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https://www.readbyqxmd.com/read/28927706/cardiovascular-safety-and-efficacy-of-the-pcsk9-inhibitor-evolocumab-in-patients-with-and-without-diabetes-and-the-effect-of-evolocumab-on-glycaemia-and-risk-of-new-onset-diabetes-a-prespecified-analysis-of-the-fourier-randomised-controlled-trial
#1
Marc S Sabatine, Lawrence A Leiter, Stephen D Wiviott, Robert P Giugliano, Prakash Deedwania, Gaetano M De Ferrari, Sabina A Murphy, Julia F Kuder, Ioanna Gouni-Berthold, Basil S Lewis, Yehuda Handelsman, Armando Lira Pineda, Narimon Honarpour, Anthony C Keech, Peter S Sever, Terje R Pedersen
BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduced LDL cholesterol and cardiovascular events in the FOURIER trial. In this prespecified analysis of FOURIER, we investigated the efficacy and safety of evolocumab by diabetes status and the effect of evolocumab on glycaemia and risk of developing diabetes. METHODS: FOURIER was a randomised trial of evolocumab (140 mg every 2 weeks or 420 mg once per month) versus placebo in 27 564 patients with atherosclerotic disease who were on statin therapy, followed up for a median of 2·2 years...
September 14, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28926730/impact-of-evolocumab-treatment-on-low-density-lipoprotein-cholesterol-levels-in-heterozygous-familial-hypercholesterolemic-patients-withdrawing-from-regular-apheresis
#2
Masa-Aki Kawashiri, Atsushi Nohara, Toshinori Higashikata, Hayato Tada, Chiaki Nakanishi, Hirofumi Okada, Tetsuo Konno, Kenji Sakata, Kenshi Hayashi, Akihiro Inazu, Hiroshi Mabuchi, Masakazu Yamagishi
BACKGROUND AND AIMS: Low-density lipoprotein (LDL) apheresis has been used to treat refractory hyperlipidemia such as familial hypercholesterolemia (FH). Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor used in clinical settings, can reduce LDL cholesterol (LDL-C) levels by >70%. Therefore, this study aimed to assess the impact of evolocumab on withdrawal from regular LDL apheresis in patients with heterozygous FH (HeFH). METHODS: Eleven patients with HeFH undergoing biweekly LDL apheresis were enrolled and were subsequently switched to a biweekly subcutaneous injection of 140 mg of evolocumab...
September 9, 2017: Atherosclerosis
https://www.readbyqxmd.com/read/28919772/anti-pcsk9-antibodies-for-the-treatment-of-heterozygous-familial-hypercholesterolemia-patient-selection-and-perspectives
#3
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/28915766/should-an-ldl-cholesterol-target-based-approach-be-readopted
#4
C Michael White, Erin R Weeda, Elaine Nguyen
OBJECTIVE: To review clinical trials driving the evolution of hyperlipidemic guidelines, discuss whether low-density lipoprotein (LDL) targets and adjunctive therapy on top of statins should be used, and summarize the pharmacist's role in helping achieve LDL goals. DATA SOURCES: MEDLINE search (1/1980-5/2017) using terms including LDL, lipid, and statin, with forward and backward citation tracking. STUDY SELECTION AND DATA EXTRACTION: English-language studies and guidelines assessing LDL-lowering therapy were included...
July 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28914630/strategies-for-the-use-of-nonstatin-therapies
#5
Angela Pirillo, Giuseppe D Norata, Alberico L Catapano
PURPOSE OF REVIEW: Dyslipidaemias are a major risk factor for cardiovascular disease (CVD); in particular, high levels of low-density lipoprotein cholesterol (LDL-C) have been associated to a higher cardiovascular risk. Reducing LDL-C levels decreases the risk of coronary heart disease (CHD), and the greater the LDL-C reduction, the greater the decrease in cardiovascular risk. Although statins represent the first line lipid-lowering therapy, many patients do not reach the recommended goals or exhibit adverse side effects leading to therapy discontinuation; in addition, a significant percentage of statin-treated patients continue to experience cardiovascular events even in the presence of well controlled LDL-C levels, because of alterations in other lipid/lipoprotein classes, including triglycerides and high-density lipoprotein cholesterol...
September 12, 2017: Current Opinion in Lipidology
https://www.readbyqxmd.com/read/28913682/-therapeutic-options-in-hyperlipidemia
#6
Robert Berent, Theresa Berent, Helmut Sinzinger
Treatment of lipid disorders (dyslipidemia) is the cornerstone of atherosclerosis prevention and reduction of progression. Lifestyle modification is the first step to improve the plasma lipid profile. Statins play a central role in the reduction of LDL cholesterol. Whether and to what extent other lipids such as triglycerides or lipoprotein(a) should also be treated depends on the extent of atherosclerotic disease and its progression over time. Especially in residential cardiac rehabilitation we have the opportunity to encourage adherence and adapt medication as necessary due to a face to face contact over 4 weeks...
September 14, 2017: Wiener Medizinische Wochenschrift
https://www.readbyqxmd.com/read/28903137/nationwide-coverage-and-cost-sharing-for-pcsk9-inhibitors-among-medicare-part-d-plans
#7
Dhruv S Kazi, Christine Y Lu, Grace A Lin, Colette DeJong, R Adams Dudley, Randi Chen, Chien-Wen Tseng
No abstract text is available yet for this article.
September 13, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28902717/new-approaches-to-address-dyslipidemia
#8
Klaus G Parhofer
PURPOSE OF REVIEW: Although lipid-lowering treatment with statins, ezetimibe, and PCSK9 inhibitors is a very successful strategy to prevent cardiovascular events, there is a need for further drug developments. Not all patients respond sufficiently to the available therapy (very high baseline values, intolerance). Furthermore, patients may be characterized by dyslipidemias not accessible to available drugs such as patients with homozygous familial hypercholesterolemia, chylomicronemia syndrome, or elevated lipoprotein(a)...
September 11, 2017: Current Opinion in Lipidology
https://www.readbyqxmd.com/read/28894089/heparan-sulfate-proteoglycans-present-pcsk9-to-the-ldl-receptor
#9
Camilla Gustafsen, Ditte Olsen, Joachim Vilstrup, Signe Lund, Anika Reinhardt, Niels Wellner, Torben Larsen, Christian B F Andersen, Kathrin Weyer, Jin-Ping Li, Peter H Seeberger, Søren Thirup, Peder Madsen, Simon Glerup
Coronary artery disease is the main cause of death worldwide and accelerated by increased plasma levels of cholesterol-rich low-density lipoprotein particles (LDL). Circulating PCSK9 contributes to coronary artery disease by inducing lysosomal degradation of the LDL receptor (LDLR) in the liver and thereby reducing LDL clearance. Here, we show that liver heparan sulfate proteoglycans are PCSK9 receptors and essential for PCSK9-induced LDLR degradation. The heparan sulfate-binding site is located in the PCSK9 prodomain and formed by surface-exposed basic residues interacting with trisulfated heparan sulfate disaccharide repeats...
September 11, 2017: Nature Communications
https://www.readbyqxmd.com/read/28886926/2017-focused-update-of-the-2016%C3%A2-acc%C3%A2-expert-consensus-decision-pathway-on-the-role-of-non-statin-therapies-for-ldl-cholesterol-lowering-in%C3%A2-the-management-of-atherosclerotic-cardiovascular-disease-risk-a-report-of-the-american-college-of-cardiology-task-force
#10
Donald M Lloyd-Jones, Pamela B Morris, Christie M Ballantyne, Kim K Birtcher, David D Daly, Sondra M DePalma, Margo B Minissian, Carl E Orringer, Sidney C Smith
In 2016, the American College of Cardiology published the first expert consensus decision pathway (ECDP) on the role of non-statin therapies for low-density lipoprotein (LDL)-cholesterol lowering in the management of atherosclerotic cardiovascular disease (ASCVD) risk. Since the publication of that document, additional evidence and perspectives have emerged from randomized clinical trials and other sources, particularly considering the longer-term efficacy and safety of proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors in secondary prevention of ASCVD...
August 30, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28884604/novel-treatment-options-for-the-management-of-heterozygous-familial-hypercholesterolemia
#11
Georgios Polychronopoulos, Konstantinos Tziomalos
Even though statins represent the mainstay of treatment of heterozygous familial hypercholesterolemia (FH), their low-density lipoprotein cholesterol (LDL-C) lowering efficacy is finite and most patients with FH will not achieve LDL-C targets with statin monotherapy. Addition of ezetimibe with or without bile acid sequestrants will also not lead to treatment goals in many of these patients, particularly in those with established cardiovascular disease. In this selected subgroup of the FH population, proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors provide substantial reductions in LDL-C levels, reduce cardiovascular morbidity and appear to be safe...
September 8, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28879791/incorporation-of-pcsk9-inhibitors-into-prevention-of-atherosclerotic-cardiovascular-disease
#12
Cezary Wójcik
Primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD) has become recently more complex than ever, leaving the clinicians perplexed with outdated guidelines and emerging evidence about new LDL-C lowering therapies. 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines have focused on high intensity statin therapy for specific groups of patients, while abandoning long established LDL-C goals, a strategy which no longer seems valid. PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors have emerged as the add-on therapy on top of statins and/or ezetimibe for the treatment of hypercholesterolemia and ASCVD prevention...
September 7, 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/28871349/recent-insights-into-pharmacologic-cardiovascular-risk-reduction-in-type-2-diabetes-mellitus
#13
Scott L Purga, Mandeep Sidhu, Michael Farkouh, Joshua Schulman-Marcus
Diabetes mellitus (DM) affects nearly 30 million Americans and carries an increased risk of macrovascular complications of myocardial infarction, stroke, and cardiovascular death. While aggressive cardiovascular risk factor reduction has long been advocated in patients with diabetes, clinical trials have only recently demonstrated that such reductions result in improved outcomes. This review discusses recent evidence for risk reduction strategies and therapies with a focus on the management of glycemia, dyslipidemia, and hypertension...
September 4, 2017: Cardiovascular Drugs and Therapy
https://www.readbyqxmd.com/read/28859947/clinical-efficacy-and-safety-of-achieving-very-low-ldl-cholesterol-concentrations-with-the-pcsk9-inhibitor-evolocumab-a-prespecified-secondary-analysis-of-the-fourier-trial
#14
Robert P Giugliano, Terje R Pedersen, Jeong-Gun Park, Gaetano M De Ferrari, Zbigniew A Gaciong, Richard Ceska, Kalman Toth, Ioanna Gouni-Berthold, Jose Lopez-Miranda, François Schiele, François Mach, Brian R Ott, Estella Kanevsky, Armando Lira Pineda, Ransi Somaratne, Scott M Wasserman, Anthony C Keech, Peter S Sever, Marc S Sabatine
BACKGROUND: LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relationship between progressively lower LDL-cholesterol concentrations achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial of evolocumab, a monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9). METHODS: In this prespecified secondary analysis of 25 982 patients from the randomised FOURIER trial, the relationship between achieved LDL-cholesterol concentration at 4 weeks and subsequent cardiovascular outcomes (primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or unstable angina; key secondary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over a median of 2·2 years of follow-up...
August 25, 2017: Lancet
https://www.readbyqxmd.com/read/28857822/impact-of-protease-inhibitors-on-circulating-pcsk9-levels-in-hiv-infected-antiretroviral-na%C3%A3-ve-patients-from-the-anrs-copana-cohort
#15
Franck Boccara, Mathilde Ghislain, Laurence Meyer, Cecile Goujard, Cedric Le May, Corinne Vigouroux, Jean Philippe Bastard, Soraya Fellahi, Jacqueline Capeau, Ariel Cohen, Bertrand Cariou
OBJECTIVE: The study aims to assess the association between proprotein convertase subtilisin/kexin type 9 (PCSK9), a major regulator of low-density lipoprotein cholesterol (LDL-C) homeostasis, and HIV-related dyslipidaemia in a cohort of HIV+ patients under protease inhibitors (PI). METHODS: Plasma PCSK9 levels were measured in 103 HIV-positive patients (HIV+) before and after initiating PI-based antiretroviral therapy (ART), and in 90 HIV-negative controls (HIV-) matched for age and sex...
August 28, 2017: AIDS
https://www.readbyqxmd.com/read/28857083/dyslipidaemia-no-effect-of-pcsk9-inhibitors-on-cognitive-function
#16
Irene Fernández-Ruiz
No abstract text is available yet for this article.
October 2017: Nature Reviews. Cardiology
https://www.readbyqxmd.com/read/28854074/implementation-of-a-new-clinic-based-pharmacist-managed-pcsk9-inhibitor-consultation-service
#17
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/28840737/-clinical-study-fourier
#18
Ján Murín
A new group of hypolipidemic substances, i.e. PCSK9 protein inhibitors, is now coming into use in clinical practice, to what extent a high residual cardiovascular risk remains also in patients treated with statins. The FOURIER study (Further cardiovascular OUtcomes Research with PCSK9 Inhibition subjects with Elevated Risk) is the first "event" study which has shown that evolocumab (PCSK9 antibody) further significantly reduces serum LDL cholesterol and subsequently also cardiovascular morbidity and mortality: (a) composite primary goal (cardiovascular mortality, incidence of heart attacks, strokes, hospitalizations for unstable angina, coronary revascularization) by 15 % (p < 0...
2017: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/28829863/updated-cost-effectiveness-analysis-of-pcsk9-inhibitors-based-on-the-results-of-the-fourier-trial
#19
Dhruv S Kazi, Joanne Penko, Pamela G Coxson, Andrew E Moran, Daniel A Ollendorf, Jeffrey A Tice, Kirsten Bibbins-Domingo
No abstract text is available yet for this article.
August 22, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28829851/pcsk9-inhibitors-and-the-choice-between-innovation-efficiency-and-affordability
#20
EDITORIAL
Daniel B Mark, Kevin A Schulman
No abstract text is available yet for this article.
August 22, 2017: JAMA: the Journal of the American Medical Association
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