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Evolocumab

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https://www.readbyqxmd.com/read/28994502/pro-protein-subtilisin-kexin-9-pcsk9-inhibition-in-practice-lipid-clinic-experience-in-2-contrasting-uk-centres
#1
Monika Kohli, Kinjal Patel, Zofia MacMahon, Radha Ramachandran, Martin A Crook, Timothy M Reynolds, Anthony S Wierzbicki
BACKGROUND: Prescribing criteria have been suggested for proprotein convertase subtilisin kexin-9 (PCSK-9) inhibitors but few studies exist of their real-world effectiveness. METHODS: This study audited PCSK-9 inhibitor therapy in 105 consecutive patients from two hospital centres-a university hospital (UH; n = 70) and a district general hospital (DGH; n = 35). Baseline characteristics including cardiovascular disease risk factors, NICE qualification criteria, efficacy and side effects were assessed...
October 10, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28988500/a-safety-evaluation-of-evolocumab
#2
Eli M Roth
Evolocumab is an injectable, fully human monoclonal antibody and a member of the newest class of low density lipoprotein cholesterol (LDL-C) lowering agents called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. The PCSK9 inhibitors are the most significant advance in lipid therapy since the introduction of the first statin 30 years ago. Areas covered: The PCSK9 monoclonal antibodies have demonstrated a consistently high LDL-C lowering efficacy with and without statins and/or other lipid lowering therapies (LLT)...
October 9, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28978220/pcsk9-inhibitors-and-managing-cost-in-the-managed-care-setting
#3
Sheila L Stadler, Thomas J Cook
In patients with hypercholesterolemia who have atherosclerotic cardiovascular disease and/or familial hypercholesterolemia, a new class of drugs may be helpful in reducing serum levels of low-density lipoprotein cholesterol (LDL-C) beyond maximally tolerated statin therapy. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors lower LDL-C through a different mechanism of action than standard cholesterol-lowering therapies. Currently approved PCSK9 inhibitors are the monoclonal antibodies alirocumab and evolocumab...
June 2017: American Journal of Managed Care
https://www.readbyqxmd.com/read/28971955/systematic-review-and-network-meta-analysis-on-the-efficacy-of-evolocumab-and-other-therapies-for-the-management-of-lipid-levels-in-hyperlipidemia
#4
REVIEW
Peter P Toth, Gillian Worthy, Shravanthi R Gandra, Naveed Sattar, Sarah Bray, Lung-I Cheng, Ian Bridges, Gavin M Worth, Ricardo Dent, Carol A Forbes, Sohan Deshpande, Janine Ross, Jos Kleijnen, Erik S G Stroes
BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors evolocumab and alirocumab substantially reduce low-density lipoprotein cholesterol (LDL-C) when added to statin therapy in patients who need additional LDL-C reduction. METHODS AND RESULTS: We conducted a systematic review and network meta-analysis of randomized trials of lipid-lowering therapies from database inception through August 2016 (45 058 records retrieved). We found 69 trials of lipid-lowering therapies that enrolled patients requiring further LDL-C reduction while on maximally tolerated medium- or high-intensity statin, of which 15 could be relevant for inclusion in LDL-C reduction networks with evolocumab, alirocumab, ezetimibe, and placebo as treatment arms...
October 2, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28937411/implications-of-glagov-study
#5
Stephen J Nicholls, Rishi Puri
PURPOSE OF REVIEW: Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibition has emerged as a novel approach to lowering levels of low-density lipoprotein cholesterol (LDL-C). The impact of PCSK9 inhibition in statin-treated patients on coronary atherosclerosis had remained unknown. RECENT FINDINGS: The GLAGOV trial compared the effect of the PCSK9 inhibitor, evolocumab, and placebo on progression of coronary atherosclerosis in patients treated with at least moderate intensity statin therapy...
September 20, 2017: Current Opinion in Lipidology
https://www.readbyqxmd.com/read/28927706/cardiovascular-safety-and-efficacy-of-the-pcsk9-inhibitor-evolocumab-in-patients-with-and-without-diabetes-and-the-effect-of-evolocumab-on-glycaemia-and-risk-of-new-onset-diabetes-a-prespecified-analysis-of-the-fourier-randomised-controlled-trial
#6
Marc S Sabatine, Lawrence A Leiter, Stephen D Wiviott, Robert P Giugliano, Prakash Deedwania, Gaetano M De Ferrari, Sabina A Murphy, Julia F Kuder, Ioanna Gouni-Berthold, Basil S Lewis, Yehuda Handelsman, Armando Lira Pineda, Narimon Honarpour, Anthony C Keech, Peter S Sever, Terje R Pedersen
BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduced LDL cholesterol and cardiovascular events in the FOURIER trial. In this prespecified analysis of FOURIER, we investigated the efficacy and safety of evolocumab by diabetes status and the effect of evolocumab on glycaemia and risk of developing diabetes. METHODS: FOURIER was a randomised trial of evolocumab (140 mg every 2 weeks or 420 mg once per month) versus placebo in 27 564 patients with atherosclerotic disease who were on statin therapy, followed up for a median of 2·2 years...
September 14, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28926730/impact-of-evolocumab-treatment-on-low-density-lipoprotein-cholesterol-levels-in-heterozygous-familial-hypercholesterolemic-patients-withdrawing-from-regular-apheresis
#7
Masa-Aki Kawashiri, Atsushi Nohara, Toshinori Higashikata, Hayato Tada, Chiaki Nakanishi, Hirofumi Okada, Tetsuo Konno, Kenji Sakata, Kenshi Hayashi, Akihiro Inazu, Hiroshi Mabuchi, Masakazu Yamagishi
BACKGROUND AND AIMS: Low-density lipoprotein (LDL) apheresis has been used to treat refractory hyperlipidemia such as familial hypercholesterolemia (FH). Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor used in clinical settings, can reduce LDL cholesterol (LDL-C) levels by >70%. Therefore, this study aimed to assess the impact of evolocumab on withdrawal from regular LDL apheresis in patients with heterozygous FH (HeFH). METHODS: Eleven patients with HeFH undergoing biweekly LDL apheresis were enrolled and were subsequently switched to a biweekly subcutaneous injection of 140 mg of evolocumab...
September 9, 2017: Atherosclerosis
https://www.readbyqxmd.com/read/28925859/effects-of-evolocumab-on-cardiovascular-events
#8
Nasser Mikhail
BACKGROUND: Evolocumab is a potent lipid-lowering drug that decreases plasma levels of low-density lipoprotein cholesterol (LDL-C) by 50-60%. FOURIER is a landmark randomized, trial involving 27,564 patients with established cardiovascular disease already on statins and plasma LDL-C levels > 70 mg/dl. OBJECTIVE: the main objective of FOURIER was to examine the effects of evolocumab on cardiovascular events. RESULTS: After a mean follow-up of 2...
September 18, 2017: Current Cardiology Reviews
https://www.readbyqxmd.com/read/28919772/anti-pcsk9-antibodies-for-the-treatment-of-heterozygous-familial-hypercholesterolemia-patient-selection-and-perspectives
#9
REVIEW
Alberico Luigi Catapano, Angela Pirillo, Giuseppe Danilo Norata
Heterozygous familial hypercholesterolemia (FH) is a genetic disorder characterized by high low-density lipoprotein cholesterol levels from birth, which exposes the arteries to high levels of atherogenic lipoproteins lifelong and results in a significantly increased risk of premature cardiovascular events. The diagnosis of FH, followed by an appropriate and early treatment is critical to reduce the cardiovascular burden in this population. Phase I-III clinical trials showed the benefit of proprotein convertase subtilisin kexin 9 inhibitors, both alirocumab and evolocumab, in these patients with an average low-density lipoprotein cholesterol reduction ranging from -40% to -60%...
2017: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/28886926/2017-focused-update-of-the-2016%C3%A2-acc%C3%A2-expert-consensus-decision-pathway-on-the-role-of-non-statin-therapies-for-ldl-cholesterol-lowering-in%C3%A2-the-management-of-atherosclerotic-cardiovascular-disease-risk-a-report-of-the-american-college-of-cardiology-task-force
#10
Donald M Lloyd-Jones, Pamela B Morris, Christie M Ballantyne, Kim K Birtcher, David D Daly, Sondra M DePalma, Margo B Minissian, Carl E Orringer, Sidney C Smith
In 2016, the American College of Cardiology published the first expert consensus decision pathway (ECDP) on the role of non-statin therapies for low-density lipoprotein (LDL)-cholesterol lowering in the management of atherosclerotic cardiovascular disease (ASCVD) risk. Since the publication of that document, additional evidence and perspectives have emerged from randomized clinical trials and other sources, particularly considering the longer-term efficacy and safety of proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors in secondary prevention of ASCVD...
October 3, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28859947/clinical-efficacy-and-safety-of-achieving-very-low-ldl-cholesterol-concentrations-with-the-pcsk9-inhibitor-evolocumab-a-prespecified-secondary-analysis-of-the-fourier-trial
#11
Robert P Giugliano, Terje R Pedersen, Jeong-Gun Park, Gaetano M De Ferrari, Zbigniew A Gaciong, Richard Ceska, Kalman Toth, Ioanna Gouni-Berthold, Jose Lopez-Miranda, François Schiele, François Mach, Brian R Ott, Estella Kanevsky, Armando Lira Pineda, Ransi Somaratne, Scott M Wasserman, Anthony C Keech, Peter S Sever, Marc S Sabatine
BACKGROUND: LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relationship between progressively lower LDL-cholesterol concentrations achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial of evolocumab, a monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9). METHODS: In this prespecified secondary analysis of 25 982 patients from the randomised FOURIER trial, the relationship between achieved LDL-cholesterol concentration at 4 weeks and subsequent cardiovascular outcomes (primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or unstable angina; key secondary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over a median of 2·2 years of follow-up...
August 25, 2017: Lancet
https://www.readbyqxmd.com/read/28855205/evolocumab-must-become-cheaper-to-be-cost-effective-in-enhancing-benefits-of-statins
#12
Nigel Hawkes
No abstract text is available yet for this article.
August 30, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28854074/implementation-of-a-new-clinic-based-pharmacist-managed-pcsk9-inhibitor-consultation-service
#13
Adenike Atanda, Nancy L Shapiro, JoAnn Stubbings, Vicki Groo
BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab were approved by the FDA in 2015. In anticipation of provider interest and a potential increase in referrals to the on-site specialty pharmacy, we created a pharmacist-managed consultation service. PROGRAM DESCRIPTION: The development of a clinic-based pharmacist-managed consultation service for the management of the PCSK9 inhibitor agents alirocumab and evolocumab is described...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28844508/effect-of-the-proprotein-convertase-subtilisin-kexin-type-9-inhibitor-evolocumab-on-glycemia-body-weight-and-new-onset-diabetes-mellitus
#14
Naveed Sattar, Peter P Toth, Dirk J Blom, Michael J Koren, Handrean Soran, Magdalena Uhart, Mary Elliott, Marcoli Cyrille, Ransi Somaratne, David Preiss
Statin therapy modestly increases new-onset diabetes risk. The effect of proprotein convertase subtilisin/kexin type 9 inhibition on new-onset diabetes, glycemia, and weight remains unclear. We studied the effects of the proprotein convertase subtilisin/kexin type 9 inhibitor evolocumab on fasting plasma glucose, glycated hemoglobin, weight, and new-onset diabetes mellitus. We pooled 1-year (48-week) data for participants who had completed an evolocumab parent study before entering an open-label extension (OLE) trial...
November 1, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28840737/-clinical-study-fourier
#15
Ján Murín
A new group of hypolipidemic substances, i.e. PCSK9 protein inhibitors, is now coming into use in clinical practice, to what extent a high residual cardiovascular risk remains also in patients treated with statins. The FOURIER study (Further cardiovascular OUtcomes Research with PCSK9 Inhibition subjects with Elevated Risk) is the first "event" study which has shown that evolocumab (PCSK9 antibody) further significantly reduces serum LDL cholesterol and subsequently also cardiovascular morbidity and mortality: (a) composite primary goal (cardiovascular mortality, incidence of heart attacks, strokes, hospitalizations for unstable angina, coronary revascularization) by 15 % (p < 0...
2017: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/28834473/evolocumab-in-patients-with-cardiovascular-disease
#16
LETTER
José P L Nunes
No abstract text is available yet for this article.
August 24, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28834472/evolocumab-in-patients-with-cardiovascular-disease
#17
LETTER
Konstantinos C Koskinas, Stephan Windecker
No abstract text is available yet for this article.
August 24, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28834471/evolocumab-in-patients-with-cardiovascular-disease
#18
LETTER
Marc S Sabatine, Robert P Giugliano, Terje R Pedersen
New England Journal of Medicine, Volume 377, Issue 8, Page 785-788, August 2017.
August 24, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28832867/cost-effectiveness-of-evolocumab-therapy-for-reducing-cardiovascular-events-in-patients-with-atherosclerotic-cardiovascular-disease
#19
Gregg C Fonarow, Anthony C Keech, Terje R Pedersen, Robert P Giugliano, Peter S Sever, Peter Lindgren, Ben van Hout, Guillermo Villa, Yi Qian, Ransi Somaratne, Marc S Sabatine
Importance: The proprotein convertase subtilisin/kexin type 9 inhibitor evolocumab has been demonstrated to reduce the composite of myocardial infarction, stroke, or cardiovascular death in patients with established atherosclerotic cardiovascular disease. To our knowledge, long-term cost-effectiveness of this therapy has not been evaluated using clinical trial efficacy data. Objective: To evaluate the cost-effectiveness of evolocumab in patients with atherosclerotic cardiovascular disease when added to standard background therapy...
August 23, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28817679/increased-half-life-and-enhanced-potency-of-fc-modified-human-pcsk9-monoclonal-antibodies-in-primates
#20
Yijun Shen, Hua Li, Li Zhao, Gang Li, Ben Chen, Qingsong Guo, Bei Gao, Jinsong Wu, Tong Yang, Li Jin, Yong Su
Blocking proprotein convertase subtilisin kexin type 9 (PCSK9) binding to low-density lipoprotein receptor (LDLR) can profoundly lower plasma LDL levels. Two anti-PCKS9 monoclonal antibodies (mAbs), alirocumab and evolocumab, were approved by the FDA in 2015. The recommended dose is 75 mg to 150 mg every two weeks for alirocumab and 140mg every two weeks or 420 mg once a month for evolocumab. This study attempted to improve the pharmacokinetic properties of F0016A, an IgG1 anti-PCKS9 mAb, to generate biologically superior molecules...
2017: PloS One
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