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Article ; Online: Something important is missing in the ACC/AHA cholesterol treatment guidelines.

McKenney, James M

Journal of the American Pharmacists Association : JAPhA

2015 Volume 55, Issue 3, Page(s) 324–329

Abstract: Objective: To discuss factors surrounding development of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines and reasons they have not yet been adopted by clinicians.: Summary: The new ACC/AHA ... ...

Abstract	Objective: To discuss factors surrounding development of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines and reasons they have not yet been adopted by clinicians. Summary: The new ACC/AHA cholesterol guidelines were released in November 2013. The guidelines are based on randomized controlled trial evidence and, if fully implemented, are likely to result in a reduction of atherosclerotic cardiovascular disease (ASCVD) in Americans. Despite this, the guidelines have not been adopted by clinicians. This is because the guidelines are missing something very important-guidance for the clinician and the public. Guidelines are supposed to give guidance to clinicians on how to manage the various clinical presentations encountered in daily practice and to help them translate science into practice. Guidelines are also supposed to help the public define dyslipidemias in a way they can understand and thus seek treatment and actively follow the progress of their treatment. Conclusion: The National Lipid Association (NLA) stepped in to help fill the void in the ACC/AHA cholesterol guidelines and offered recommendations for treating individual patients who have increased risk of ASCVD. The NLA recommendations give clinicians the expert guidance and LDL-C goal rudder they need to successfully manage their patient's cholesterol.
MeSH term(s)	Cholesterol/standards ; Guideline Adherence ; Guidelines as Topic/standards ; Humans
Chemical Substances	Cholesterol (97C5T2UQ7J)
Language	English
Publishing date	2015-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	2118585-2
ISSN	1544-3450 ; 1544-3191 ; 1086-5802
ISSN (online)	1544-3450
ISSN	1544-3191 ; 1086-5802
DOI	10.1331/JAPhA.2015.15008
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Article: Understanding PCSK9 and anti-PCSK9 therapies.

McKenney, James M

Journal of clinical lipidology

2015 Volume 9, Issue 2, Page(s) 170–186

Abstract: Inhibitors of proprotein convertase subtilisin kexin type 9 (PCSK9) represent a new therapeutic category of drugs for the treatment of dyslipidemia and atherosclerotic cardiovascular disease. To appreciate the efficacy of these agents and interpret ... ...

Abstract	Inhibitors of proprotein convertase subtilisin kexin type 9 (PCSK9) represent a new therapeutic category of drugs for the treatment of dyslipidemia and atherosclerotic cardiovascular disease. To appreciate the efficacy of these agents and interpret research results, it is important to understand the dynamic relationship between PCSK9, low-density lipoprotein-receptors, intrahepatic cholesterol synthesis, and blood cholesterol levels. Drugs which negate the action of PCSK9 can produce substantial reductions in atherogenic lipoprotein cholesterol-carrying particles and thereby hold the potential for further reducing events associated with atherosclerotic cardiovascular disease. This article will describe and discuss PCSK9 interactive mechanisms and apply them to the interpretation of clinical trial results, which involve PCSK9 monoclonal antibodies.
MeSH term(s)	Antibodies, Monoclonal/therapeutic use ; Atherosclerosis/drug therapy ; Atherosclerosis/genetics ; Atherosclerosis/pathology ; Cholesterol/biosynthesis ; Cholesterol/blood ; Cholesterol/genetics ; Dyslipidemias/drug therapy ; Dyslipidemias/genetics ; Dyslipidemias/pathology ; Humans ; Proprotein Convertase 9 ; Proprotein Convertases/antagonists & inhibitors ; Proprotein Convertases/genetics ; Serine Endopeptidases/genetics
Chemical Substances	Antibodies, Monoclonal ; Cholesterol (97C5T2UQ7J) ; PCSK9 protein, human (EC 3.4.21.-) ; Proprotein Convertase 9 (EC 3.4.21.-) ; Proprotein Convertases (EC 3.4.21.-) ; Serine Endopeptidases (EC 3.4.21.-)
Language	English
Publishing date	2015-03
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2365061-8
ISSN	1876-4789 ; 1933-2874
ISSN (online)	1876-4789
ISSN	1933-2874
DOI	10.1016/j.jacl.2015.01.001
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Article ; Online: Combination treatment with atorvastatin plus niacin provides effective control of complex dyslipidemias: a literature review.

McKenney, James M

Postgraduate medicine

2012 Volume 124, Issue 1, Page(s) 7–20

Abstract: Patients with dyslipidemia receive a cardiovascular benefit from lowering low-density lipoprotein cholesterol (LDL-C). Atorvastatin is currently one of the most effective approved medications for lowering LDL-C, and has been shown to significantly reduce ...

Abstract	Patients with dyslipidemia receive a cardiovascular benefit from lowering low-density lipoprotein cholesterol (LDL-C). Atorvastatin is currently one of the most effective approved medications for lowering LDL-C, and has been shown to significantly reduce cardiovascular risk in many patient groups. However, even with substantial lowering of LDL-C with atorvastatin, patients still have a residual risk for coronary heart disease. Elevated triglyceride levels and low high-density lipoprotein cholesterol (HDL-C) levels may contribute to this risk. Approved medications targeting these secondary lipid parameters include fibrates, omega-3 fatty acids, and niacin. Among these medications, niacin provides the optimal increase in HDL-C levels and has efficacy similar to the other medications in lowering triglyceride levels. However, there are challenges to adherence with niacin treatment. The most common challenge during niacin treatment is flushing, although it typically decreases with ongoing use and can be ameliorated by pretreatment with aspirin and counseling by the prescriber. A combination of atorvastatin and niacin may provide more complete normalization of the lipid profile and increased cardiovascular benefits. A literature review of the PubMed and Embase databases was conducted for clinical studies that reported on the lipid-modifying efficacy of the atorvastatin plus niacin combination. Identified studies involved patients at risk for coronary heart disease and patients with established coronary heart disease. Overall, the studies were small but indicated that atorvastatin in combination with niacin was efficacious in normalizing lipid parameters. Larger lipid studies as well as studies evaluating cardiovascular outcomes during atorvastatin plus niacin treatment are warranted.
MeSH term(s)	Atorvastatin Calcium ; Coronary Disease/etiology ; Coronary Disease/prevention & control ; Drug Therapy, Combination ; Dyslipidemias/complications ; Dyslipidemias/drug therapy ; Flushing/chemically induced ; Heptanoic Acids/adverse effects ; Heptanoic Acids/therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Hypolipidemic Agents/adverse effects ; Hypolipidemic Agents/therapeutic use ; Medication Adherence ; Niacin/adverse effects ; Niacin/therapeutic use ; Pyrroles/adverse effects ; Pyrroles/therapeutic use
Chemical Substances	Heptanoic Acids ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Hypolipidemic Agents ; Pyrroles ; Niacin (2679MF687A) ; Atorvastatin Calcium (48A5M73Z4Q)
Language	English
Publishing date	2012-01
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	410138-8
ISSN	1941-9260 ; 0032-5481
ISSN (online)	1941-9260
ISSN	0032-5481
DOI	10.3810/pgm.2012.01.2513
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Article ; Online: Experimental characterization of a planar phase-engineered metamaterial lenslet for millimeter astronomy.

Gascard, Thomas / Pisano, Giampaolo / Doyle, Simon / Thompson, Jonathan / Shitvov, Alexey / Austermann, Jason / Beall, James / Hubmayr, Johannes / Raymond, Benjamin / Halverson, Nils / Jaehnig, Gregory / McKenney, Christopher M / Suzuki, Aritoki

Applied optics

2023 Volume 62, Issue 11, Page(s) 2906–2916

Abstract: To unveil presently inscrutable details of the origins of our universe imprinted in the cosmic microwave background, future experiments in the millimeter and submillimeter range are focusing on the detection of fine features, which necessitate large and ... ...

Abstract	To unveil presently inscrutable details of the origins of our universe imprinted in the cosmic microwave background, future experiments in the millimeter and submillimeter range are focusing on the detection of fine features, which necessitate large and sensitive detector arrays to enable multichroic mapping of the sky. Currently, various approaches for coupling light to such detectors are under investigation, namely, coherently summed hierarchical arrays, platelet horns, and antenna-coupled planar lenslets. The last option offers increased bandwidth and a simpler fabrication while maintaining the desired optical performance. In this work, the design, fabrication, and experimental characterization of a prototype planar metamaterial phase-engineered lenslet operating in W-band [75 GHz; 110 GHz] is presented. Its radiated field, initially modeled and measured on a systematics-limited optical bench, is compared against a simulated hyperhemispherical lenslet, a more established technology. It is reported here that our device reaches the cosmic microwave background (CMB) specification for the next stages of experiments, demonstrating power coupling above 95% and beam Gaussicity above 97% while maintaining ellipticity below 10% and a cross-polarization level below -21
Language	English
Publishing date	2023-05-03
Publishing country	United States
Document type	Journal Article
ISSN	1539-4522
ISSN (online)	1539-4522
DOI	10.1364/AO.480933
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Article: Lipid lowering with bempedoic acid added to a proprotein convertase subtilisin/kexin type 9 inhibitor therapy: A randomized, controlled trial.

Rubino, John / MacDougall, Diane E / Sterling, Lulu Ren / Kelly, Stephanie E / McKenney, James M / Lalwani, Narendra D

Journal of clinical lipidology

2021 Volume 15, Issue 4, Page(s) 593–601

Abstract: Background: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) lower low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia. However, some patients receiving PCSK9i therapy might require additional lipid- ... ...

Abstract	Background: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) lower low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia. However, some patients receiving PCSK9i therapy might require additional lipid-lowering therapy (LLT) to reach LDL-C goals. Bempedoic acid is an oral, once-daily, ATP-citrate lyase inhibitor that significantly lowers LDL-C in patients with hypercholesterolemia when given alone or as add-on therapy to statins and/or ezetimibe. Objective: Assess safety and efficacy of bempedoic acid added to PCSK9i (evolocumab) background therapy in patients with hypercholesterolemia. Methods: This phase 2, randomized, double-blind, placebo-controlled study was conducted in three phases: 1.5-month screening/washout period including discontinuation of all LLTs, a 3-month period wherein patients initiated background PCSK9i therapy, and a 2-month treatment period in which patients were randomized 1:1 to receive bempedoic acid 180 mg or placebo once daily while continuing PCSK9i therapy. Results: Of 59 patients randomized, 57 completed the study. Mean baseline LDL-C after 3 months of PCSK9i background therapy was 103.1 ± ± 30.4 mg/dL. Bempedoic acid added to background PCSK9i therapy significantly lowered LDL-C by 30.3% (P < .001) vs placebo. Compared with placebo, bempedoic acid significantly lowered apolipoprotein B, non-high-density lipoprotein cholesterol, and total cholesterol (nominal P < .001 for all), and high-sensitivity C-reactive protein (P = .029). When added to background PCSK9i therapy, the safety profile of bempedoic acid was comparable to that observed for placebo. Conclusions: When added to a background of PCSK9i therapy, bempedoic acid significantly lowered LDL-C levels with a safety profile comparable to placebo in patients with hypercholesterolemia.
MeSH term(s)	Aged ; Cholesterol, LDL/antagonists & inhibitors ; Cholesterol, LDL/blood ; Dicarboxylic Acids/administration & dosage ; Double-Blind Method ; Drug Therapy, Combination ; Fatty Acids/administration & dosage ; Female ; Humans ; Hypercholesterolemia/blood ; Hypercholesterolemia/drug therapy ; Hypolipidemic Agents/administration & dosage ; Male ; Middle Aged ; PCSK9 Inhibitors/administration & dosage ; Proprotein Convertase 9/blood
Chemical Substances	Cholesterol, LDL ; Dicarboxylic Acids ; Fatty Acids ; Hypolipidemic Agents ; PCSK9 Inhibitors ; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid (1EJ6Z6Q368) ; PCSK9 protein, human (EC 3.4.21.-) ; Proprotein Convertase 9 (EC 3.4.21.-)
Language	English
Publishing date	2021-05-28
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2365061-8
ISSN	1876-4789 ; 1933-2874
ISSN (online)	1876-4789
ISSN	1933-2874
DOI	10.1016/j.jacl.2021.05.002
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Article ; Online: Trauma Prevalence and Resource Utilization During 4 COVID-19 "Surges": A National Analysis of Trauma Patients From 92 Trauma Centers.

Elkbuli, Adel / Sen-Crowe, Brendon / Morse, Jennifer L / Wyse, Ransom J / Berg, Gina M / Garland, Jeneva M / Slivinski, Andrea / Dunne, James R / Fakhry, Samir M / McKenney, Mark

The Journal of surgical research

2022 Volume 276, Page(s) 208–220

Abstract: Introduction: We aim to assess the trends in trauma patient volume, injury characteristics, and facility resource utilization that occurred during four surges in COVID-19 cases.: Methods: A retrospective cohort study of 92 American College of ... ...

Abstract	Introduction: We aim to assess the trends in trauma patient volume, injury characteristics, and facility resource utilization that occurred during four surges in COVID-19 cases. Methods: A retrospective cohort study of 92 American College of Surgeons (ACS)-verified trauma centers (TCs) in a national hospital system during 4 COVID-19 case surges was performed. Patients who were directly transported to the TC and were an activation or consultation from the emergency department (ED) were included. Trends in injury characteristics, patient demographics & outcomes, and hospital resource utilization were assessed during four COVID-19 case surges and compared to the same dates in 2019. Results: The majority of TCs were within a metropolitan or micropolitan division. During the pandemic, trauma admissions decreased overall, but displayed variable trends during Surges 1-4 and across U.S. regions and TC levels. Patients requiring surgery or blood transfusion increased significantly during Surges 1-3, whereas the proportion of patients requiring plasma and/or platelets increased significantly during Surges 1-2. Patients admitted to the hospital had significantly higher Injury Severity Score (ISS) and mortality as compared to pre-pandemic during Surge 1 and 2. Patients with Medicaid or uninsured increased significantly during the pandemic. Hospital length of stay (LOS) decreased significantly during the pandemic and more trauma patients were discharged home. Conclusions: Trauma admissions decreased during Surge 1, but increased during Surge 2, 3 and 4. Penetrating injuries and firearm-related injuries increased significantly during the pandemic, patients requiring surgery or packed red blood cells (PRBCs) transfusion increased significantly during Surges 1-3. The number of patients discharged home increased during the pandemic and was accompanied by a decreased hospital length of stay (LOS).
MeSH term(s)	COVID-19/epidemiology ; Humans ; Injury Severity Score ; Length of Stay ; Prevalence ; Retrospective Studies ; Trauma Centers ; United States/epidemiology
Language	English
Publishing date	2022-03-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	80170-7
ISSN	1095-8673 ; 0022-4804
ISSN (online)	1095-8673
ISSN	0022-4804
DOI	10.1016/j.jss.2022.02.053
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Zs.A 178: Show issues

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Article ; Online: ODYSSEY MONO: effect of alirocumab 75 mg subcutaneously every 2 weeks as monotherapy versus ezetimibe over 24 weeks.

Roth, Eli M / McKenney, James M

Future cardiology

2015 Volume 11, Issue 1, Page(s) 27–37

Abstract: ABSTRACT Alirocumab is a fully human monoclonal antibody to PCSK9. The ODYSSEY MONO study was the first alirocumab Phase III study to test a previously unused dose of 75 mg subcutaneously every 2 weeks in a population on no lipid-lowering therapy. A ... ...

Abstract	ABSTRACT Alirocumab is a fully human monoclonal antibody to PCSK9. The ODYSSEY MONO study was the first alirocumab Phase III study to test a previously unused dose of 75 mg subcutaneously every 2 weeks in a population on no lipid-lowering therapy. A total of 103 patients were randomly assigned to alirocumab starting at 75 mg subcutaneously every 2 weeks or ezetimibe 10 mg per os every day with alirocumab dose uptitration at 12 weeks based on achieved LDL-cholesterol level at week 8 and followed to week 24. At the week-24 primary end point, the alirocumab intent-to-treat group showed a 47.2% (least square [LS] mean) reduction in LDL-cholesterol compared with a 15.6% (LS mean) reduction with ezetimibe (LS mean difference of 31.6%; p < 0.0001). Safety parameters and adverse events were similar between the two groups.
MeSH term(s)	Antibodies, Monoclonal/administration & dosage ; Anticholesteremic Agents/administration & dosage ; Azetidines/administration & dosage ; Cholesterol, LDL/blood ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Ezetimibe ; Female ; Humans ; Hypercholesterolemia/drug therapy ; Injections, Subcutaneous ; Male ; Middle Aged
Chemical Substances	Antibodies, Monoclonal ; Anticholesteremic Agents ; Azetidines ; Cholesterol, LDL ; Ezetimibe (EOR26LQQ24) ; alirocumab (PP0SHH6V16)
Language	English
Publishing date	2015
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2274267-0
ISSN	1744-8298 ; 1479-6678
ISSN (online)	1744-8298
ISSN	1479-6678
DOI	10.2217/fca.14.82
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Zs.A 6836: Show issues

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Article: Development of Flat Silicon-Based Mesh Lens Arrays for Millimeter and Sub-millimeter Wave Astronomy.

Pisano, Giampaolo / Austermann, Jason / Beall, James / Halverson, Nils / Hubmayr, Johannes / Jaehnig, Gregory / McKenney, Christopher M / Raymond, Benjamin / Suzuki, Aritoki

Journal of low temperature physics

2020 Volume 199, Issue 3, Page(s) 923–934

Abstract: The high sensitivity requirements set by future cosmic microwave background instruments are pushing the current technologies to produce highly performant focal plane arrays with thousands of detectors. The coupling of the detectors to the telescope ... ...

Abstract	The high sensitivity requirements set by future cosmic microwave background instruments are pushing the current technologies to produce highly performant focal plane arrays with thousands of detectors. The coupling of the detectors to the telescope optics is a challenging task. Current implemented solutions include phased-array antenna-coupled detectors, platelet horn arrays, and lenslet-coupled planar antennas. There are also recent developments of flat graded-index lenses based on etched silicon. However, there are strong requirements in terms of electromagnetic performance, such as coupling efficiency and bandwidth, as well as requirements in terms of easy manufacturing and scalability, and it is very challenging to meet all these requirements with one of the above solutions. Here, we present a novel approach for producing flat metal-mesh lenslet arrays based on devices previously realized using the mesh-filter technology. We have now adapted the polypropylene-based mesh lens design to silicon substrates, thus providing a good mechanical match to the silicon-based detector arrays. The measured performance of prototype pixels operating at millimeter wavelengths is presented.
Language	English
Publishing date	2020-01-24
Publishing country	United States
Document type	Journal Article
ZDB-ID	2016984-X
ISSN	1573-7357 ; 0022-2291
ISSN (online)	1573-7357
ISSN	0022-2291
DOI	10.1007/s10909-019-02327-y
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Article: JCL roundtable: PCSK9 inhibitors in clinical practice.

Brown, W Virgil / Moriarty, Patrick M / McKenney, James M

Journal of clinical lipidology

2016 Volume 10, Issue 1, Page(s) 5–14

Abstract: ... experts, the implications of these indications for the practicing physician. Dr McKenney and Dr Moriarty ...

Abstract	The roundtable this month will involve a discussion of two new drugs that have been approved by the Food and Drug Administration for the reduction of low-density lipoprotein cholesterol (LDL-C). The Food and Drug Administration approved the first of these, alirocumab as an "adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL [low-density lipoprotein]-cholesterol." Evolucumab has similar indications plus an indication specifically for treatment of homozygous familial hypercholesterolemia. This sets the stage for their clinical use and in this roundtable, we will discuss with two experts, the implications of these indications for the practicing physician. Dr McKenney and Dr Moriarty have had extensive experience in the conduct of clinical trials that provided the evidence of safety and efficacy of these so called PCSK9 inhibitors.
MeSH term(s)	Adult ; Animals ; Humans ; Proprotein Convertase 9 ; Proprotein Convertases/antagonists & inhibitors ; Safety ; Serine Endopeptidases ; Serine Proteinase Inhibitors/adverse effects ; Serine Proteinase Inhibitors/pharmacology
Chemical Substances	Serine Proteinase Inhibitors ; PCSK9 protein, human (EC 3.4.21.-) ; Proprotein Convertase 9 (EC 3.4.21.-) ; Proprotein Convertases (EC 3.4.21.-) ; Serine Endopeptidases (EC 3.4.21.-)
Language	English
Publishing date	2016-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2365061-8
ISSN	1876-4789 ; 1933-2874
ISSN (online)	1876-4789
ISSN	1933-2874
DOI	10.1016/j.jacl.2015.12.004
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Article ; Online: Traumatic Axonal Injury in the Optic Nerve: The Selective Role of SARM1 in the Evolution of Distal Axonopathy.

Alexandris, Athanasios S / Lee, Youngrim / Lehar, Mohamed / Alam, Zahra / McKenney, James / Perdomo, Dianela / Ryu, Jiwon / Welsbie, Derek / Zack, Donald J / Koliatsos, Vassilis E

Journal of neurotrauma

2023 Volume 40, Issue 15-16, Page(s) 1743–1761

Abstract: Traumatic axonal injury (TAI), thought to be caused by rotational acceleration of the head, is a prevalent neuropathology in traumatic brain injury (TBI). TAI in the optic nerve is a common finding in multiple blunt-force TBI models and hence a great ... ...

Abstract	Traumatic axonal injury (TAI), thought to be caused by rotational acceleration of the head, is a prevalent neuropathology in traumatic brain injury (TBI). TAI in the optic nerve is a common finding in multiple blunt-force TBI models and hence a great model to study mechanisms and treatments for TAI, especially in view of the compartmentalized anatomy of the visual system. We have previously shown that the somata and the proximal, but not distal, axons of retinal ganglion cells (RGC) respond to DLK/LZK blockade after impact acceleration of the head (IA-TBI). Here, we explored the role of the sterile alpha and TIR-motif containing 1 (SARM1), the key driver of Wallerian degeneration (WD), in the progressive breakdown of distal and proximal segments of the optic nerve following IA-TBI with high-resolution morphological and classical neuropathological approaches. Wild type and
MeSH term(s)	Mice ; Animals ; Axons/pathology ; Retinal Ganglion Cells/metabolism ; Retinal Ganglion Cells/pathology ; Brain Injuries, Traumatic/pathology ; Optic Nerve/pathology ; Mice, Knockout ; Cytoskeletal Proteins/genetics ; Cytoskeletal Proteins/metabolism ; Armadillo Domain Proteins/genetics ; Armadillo Domain Proteins/metabolism
Chemical Substances	SARM1 protein, mouse ; Cytoskeletal Proteins ; Armadillo Domain Proteins
Language	English
Publishing date	2023-03-14
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	645092-1
ISSN	1557-9042 ; 0897-7151
ISSN (online)	1557-9042
ISSN	0897-7151
DOI	10.1089/neu.2022.0416
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Zs.A 2016: Show issues

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