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https://www.readbyqxmd.com/read/28434484/practical-aspects-in-the-management-of-statin-associated-muscle-symptoms-sams
#1
Ulrich Laufs, Krysztof J Filipiak, Ioanna Gouni-Berthold, Alberico L Catapano
BACKGROUND AND AIMS: Statin-associated muscle symptoms (SAMS) frequently cause statin non-adherence, switching and discontinuation, contributing to adverse cardiovascular (CV) outcomes. Therefore, the management of SAMS is key in the effective treatment of patients with cardiovascular disease (CVD), through achievement of maximum-tolerated statin dosing and other practical aspects. The aim of this article is to provide practical, focused advice for healthcare professionals on the management of patients with SAMS...
April 2017: Atherosclerosis. Supplements
https://www.readbyqxmd.com/read/28434482/how-to-implement-clinical-guidelines-to-optimise-familial-hypercholesterolaemia-diagnosis-and-treatment
#2
Michel Farnier, Fernando Civeira, Olivier Descamps
BACKGROUND AND AIMS: Familial hypercholesterolaemia (FH) is a genetic disorder associated with significantly elevated plasma low-density lipoprotein cholesterol (LDL-C) and premature coronary heart disease (CHD). Optimal management of FH relies on early identification and treatment with statins alone or in combination with other lipid-lowering therapies. A lack of awareness of FH and its manifestations among primary care physicians and specialists has led to many individuals being misdiagnosed in the early stages of the disease, further increasing the risk of CHD and requiring much more intensive lipid-lowering strategies...
April 2017: Atherosclerosis. Supplements
https://www.readbyqxmd.com/read/28424973/pcsk9-inhibitors-in-hyperlipidemia-current-status-and-clinical-outlook
#3
Belinda Di Bartolo, Daniel J Scherer, Alex Brown, Peter J Psaltis, Stephen J Nicholls
The clinical reality of residual risk despite statin (HMG-CoA reductase inhibitor) therapy and emergence of statin intolerance support the need to develop additional lipid-lowering strategies. Proprotein convertase subtilisin kexin type 9 (PCSK9) has received considerable attention by virtue of genetic and clinical studies that have revealed its pivotal role in the regulation of cholesterol homeostasis. Monoclonal antibodies have been developed targeting PCSK9, which have been demonstrated to produce profound low-density lipoprotein cholesterol (LDL-C) lowering when provided as monotherapy or in combination with statins...
April 19, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28424373/statins-pcsk9-inhibitors-and-cholesterol-homeostasis-a-view-from-within-the-hepatocyte
#4
EDITORIAL
Allan D Sniderman, Robert Scott Kiss, Thomas Reid, George Thanassoulis, Gerald F Watts
Statins and PCSK9 inhibitors dramatically lower plasma LDL levels and dramatically increase LDL receptor number within hepatocyte cell membranes. It seems self-evident that total clearance of LDL particles from plasma and total delivery of cholesterol to the liver must increase in consequence. However, based on the results of stable isotope tracer studies, this analysis demonstrates the contrary to be the case. Statins do not change the production rate of LDL particles. Accordingly, at steady state, the clearance rate cannot change...
May 1, 2017: Clinical Science (1979-)
https://www.readbyqxmd.com/read/28418263/systematic-bias-in-predictions-of-new-drugs-budget-impact-analysis-of-a-sample-of-recent-us-drug-launches
#5
Michael S Broder, Jenelle M Zambrano, Jackie Lee, Richard S Marken
OBJECTIVE: Expectations about the budget impact of new drug launches may affect payer behavior and ultimately consumer costs. Therefore, we evaluated the accuracy of pre-launch US budget impact estimates for a sample of new drugs. METHODS: We searched for publicly available budget impact estimates made pre-launch for drugs approved in the US from 1(st) September 2010 to 1(st) September 2015 and compared them to actual sales. Accuracy was calculated as the ratio of pre-launch estimate to actual sales...
April 18, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28408313/preventing-cardiovascular-heart-disease-promising-nutraceutical-and-non-nutraceutical-treatments-for-cholesterol-management
#6
REVIEW
T P Johnston, T A Korolenko, M Pirro, A Sahebkar
Hypercholesterolemia is one of the major risk factors for the development of cardiovascular disease. Atherosclerosis resulting from hypercholesterolemia causes many serious cardiovascular diseases. Statins are generally accepted as a treatment of choice for lowering low-density lipoprotein (LDL) cholesterol, which reduces coronary heart disease morbidity and mortality. Since statin use can be associated with muscle problems and other adverse symptoms, non-adherence and discontinuation of statin therapy often leads to inadequate control of plasma cholesterol levels and increased cardiovascular risk...
April 10, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28401639/targeting-ldl-cholesterol-with-pcsk9-inhibitors
#7
REVIEW
Daniel J Scherer, Adam Nelson, Peter J Psaltis, Stephen J Nicholls
Over the last quarter century, clinical trials have consistently demonstrated that lowering levels of low-density lipoprotein cholesterol (LDL-C) with statins reduce the rate of major adverse cardiovascular events. However, the findings that many patients continue to experience events or harbour inappropriately high LDL-C levels despite intensive statin therapy and the clinical reality of statin intolerance suggests that additional therapeutic strategies are required in order to achieve more effective reductions in cardiovascular risk...
April 12, 2017: Internal Medicine Journal
https://www.readbyqxmd.com/read/28391886/efficacy-and-safety-of-the-proprotein-convertase-subtilisin-kexin-type-9-monoclonal-antibody-alirocumab-vs-placebo-in-patients-with-heterozygous-familial-hypercholesterolemia
#8
John J P Kastelein, G Kees Hovingh, Gisle Langslet, Marie T Baccara-Dinet, Daniel A Gipe, Umesh Chaudhari, Jian Zhao, Pascal Minini, Michel Farnier
BACKGROUND: Patients with heterozygous familial hypercholesterolemia (HeFH) are characterized by elevated low-density lipoprotein cholesterol (LDL-C) levels. Long-term effects of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition have not been thoroughly investigated in these patients. OBJECTIVE: We evaluated efficacy and safety of alirocumab, a PCSK9 inhibitor, vs placebo in patients with HeFH. METHODS: In total, 1257 patients with HeFH on maximally tolerated statin ± other lipid-lowering therapies from four 78-week ODYSSEY trials were analyzed...
January 2017: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/28363723/regulation-of-pcsk9-by-nutraceuticals
#9
REVIEW
Amir Abbas Momtazi, Maciej Banach, Matteo Pirro, Niki Katsiki, Amirhossein Sahebkar
PCSK9 (proprotein convertase subtilisin kexin type 9) is a liver secretory enzyme that regulates plasma low-density lipoprotein (LDL) cholesterol (LDL-C) levels through modulation of LDL receptor (LDLR) density on the surface of hepatocytes. Inhibition of PCSK9 using monoclonal antibodies can efficiently lower plasma LDL-C, non-high-density lipoprotein cholesterol and lipoprotein (a). PCSK9 inhibition is also an effective adjunct to statin therapy; however, the cost-effectiveness of currently available PCSK9 inhibitors is under question...
March 29, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28347654/efficacy-and-safety-of-alirocumab-in-insulin-treated-patients-with-type-1-or-type-2-diabetes-and-high-cardiovascular-risk-rationale-and-design-of-the-odyssey-dm-insulin-trial
#10
B Cariou, L A Leiter, D Müller-Wieland, G Bigot, H M Colhoun, S Del Prato, R R Henry, F J Tinahones, A Letierce, L Aurand, J Maroni, K K Ray, M Bujas-Bobanovic
AIMS: The coadministration of alirocumab, a PCSK9 inhibitor for treatment of hypercholesterolaemia, and insulin in diabetes mellitus (DM) requires further study. Described here is the rationale behind a phase-IIIb study designed to characterize the efficacy and safety of alirocumab in insulin-treated patients with type 1 (T1) or type 2 (T2) DM with hypercholesterolaemia and high cardiovascular (CV) risk. METHODS: ODYSSEY DM-INSULIN (NCT02585778) is a randomized, double-blind, placebo-controlled, multicentre study that planned to enrol around 400 T2 and up to 100 T1 insulin-treated DM patients...
March 24, 2017: Diabetes & Metabolism
https://www.readbyqxmd.com/read/28341307/the-efficacy-advantage-of-evolocumab-amg-145-dosed-at-140mg-every-2weeks-versus-420mg-every-4weeks-in-patients-with-hypercholesterolemia-evidence-from-a-meta-analysis
#11
Xiao-Xiao He, Rong Zhang, Pei-Yuan Zuo, Yu-Wei Liu, Xiang-Nan Zha, Sheng-Shuai Shan, Cheng-Yun Liu
BACKGROUND: Evolocumab (AMG 145), a PCSK9 inhibitor, has been shown to decrease low-density lipoprotein cholesterol (LDL-C) levels. Doses of 140mg administered every 2weeks (Q2W) and 420mg administered every 4weeks (Q4W) are widely used, and both dosing schedules were effective in clinical trials. However, some researchers have speculated that 140mg Q2W administration has equal or even greater efficacy. This meta-analysis was performed to assess the differences in efficacy and safety between the two doses...
March 2017: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/28329241/lipoprotein-a-the-revenant
#12
Baris Gencer, Florian Kronenberg, Erik S Stroes, François Mach
In the mid-1990s, the days of lipoprotein(a) [Lp(a)] were numbered and many people would not have placed a bet on this lipid particle making it to the next century. However, genetic studies brought Lp(a) back to the front-stage after a Mendelian randomization approach used for the first time provided strong support for a causal role of high Lp(a) concentrations in cardiovascular disease and later also for aortic valve stenosis. This encouraged the use of therapeutic interventions to lower Lp(a) as well numerous drug developments, although these approaches mainly targeted LDL cholesterol, while the Lp(a)-lowering effect was only a 'side-effect'...
February 17, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28328015/pcsk9-inhibitor-access-barriers-issues-and-recommendations-improving-the-access-process-for-patients-clinicians-and-payers
#13
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/28325524/current-status-of-lipid-management-in-acute-coronary-syndrome
#14
REVIEW
Koichiro Fujisue, Kenichi Tsujita
The development of coronary revascularization has dramatically improved early cardiovascular outcomes in patients with acute coronary syndrome (ACS). However, patients who have experienced myocardial infarction (MI) are at high risk of recurrence of cardiovascular events compared with those who are healthy or have stable coronary artery disease. Acute coronary events induce further inflammatory responses and plaque vulnerability in either a coronary culprit or whole vessels. The majority of data have supported the importance of coronary risk management to prevent secondary events...
March 18, 2017: Journal of Cardiology
https://www.readbyqxmd.com/read/28304242/cardiovascular-efficacy-and-safety-of-bococizumab-in-high-risk-patients
#15
Paul M Ridker, James Revkin, Pierre Amarenco, Robert Brunell, Madelyn Curto, Fernando Civeira, Marcus Flather, Robert J Glynn, Jean Gregoire, J Wouter Jukema, Yuri Karpov, John J P Kastelein, Wolfgang Koenig, Alberto Lorenzatti, Pravin Manga, Urszula Masiukiewicz, Michael Miller, Arend Mosterd, Jan Murin, Jose C Nicolau, Steven Nissen, Piotr Ponikowski, Raul D Santos, Pamela F Schwartz, Handrean Soran, Harvey White, R Scott Wright, Michal Vrablik, Carla Yunis, Charles L Shear, Jean-Claude Tardif
Background Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. Methods In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo...
April 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28295777/can-ldl-cholesterol-be-too-low-possible-risks-of-extremely-low-levels
#16
Anders G Olsson, Bo Angelin, Gerd Assmann, Christoph J Binder, Ingemar Björkhem, Angel Cedazo-Minguez, Jonathan Cohen, Arnold von Eckardstein, Eduardo Farinaro, Dirk Müller-Wieland, Klaus G Parhofer, Paolo Parini, Robert S Rosenson, Jakob Starup-Linde, Matti J Tikkanen, Laurent Yvan-Charvet
Following the continuous accumulation of evidence supporting the beneficial role of reducing low-density lipoprotein cholesterol (LDL-C) levels in the treatment and prevention of atherosclerotic cardiovascular disease and its complications, therapeutic possibilities now exist to lower LDL-C to very low levels, similar to or even lower than those seen in newborns and nonhuman species. In addition to the important task of evaluating potential side-effects of such treatments, the question arises whether extremely low LDL-C levels per se may provoke adverse effects in humans...
March 14, 2017: Journal of Internal Medicine
https://www.readbyqxmd.com/read/28291870/long-term-low-density-lipoprotein-cholesterol-lowering-efficacy-persistence-and-safety-of-evolocumab-in-treatment-of-hypercholesterolemia-results-up-to-4-years-from-the-open-label-osler-1-extension-study
#17
Michael J Koren, Marc S Sabatine, Robert P Giugliano, Gisle Langslet, Stephen D Wiviott, Helina Kassahun, Andrea Ruzza, Yuhui Ma, Ransi Somaratne, Frederick J Raal
Importance: The Open-Label Study of Long-term Evaluation Against LDL-C (OSLER-1) evaluated the durability of long-term efficacy and safety during long-term therapy with evolocumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9). Objective: To determine whether LDL-C level reductions with evolocumab persist across different populations. Secondary objectives included assessment of adverse events, antidrug antibodies, and factors contributing to treatment discontinuation...
March 14, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28291840/a-wild-type-mouse-based-model-for-the-regression-of-inflammation-in-atherosclerosis
#18
Michael Peled, Hitoo Nishi, Ada Weinstock, Tessa J Barrett, Felix Zhou, Alexandra Quezada, Edward A Fisher
Atherosclerosis can be induced by the injection of a gain-of-function mutant of proprotein convertase subtilisin/kexin type 9 (PCSK9)-encoding adeno-associated viral vector (AAVmPCSK9), avoiding the need for knockout mice models, such as low-density lipoprotein receptor deficient mice. As regression of atherosclerosis is a crucial therapeutic goal, we aimed to establish a regression model based on AAVmPCSK9, which will eliminate the need for germ-line genetic modifications. C57BL6/J mice were injected with AAVmPCSK9 and were fed with Western diet for 16 weeks, followed by reversal of hyperlipidemia by a diet switch to chow and treatment with a microsomal triglyceride transfer protein inhibitor (MTPi)...
2017: PloS One
https://www.readbyqxmd.com/read/28289523/pcsk9-inhibitors-a-new-era-of-lipid-lowering-therapy
#19
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/28286091/pcsk9-monoclonal-antibodies-in-2016-current-status-and-future-challenges
#20
REVIEW
Hashrul Rashid, Ian T Meredith, Arthur Nasis
Cardiovascular disease remains the leading cause of morbidity and mortality in developed nations, with elevated low-density lipoprotein-cholesterol (LDL-C) levels being a major modifiable risk factor for coronary atherosclerosis. While lipid-lowering therapies such as statins are effective in lowering LDL-C, a proportion of patients do not achieve target LDL-C goals with statins or are intolerant to statins necessitating other treatment options. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new class of agents that reduce LDL-C beyond the maximum achievable LDL-C reductions with statins, and have been well studied in different patient groups...
January 23, 2017: Heart, Lung & Circulation
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