In-vitro evaluation of microleakage of bioceramic root-end filling materials: A spectrophotometric study.

Aim: To evaluate the microleakage of newer bioceramic root-end filling materials.

Material And Method: Sixty freshly extracted human single-rooted mandibular premolar teeth were selected for the study. Teeth with fractured root, cracks, anddilacerations were rejected.

The second mesiobuccal canal in three-rooted maxillary first molar of Karnataka Indian sub-populations: A cone-beam computed tomography study.

Introduction: Elusive second mesiobuccal canal (MB2) in maxillary first molar are often missed during endodontic therapy and are a major cause of treatment failures. Its prevalence is known to vary among different populations and there is limited information on its prevalence in Indian population.

Aim: This study investigated the prevalence and location of second mesiobuccal (MB2) canal in mesiobuccal root of maxillary first molar using cone beam computed tomography (CBCT) images in an Indian population.

Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial.

Importance: Secondary hyperparathyroidism contributes to extraskeletal calcification and is associated with all-cause and cardiovascular mortality. Control is suboptimal in the majority of patients receiving hemodialysis. An intravenously (IV) administered calcimimetic could improve adherence and reduce adverse gastrointestinal effects.

Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials.

Importance: Secondary hyperparathyroidism contributes to extraskeletal complications in chronic kidney disease.

Objective: To evaluate the effect of the intravenous calcimimetic etelcalcetide on serum parathyroid hormone (PTH) concentrations in patients receiving hemodialysis.

Design, Setting, And Participants: Two parallel, phase 3, randomized, placebo-controlled treatment trials were conducted in 1023 patients receiving hemodialysis with moderate to severe secondary hyperparathyroidism.

C-Reactive Protein and Risk of ESRD: Results From the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT).

Background: To better understand a potential association of elevated C-reactive protein (CRP) level with progression of chronic kidney disease (CKD), we examined the relationship of CRP level with the development of end-stage renal disease (ESRD) in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT).

Study Design: Post hoc analysis of a randomized controlled trial.

Setting & Participants: 4,038 patients with type 2 diabetes, CKD, and anemia in TREAT.

Overcoming Barriers in Kidney Health-Forging a Platform for Innovation.

Innovation in kidney diseases is not commensurate with the effect of these diseases on human health and mortality or innovation in other key therapeutic areas. A primary cause of the dearth in innovation is that kidney diseases disproportionately affect a demographic that is largely disenfranchised, lacking sufficient advocacy, public attention, and funding. A secondary and likely consequent cause is that the existing infrastructure supporting nephrology research pales in comparison with those for other internal medicine specialties, especially cardiology and oncology.

Coronary Artery Disease Is a Predictor of Progression to Dialysis in Patients With Chronic Kidney Disease, Type 2 Diabetes Mellitus, and Anemia: An Analysis of the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT).

Background: Although clear evidence shows that chronic kidney disease is a predictor of cardiovascular events, death, and accelerated coronary artery disease (CAD) progression, it remains unknown whether CAD is a predictor of progression of chronic kidney disease to end-stage renal disease. We sought to assess whether CAD adds prognostic information to established predictors of progression to dialysis in patients with chronic kidney disease, diabetes, and anemia.

Methods And Results: Using the previously described Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) population, we compared baseline characteristics of patients with and without CAD.

Treatment of Secondary Hyperparathyroidism: Results of a Phase 2 Trial Evaluating an Intravenous Peptide Agonist of the Calcium-Sensing Receptor.

Background/aims: This study evaluated the efficacy and safety of AMG416 (etelcalcitide), a novel peptide agonist of the calcium (Ca)-sensing receptor given intravenously (IV) after each hemodialysis session for the treatment of secondary hyperparathyroidism (SHPT).

Methods: Adult subjects with SHPT on hemodialysis enrolled in a 12-week, dose titration (parent) study followed by an open-label extension phase. AMG416 was administered IV, thrice weekly starting at 5 mg/session and titrated based on the subject's parathyroid hormone (PTH) and albumin-corrected Ca (cCa) to target a PTH of 150-300 pg/ml.

AMG 151 (ARRY-403), a novel glucokinase activator, decreases fasting and postprandial glycaemia in patients with type 2 diabetes.

Phase I studies have shown that AMG 151 activates glucokinase, a key enzyme in glucose homeostasis. The present randomized, placebo-controlled phase IIa study evaluated the dose-effect relationship of the glucokinase activator AMG 151 relative to placebo on fasting plasma glucose (FPG) in 236 patients (33-35 patients per arm) with type 2 diabetes treated with metformin. Patients received oral AMG 151 at 50, 100 or 200 mg twice daily, AMG 151 at 100, 200 or 400 mg once daily or matching placebo for 28 days.

Race and ethnicity influences on cardiovascular and renal events in patients with diabetes mellitus.

Background: The incidence of end-stage renal disease (ESRD) has been consistently shown to be higher among blacks and Hispanics compared to whites with unmeasured risk factors and access to care as suggested explanations. In a high-risk cohort with frequent protocol-directed follow-up, we evaluated the influence of race on cardiovascular (CV) outcomes and incidence of ESRD.

Methods: TREAT was a randomized, double-blind, placebo-controlled study.

Albuminuria and racial disparities in the risk for ESRD.

The causes of the increased risk for ESRD among African Americans are not completely understood. Here, we examined whether higher levels of urinary albumin excretion among African Americans contributes to this disparity. We analyzed data from 27,911 participants in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study who had urinary albumin-to-creatinine ratio (ACR) and estimated GFR (eGFR) measured at baseline.

Association between cardiac biomarkers and the development of ESRD in patients with type 2 diabetes mellitus, anemia, and CKD.

Background: In patients with chronic kidney disease (CKD), as in other populations, elevations in cardiac biomarker levels predict increased risk of cardiovascular events. We examined the value of troponin T (TnT) and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) in assessing the risk of developing end-stage renal disease (ESRD) in diabetic patients with CKD.

Study Design: Prospective cohort study nested within a randomized clinical trial.

Changes in erythropoiesis-stimulating agent (ESA) dosing and haemoglobin levels in US non-dialysis chronic kidney disease patients between 2005 and 2009.

Background: Recent clinical trials in cancer patients treated with erythropoiesis-stimulating agents (ESAs) and in CKD patients treated to haemoglobin (Hb) targets above the labeled range of 10-12 g/dL with ESAs raised safety concerns regarding ESA therapy. Subsequently, product labeling was revised including addition of a black-box warning and removal of many quality of life claims not supported by current standards, and there were changes in reimbursement and anaemia guidelines. The extent to which these events influenced ESA dosing and Hb levels in patients with chronic kidney disease not on dialysis (CKD-NOD) is not known.

Kidney function, albuminuria, and all-cause mortality in the REGARDS (Reasons for Geographic and Racial Differences in Stroke) study.

Background: Chronic kidney disease and albuminuria are associated with increased risk of all-cause mortality.

Study Design: Prospective observational cohort study.

Setting & Participants: 17,393 participants (mean age, 64.

Prevalence and severity of chronic kidney disease and anemia in the nursing home population.

Objectives: Chronic kidney disease (CKD) is an emerging health concern and may have important implications for the management of older people with many other chronic conditions, such as the nursing home (NH) resident population. This study was designed to describe the prevalence of CKD and associated comorbidities in a representative sample of NH residents.

Design: Cross-sectional descriptive study as a component of a prospective observational study of CKD and anemia in the NH population.

A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease.

Background: Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested.

Methods: In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.

Every-other-week darbepoetin alfa in the correction and maintenance of haemoglobin levels in elderly patients with chronic kidney disease: post hoc subanalysis of data from two clinical trials.

Background: Anaemia is a common complication of chronic kidney disease (CKD) and is associated with increased rates of mortality and diminished quality of life in patients with CKD. Although extended dosing with darbepoetin alfa, an erythropoiesis-stimulating agent (ESA), has been shown to be effective in maintaining haemoglobin (Hb) levels in CKD patients, little information is published on the use of darbepoetin alfa in the correction and maintenance of Hb levels in elderly CKD patients naive to ESA therapy.

Objective: This post hoc subanalysis of data from two clinical trials was conducted to investigate the efficacy and safety profile of de novo every-other-week (q2w) darbepoetin alfa in elderly patients with CKD-associated anaemia (not on dialysis), as compared with that of a younger (aged <65 years) patient cohort.

Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT).

Background: Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics and therapies of TREAT participants and subgroups defined by the presence or absence of overt proteinuria and history of cardiovascular disease.

Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naïve to erythropoiesis-stimulating agents.

Objective: To evaluate the efficacy and safety of darbepoetin alfa dosed every-other-week (Q2W) to treat anemia in subjects with chronic kidney disease (CKD), not receiving dialysis, who were naïve to erythropoiesis-stimulating agent (ESA) therapy.

Research Design And Methods: This was an open-label, multicenter, single-arm study enrolling ESA-naïve CKD subjects with baseline hemoglobin (Hb) < 11.0 g/dL.

Chronic kidney disease and US healthcare resource utilization in a nationally representative sample.

Background: Chronic kidney disease (CKD) is a prevalent condition; however, little is known about healthcare resource utilization (HRU) by CKD patients.

Methods: This analysis included NHANES participants aged > or =18 years, with serum creatinine, urine protein, and hemoglobin measurements. We assessed the association between CKD (stratified by stage) and HRU based on self-reported physician visits and hospitalizations in the year preceding the survey.

Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis.

Pre-clinical studies indicate that pharmacologic agents can augment fracture union. If these pharmacologic approaches could be translated into clinical benefit and offered to patients with osteoporosis or patients with other risks for impaired fracture union (e.g.

Association of anemia correction with health related quality of life in patients not on dialysis.

Objective: This was an open-label study to asses the association of changes in hemoglobin with changes in health related quality of life (HRQOL) in patients treated with darbepoetin alfa.

Methods: Originally, 81 chronic kidney disease (CKD) patients not on dialysis and naïve to erythropoiesis stimulating agents (ESA) were randomly assigned into two open-label groups (3 : 1). As a majority of control group patients opted out of control status, this study reports on the single arm study analysis that was performed on the 48 patients who received the drug through week 16.

Assessment of the impact of weekly versus monthly erythropoiesis stimulating protein therapy on patients with CKD and their families.

This cross-sectional study measured patient and family member reported treatment and economic burden associated with monthly versus weekly erythropoiesis stimulating protein therapies for anemia in patients with CKD who were not yet on dialysis. The results indicated that compared to a weekly regimen, a monthly regimen saved patients 7 hours and family members 19 hours per month for routine anemia management. The monthly regimen substantially reduced the reported economic and treatment burdens of patient and their family members.

Assessment of time and practice resources required to provide weekly or monthly erythropoiesis-stimulating protein therapy to chronic kidney disease patients in the physician office setting.

Background: There is an epidemic of chronic kidney disease (CKD) and a high prevalence of anemia (47%) observed in CKD patients. Little is known about the cost in physician office resources of routine erythropoiesis-stimulating protein (ESP) administration to treat patients with nondialysis CKD.

Objectives: The objectives of this research were (1) to explore the patterns of care in physician offices where nondialysis CKD patients receive routine ESP injections, (2) to examine differences in the monthly resources and related costs incurred by physician offices in treating patients receiving either weekly (QW) or monthly (QM) ESP regimens, and (3) to identify opportunities to minimize the burden of CKD treatment on physician offices.