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  1. Article: Hypercalcaemic and hypocalcaemic conditions due to calcium-sensing receptor mutations.

    Egbuna, Ogo I / Brown, Edward M

    Best practice & research. Clinical rheumatology

    2008  Volume 22, Issue 1, Page(s) 129–148

    Abstract: The extracellular calcium (Ca2+o)-sensing receptor (CaSR) enables the parathyroid glands and other CaSR-expressing cells involved in calcium homeostasis, such as the kidney and bone, to sense alterations in the level of Ca2+o and to respond with changes ... ...

    Abstract The extracellular calcium (Ca2+o)-sensing receptor (CaSR) enables the parathyroid glands and other CaSR-expressing cells involved in calcium homeostasis, such as the kidney and bone, to sense alterations in the level of Ca2+o and to respond with changes in function that are directed at normalizing the blood calcium concentration. Several disorders of Ca2+o sensing arise from inherited or acquired abnormalities that 'reset' the serum calcium concentration upwards or downwards. Heterozygous inactivating mutations of the CaSR produce a benign form of hypercalcaemia, termed 'familial hypocalciuric hypercalcaemia', while homozygous mutations produce a much more severe hypercalcaemic disorder resulting from marked hyperparathyroidism, called 'neonatal severe hyperparathyroidism'. Activating mutations cause a hypocalcaemic syndrome of varying severity, termed 'autosomal-dominant hypocalcaemia or hypoparathyroidism' as well as Bartter's syndrome type V. Calcimimetic CaSR activators and calcilytic CaSR antagonists have also been developed with potential for use in the treatment of these disorders.
    MeSH term(s) Bartter Syndrome/genetics ; Humans ; Hypercalcemia/genetics ; Hyperparathyroidism, Primary/physiopathology ; Hypocalcemia/genetics ; Infant, Newborn ; Infant, Newborn, Diseases/physiopathology ; Kidney/physiology ; Mutation, Missense ; Parathyroid Glands/metabolism ; Polymorphism, Genetic ; Receptors, Calcium-Sensing/antagonists & inhibitors ; Receptors, Calcium-Sensing/genetics ; Receptors, Calcium-Sensing/metabolism ; Receptors, Calcium-Sensing/physiology ; Tissue Distribution
    Chemical Substances Receptors, Calcium-Sensing
    Language English
    Publishing date 2008-02-04
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 2052323-3
    ISSN 1521-6942
    ISSN 1521-6942
    DOI 10.1016/j.berh.2007.11.006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Performance of the pegfilgrastim on-body injector as studied with placebo buffer in healthy volunteers.

    Joshi, Rajeshree S / Egbuna, Ogo I / Cairns, Alex S / Friedman, Michael J / Abosaleem, Bassam / Reiner, Maureen T / Morrow, Phuong Khanh

    Current medical research and opinion

    2017  Volume 33, Issue 2, Page(s) 379–384

    Abstract: Objective: The pegfilgrastim on-body injector (OBI) is a single-use, disposable, battery-powered injector that is designed to automatically deliver a single subcutaneous dose of pegfilgrastim beginning approximately 27 hours after activation and ... ...

    Abstract Objective: The pegfilgrastim on-body injector (OBI) is a single-use, disposable, battery-powered injector that is designed to automatically deliver a single subcutaneous dose of pegfilgrastim beginning approximately 27 hours after activation and continuing over approximately 45 minutes. In this open-label study, we assessed performance of the OBI delivering placebo buffer in healthy volunteers.
    Research design and methods: Healthy men and women aged 18-55 years, with a body mass index of 18-35 kg/m
    Main outcome measures: The primary endpoint of the study was successful delivery of placebo buffer based on a composite of the following: no substantial leakage during or after administration, green status light indicator on the injector during and after administration, and fill indicator bar at the empty position after administration. The secondary endpoint was the incidence of treatment-emergent adverse events (AEs).
    Results: Of the 150 subjects enrolled, 149 (99.3%) completed the study. Study subjects were 48.0% men, and 52.0% women; 47.3% were white, 35.3% black or African American, 12.7% Asian, and 4.7% other. Mean (SD) age was 35.9 (10.8) years. Of the 297 total deliveries, 292 (98.3%) were considered successful: 147/149 (98.7%; 95% confidence interval [CI]: 95.2%-99.6%) to the abdomen and 145/148 (98.0%; 95% CI: 94.2%-99.3%) to the back of the upper arm. Five deliveries were considered unsuccessful: two due to hazard alarms, and three due to substantial leakage. The most common treatment-emergent AEs (in >2% of subjects overall) by preferred term were medical device site reaction (20.7%), catheter-site hemorrhage (8.7%), and headache (3.3%). No serious AEs were reported.
    Conclusions: The pegfilgrastim OBI was well tolerated, and deliveries of placebo buffer were successful 98.3% of the time. The generalizability of these results may be limited by the conduct of this study in healthy subjects in a controlled environment.
    MeSH term(s) Adolescent ; Adult ; Female ; Filgrastim ; Granulocyte Colony-Stimulating Factor/administration & dosage ; Granulocyte Colony-Stimulating Factor/adverse effects ; Healthy Volunteers ; Humans ; Injections ; Male ; Middle Aged ; Neutropenia/chemically induced ; Neutropenia/prevention & control ; Placebos ; Polyethylene Glycols ; Recombinant Proteins/administration & dosage ; Recombinant Proteins/adverse effects
    Chemical Substances Placebos ; Recombinant Proteins ; Granulocyte Colony-Stimulating Factor (143011-72-7) ; Polyethylene Glycols (30IQX730WE) ; pegfilgrastim (3A58010674) ; Filgrastim (PVI5M0M1GW)
    Language English
    Publishing date 2017-02
    Publishing country England
    Document type Journal Article
    ZDB-ID 80296-7
    ISSN 1473-4877 ; 0300-7995
    ISSN (online) 1473-4877
    ISSN 0300-7995
    DOI 10.1080/03007995.2016.1257980
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Elevated calcium phosphate product after renal transplantation is a risk factor for graft failure.

    Egbuna, Ogo I / Taylor, Jeremy G / Bushinsky, David A / Zand, Martin S

    Clinical transplantation

    2007  Volume 21, Issue 4, Page(s) 558–566

    Abstract: Background: Abnormal mineral metabolism is not uncommon after renal transplant (TXP). In dialysis patients, elevated serum phosphorous (P), calcium (Ca), CaP product, and parathyroid hormone (PTH) are associated with increased morbidity and mortality. ... ...

    Abstract Background: Abnormal mineral metabolism is not uncommon after renal transplant (TXP). In dialysis patients, elevated serum phosphorous (P), calcium (Ca), CaP product, and parathyroid hormone (PTH) are associated with increased morbidity and mortality. The effect of these abnormalities on recipient and graft survival after renal transplantation is unknown.
    Methods: We retrospectively analyzed 422 kidney-only transplants performed between June 1996 and June 2003. Cases with graft or recipient survival less than three months, pre-TXP parathyroidectomy (PTX), cinacalcet therapy and incomplete records were excluded, leaving 303 cases for analysis using Cox models that included post-TXP PTX, levels of albumin-adjusted Ca(Ca(adj)), P, Ca(adj)P product and PTH.
    Results: There was an 11-25% prevalence of abnormal serum Ca(adj), P or Ca(adj)P product within the first year post-TXP. At least 24% of recipients not undergoing PTX with an equation estimated GFR of 40-60 mL/min had PTH levels >130 pg/mL at one yr post-TXP. This is above levels recommended by the U.S National Kidney Foundation kidney disease quality initiative for patients with stages I-IV chronic kidney disease. Adjusted Ca > 10.5 mg/dL at three months post-TXP was an independent risk for recipient death (OR 3.0; 95% CI: 1.2-7.4). A Ca(adj)P product >35 mg(2)/dL(2) at six months (OR 4.0; 95% CI: 1.2-13.1), and Ca >10.5 mg/dL at 12 months post-TXP (OR 4.0; 95% CI: 1.2-14) were independent risks for death-censored graft loss. Twenty-two recipients underwent PTX for severe hyperparathyroidism.
    Conclusion: Abnormalities of mineral metabolism are common early after renal TXP. An elevated serum Ca(adj) at three months post-TXP increases the risk for recipient death, while an elevated Ca(adj)P and Ca(adj) later in the first post-TXP year increases the risk of long-term death-censored graft loss.
    MeSH term(s) Adult ; Calcium/blood ; Calcium Phosphates/blood ; Female ; Graft Rejection/blood ; Humans ; Kidney Transplantation ; Male ; Middle Aged ; Prognosis ; Retrospective Studies ; Risk Factors
    Chemical Substances Calcium Phosphates ; Calcium (SY7Q814VUP)
    Language English
    Publishing date 2007-07
    Publishing country Denmark
    Document type Journal Article
    ZDB-ID 639001-8
    ISSN 1399-0012 ; 0902-0063
    ISSN (online) 1399-0012
    ISSN 0902-0063
    DOI 10.1111/j.1399-0012.2007.00690.x
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  4. Article ; Online: Effects of denosumab on fracture and bone mineral density by level of kidney function.

    Jamal, Sophie A / Ljunggren, Osten / Stehman-Breen, Catherine / Cummings, Steven Ron / McClung, Michael R / Goemaere, Stefan / Ebeling, Peter R / Franek, Edward / Yang, Yu-Ching / Egbuna, Ogo I / Boonen, Steven / Miller, Paul D

    Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research

    2011  Volume 26, Issue 8, Page(s) 1829–1835

    Abstract: The incidences of osteoporosis and chronic kidney disease (CKD) both increase with increasing age, yet there is a paucity of data on treatments for osteoporosis in the setting of impaired kidney function. We examined the efficacy and safety of denosumab ( ...

    Abstract The incidences of osteoporosis and chronic kidney disease (CKD) both increase with increasing age, yet there is a paucity of data on treatments for osteoporosis in the setting of impaired kidney function. We examined the efficacy and safety of denosumab (DMAb) among subjects participating in the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) Study. We estimated creatinine clearance (eGFR) using Cockcroft-Gault and classified levels of kidney function using the modified National Kidney Foundation classification of CKD. We examined incident fracture rates; changes in bone mineral density (BMD), serum calcium, and creatinine; and the incidence of adverse events after 36 months of follow-up in subjects receiving DMAb or placebo, stratified by level of kidney function. We used a subgroup interaction term to determine if there were differences in treatment effect by eGFR. Most (93%) women were white, and the mean age was 72.3 ± 5.2 years; 73 women had an eGFR of 15 to 29 mL/min; 2817, between 30 to 59 mL/min; 4069, between 60 to 89 mL/min, and 842 had an eGFR of 90 mL/min or greater. None had stage 5 CKD. Fracture risk reduction and changes in BMD at all sites were in favor of DMAb. The test for treatment by subgroup interaction was not statistically significant, indicating that treatment efficacy did not differ by kidney function. Changes in creatinine and calcium and the incidence of adverse events were similar between groups and did not differ by level of kidney function. It is concluded that DMAb is effective at reducing fracture risk and is not associated with an increase in adverse events among patients with impaired kidney function.
    MeSH term(s) Aged ; Aged, 80 and over ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/pharmacology ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Bone Density/drug effects ; Bone Density/physiology ; Bone Density Conservation Agents/adverse effects ; Bone Density Conservation Agents/pharmacology ; Bone Density Conservation Agents/therapeutic use ; Creatinine/blood ; Denosumab ; Female ; Fractures, Bone/blood ; Fractures, Bone/drug therapy ; Fractures, Bone/physiopathology ; Glomerular Filtration Rate ; Humans ; Kidney Failure, Chronic/blood ; Kidney Failure, Chronic/complications ; Kidney Failure, Chronic/physiopathology ; Kidney Function Tests ; Middle Aged ; Odds Ratio ; Placebos ; RANK Ligand/adverse effects ; RANK Ligand/pharmacology ; RANK Ligand/therapeutic use
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Bone Density Conservation Agents ; Placebos ; RANK Ligand ; Denosumab (4EQZ6YO2HI) ; Creatinine (AYI8EX34EU)
    Language English
    Publishing date 2011-08
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 632783-7
    ISSN 1523-4681 ; 0884-0431
    ISSN (online) 1523-4681
    ISSN 0884-0431
    DOI 10.1002/jbmr.403
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    Zs.A 2142: Show issues Location:
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  5. Article ; Online: Outcomes with conversion from calcineurin inhibitors to sirolimus after renal transplantation in the context of steroid withdrawal or steroid continuation.

    Egbuna, Ogo I / Davis, Roger B / Chudinski, Robyn / Pavlakis, Martha / Rogers, Christin / Molakatalla, Phani / Johnson, Scott R / Karp, Seth / Monaco, Anthony P / Tang, Hongying / Hanto, Douglas W / Mandelbrot, Didier A

    Transplantation

    2009  Volume 88, Issue 5, Page(s) 684–692

    Abstract: Background: A number of studies have suggested that conversion from calcineurin inhibitors (CNI) to sirolimus (SRL) can improve graft function in renal transplant patients. None of these studies has converted patients to SRL in the absence of steroids.!# ...

    Abstract Background: A number of studies have suggested that conversion from calcineurin inhibitors (CNI) to sirolimus (SRL) can improve graft function in renal transplant patients. None of these studies has converted patients to SRL in the absence of steroids.
    Methods: We describe our experience with 278 renal transplants of which 153 were converted from CNI to SRL. The majority of patients had steroids withdrawn after 6 days. Almost all patients received antithymocyte globulin induction and were maintained on mycophenolate mofetil.
    Results: Six months after conversion, patients remaining on SRL therapy had a mean increase in estimated glomerular filtration rate of 6.93 mL/min/1.73 m2 (P<0.0001) compared with preconversion values. SRL-converted patients analyzed by intention-to-treat increased estimated glomerular filtration rate by 5.00 mL/min/1.73 m2 (P=0.0005). Eighty-one percent of patients remaining on SRL had a successful conversion, defined as stable or improved renal function at 6 months. The only factor predictive of unsuccessful conversion was urine protein-to-creatinine ratio more than 1. The benefits of SRL conversion were seen in patients at high immunological risk as well as those at lower risk. Proteinuria increased by a mean of 0.1 (P=0.43) at 6 months. Thirty-six percent of SRL-converted patients experienced adverse effects requiring conversion back to CNI. Rates of rejection, graft loss, and patient death with SRL conversion were low.
    Conclusions: The results from our clinical practice suggest that even in the absence of steroids, SRL conversion significantly improves renal function, with acceptable rates of adverse events.
    MeSH term(s) Adolescent ; Adult ; Aged ; Antilymphocyte Serum/therapeutic use ; Calcineurin Inhibitors ; Child ; Child, Preschool ; Female ; Humans ; Immunosuppressive Agents/therapeutic use ; Infant ; Infant, Newborn ; Kidney Transplantation/methods ; Male ; Middle Aged ; Mycophenolic Acid/analogs & derivatives ; Mycophenolic Acid/therapeutic use ; Sirolimus/pharmacology ; Steroids/therapeutic use ; Treatment Outcome
    Chemical Substances Antilymphocyte Serum ; Calcineurin Inhibitors ; Immunosuppressive Agents ; Steroids ; Mycophenolic Acid (HU9DX48N0T) ; Sirolimus (W36ZG6FT64)
    Language English
    Publishing date 2009-09-15
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 208424-7
    ISSN 1534-6080 ; 0041-1337
    ISSN (online) 1534-6080
    ISSN 0041-1337
    DOI 10.1097/TP.0b013e3181b27d44
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: The calcium-sensing receptor (CaSR) defends against hypercalcemia independently of its regulation of parathyroid hormone secretion.

    Kantham, Lakshmi / Quinn, Steven J / Egbuna, Ogo I / Baxi, Khanjan / Butters, Robert / Pang, Jian L / Pollak, Martin R / Goltzman, David / Brown, Edward M

    American journal of physiology. Endocrinology and metabolism

    2009  Volume 297, Issue 4, Page(s) E915–23

    Abstract: The calcium-sensing receptor (CaSR) controls parathyroid hormone (PTH) secretion, which, in turn, via direct and indirect actions on kidney, bone, and intestine, maintains a normal extracellular ionized calcium concentration (Ca(2+)(o)). There is less ... ...

    Abstract The calcium-sensing receptor (CaSR) controls parathyroid hormone (PTH) secretion, which, in turn, via direct and indirect actions on kidney, bone, and intestine, maintains a normal extracellular ionized calcium concentration (Ca(2+)(o)). There is less understanding of the CaSR's homeostatic importance outside of the parathyroid gland. We have employed single and double knockout mouse models, namely mice lacking PTH alone (CaSR(+/+) PTH(-/-), referred to as C(+)P(-)), lacking both CaSR and PTH (CaSR(-/-) PTH(-/-), C(-)P(-)) or wild-type (CaSR(+/+) PTH(+/+), C(+)P(+)) mice to study CaSR-specific functions without confounding CaSR-mediated changes in PTH. The mice received three hypercalcemic challenges: an oral Ca(2+) load, injection or constant infusion of PTH via osmotic pump, or a phosphate-deficient diet. C(-)P(-) mice show increased susceptibility to developing hypercalcemia with all three challenges compared with the other two genotypes, whereas C(+)P(-) mice defend against hypercalcemia similarly to C(+)P(+) mice. Reduced renal Ca(2+) clearance contributes to the intolerance of the C(-)P(-) mice to Ca(2+) loads, as they excrete less Ca(2+) at any given Ca(2+)(o) than the other two genotypes, confirming the CaSR's direct role in regulating renal Ca(2+) handling. In addition, C(+)P(+) and C(+)P(-), but not C(-)P(-), mice showed increases in serum calcitonin (CT) levels during hypercalcemia. The level of 1,25(OH)(2)D(3) in C(-)P(-) mice, in contrast, was similar to those in C(+)P(-) and C(+)P(+) mice during an oral Ca(2+) load, indicating that increased 1,25(OH)(2)D(3) production cannot account for the oral Ca(2+)-induced hypercalcemia in the C(-)P(-) mice. Thus, CaSR-stimulated PTH release serves as a "floor" to defend against hypocalcemia. In contrast, high-Ca(2+)(o)-induced inhibition of PTH is not required for a robust defense against hypercalcemia, at least in mice, whereas high-Ca(2+)(o)-stimulated, CaSR-mediated CT secretion and renal Ca(2+) excretion, and perhaps other factors, serve as a "ceiling" to limit hypercalcemia resulting from various types of hypercalcemic challenges.
    MeSH term(s) Amino Acids/urine ; Animals ; Bone and Bones/metabolism ; Calcifediol/metabolism ; Calcitonin/blood ; Calcium/blood ; Calcium/pharmacology ; Calcium/urine ; Drug Implants ; Homeostasis/genetics ; Homeostasis/physiology ; Hypercalcemia/physiopathology ; Kidney/metabolism ; Mice ; Mice, Inbred C57BL ; Mice, Knockout ; Osteocalcin/blood ; Parathyroid Hormone/genetics ; Parathyroid Hormone/pharmacology ; Parathyroid Hormone/physiology ; Phosphates/deficiency ; Receptors, Calcium-Sensing/genetics ; Receptors, Calcium-Sensing/physiology
    Chemical Substances Amino Acids ; Drug Implants ; Parathyroid Hormone ; Phosphates ; Receptors, Calcium-Sensing ; Osteocalcin (104982-03-8) ; deoxypyridinoline (90032-33-0) ; Calcitonin (9007-12-9) ; Calcifediol (P6YZ13C99Q) ; Calcium (SY7Q814VUP)
    Language English
    Publishing date 2009-09-24
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 603841-4
    ISSN 1522-1555 ; 0193-1849
    ISSN (online) 1522-1555
    ISSN 0193-1849
    DOI 10.1152/ajpendo.00315.2009
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