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Evolocumab

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https://www.readbyqxmd.com/read/28424973/pcsk9-inhibitors-in-hyperlipidemia-current-status-and-clinical-outlook
#1
Belinda Di Bartolo, Daniel J Scherer, Alex Brown, Peter J Psaltis, Stephen J Nicholls
The clinical reality of residual risk despite statin (HMG-CoA reductase inhibitor) therapy and emergence of statin intolerance support the need to develop additional lipid-lowering strategies. Proprotein convertase subtilisin kexin type 9 (PCSK9) has received considerable attention by virtue of genetic and clinical studies that have revealed its pivotal role in the regulation of cholesterol homeostasis. Monoclonal antibodies have been developed targeting PCSK9, which have been demonstrated to produce profound low-density lipoprotein cholesterol (LDL-C) lowering when provided as monotherapy or in combination with statins...
April 19, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28419071/reduction-of-cardiovascular-risk-with-evolocumab-repatha
#2
(no author information available yet)
No abstract text is available yet for this article.
April 24, 2017: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/28367845/one-year-efficacy-and-safety-of-evolocumab-in-japanese-patients%C3%A3-a-pooled-analysis-from-the-open-label-extension-osler-studies
#3
Atsushi Hirayama, Shizuya Yamashita, Hyoe Inomata, Helina Kassahun, Marcoli Cyrille, Andrea Ruzza, Masayuki Yoshida, Arihiro Kiyosue, Yuhui Ma, Tamio Teramoto
BACKGROUND: Evolocumab, a fully human monoclonal antibody against PCSK9, significantly reduced low-density lipoprotein-cholesterol (LDL-C) levels in Japanese patients by up to 76% when administered with a statin. We evaluated the efficacy and safety of 1 year of evolocumab in a pooled analysis of patients from the 12-week YUKAWA studies who continued into the open-label extension (OLE) OSLER studies.Methods and Results:YUKAWA-1 and YUKAWA-2 were conducted in hypercholesterolemic, high-cardiovascular-risk Japanese patients who were receiving statin therapy...
March 29, 2017: Circulation Journal: Official Journal of the Japanese Circulation Society
https://www.readbyqxmd.com/read/28366593/cost-effectiveness-of-evolocumab-in-patients-with-high-cardiovascular-risk-in-spain
#4
Guillermo Villa, Mickael Lothgren, Lucie Kutikova, Peter Lindgren, Shravanthi R Gandra, Gregg C Fonarow, Francesc Sorio, Lluis Masana, Antoni Bayes-Genis, Ben van Hout
PURPOSE: Our objective was to assess the cost-effectiveness of evolocumab in patients at high risk of cardiovascular (CV) events from the Spanish National Health System perspective. METHODS: A Markov model was used to assess the cost-effectiveness (incremental [∆] cost per ∆ quality-adjusted life-year [QALY]; or cost utility) of evolocumab plus standard of care (SoC; statins) versus SoC, assuming lifetime treatment. Cohorts with baseline LDL-C >100 mg/dL and familial hypercholesterolemia (FH) or CV event history (secondary prevention [SP]) were considered...
March 30, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28341307/the-efficacy-advantage-of-evolocumab-amg-145-dosed-at-140mg-every-2weeks-versus-420mg-every-4weeks-in-patients-with-hypercholesterolemia-evidence-from-a-meta-analysis
#5
Xiao-Xiao He, Rong Zhang, Pei-Yuan Zuo, Yu-Wei Liu, Xiang-Nan Zha, Sheng-Shuai Shan, Cheng-Yun Liu
BACKGROUND: Evolocumab (AMG 145), a PCSK9 inhibitor, has been shown to decrease low-density lipoprotein cholesterol (LDL-C) levels. Doses of 140mg administered every 2weeks (Q2W) and 420mg administered every 4weeks (Q4W) are widely used, and both dosing schedules were effective in clinical trials. However, some researchers have speculated that 140mg Q2W administration has equal or even greater efficacy. This meta-analysis was performed to assess the differences in efficacy and safety between the two doses...
March 2017: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/28328015/pcsk9-inhibitor-access-barriers-issues-and-recommendations-improving-the-access-process-for-patients-clinicians-and-payers
#6
REVIEW
Seth J Baum, Peter P Toth, James A Underberg, Paul Jellinger, Joyce Ross, Katherine Wilemon
The proprotein convertase subtilisin/kexin type 9 inhibitors or monoclonal antibodies likely represent the greatest advance in lipid management in 30 years. In 2015 the US Food and Drug Administration approved both alirocumab and evolocumab for high-risk patients with familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease requiring additional lowering of low-density lipoprotein cholesterol. Though many lipid specialists, cardiovascular disease prevention experts, endocrinologists, and others prescribed the drugs on label, they found their directives denied 80% to 90% of the time...
March 22, 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28320695/evolocumab-reduces-cardiovascular-events-in-patients-with-heart-disease-finds-study
#7
Susan Mayor
No abstract text is available yet for this article.
March 19, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28304224/evolocumab-and-clinical-outcomes-in-patients-with-cardiovascular-disease
#8
Marc S Sabatine, Robert P Giugliano, Anthony C Keech, Narimon Honarpour, Stephen D Wiviott, Sabina A Murphy, Julia F Kuder, Huei Wang, Thomas Liu, Scott M Wasserman, Peter S Sever, Terje R Pedersen
Background Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. Methods We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy...
March 17, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28291870/long-term-low-density-lipoprotein-cholesterol-lowering-efficacy-persistence-and-safety-of-evolocumab-in-treatment-of-hypercholesterolemia-results-up-to-4-years-from-the-open-label-osler-1-extension-study
#9
Michael J Koren, Marc S Sabatine, Robert P Giugliano, Gisle Langslet, Stephen D Wiviott, Helina Kassahun, Andrea Ruzza, Yuhui Ma, Ransi Somaratne, Frederick J Raal
Importance: The Open-Label Study of Long-term Evaluation Against LDL-C (OSLER-1) evaluated the durability of long-term efficacy and safety during long-term therapy with evolocumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9). Objective: To determine whether LDL-C level reductions with evolocumab persist across different populations. Secondary objectives included assessment of adverse events, antidrug antibodies, and factors contributing to treatment discontinuation...
March 14, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28289523/pcsk9-inhibitors-a-new-era-of-lipid-lowering-therapy
#10
REVIEW
Rahul Chaudhary, Jalaj Garg, Neeraj Shah, Andrew Sumner
Hyperlipidemia is a well-established risk factor for developing cardiovascular disease (CVD). The recent American College of Cardiology and American Heart Association guidelines on lipid management emphasize treatment of individuals at increased risk for developing CVD events with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) at doses proven to reduce CVD events. However, there are limited options for patients who are either intolerant to statin therapy, develop CVD despite being on maximally tolerated statin therapy, or have severe hypercholesterolemia...
February 26, 2017: World Journal of Cardiology
https://www.readbyqxmd.com/read/28285379/evolocumab-for-treating-primary-hypercholesterolaemia-and-mixed-dyslipidaemia-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#11
Christopher Carroll, Paul Tappenden, Rachid Rafia, Jean Hamilton, Duncan Chambers, Mark Clowes, Paul Durrington, Nadeem Qureshi, Anthony S Wierzbicki
As part of its single technology appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer of evolocumab (Amgen) to submit evidence on the clinical and cost effectiveness of evolocumab. The appraisal assessed evolocumab as monotherapy or in combination with a statin with or without ezetimibe, or in combination with ezetimibe (without statin therapy), in adult patients with primary hypercholesterolaemia (which includes mixed dyslipidaemia), for whom statins do not provide optimal control of their low-density lipoprotein cholesterol (LDL-C) levels and/or for whom statins are contraindicated or not tolerated...
May 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28263403/alternative-treatment-regimens-with-the-pcsk9-inhibitors-alirocumab-and-evolocumab-a-pharmacokinetic-and-pharmacodynamic-modeling-approach
#12
Nina Scherer, Christiane Dings, Michael Böhm, Ulrich Laufs, Thorsten Lehr
Alirocumab and evolocumab are 2 human monoclonal antibodies that inhibit the proprotein convertase subtilisin/kexin type 9 (PCSK9). These antibodies can potently lower low-density lipoprotein cholesterol (LDLc) serum concentrations. The aims of this analysis were to develop a pharmacokinetic (PK) and pharmacodynamic (PD) model for both antibodies, to simulate and investigate different dosage and application regimens, and finally, to note the effects on LDLc levels. Alirocumab was clinically studied and approved with 2 doses, 75 and 150 mg every 2 weeks (Q2W), whereas evolocumab was tested and approved with 2 dosing intervals, 140 mg Q2W and 420 mg Q4W...
March 6, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28260498/treatment-with-proprotein-convertase-subtilisin-kexin-type-9-pcsk9-inhibitors-to-reduce-cardiovascular-inflammation-and-outcomes
#13
Aldo Bonaventura, Federico Carbone, Alessandra Vecchié, Franco Dallegri, Giovanni G Camici, Fabrizio Montecucco, Luca Liberale
Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) is a serine protease involved in cholesterol homeostasis. After binding to the complex low-density lipoprotein (LDL)-receptor, PCSK9 induces its intracellular degradation, thus reducing serum LDL clearance. PCSK9 is mainly secreted by the liver, but it is also expressed to a lesser extent in other organs. Apart from the well-known activity concerning hepatic LDL receptor-mediated pathway, PCSK9 has been supposed to potentially interfere with vascular inflammation in atherogenesis...
March 3, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28249876/pooled-safety-analysis-of-evolocumab-in-over-6000-patients-from-double-blind-and-open-label-extension-studies
#14
Peter P Toth, Olivier Descamps, Jacques Genest, Naveed Sattar, David Preiss, Ricardo E Dent, Constantine S Djedjos, Yuna Wu, Michelle Geller, Magdalena Uhart, Ransi Somaratne, Scott M Wasserman
Background -Evolocumab, a fully human monoclonal antibody to PCSK9, markedly reduces LDL-C across diverse patient populations. The objective of this study was to assess the safety and tolerability of evolocumab in a pooled safety analysis from phase 2 or 3 randomized and placebo or comparator-controlled trials (integrated parent trials) and the first year of open-label extension (OLE) trials that included a standard-of-care control group. Methods -This analysis included adverse event (AE) data from 6026 patients in 12 phase 2 and 3 parent trials, with a median exposure of 2...
March 1, 2017: Circulation
https://www.readbyqxmd.com/read/28215937/long-term-treatment-with-evolocumab-added-to-conventional-drug-therapy-with-or-without-apheresis-in-patients-with-homozygous-familial-hypercholesterolaemia-an-interim-subset-analysis-of-the-open-label-taussig-study
#15
Frederick J Raal, G Kees Hovingh, Dirk Blom, Raul D Santos, Mariko Harada-Shiba, Eric Bruckert, Patrick Couture, Handrean Soran, Gerald F Watts, Christopher Kurtz, Narimon Honarpour, Lihua Tang, Sree Kasichayanula, Scott M Wasserman, Evan A Stein
BACKGROUND: Homozygous familial hypercholesterolaemia is a genetic disorder characterised by substantially raised LDL cholesterol, reduced LDL receptor function, xanthomas, and cardiovascular disease before age 20 years. Conventional therapy is with statins, ezetimibe, and apheresis. We aimed to assess the long-term safety and efficacy of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab in a subset of patients with homozygous familial hypercholesterolaemia enrolled in an open-label, non-randomised phase 3 trial...
February 16, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28207168/design-and-rationale-of-the-ebbinghaus-trial-a-phase-3-double-blind-placebo-controlled-multicenter-study-to-assess-the-effect-of-evolocumab-on-cognitive-function-in-patients-with-clinically-evident-cardiovascular-disease-and-receiving-statin-background-lipid
#16
Robert P Giugliano, Francois Mach, Kenton Zavitz, Christopher Kurtz, Jingjing Schneider, Huei Wang, Anthony Keech, Terje R Pedersen, Marc S Sabatine, Peter S Sever, Narimon Honarpour, Scott M Wasserman, Brian R Ott
Some observational studies raised concern that statins may cause memory impairment, leading to a US Food and Drug Administration warning. Similar questions were raised regarding proprotein convertase subtilisin/kexin-type 9 inhibitors (PCSK9i) and neurocognitive function. No prospectively designed study has evaluated the relationship between long-term PCSK9i use and cognition changes. Patients with prior cardiovascular disease treated with maximally tolerated statin enrolled in FOURIER (the randomized, double-blind, placebo-controlled cardiovascular outcome study of the PCSK9i evolocumab) could participate in this prospective assessment of cognitive function (EBBINGHAUS)...
February 16, 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28163543/proprotein-convertase-subtilisin-kexin-type-9-enzyme-inhibitors-an-emerging-new-therapeutic-option-for-the-treatment-of-dyslipidemia
#17
Faizan Mazhar, Nafis Haider
The treatment of hypercholesterolemia entered in a new phase of development with the introduction of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in the market. The Food and Drug Administration and European Medicines Agency recently approved the alirocumab and evolocumab, subcutaneously injectable monoclonal antibody every 2 or 4 weeks against PCSK9, for the treatment of hypercholesterolemia in patients with intolerance or inadequate response to statins, especially for the secondary prevention or in the case of familial hypercholesterolemia...
October 2016: Journal of Pharmacology & Pharmacotherapeutics
https://www.readbyqxmd.com/read/28155622/the-role-of-proprotein-convertase-subtilisin-kexin-type-9-inhibitors-in-the-management-of-dyslipidemia
#18
Konstantinos Tziomalos
BACKGROUND: Treatment with statins substantially reduces cardiovascular morbidity and mortality both in patients with and without established cardiovascular disease. Accordingly, statins represent the cornerstone of lipid-lowering treatment. However, there are still unmet clinical needs in the management of dyslipidemia. Indeed, it is difficult to achieve low-density lipoprotein cholesterol (LDL-C) targets in many patients, particularly in those at very high cardiovascular risk or in those with very high baseline LDL-C levels [e...
February 1, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28137217/anti-pcsk9-antibodies-a-new-era-in-the-treatment-of-dyslipidemia
#19
Joel Schmitz, Ioanna Gouni-Berthold
The serine protease proprotein convertase subtilisin/kexin type 9 (PCSK9) binds to the low-density lipoprotein (LDL) receptor (LDLR) and directs it to lysosomal degradation. This results in decreased numbers of LDLR available on the cell surface to bind LDL particles and remove them from the circulation which in turn leads to an increase in circulating LDL-cholesterol (LDL-C) concentrations. Since the role PCSK9 plays in LDL-C metabolism has been discovered in 2003 there have been major efforts in finding efficient and safe methods to inhibit it...
January 30, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28131656/integration-of-recent-evidence-into-management-of-patients-with-atherosclerotic-cardiovascular-disease-and-type-2-diabetes
#20
REVIEW
Eberhard Standl, Oliver Schnell, Darren K McGuire, Antonio Ceriello, Lars Rydén
Cardiovascular outcome trials of antihyperglycaemic drugs and non-statin LDL-cholesterol-lowering drugs in patients with type 2 diabetes who have, or who are at high risk of, atherosclerotic cardiovascular disease have provided new evidence that has substantially affected the management of cardiovascular risk in these patients. On the basis of proven cardiovascular and renal benefit, the antihyperglycaemic drugs empagliflozin, liraglutide, and semaglutide-the latter being under review for approval by the US Food and Drug Administration and the European Medicines Agency-should be preferentially used as second-line treatments in these patient populations, typically in addition to metformin...
January 25, 2017: Lancet Diabetes & Endocrinology
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