absorption Ertugliflozin was well absorbed and demonstrated low to moderate clearance (1.6 – 14 mL/min/kg) with a moderate volume of distribution (0.8 – 1.6 L/kg) in the nonclinical species evaluated. Mean apparent terminal half-life (t½) values for ertugliflozin ranged from approximately 2.7 to 7.6 hours in nonclinical species and oral bioavailability was moderate to high (56% to 97%). Absorption was rapid with a mean time to Cmax occurrence (Tmax) occurring at 0.5 hours postdose in mouse, 0.67 to 2.3

2018 European Medicines Agency - EPARs

66. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

treated with ertugliflozin concomitant with a 12% loss in body weight from baseline value of 307 ?4 g and 22% reduction in body weight compared to control SHR. Similar to the Sprague Dawley rats, ertugliflozin increased water intake, urine volume, percent of urine volume to water intake, and hematocrit, indicating a diuretic effect. Concurrent with the diuresis, ertugliflozin lowered mean systolic blood pressure by 11%, mean arterial blood pressure by 13%, and heart rate by 15% when compared (...) –hour UGE and resulted in 5 % reduction in body weight in pair-fed rats compared to control rats (an effect that was not significant compared to baseline values), while furosemide did not have any significant effect on body weight. Both compounds lowered mean systolic blood pressure, diastolic blood pressure and mean blood pressure to the same degree (8-10%) as compared to control rats. Although ertugliflozin increased the urine volume to water intake ratio, indicating a diuretic effect, plasma

2018 European Medicines Agency - EPARs

67. Rucaparib camsylate - Ovarian Neoplasms

resulted in dose-dependent and statistically significant reduction in mean tumour volumes on the last day of dosing (Day 28) in all rucaparib treated groups, with > 100% TGI observed at 50 and 150 mg/kg BID. At study termination (Day 39) there was a dose-dependent and statistically significant TGI in all rucaparib treated groups. Dose, Exposure and Response Relationship of Rucaparib in the MDA-MB-436 (BRCA1 Mutant) Orthotopic Breast Cancer Model The dose, exposure and response relationship of rucaparib (...) in tumour growth, with mean tumour/control (T/C) volumes ranging from 7.0-15.2% and 0.6-14.7% in the HBCx-17 and HBCx-6 models, respectively. In both studies, tumours were monitored for 13-15 days after rucaparib dosing was discontinued. In the HBCx-17 model, 50% of the mice treated with 150 mg/kg BID rucaparib had a PR or CR, whereas in the HBCx-6 model 100% of the mice treated with 150 mg/kg QD or 300 mg/kg BID rucaparib had a PR or CR. Rucaparib Efficacy in 3 BRCA2 Mutant Pancreatic PDX Models

2018 European Medicines Agency - EPARs

68. Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial. (PubMed)

drops or iron polysaccharide complex drops for 12 weeks.Primary outcome was change in hemoglobin over 12 weeks. Secondary outcomes included complete resolution of IDA (defined as hemoglobin concentration >11 g/dL, mean corpuscular volume >70 fL, reticulocyte hemoglobin equivalent >25 pg, serum ferritin level >15 ng/mL, and total iron-binding capacity <425 μg/dL at the 12-week visit), changes in serum ferritin level and total iron-binding capacity, adverse effects.Of 80 randomized infants (...) and children (median age, 22 months; 55% male; 61% Hispanic white; 40 per group), 59 completed the trial (28 [70%] in ferrous sulfate group; 31 [78%] in iron polysaccharide complex group). From baseline to 12 weeks, mean hemoglobin increased from 7.9 to 11.9 g/dL (ferrous sulfate group) vs 7.7 to 11.1 g/dL (iron complex group), a greater difference of 1.0 g/dL (95% CI, 0.4 to 1.6 g/dL; P < .001) with ferrous sulfate (based on a linear mixed model). Proportion with a complete resolution of IDA was higher

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2017 JAMA

69. Quantitative data on red cell measures of iron status and their relation to the magnitude of the systemic inflammatory response and survival in patients with colorectal cancer. (PubMed)

, at a single centre between 2008 and 2017 were included (n = 824). Blood samples taken for C-reactive protein (CRP), albumin, and full blood count (FBC) allowed patients to be grouped by modified Glasgow Prognostic Score (mGPS), and anaemia subtype (haemoglobin (Hb) M < 130 mg/L and F < 120 mg/L, with microcytic anaemia being mean corpuscular volume (MCV) < 80 f/L, and normocytic anaemia with MCV 80-100 f/L). Relationships between these groupings and red cell measures iron status including Hb, MCV, mean (...) corpuscular haemoglobin (MCH) and red cell distribution width (RDW) were examined.The combination of increasing T stage and increasing mGPS was associated with lower Hb, lower MCV, lower MCH, higher RDW, and higher prevalence of both microcytic and normocytic anaemia (all p < 0.001). The combination of CRP >10 mg/L and albumin <35  g/L was associated with lower Hb, lower MCV, lower MCH, higher RDW, and higher prevalence of both microcytic and normocytic anaemia (all p < 0.010). At multivariate Cox

2019 European Journal of Surgical Oncology

70. Association of active Helicobacter pylori infection and anemia in elderly males. (PubMed)

for anemia of the H. pylori positive group was 2.53 (P = .033). No correlation between H. pylori infection and serum iron and ferritin levels was found. The mean corpuscular volume of the H. pylori positive and negative group was 91.17 ± 3.94 fl and 91.17 ± 4.09 fl (mean ± SD), respectively (P = .986). The CRP level in the H. pylori positive group was higher than that in the H. pylori negative group (Median: 0.17 mg/dL vs. 0.10 mg/dL, P < .001).H. pylori infection seems to be associated with normocytic (...) comorbidities.Data from 646 subjects were analyzed. The mean age of the study cohort was 79.4 ± 8.9 years. The overall prevalence of H. pylori infection was 35.3%. The prevalence of anemia in the H. pylori positive group was higher than that in the negative group (5.3% vs. 2.2%, P = .033). Among the patients who had higher CCI scores (> 2), the prevalence of anemia in the H. pylori positive and negative groups were 10.3 and 1.4%, respectively (P = .009). Compared to the H. pylori negative group, the odds ratio

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2019 BMC Infectious Diseases

71. <b>Six weeks of oral <i>Echinacea purpurea</i> supplementation does not enhance the production of serum erythropoietin or erythropoietic status in recreationally active males with above average aerobic fitness</b>. (PubMed)

, hemoglobin concentration, hematocrit, mean corpuscular volume, and mean corpuscular hemoglobin concentration. Separate 2 × 4 (Group × Time) factorial ANOVA with repeated measures on time were used to determine statistical differences with significance set at p ≤ 0.05. There were no significant interaction, group, or time effects observed for EPO or erythropoietic status markers for any of the measurement points (p ≤ 0.05). The present study indicated that six weeks of oral ECH (...) Six weeks of oral Echinacea purpurea supplementation does not enhance the production of serum erythropoietin or erythropoietic status in recreationally active males with above average aerobic fitness. The purpose of this study was to investigate the effect of six weeks of oral Echinacea purpurea supplementation on serum erythropoietin (EPO) and erythropoietic status. Twenty-four males (mean ± SE): age = 25.2 ± 1.4 yr, height = 178.1 ± 1.4 cm, body mass = 78.1 ± 1.6 kg, body

2019 Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme

72. Malaria early in the first pregnancy: Potential impact of iron status. (PubMed)

a randomized controlled trial of long-term weekly iron supplementation in rural Burkina Faso. Malaria parasitaemia was monitored and biomarkers and red cell indices measured at study end-points: plasma ferritin, transferrin receptor (sTfR), zinc protoporphyrin, hepcidin, sTfR/log10 ferritin ratio, body iron, haemoglobin, red cell distribution width; mean corpuscular haemoglobin concentration/volume, and C-reactive protein. Correlation coefficients between biomarkers and red cell indices were determined (...) . A regression correction approach based on ferritin was used to estimate iron body stores, allowing for inflammation. Body iron differences were compared between nulliparae and primigravidae, and the association determined of iron biomarkers and body iron stores with malaria.Iron and haematological indices of 972 nulliparae (mean age 16.5 years) and 314 primigravidae (median gestation 18 weeks) were available. Malaria prevalence was 54.0% in primigravidae and 41.8% in nulliparae (relative risk 1.28, 95% CI

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2019 Clinical nutrition (Edinburgh, Scotland)

73. Mendelian Randomization Analysis of Hemoglobin A<sub>1c</sub> as a Risk Factor for Coronary Artery Disease. (PubMed)

[1.08, 1.57], P = 0.004). Genetically decreased Hb, with concomitantly decreased mean corpuscular volume, was associated with higher A1C (0.30 [0.27, 0.33] %-unit, P = 2.9 × 10-6) per g/dL and higher CAD risk (1.18 [1.04, 1.33], P = 0.009).Genetic evidence supports a causal link between higher A1C and higher CAD risk. This relationship is driven not only by glycemic but also by erythrocytic, glycemia-independent factors.© 2019 by the American Diabetes Association.

2019 Diabetes Care

74. Efficacy of SXN in the Treatment of Iron Deficiency Anemia: A Phase IV Clinical Trial. (PubMed)

increased at the end of treatment in the M-SXN and H-SXN adult groups and in the M-SXN child group. For both children and adults, SXN in the three dose groups was found to significantly elevate red blood cell level, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. The total effective rate in the SXN-treated group reached 84.8%. The incidence of adverse events was 4.07%. The most common side effects were nausea (2.83%), diarrhea (0.74%), and rash (0.25

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2019 Evidence-based Complementary and Alternative Medicine (eCAM)

75. Long-term effect of NUDT15 R139C on hematologic indices in inflammatory bowel disease patients treated with thiopurine. (PubMed)

on anti-TNF-α agents and had used thiopurine. NUDT15 R139C was genotyped by PCR. We retrospectively reviewed patient clinical charts to collect data on white blood cell (WBC) count, mean corpuscular volume (MCV), hemoglobin, and platelet count during the 24 months following thiopurine initiation.The included patients had either Crohn's disease (54; 65.1%) or ulcerative colitis (29; 34.9%). Genotyping of NUDT15 R139C identified 62 patients (74.7%) of genotype C/C and 21 (25.3%) of genotype C/T (...) . The median dose of thiopurine was lower in the C/T group than in the C/C group after starting thiopurine. At 6 months, the mean WBC count of the C/T group became significantly lower than that of the C/C group (0.008) and remained lower through the 24 months. The C/T group developed grade 2-4 leukopenia by 6 months, which persisted through 12-24 months. The mean MCV in the C/T group became higher than that of the C/C group after 3 months.NUDT15 R139C heterozygosity affected the WBC count and MCV for 24

2019 Journal of gastroenterology and hepatology

76. Elevated Nucleated Red Blood Cells in Neonates with Down Syndrome and Pulmonary Hypertension. (PubMed)

Elevated Nucleated Red Blood Cells in Neonates with Down Syndrome and Pulmonary Hypertension. We report an association between higher absolute nucleated red blood cells and mean corpuscular volume and idiopathic persistent pulmonary hypertension of the newborn in neonates with Down syndrome. Elevation of these blood indicies should prompt echocardiographic studies to monitor pulmonary arterial pressures.Copyright © 2019 Elsevier Inc. All rights reserved.

2019 Journal of Pediatrics

77. What are the recommended clinical assessment and screening tests during pregnancy?

of the 3 rd trimester may be indicated ahead of childbirth. Strong NA (CBR)* KCE 2004 amended ? There is no evidence that platelet and leukocyte counts are useful during pregnancy. However, in Belgium, this test is often routinely performed in the laboratory at the time of anaemia detection. NA NA * Level of evidence from Australian 2014 guideline: CBR= Consensus based recommendation because insufficient evidence to support recommendation (see Table 3 in chapter 5.3.). **MCV= Mean corpuscular volume (...) ; MCH= Mean corpuscular haemoglobin; MCHC= Mean corpuscular haemoglobin concentration KCE Report 248Cs Assessment and screening during pregnancy 15 4.4.2. Blood group, rhesus and atypical red cell antibodies – update KCE 2004 Recommendation Strength of Recommendation Level of Evidence ? Offer to determine in early pregnancy each pregnant woman’s blood group and rhesus (Rh) factor if they are unknown and to screen for atypical red cell antibodies. Strong B* * Level of evidence from NICE 2008

2015 Belgian Health Care Knowledge Centre

78. Alabel/Alaglio (aminolevulinic acid hydrochloride)

pigmentation was found in small bile ducts, hepatocytes, Kupffer cells and proximal tubule epithelial cells in males and females at =44 mg/kg/day. In both males and females at =183 mg/kg/day, brown urine, decreases in hemoglobin concentration, mean corpuscular hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin concentration, and platelet count, increases in reticulocyte count and monocyte proportion, increases in AST, ALT, LDH, total cholesterol and phospholipid, decreased urine pH, dark (...) [in terms of hydrochloride]) were given to male and female Wistar rats (n = 10/sex/group) for 13 weeks. In the =44 mg/kg/day groups, decreases in mean corpuscular hemoglobin and mean corpuscular volume, brown pigmentation in the liver and kidney, and bile duct hyperplasia were found in both males and females, and increases in reticulocyte count and total bilirubin, unicellular and focal hepatocellular necroses, and periductal lymphocytic infiltration were found in males. In the 183 mg/kg/day group, hair

2013 Pharmaceuticals and Medical Devices Agency, Japan

79. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

validated in accordance with ICH guidelines. The stability indicating nature of the methods for assay and impurities was demonstrated by means of forced degradation studies. Satisfactory information regarding the reference standard used for assay and impurities testing has been presented. Batch analysis data are provided for twenty eight venetoclax batches manufactured by the commercial process at production scale and above. Eight of the batches were manufactured at the commercial manufacturing site

2017 European Medicines Agency - EPARs

80. Laboratory diagnosis of non-immune hereditary red cell membrane disorders

indices, MCV is not discriminative for HS. MCHC has been found useful as indicator for HS with concurrent neonatal jaundice . In the case of HS with compensated hemolytic anemia, MCHC is often in the upper limit of the normal range or increased . Both the MCV and the mean sphered cell volume (MSCV) values for red cells are displayed by the Beckman Coulter cell analyzer. The MSCV value is expected to be greater than that of MCV as a result of cell volume increase after spherization in a hypo‐osmolar (...) of hemolytic conditions in which the ‘primary’ lesion is a ‘leak’ to the monovalent cations sodium (Na + ) and potassium (K + ) , , resulting in an altered hydration status shown by a significant change in mean cell volume (MCV) . Four subtypes have been identified: overhydrated HSt, dehydrated HSt, cryohydrocytosis (CHC), and familial pseudohyperkalemia (FP) (Table ). Only FP is an asymptomatic trait, whereas the other three conditions vary in both clinical severity and in qualitative features. All

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2015 British Committee for Standards in Haematology

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