The use of a target hemoglobin level of 13.5 g per deciliter (as compared with 11.3 g per deciliter) was associated with increased risk and no incremental improvement in the quality of life. (ClinicalTrials.gov number, NCT00211120 [ClinicalTrials.gov].).
The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.)
Trials of anemia correction in chronic kidney disease have found either no benefit or detrimental outcomes of higher targets. We did a secondary analysis of patients with chronic kidney disease enrolled in the Correction of Hemoglobin in the Outcomes in Renal Insufficiency trial to measure the potential for competing benefit and harm from achieved hemoglobin and epoetin dose trials. In the 4 month analysis, significantly more patients in the high-hemoglobin compared to the low-hemoglobin arm were unable to achieve target hemoglobin and required high-dose epoetin-α. In unadjusted analyses, the inability to achieve a target hemoglobin and high-dose epoetin-α were each significantly associated with increased risk of a primary endpoint (death, myocardial infarction, congestive heart failure or stroke). In adjusted models, high-dose epoetin-α was associated with a significant increased hazard of a primary endpoint but the risk associated with randomization to the high hemoglobin arm did not suggest a possible mediating effect of higher target via dose. Similar results were seen in the 9 month analysis. Our study demonstrates that patients achieving their target had better outcomes than those who did not; and among subjects who achieved their randomized target, no increased risk associated with the higher hemoglobin goal was detected. Prospective studies are needed to confirm this relationship and determine safe dosing algorithms for patients unable to achieve target hemoglobin.
Few data exist to guide treatment of anemic hemodialysis patients with high ferritin and low transferrin saturation (TSAT).The Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) trial was designed to evaluate the efficacy of intravenous ferric gluconate in such patients. Inclusion criteria were hemoglobin <11 g/dl, ferritin 500 to 1200 ng/ml, TSAT <25%, and epoetin dosage >225 IU/kg per wk or >22,500 IU/wk. Patients with known infections or recent significant blood loss were excluded. Participants (n ؍ 134) were randomly assigned to no iron (control) or to ferric gluconate 125 mg intravenously with eight consecutive hemodialysis sessions (intravenous iron). At randomization, epoetin was increased 25% in both groups; further dosage changes were prohibited. At 6 wk, hemoglobin increased significantly more (P ؍ 0.028) in the intravenous iron group (1.6 ؎ 1.3 g/dl) than in the control group (1.1 ؎ 1.4 g/dl). Hemoglobin response occurred faster (P ؍ 0.035) and more patients responded after intravenous iron than in the control group (P ؍ 0.041). Ferritin <800 or >800 ng/ml had no relationship to the magnitude or likelihood of responsiveness to intravenous iron relative to the control group. Similarly, the superiority of intravenous iron compared with no iron was similar whether baseline TSAT was above or below the study median of 19%. Ferritin decreased in control subjects (؊174 ؎ 225 ng/ml) and increased after intravenous iron (173 ؎ 272 ng/ml; P < 0.001). Intravenous iron resulted in a greater increase in TSAT than in control subjects (7.5 ؎ 7.4 versus 1.8 ؎ 5.2%; P < 0.001). Reticulocyte hemoglobin content fell only in control subjects, suggesting worsening iron deficiency. Administration of ferric gluconate (125 mg for eight treatments) is superior to no iron therapy in anemic dialysis patients receiving adequate epoetin dosages and have a ferritin 500 to 1200 ng/ml and TSAT <25%.
BackgroundThere is a rising incidence of chronic kidney disease that is likely to pose major problems for both healthcare and the economy in future years. In India, it has been recently estimated that the age-adjusted incidence rate of ESRD to be 229 per million population (pmp), and >100,000 new patients enter renal replacement programs annually.MethodsWe cross-sectionally screened 6120 Indian subjects from 13 academic and private medical centers all over India. We obtained personal and medical history data through a specifically designed questionnaire. Blood and urine samples were collected.ResultsThe total cohort included in this analysis is 5588 subjects. The mean ± SD age of all participants was 45.22 ± 15.2 years (range 18–98 years) and 55.1% of them were males and 44.9% were females. The overall prevalence of CKD in the SEEK-India cohort was 17.2% with a mean eGFR of 84.27 ± 76.46 versus 116.94 ± 44.65 mL/min/1.73 m2 in non-CKD group while 79.5% in the CKD group had proteinuria. Prevalence of CKD stages 1, 2, 3, 4 and 5 was 7%, 4.3%, 4.3%, 0.8% and 0.8%, respectively.ConclusionThe prevalence of CKD was observed to be 17.2% with ~6% have CKD stage 3 or worse. CKD risk factors were similar to those reported in earlier studies.It should be stressed to all primary care physicians taking care of hypertensive and diabetic patients to screen for early kidney damage. Early intervention may retard the progression of kidney disease. Planning for the preventive health policies and allocation of more resources for the treatment of CKD/ESRD patients are imperative in India.
Acute epiploic appendagitis most commonly manifests with acute lower quadrant pain. Its clinical features are similar to those of acute diverticulitis or, less commonly, acute appendicitis. The conditions that may mimic acute epiploic appendagitis at computed tomography (CT) include acute omental infarction, mesenteric panniculitis, fat-containing tumor, and primary and secondary acute inflammatory processes in the large bowel (eg, diverticulitis and appendicitis). Whereas the location of acute epiploic appendagitis is most commonly adjacent to the sigmoid colon, acute omental infarction is typically located in the right lower quadrant and often is mistaken for acute appendicitis. It is important to correctly diagnose acute epiploic appendagitis and acute omental infarction on CT images because these conditions may be mistaken for acute abdomen, and the mistake may lead to unnecessary surgery. The CT features of acute epiploic appendagitis include an oval lesion 1.5-3.5 cm in diameter, with attenuation similar to that of fat and with surrounding inflammatory changes, that abuts the anterior sigmoid colon wall. The CT features of acute omental infarction include a well-circumscribed triangular or oval heterogeneous fatty mass with a whorled pattern of concentric linear fat stranding between the anterior abdominal wall and the transverse or ascending colon. As CT increasingly is used for the evaluation of acute abdomen, radiologists are likely to see acute epiploic appendagitis and its mimics more often. Recognition of these conditions on CT images will allow appropriate management of acute abdominal pain and may help to prevent unnecessary surgery.
A poor initial hematopoietic response to darbepoetin alfa was associated with an increased subsequent risk of death or cardiovascular events as doses were escalated to meet target hemoglobin levels. Although the mechanism of this differential effect is not known, these findings raise concern about current target-based strategies for treating anemia in patients with chronic kidney disease. (Funded by Amgen; ClinicalTrials.gov number, NCT00093015.)
Abstract. The ability of the Modification of Renal Disease (MDRD) equation to predict GFR when compared with multiple other prediction equations in healthy subjects without known kidney disease was analyzed. Between May 1995 and December 2001, a total of 117 healthy individuals underwent 125 I-iothalamate or 99m Tc-diethylenetriamine-pentaacetic acid (DTPA) renal studies as part of a routine kidney donor evaluation at either Brigham and Women's Hospital or Boston Children's Hospital. On chart review, 100 individuals had sufficient data for analysis. The MDRD 1, MDRD 2 (simplified MDRD equation), Cockcroft-Gault (CG), Cockcroft-Gault corrected for GFR (CG-GFR), and other equations were tested. The median absolute difference in ml/min per 1.73 m 2 between calculated and measured GFR was 28.7 for MDRD 1, 18.5 for MDRD 2, 33.1 for CG, and 28.6 for CG-GFR in the 125 Iiothalamate group and was 31.1 for MDRD 1, 38.2 for MDRD 2, 22.0 for CG, and 31.1 for CG-GFR in the 99m Tc-DTPA group. Bias was Ϫ0.5, Ϫ3.3, 25.6, and 5.0 for MDRD 1, MDRD 2, CG, and CG-GFR, respectively, in subjects who received 125 I-iothalamate and Ϫ33.2, Ϫ36.5, 6.0, and Ϫ15.0 for MDRD 1, MDRD 2, CG, and CG-GFR, respectively, in those who received 99m Tc-DTPA studies. Precision testing, as measured by linear regression, yielded R 2 values of 0.04 for CG, 0.05 for CG-GFR, 0.15 for MDRD 1, and 0.14 for MDRD in those who underwent 125 I-iothalamate studies and 0.18 for CG, 0.21 for CG-GFR, 0.40 for MDRD 1, and 0.38 for MDRD 2 for those who underwent 99m Tc-DTPA studies. The MDRD equations were more accurate within 30 and 50% of the measured GFR compared with the CG and CG-GFR equations. When compared with the CG equation, the MDRD equations are more precise and more accurate for predicting GFR in healthy adults. The MDRD equations, however, consistently underestimate GFR, whereas the CG equations consistently overestimate measured GFR in people with normal renal function. In potential kidney donors, prediction equations may not be sufficient for estimating GFR; radioisotope studies may be needed for a better assessment of GFR. Further studies are needed to derive and assess GFR prediction equations in people with normal or mildly impaired renal function.
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