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Alirocumab

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https://www.readbyqxmd.com/read/29299849/lipid-management-in-chronic-kidney-disease-systematic-review-of-pcsk9-targeting
#1
REVIEW
BinBin Zheng-Lin, Alberto Ortiz
Cardiovascular disease is the leading cause of death in patients with chronic kidney disease (CKD) and CKD is considered a coronary artery disease risk equivalent. So far, statins have been the mainstay of primary and secondary prevention of cardiovascular disease in the general population. However, their benefit on outcomes is limited and controversial in CKD patients and new therapeutic approaches to reduce cardiovascular risk are needed. Monoclonal antibodies targeting proprotein convertase subtilisin/kexin 9 (PCSK9) reduce low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) in high-risk populations and cardiovascular events in secondary prevention...
January 3, 2018: Drugs
https://www.readbyqxmd.com/read/29285510/the-odyssey-dm-dyslipidemia-trial-confirming-the-benefits-of-alirocumab-in-diabetic-mixed-dyslipidemia
#2
EDITORIAL
Paul Chan, Li Shao, Brian Tomlinson, Zhong-Min Liu
No abstract text is available yet for this article.
December 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/29231064/pharmacokinetics-pharmacodynamics-and-clinical-efficacy-of-non-statin-treatments-for-hypercholesterolemia
#3
REVIEW
Arrigo F G Cicero, Marilisa Bove, Claudio Borghi
Hypercholesterolemia is the main modifiable risk factor for atherosclerosis progression and cardiovascular disease (CVD) development. Its pharmacological management is usually based on the prescription of statins, that in some cases are not however fully effective to reach the desired Low-Density-Lipoproteins cholesterol (LDL-C) target, or are not tolerated by patients due to side effects. Areas covered: This manuscript summarizes the basic properties of the emerging new classes of lipid-lowering drugs such as ezetimibe, Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors, and Microsomal Triglyceride Transfer Protein (MTP) inhibitors, also citing new drugs in development...
January 2018: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/29223954/effect-of-pcsk9-inhibitors-on-clinical-outcomes-in-patients-with-hypercholesterolemia-a-meta-analysis-of-35-randomized-controlled-trials
#4
REVIEW
Aris Karatasakis, Barbara A Danek, Judit Karacsonyi, Bavana V Rangan, Michele K Roesle, Thomas Knickelbine, Michael D Miedema, Houman Khalili, Zahid Ahmad, Shuaib Abdullah, Subhash Banerjee, Emmanouil S Brilakis
BACKGROUND: We sought to examine the efficacy and safety of 2 PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors: alirocumab and evolocumab. METHODS AND RESULTS: We performed a systematic review and meta-analysis of randomized controlled trials comparing treatment with and without PCSK9 inhibitors; 35 randomized controlled trials comprising 45 539 patients (mean follow-up: 85.5 weeks) were included. Mean age was 61.0±2.8 years, and mean baseline low-density lipoprotein cholesterol was 106±22 mg/dL...
December 9, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/29186504/no-evidence-of-neurocognitive-adverse-events-associated-with-alirocumab-treatment-in-3340-patients-from-14-randomized-phase-2-and-3-controlled-trials-a-meta-analysis-of-individual-patient-data
#5
Philip D Harvey, Marwan N Sabbagh, John E Harrison, Henry N Ginsberg, M John Chapman, Garen Manvelian, Angele Moryusef, Jonas Mandel, Michel Farnier
Aims: Despite patient reports of neurocognitive disorders with lipid-lowering treatments (LLTs), large clinical trials have found no significant association between neurocognitive disorders and LLTs. We assessed incidence of neurocognitive treatment-emergent adverse events (TEAEs) from 14 Phase 2 and 3 trials of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab. Methods and results: Patients (most on background maximally tolerated statin) received alirocumab 75/150 mg every 2 weeks (n = 3340; 4029 patient-years of exposure), placebo (n = 1276), or ezetimibe (n = 618)...
November 27, 2017: European Heart Journal
https://www.readbyqxmd.com/read/29181773/budget-impact-analysis-of-pcsk9-inhibitors-for-the-management-of-adult-patients-with-heterozygous-familial-hypercholesterolemia-or-clinical-atherosclerotic-cardiovascular-disease
#6
Usha G Mallya, Susan H Boklage, Andrew Koren, Thomas E Delea, C Daniel Mullins
OBJECTIVE: The aim of this study was to assess the budget impact of introducing the proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) alirocumab and evolocumab to market for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular (CV) disease requiring additional lowering of low-density lipoprotein cholesterol (LDL-C). METHODS: A 3-year model estimated the costs of lipid-modifying therapy (LMT) and CV events to a hypothetical US health plan of 1 million members, comparing two scenarios-with and without the availability of PCSK9i as add-on therapy to statins...
November 27, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/29171769/alirocumab-for-the-treatment-of-hyperlipidemia-in-high-risk-patients-an-updated-review
#7
Michael Farnier
Alirocumab is a fully human immunoglobulin G1 monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9) approved for the treatment of hypercholesterolemia in high-risk patients. The objective is to provide an updated review of the recent data published for alirocumab. Areas covered: The efficacy and safety of alirocumab has been initially evaluated in a comprehensive phase 3 program conducted in more than 6 000 patients with primary non-familial and heterozygous familial hypercholesterolemia: alirocumab reduced LDL-cholesterol up to 62% in phase 3 with every 2-week dosing compared with placebo, and up to 36% compared with ezetimibe, with an excellent safety and tolerability profile...
November 24, 2017: Expert Review of Cardiovascular Therapy
https://www.readbyqxmd.com/read/29153823/a-randomized-trial-evaluating-the-efficacy-and-safety-of-alirocumab-in-south-korea-and-taiwan-odyssey-kt
#8
Kwang Kon Koh, Chang Wook Nam, Ting-Hsing Chao, Ming-En Liu, Chiung-Jen Wu, Dong-Soo Kim, Chong-Jin Kim, Ivy Li, Jianyong Li, Marie T Baccara-Dinet, Pi-Jung Hsiao, Chern-En Chiang
BACKGROUND: Alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, has been shown to provide significant reductions in low-density lipoprotein cholesterol (LDL-C). Data about its efficacy and safety in patients from South Korea and Taiwan are limited. OBJECTIVE: ODYSSEY KT assessed the efficacy and safety of alirocumab in patients from South Korea and Taiwan. METHODS: Patients with hypercholesterolemia at high cardiovascular risk who were on maximally tolerated statin were randomized (1:1) to alirocumab (75 mg every 2 weeks, with dose increase to 150 mg every 2 weeks at week 12 if LDL-C ≥70 mg/dL at week 8) or placebo for 24 weeks...
October 19, 2017: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/29121222/neurological-effects-of-proprotein-convertase-subtilisin-kexin-type-9-inhibitors-direct-comparisons
#9
Navkaranbir S Bajaj, Nirav Patel, Rajat Kalra, Amier Ahmad, Anand Venkatraman, Garima Arora, Pankaj Arora
Aims: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors considerably alter the lipid profile. We sought to examine rates of ischemic stroke, and neurocognitive deficits in patients treated with and without PCSK9 inhibitors. Methods and Results: Randomized controlled trials (RCTs) reporting rates of ischemic stroke, and neurocognitive deficits in patients using PCSK9 inhibitors were identified. Standard meta-analysis techniques were used to compare these outcomes among patients treated with and without PCSK9 inhibitors, and the two U...
October 6, 2017: European Heart Journal. Quality of Care & Clinical Outcomes
https://www.readbyqxmd.com/read/29116337/effects-of-monoclonal-antibodies-against-pcsk9-on-clinical-cardiovascular-events-a%C3%A2-meta-analysis-of-randomized-controlled-trials
#10
Y Zhu, X Shen, Q Jiang, Z Wang, Z Wang, X Dong, J Li, Q Han, J Zhao, B Wang, L Liu
BACKGROUND: The present meta-analysis was designed to improve statistical power and review the effects of monoclonal antibodies against PCSK9 on clinical cardiovascular events. METHODS: PubMed, Embase, Web of Science, and the Cochrane Library were searched from inception to May 2017. Studies considered to be eligible were randomized controlled trials about the effects of monoclonal antibodies against PCSK9 on clinical cardiovascular events. The primary endpoint was positively adjudicated cardiovascular events; the secondary endpoint comprised cardiac mortality, myocardial infarction (MI), coronary revascularization, stroke, and hospitalization for unstable angina...
November 7, 2017: Herz
https://www.readbyqxmd.com/read/29096867/the-efficacy-of-anti-pcsk9-antibodies-results-from-recent-trials
#11
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 the lysosome for degradation. This results in decreased numbers of LDLR available on the cell surface to bind LDL particles and remove them from the circulation and a subsequent 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...
November 2017: Atherosclerosis. Supplements
https://www.readbyqxmd.com/read/29056268/successful-treatment-of-a-patient-with-statin-induced-myopathy-and-myotonic-dystrophy-type-ii-with-proprotein-convertase-subtilisin-kexin-type-9-inhibitor-alirocumab-praluent
#12
Mohamed K M Shakir, Terry Shin, Thanh D Hoang, Vinh Q Mai
Presently there are limited treatment options for hypercholesterolemia in patients with statin intolerance and myotonic dystrophy. A 74 year-old male presented to endocrine clinic with hypercholesterolemia (serum LDL-C 210 mg/dL), hypogonadism, insulin-controlled type 2 diabetes mellitus, and minimally elevated serum creatine kinase (CK) levels (184 U/L, ref. range 38-174). Shortly after simvastatin treatment, patient developed severe myalgias in the proximal lower and upper extremities; and serum CK increased to 317 U/L...
September 4, 2017: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/29038906/pcsk9-mutations-in-familial-hypercholesterolemia-from-a-groundbreaking-discovery-to-anti-pcsk9-therapies
#13
REVIEW
Petra El Khoury, Sandy Elbitar, Youmna Ghaleb, Yara Abou Khalil, Mathilde Varret, Catherine Boileau, Marianne Abifadel
PURPOSE OF REVIEW: In 2003, Abifadel et al. (Nat. Genet. 34:154-156, 2003) identified PCSK9, encoding proprotein convertase subtilisin/kexin type 9, as the third causal gene for autosomal dominant hypercholesterolemia. This review focuses on the main steps from this major breakthrough in familial hypercholesterolemia (FH) to the latest clinical trials with the anti-PCSK9 antibodies. RECENT FINDINGS: The year 2015 was remarkable in cardiovascular disease through the field of cholesterol...
October 17, 2017: Current Atherosclerosis Reports
https://www.readbyqxmd.com/read/28994502/pro-protein-subtilisin-kexin-9-pcsk9-inhibition-in-practice-lipid-clinic-experience-in-2-contrasting-uk-centres
#14
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/28978220/pcsk9-inhibitors-and-managing-cost-in-the-managed-care-setting
#15
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/28974137/re-praluent-alirocumab-induced-renal-injury
#16
Robert S Rosenson, Dominique Larrey, David D Waters, Anders G Olsson
No abstract text is available yet for this article.
January 1, 2017: Journal of Pharmacy Practice
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
#17
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/28964736/efficacy-of-alirocumab-in-1191-patients-with-a-wide-spectrum-of-mutations-in-genes-causative-for-familial-hypercholesterolemia
#18
Joep C Defesche, Claudia Stefanutti, Gisle Langslet, Paul N Hopkins, Werner Seiz, Marie T Baccara-Dinet, Sara C Hamon, Poulabi Banerjee, John J P Kastelein
BACKGROUND: Mutation(s) in genes involved in the low-density lipoprotein receptor (LDLR) pathway are typically the underlying cause of familial hypercholesterolemia. OBJECTIVE: The objective of the study was to examine the influence of genotype on treatment responses with alirocumab. METHODS: Patients from 6 trials (n = 1191, including 758 alirocumab-treated; Clinicaltrials.gov identifiers: NCT01266876; NCT01507831; NCT01623115; NCT01709500; NCT01617655; NCT01709513) were sequenced for mutations in LDLR, apolipoprotein B (APOB), proprotein convertase subtilisin/kexin type 9 (PCSK9), LDLR adaptor protein 1, and signal-transducing adaptor protein 1 genes...
September 4, 2017: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/28919772/anti-pcsk9-antibodies-for-the-treatment-of-heterozygous-familial-hypercholesterolemia-patient-selection-and-perspectives
#19
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/28905478/efficacy-and-safety-of-alirocumab-in-insulin-treated-individuals-with-type-1-or-type-2-diabetes-and-high-cardiovascular-risk-the-odyssey-dm-insulin-randomized-trial
#20
Lawrence A Leiter, Bertrand Cariou, Dirk Müller-Wieland, Helen M Colhoun, Stefano Del Prato, Francisco J Tinahones, Kausik K Ray, Maja Bujas-Bobanovic, Catherine Domenger, Jonas Mandel, Rita Samuel, Robert R Henry
AIMS: To investigate the efficacy and safety of alirocumab in participants with type 2 (T2D) or type 1 diabetes (T1D) treated with insulin who have elevated LDL cholesterol levels despite maximally tolerated statin therapy. METHODS: Participants at high cardiovascular risk with T2D (n = 441) or T1D (n = 76) and LDL cholesterol levels ≥1.8 mmol/L (≥70 mg/dL) were randomized 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks, for 24 weeks' double-blind treatment...
September 14, 2017: Diabetes, Obesity & Metabolism
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