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https://www.readbyqxmd.com/read/28328015/pcsk9-inhibitor-access-barriers-issues-and-recommendations-improving-the-access-process-for-patients-clinicians-and-payers
#1
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/28304229/antidrug-antibodies-in-patients-treated-with-alirocumab
#2
Eli M Roth, Anne C Goldberg, Alberico L Catapano, Albert Torri, George D Yancopoulos, Neil Stahl, Aurélie Brunet, Guillaume Lecorps, Helen M Colhoun
No abstract text is available yet for this article.
March 17, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28292488/psychometric-evaluation-of-a-treatment-acceptance-measure-for-use-in-patients-receiving-treatment-via-subcutaneous-injection
#3
Sophi Tatlock, Rob Arbuckle, Robert Sanchez, Laura Grant, Irfan Khan, Garen Manvelian, John A Spertus
BACKGROUND: Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, significantly reduces low-density lipoprotein cholesterol, but requires subcutaneous injections rather than oral pills. To measure patients' acceptance of this treatment modality, a new patient-reported outcome, the Injection-Treatment Acceptance Questionnaire (I-TAQ), was developed. OBJECTIVES: To psychometrically evaluate the I-TAQ with patients at high risk of cardiovascular events receiving alirocumab...
March 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28289523/pcsk9-inhibitors-a-new-era-of-lipid-lowering-therapy
#4
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/28277798/alirocumab-for-the-treatment-of-hypercholesterolaemia
#5
Brian Tomlinson, Miao Hu, Yuzhen Zhang, Paul Chan, Zhong-Min Liu
Alirocumab is a human monoclonal antibody inhibiting proprotein convertase subtilisin/kexin type 9 (PCSK9) that is administered by subcutaneous injection every 2 weeks. Area covered: Herein, the authors discuss the background to inhibition of PCSK9 and the pharmacodynamics, pharmacokinetics and clinical trials with alirocumab. Alirocumab produces substantial reductions in low density lipoprotein cholesterol (LDL-C) in patients with and without background statin treatment. The safety profile appears very promising from the relatively short term studies that have been completed but there are some remaining concerns about long term risks of neurocognitive events and developing diabetes...
March 9, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28263403/alternative-treatment-regimens-with-the-pcsk9-inhibitors-alirocumab-and-evolocumab-a-pharmacokinetic-and-pharmacodynamic-modeling-approach
#6
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
#7
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/28206704/lipid-lowering-efficacy-and-safety-of-alirocumab-in-patients-with-or-without-diabetes-a-sub-analysis-of-odyssey-combo-ii
#8
Lawrence A Leiter, Jose Luis Zamorano, Maja Bujas-Bobanovic, Michael J Louie, Guillaume Lecorps, Christopher P Cannon, Yehuda Handelsman
AIM: This sub-analysis of the ODYSSEY COMBO II study compared the effects of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in high cardiovascular risk patients with or without diabetes mellitus (DM) receiving maximally tolerated statin therapy. MATERIALS AND METHODS: COMBO II was a 104-week, double-blind study (n = 720) enrolling patients with documented atherosclerotic cardiovascular disease (ASCVD) and baseline LDL-C ≥70 mg/dL (1...
February 16, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28163543/proprotein-convertase-subtilisin-kexin-type-9-enzyme-inhibitors-an-emerging-new-therapeutic-option-for-the-treatment-of-dyslipidemia
#9
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
#10
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/28153102/safety-of-very-low-low-density-lipoprotein-cholesterol-levels-with%C3%A2-alirocumab-pooled-data-from-randomized-trials
#11
Jennifer G Robinson, Robert S Rosenson, Michel Farnier, Umesh Chaudhari, William J Sasiela, Laurence Merlet, Kathryn Miller, John J P Kastelein
BACKGROUND: Proprotein convertase subtilisin/kexin type 9 monoclonal antibodies can reduce low-density lipoprotein cholesterol (LDL-C) to very low levels when added to background lipid-lowering therapy. OBJECTIVES: The safety of alirocumab was evaluated in patients with at least 2 consecutive LDL-C values <25 or <15 mg/dl in the ODYSSEY program, with follow-up as long as 104 weeks. METHODS: Pooled data from 14 trials were analyzed (double-blind treatment 8 to 104 weeks; n = 3,340 alirocumab, n = 1,894 control [placebo or ezetimibe]; representing 4,029 [alirocumab] and 2,114 [control] double-blind patient-years' exposure)...
February 7, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28137217/anti-pcsk9-antibodies-a-new-era-in-the-treatment-of-dyslipidemia
#12
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
#13
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
https://www.readbyqxmd.com/read/28115017/efficacy-safety-low-density-lipoprotein-cholesterol-lowering-and-calculated-10-year-cardiovascular-risk-reduction-of-alirocumab-and-evolocumab-in-addition-to-maximal-tolerated-cholesterol-lowering-therapy-a-post-commercialization-study
#14
Parth Shah, Charles J Glueck, Naila Goldenberg, Sarah Min, Chris Mahida, Ilana Schlam, Matan Rothschild, Ali Huda, Ping Wang
BACKGROUND: Efficacy and safety of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, alirocumab (ALI) and evolocumab (EVO) have previously been evaluated through controlled clinical trials with selective patient groups. Post-commercially, in patients with heterozygous familial hypercholesterolemia (HeFH) and/or cardiovascular disease (CVD) with suboptimal LDL cholesterol (LDLC) lowering on maximal tolerated cholesterol lowering therapy, we assessed efficacy and safety of ALI and EVO...
January 23, 2017: Lipids in Health and Disease
https://www.readbyqxmd.com/read/28093956/praluent-alirocumab-induced-renal-injury
#15
Kenar D Jhaveri, Valerie S Barta, James Pullman
No abstract text is available yet for this article.
February 2017: Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/28063030/target-mediated-drug-disposition-population-pharmacokinetics-model-of-alirocumab-in-healthy-volunteers-and-patients-pooled-analysis-of-randomized-phase-i-ii-iii-studies
#16
Nassim Djebli, Jean-Marie Martinez, Laura Lohan, Sonia Khier, Aurélie Brunet, Fabrice Hurbin, David Fabre
BACKGROUND AND OBJECTIVE: Proprotein convertase subtilisin/kexin type 9 inhibition with monoclonal antibodies such as alirocumab significantly reduces low-density lipoprotein-cholesterol levels ± other lipid-lowering therapies. We aimed to develop and qualify a population pharmacokinetics (PopPK) model for alirocumab in healthy subjects and patients, taking into account the mechanistic target-mediated drug disposition (TMDD) process. METHODS: This TMDD model was developed using a subset of the alirocumab clinical trial database, including nine phase I/II/III studies (n = 527); the model was subsequently expanded to a larger data set of 13 studies (n = 2870)...
January 6, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28060539/bococizumab-for-the-treatment-of-hypercholesterolaemia
#17
Nicola Ferri, Alberto Corsini, Cesare R Sirtori, Massimiliano Ruscica
Low-density lipoprotein cholesterol (LDL-C) remains a well-established risk factor for cardiovascular disease (CVD). LDL-C levels are considered primary targets of therapy. A new series of systemic biomolecules, the monoclonal antibodies (mAbs) of proprotein convertase subtilisin/kexin type 9 (PCSK9), have a higher activity in reducing LDL-C. Areas covered: The authors critically review the current evidence on the efficacy and safety of bococizumab, a humanized mAb against PCSK9, which was surprisingly discontinued in November 2016...
February 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28038950/pcsk9-inhibitors-in-the-current-management-of-atherosclerosis
#18
Thomas F Whayne
The history of proprotein convertase subtilisin/kexin type 9 (PCSK9) in medical science is fascinating and the evolution of knowledge of its function has resulted in new medications of major importance for the cardiovascular (CV) patient. PCSK9 functions as a negative control or feedback for the cell surface receptors for low-density lipoprotein including its component of cholesterol (LDL-C). The initial and key findings were that different abnormalities of PCSK9 can result in an increase or a decrease of LDL-C because of more or less suppression of cell surface receptors...
January 2017: Archivos de Cardiología de México
https://www.readbyqxmd.com/read/28025677/pcsk9-inhibition-the-dawn-of-a-new-age-in-cholesterol-lowering
#19
REVIEW
David Preiss, Marion Mafham
Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a circulating enzyme of hepatic origin that plays a key role in LDL receptor turnover. Genetic studies have confirmed that individuals with gain-of-function PCSK9 mutations have increased PCSK9 activity, elevated LDL-cholesterol levels and a severe form of familial hypercholesterolaemia. Those with variants leading to reduced PCSK9 have lower LDL-cholesterol levels and a reduced risk of coronary heart disease, and this has led to the development of various strategies aimed at reducing circulating PCSK9...
March 2017: Diabetologia
https://www.readbyqxmd.com/read/27993383/old-challenges-and-new-opportunities-in-the-clinical-management-of-heterozygous-familial-hypercholesterolemia-hefh-the-promises-of-pcsk9-inhibitors
#20
REVIEW
Marcello Arca
Heterozygous familial hypercholesterolemia (HeFH) is a common (early estimates suggested a prevalence of 1 in 500 individuals, but recent studies have indicated that it may be higher) genetic disorder characterized by markedly elevated plasma concentrations of low-density lipoprotein cholesterol (LDL-C). HeFH is associated with an elevated risk of premature coronary heart disease, stroke, and peripheral vascular disease. Despite the availability of reliable diagnostic criteria (high LDL-C levels, family history or premature CHD and hypercholesterolemia, cerebral/peripheral vascular disease, and the presence of tendon xanthomata or presence of arcus cornealis before age of 45), HeFH is underdiagnosed and undertreated worldwide...
January 2017: Atherosclerosis
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