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Alirocumab

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https://www.readbyqxmd.com/read/29153823/a-randomized-trial-evaluating-the-efficacy-and-safety-of-alirocumab-in-south-korea-and-taiwan-odyssey-kt
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
https://www.readbyqxmd.com/read/28862926/alirocumab-treatment-and-achievement-of-non-high-density-lipoprotein-cholesterol-and-apolipoprotein-b-goals-in-patients-with-hypercholesterolemia-pooled-results-from-10-phase-3-odyssey-trials
#14
Harold E Bays, Lawrence A Leiter, Helen M Colhoun, Desmond Thompson, Laurence Bessac, Robert Pordy, Peter P Toth
BACKGROUND: Non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein (apo) B are better predictors of atherosclerotic cardiovascular disease risk than low-density lipoprotein cholesterol alone. US and European lipid management guidelines support non-HDL-C and apoB as targets for lipid-lowering therapy. METHODS AND RESULTS: This analysis evaluated the efficacy of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, on non-HDL-C and apoB...
August 8, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28854074/implementation-of-a-new-clinic-based-pharmacist-managed-pcsk9-inhibitor-consultation-service
#15
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/28817679/increased-half-life-and-enhanced-potency-of-fc-modified-human-pcsk9-monoclonal-antibodies-in-primates
#16
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
https://www.readbyqxmd.com/read/28804243/a-quantitative-systems-pharmacology-platform-to-investigate-the-impact-of-alirocumab-and-cholesterol-lowering-therapies-on-lipid-profiles-and-plaque-characteristics
#17
Jeffrey E Ming, Ruth E Abrams, Derek W Bartlett, Mengdi Tao, Tu Nguyen, Howard Surks, Katherine Kudrycki, Ananth Kadambi, Christina M Friedrich, Nassim Djebli, Britta Goebel, Alex Koszycki, Meera Varshnaya, Joseph Elassal, Poulabi Banerjee, William J Sasiela, Michael J Reed, Jeffrey S Barrett, Karim Azer
Reduction in low-density lipoprotein cholesterol (LDL-C) is associated with decreased risk for cardiovascular disease. Alirocumab, an antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduces LDL-C. Here, we report development of a quantitative systems pharmacology (QSP) model integrating peripheral and liver cholesterol metabolism, as well as PCSK9 function, to examine the mechanisms of action of alirocumab and other lipid-lowering therapies, including statins. The model predicts changes in LDL-C and other lipids that are consistent with effects observed in clinical trials of single or combined treatments of alirocumab and other treatments...
2017: Gene Regulation and Systems Biology
https://www.readbyqxmd.com/read/28799203/efficacy-and-safety-of-alirocumab-in-people-with-prediabetes-vs-those-with-normoglycaemia-at-baseline-a-pooled-analysis-of-10-phase-iii-odyssey-clinical-trials
#18
L A Leiter, D Müller-Wieland, M T Baccara-Dinet, A Letierce, R Samuel, B Cariou
AIM: To assess the lipid-lowering efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in people with hypercholesterolaemia and prediabetes at baseline vs people with normoglycaemia at baseline in a pooled analysis of 10 ODYSSEY phase III trials. METHODS: People classified as having prediabetes had baseline HbA1c ≥39 mmol/mol (5.7%) and <48 mmol/mol (6.5%), or two baseline fasting plasma glucose values ≥5.6 mmol/l (100 mg/dl) but no more than one fasting plasma glucose value ≥7...
August 11, 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28798072/the-roles-of-apo-a-size-phenotype-and-dominance-pattern-in-pcsk9-inhibition-induced-reduction-in-lp-a-with-alirocumab
#19
Byambaa Enkhmaa, Erdembileg Anuurad, Wei Zhang, Kun Yue, Ching-Shang Li, Lars Berglund
An elevated level of lipoprotein (a) [Lp(a)] is a risk factor for CVD. Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9, is reported to reduce Lp(a) levels. The relationship of Lp(a) reduction with apo(a) size polymorphism, phenotype, and dominance pattern and LDL cholesterol (LDL-C) reduction was evaluated in a pooled analysis of 155 hypercholesterolemic patients (75 with heterozygous familial hypercholesterolemia) from two clinical trials. Alirocumab significantly reduced total Lp(a) (pooled median: -21%, P = 0...
October 2017: Journal of Lipid Research
https://www.readbyqxmd.com/read/28768335/simulation-of-lipid-lowering-therapy-intensification-in-a-population-with-atherosclerotic-cardiovascular-disease
#20
Christopher P Cannon, Irfan Khan, Alexa C Klimchak, Matthew R Reynolds, Robert J Sanchez, William J Sasiela
Importance: In patients with atherosclerotic cardiovascular disease (ASCVD), guidelines recommend optimizing statin treatment, and consensus pathways suggest use of ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in patients with persistently elevated low-density lipoprotein cholesterol (LDL-C) levels despite use of statins. Recent trials have provided evidence of benefit in reduction of cardiovascular events with these agents. Objective: To estimate the percentage of patients with ASCVD who would require a PCSK9 inhibitor when oral lipid-lowering therapy (LLT) is intensified first...
September 1, 2017: JAMA Cardiology
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