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PCSK9 inhibitors

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https://www.readbyqxmd.com/read/29792269/pcsk9-inhibition-ready-for-prime-time-in-ckd
#1
Marion Mafham, Richard Haynes
Lowering LDL cholesterol reduces the risk of atherosclerotic vascular disease in a wide range of patients with chronic kidney disease, with no evidence of a threshold below which further reductions no longer reduce risk. Statins safely lower LDL cholesterol, but novel inhibitors of proprotein convertase subtilisin kexin 9 (PCSK9) provide additional reductions which may reduce atherosclerotic vascular disease yet further in this high risk population.
June 2018: Kidney International
https://www.readbyqxmd.com/read/29779055/economic-evaluation-of-the-pcsk9-inhibitors-in-prevention-of-the-cardiovascular-diseases
#2
REVIEW
Parth Shah
PURPOSE OF REVIEW: This review aims to explore and summarize the current literature on the cardiovascular disease (CVD) healthcare burden and determine the cost-effectiveness of the PCSK9 inhibitors. RECENT FINDINGS: The CVD remain the largest cause of mortality in the USA presenting substantial healthcare cost burden reaching $555 billion in 2016 and projected to rise to $1.1 trillion by 2035. The PCSK9 inhibitors have shown strong efficacy in LDLC lowering, but its price of ~ 14,000-14,600 per patient per year coupled with ~ 2...
May 19, 2018: Current Cardiology Reports
https://www.readbyqxmd.com/read/29777433/are-pcsk9-inhibitors-cost-effective
#3
Max J Korman, Kjetil Retterstøl, Ivar Sønbø Kristiansen, Torbjørn Wisløff
The objective of this study was to review available health economic evaluations of PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. These drugs reduce low-density lipid cholesterol levels and cardiovascular risk, but their cost effectiveness has been questioned. We searched Medline and Embase for economic evaluations in any language at any time. Studies were included if they analysed any PCSK9 inhibitor compared with either statin alone or in combination with ezetimibe or any other therapy considered standard prior to the introduction of PCSK9 inhibitors...
May 18, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29770231/cardiovascular-outcomes-of-pcsk9-inhibitors-with-special-emphasis-on-its-effect-beyond-ldl-cholesterol-lowering
#4
REVIEW
Dhrubajyoti Bandyopadhyay, Kumar Ashish, Adrija Hajra, Arshna Qureshi, Raktim K Ghosh
PCSK9 inhibitors, monoclonal antibodies, are novel antihypercholesterolemic drugs. FDA first approved them in July 2015. PCSK9 protein (692-amino acids) was discovered in 2003. It plays a major role in LDL receptor degradation and is a prominent modulator in low-density lipoprotein cholesterol (LDL-C) metabolism. PCSK9 inhibitors are monoclonal antibodies that target PCSK9 protein in liver and inhibiting this protein leads to drastically lowering harmful LDL-C level in the bloodstream. Despite widespread use of the statin, not all the high-risk patients were able to achieve targeted level of LDL-C...
2018: Journal of Lipids
https://www.readbyqxmd.com/read/29768954/comparison-of-ldl-c-reduction-using-different-evolocumab-doses-and-intervals-biological-insights-and-treatment-implications
#5
Scott M Wasserman, Marc S Sabatine, Michael J Koren, Robert P Giugliano, Jason C Legg, Maurice G Emery, Sameer Doshi, Thomas Liu, Ransi Somaratne, John P Gibbs
BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduces low-density lipoprotein cholesterol (LDL-C) and the risk of cardiovascular events. OBJECTIVES: To compare LDL-C reduction using evolocumab 140 mg once every 2 weeks (Q2W) or 420 mg monthly (QM) versus lower doses (70 mg Q2W or 280 mg QM) or placebo. METHODS: Patients received evolocumab 70 or 140 mg Q2W, 280 or 420 mg QM, or placebo Q2W or QM in two 12-week phase 2 studies: one with and one without statins...
January 1, 2018: Journal of Cardiovascular Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29758414/role-of-pcsk9-in-lipid-metabolism-and-atherosclerosis
#6
REVIEW
Xiao-Long Lin, Le-Le Xiao, Zhi-Han Tang, Zhi-Sheng Jiang, Mi-Hua Liu
Elevated plasma low-density lipoprotein cholesterol (LDL-C) is an important risk factor for cardiovascular diseases. Statins are the most widely used therapy for patients with hyperlipidemia. However, a significant residual cardiovascular risk remains in some patients even after maximally tolerated statin therapy. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a new pharmacologically therapeutic target for decreasing LDL-C. PCSK9 reduces LDL intake from circulation by enhancing LDLR degradation and preventing LDLR recirculation to the cell surface...
May 11, 2018: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/29748356/variation-in-lipid-lowering-therapy-use-in-patients-with-low-density-lipoprotein-cholesterol-%C3%A2-190-mg-dl-insights-from-the-national-cardiovascular-data-registry-practice-innovation-and-clinical-excellence-registry
#7
Salim S Virani, Kevin F Kennedy, Julia M Akeroyd, Pamela B Morris, Vera A Bittner, Frederick A Masoudi, Neil J Stone, Laura A Petersen, Christie M Ballantyne
BACKGROUND: Patients with low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL are at high risk of atherosclerotic cardiovascular disease events. Treatment guidelines recommend intensive treatment in these patients. Variation in the use of lipid-lowering therapies (LLTs) in these patients in a national sample of cardiology practices is not known. METHODS AND RESULTS: Using data from the American College of Cardiology National Cardiovascular Data Registry-Practice Innovation and Clinical Excellence registry, we assessed the proportion of patients with LDL-C ≥190 mg/dL (n=49 447) receiving statin, high-intensity statin, LLT associated with ≥50% LDL-C lowering, ezetimibe, or a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor between January 2013 and December 2016...
May 2018: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/29747383/current-role-of-lipoprotein-apheresis-in-the-treatment-of-high-risk-patients
#8
REVIEW
Ulrich Julius
Lipoprotein apheresis (LA) is a therapeutic approach to save the lives of patients who are at an extremely high risk of developing cardiovascular events (CVE), especially after all other therapeutic options were not tolerated, or appeared not to be effective enough. Homozygous familial hypercholesterolemia represents a clear indication to start LA therapy. Another recognized indication is a severe hypercholesterolemia, which induced CVE, often in association with other risk factors. In the last years, an expressive elevation of lipoprotein(a) (Lp(a)) emerged as an indication for LA...
May 9, 2018: Journal of Cardiovascular Development and Disease
https://www.readbyqxmd.com/read/29740798/new-insight-on-a-combination-of-policosanol-and-10-dehydrogingerdione-phytochemicals-as-inhibitors-for-platelet-activation-biomarkers-and-atherogenicity-risk-in-dyslipidemic-rabbits-role-of-cetp-and-pcsk9-inhibition
#9
Mohamed Mahmoud Elseweidy, Rawia Sarhan Amin, Hebatallah Husseini Atteia, Reham Raafat El-Zeiky, Naif A Al-Gabri
Platelet markers [soluble p selectin (sP-selectin) and soluble CD40 ligand (sCD40L)] are associated with platelet activation and cardiovascular risk. Both policosanol and 10-dehydrogingerdione are natural products with proven CETP inhibitory and antiatherogenic effects. Present work aimed mainly to investigate the levels of platelet activation biomarkers in the serum of dyslipidemic rabbits and the potential of these phytochemicals either alone or in a combination form to protect against atherogenicity. Additionally, this work clarified their effect on PCSK9, a key player in atherosclerosis progression...
May 9, 2018: Applied Biochemistry and Biotechnology
https://www.readbyqxmd.com/read/29737886/role-of-proprotein-convertase-subtilisin-kexin-type-9-inhibitors-in-patients-with-coronary-artery-disease-undergoing-percutaneous-coronary-intervention
#10
Eliano P Navarese, Michalina Kołodziejczak, Aniela Petrescu, Bernhard Wernly, Michael Lichtenauer, Alexander Lauten, Antonino Buffon, Wojciech Wanha, Vincenzo Pestrichella, Gennaro Sardella, Gaetano Contegiacomo, Udaya Tantry, Kevin Bliden, Jacek Kubica, Paul A Gurbel
Although novel therapies have improved outcomes in PCI patients, a sizeable number of patients still remain at high cardiovascular risk for recurrent event. There is therefore an unmet need for novel therapies that can improve clinical outcomes, with an associated satisfactory safety profile. Proprotein convertase subtilisin/kexin type 9 (PCSK9) enzyme is a novel lipid-lowering target with a potential to impact high-cardiovascular risk populations including patients with coronary artery disease (CAD), undergoing the percutaneous coronary intervention (PCI)...
May 8, 2018: Expert Review of Cardiovascular Therapy
https://www.readbyqxmd.com/read/29737015/therapeutic-agents-targeting-cardiometabolic-risk-for-preventing-and-treating-atherosclerotic-cardiovascular-diseases
#11
Benoit J Arsenault, Nicolas Perrot, Rishi Puri
Targeting atherogenic lipoprotein levels with statins remains the current cornerstone of atherosclerotic cardiovascular disease (ACVD) management. In patients at high ACVD risk who cannot achieve the desired low-density lipoprotein (LDL) cholesterol target, the addition of compounds such as ezetimibe and proprotein subtilisin/kexin type-9 (PCSK9) inhibitors incrementally lowers cardiovascular risk. New glucose-lowering drugs such as glucacon-like peptide-1 receptor (GLP1R) agonists and sodium-glucose co-transporter-2 (SGLT2) inhibitors were also shown to improve cardiometabolic risk factors and provide cardiovascular benefits in patients with type 2 diabetes...
May 8, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29731350/the-cost-effectiveness-of-pcsk9-inhibitors-the-australian-healthcare-perspective
#12
Radya Kumar, Andrew Tonkin, Danny Liew, Ella Zomer
BACKGROUND: For patients in whom statins are not tolerated or effective as monotherapy, proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) represent a new class of lipid lowering therapies that may reduce low-density lipoprotein cholesterol (LDL-C) levels by up to 50% and lower cardiovascular events. While an important treatment option, the cost-effectiveness of PCSK9i in Australia remains unknown. This study aimed to determine the cost-effectiveness of PCSK9i compared to placebo in the prevention of atherosclerotic cardiovascular disease (CVD)...
April 26, 2018: International Journal of Cardiology
https://www.readbyqxmd.com/read/29706812/usefulness-of-alirocumab-and-evolocumab-for-the-treatment-of-patients-with-diabetic-dyslipidemia
#13
REVIEW
Jun Zhang, Kristen M Tecson, Natalia A Rocha, Peter A McCullough
In 2015, the US Food and Drug Administration (FDA) approved the anti-proprotein convertase subtilsin/kexin type 9 (PCSK9) monoclonal antibodies, alirocumab and evolocumab, to treat patients with hypercholesterolemia and mixed dyslipidemia. Since then, considerable attention has been paid to the use of these monoclonal antibodies for the treatment of diabetic dyslipidemia with a goal of reducing the risk for cardiovascular disease. Recently, consensus statements on the clinical use of PCSK9 inhibitors in patients with type 2 diabetes mellitus, who are unable to achieve the goal of low-density lipoprotein cholesterol (<70 mg/dL or <1...
April 2018: Proceedings of the Baylor University Medical Center
https://www.readbyqxmd.com/read/29692249/pcsk9-inhibitors-novel-therapeutic-strategies-for-lowering-ldl-cholesterol
#14
Zhao-Peng Liu, Yan Wang
Statins are currently the major therapeutic strategies to lower low-density lipoprotein cholesterol (LDL-C) levels. However, a number of hypercholesterolemia patients still have a residual cardiovascular disease (CVD) risk despite taking the maximum-tolerated dose of statins. Proprotein convertase subtilisin/kexin type 9 (PCSK9) binds to low-density lipoprotein receptor (LDLR), inducing its degradation in the lysosome and inhibiting LDLR recirculating to the cell membranes. The gain-of-function mutations in PCSK9 elevate the LDL-C levels in plasma...
April 22, 2018: Mini Reviews in Medicinal Chemistry
https://www.readbyqxmd.com/read/29688615/comparative-pharmacokinetics-and-pharmacodynamics-of-bococizumab-following-a-single-subcutaneous-injection-using-drug-substance-manufactured-at-two-sites-or-administration-via-two-different-devices
#15
Ellen Q Wang, Anna Plotka, Joanne Salageanu, Daniel Baltrukonis, Khurshid Mridha, Robert Frederich, Beth E Sullivan
The pharmacokinetics (PK) and pharmacodynamics (PD) of bococizumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, were compared following a single 150-mg subcutaneous dose administered to healthy subjects (n = 156-158/arm) via: (1) a prefilled syringe (PFS) using drug substance (DS) manufactured by Pfizer, (2) a PFS using DS manufactured by Boehringer Ingelheim Pharma, (3) a prefilled pen using DS manufactured by Pfizer (NCT02458209). Blood samples were collected for 12 weeks postdose...
April 24, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29685715/a-small-change-can-make-a-big-difference-a-lesson-from-evolocumab
#16
Sam Mirzaee, Paul M Thein, Dennis Wong, Arthur Nasis
BACKGROUND: Evolocumab is an expensive proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor which has been shown to significantly improve cardiovascular outcomes in high risk patients. METHODS: This is a case study describing a stepwise approach to "PCSK9 inhibitor non-response" in a patient with familial hypercholesterolaemia. There are a few described pathophysiological mechanisms for "PCSK9 inhibitor non-response" including homozygous LDL-C receptor-negative mutations and alteration in the binding site of PCSK9 inhibitors...
March 20, 2018: Heart, Lung & Circulation
https://www.readbyqxmd.com/read/29685591/cardiovascular-event-reduction-with-pcsk9-inhibition-among-1578-patients-with-familial-hypercholesterolemia-results-from-the-spire-randomized-trials-of-bococizumab
#17
Paul M Ridker, Lynda M Rose, John J P Kastelein, Raul D Santos, Caimiao Wei, James Revkin, Carla Yunis, Jean-Claude Tardif, Charles L Shear
BACKGROUND: Familial hypercholesterolemia (FH) is a dominant genetic disorder associated with elevated low-density lipoprotein cholesterol (LDL-C) and premature atherosclerotic events. Although therapeutic monoclonal antibodies that inhibit proprotein convertase subtilisin-kexin type 9 (PCSK9) are indicated for LDL-C reduction among adult patients with FH, placebo-controlled outcome data among FH patients are scant. OBJECTIVE: Directly compare the efficacy of PCSK9 inhibition as compared to placebo on hard cardiovascular outcomes in FH patients enrolled in the Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) program...
April 3, 2018: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/29674325/adenylate-cyclase-type-9-adcy9-inactivation-protects-from-atherosclerosis-only-in-the-absence-of-cholesteryl-ester-transfer-protein-cetp
#18
Yohann Rautureau, Vanessa Deschambault, Marie-Ève Higgins, Daniel Rivas, Mélanie Mecteau, Pascale Geoffroy, Géraldine Miquel, Kurunradeth Uy, Rocio Sanchez, Véronique Lavoie, Geneviève Brand, Audrey Nault, Pierre-Marc Williams, Maria Laura Suarez, Nolwenn Merlet, Line Lapointe, Natacha Duquette, Marc-Antoine Gillis, Samaneh Samami, Gaétan Mayer, Philippe Pouliot, Adeline Raignault, Foued Maafi, Mathieu R Brodeur, Sylvie Levesque, Marie-Claude Guertin, Marie-Pierre Dubé, Éric Thorin, David Rhainds, Éric Rhéaume, Jean-Claude Tardif
Background -Pharmacogenomic studies have shown that ADCY9 genotype determines the effects of the cholesteryl ester transfer protein (CETP) inhibitor dalcetrapib on cardiovascular events and atherosclerosis imaging. The underlying mechanisms responsible for the interactions between ADCY9 and CETP activity have not yet been determined. Methods - Adcy9 -inactivated ( Adcy9 Gt/Gt ) and wild-type (WT) mice, that were or not transgenic for the CETP gene (CETPtg Adcy9 Gt/Gt and CETPtg Adcy9 WT ), were submitted to an atherogenic protocol (injection of an AAV8 expressing a PCSK9 gain-of-function variant and 0...
April 19, 2018: Circulation
https://www.readbyqxmd.com/read/29667842/the-role-of-pcsk9-inhibitors-in-the-treatment-of-hypercholesterolemia
#19
Roshni S Patel, Emily M Scopelliti, Oludamilola Olugbile
OBJECTIVE: To evaluate the efficacy, safety, and cost-effectiveness of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors and describe its place in therapy for the treatment of hypercholesterolemia. DATA SOURCES: A search of MEDLINE, CINAHL, and Clinicaltrials.gov was performed from January 2012 to March 2018 to identify literature pertaining to PCSK9 inhibitors using pre-specified search terms. Additional references were identified from citations of the literature...
April 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29667439/what-is-the-impact-of-the-2017-cochrane-systematic-review-and-meta-analysis-that-evaluated-the-use-of-pcsk9-inhibitors-for-lowering-cardiovascular-disease-and-mortality
#20
Mohamed A Jalloh, Eric J Ip, Shadi Doroudgar
In 2017, Schmidt et al. conducted a Cochrane systematic review and meta-analysis to evaluate the effect of using proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors to reduce low-density-lipoprotein- cholesterol (LDL-C) and cardiovascular disease (CVD). The Cochrane review was a systematic review and meta-analysis of 20 randomized, double-blinded trials that compared the use of PCSK9 inhibitors with statins/ezetimibe, ezetimibe, or placebo for a treatment duration of at least 24 weeks. The use of PCSK9 inhibitors lowered the risk for CVD (OR 0...
April 18, 2018: Expert Opinion on Pharmacotherapy
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