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https://www.readbyqxmd.com/read/28093956/praluent-alirocumab-induced-renal-injury
#1
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
#2
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
#3
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
#4
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...
December 27, 2016: Archivos de Cardiología de México
https://www.readbyqxmd.com/read/28025677/pcsk9-inhibition-the-dawn-of-a-new-age-in-cholesterol-lowering
#5
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...
December 26, 2016: 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
#6
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...
September 2, 2016: Atherosclerosis
https://www.readbyqxmd.com/read/27986651/effects-of-pcsk9-inhibition-with-alirocumab-on-lipoprotein-metabolism-in-healthy-humans
#7
Gissette Reyes-Soffer, Marianna Pavlyha, Colleen Ngai, Tiffany Thomas, Stephen Holleran, Rajasekhar Ramakrishnan, Wahida Karmally, Renu Nandakumar, Nelson Fontanez, Joseph C Obunike, Santica M Marcovina, Alice H Lichtenstein, Nirupa R Matthan, James Matta, Magali Maroccia, Frederic Becue, Franck Poitiers, Brian Swanson, Lisa Cowan, William J Sasiela, Howard K Surks, Henry N Ginsberg
BACKGROUND: -Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), lowers plasma low density lipoprotein cholesterol (LDL-C) and apolipoprotein B100 (apoB). Although studies in mice and cells have identified increased hepatic LDL receptors as the basis for LDL lowering by PCSK9 inhibitors, there have been no human studies characterizing the effects of PCSK9 inhibitors on lipoprotein metabolism. In particular, it is not known if inhibition of PCSK9 has any effects on very low density lipoprotein (VLDL) or intermediate density lipoprotein (IDL) metabolism...
December 16, 2016: Circulation
https://www.readbyqxmd.com/read/27933632/association-of-alirocumab-therapy-with-inflammatory-lesions-of-the-vocal-folds-a-case-report
#8
Peter A Benedict, Rania M Abdou, Gregory R Dion, Peak Woo, Ryan C Branski, Milan R Amin
Therapeutic monocolonal antibodies (MAbs) are a new, rapidly growing class of medications that frequently have poorly characterized side-effect profiles. We present a patient who developed inflammatory lesions of the vocal folds in temporal relation to the initiation of alirocumab. Lesions of the vocal folds represent a previously unreported adverse effect of alirocumab therapy, making it the second MAb documented with such a side effect. The potential laryngeal effects of alirocumab specifically, and of MAbs more broadly, warrant investigation...
December 9, 2016: Laryngoscope
https://www.readbyqxmd.com/read/27888904/-anti-pcsk9-antibodies-in-type-2-diabetes-and-secondary-prevention-of-cardiovascular-diseases
#9
José López-Miranda, Xavier Pintó
Patients with type 2 diabetes are considered to have the same cardiovascular risk as patients with ischemia. However, the degree of lipid control in diabetic and ischemic patients remains highly deficient. The availability of new agents, such as anti-PCSK9 monoclonal antibodies, could represent a notable advance in meeting this unmet need. Alirocumab and evolucumab, followed by bococizumab, are currently under the advanced phase of research. A growing database has demonstrated a relationship between glucose metabolism, body weight and PCSK9 function, but the clinical implications of this relationship have not been well defined...
May 2016: Clínica e Investigación en Arteriosclerosis
https://www.readbyqxmd.com/read/27888902/-unmet-needs-patients-with-statin-intolerance-or-familial-hypercholesterolemia
#10
Luis Masana, Fernando Civeira
The achievement of low-density lipoprotein (LDL) therapeutic targets is especially difficult in some patients at high cardiovascular risk. These patients include persons with statin intolerance and those with very high LDL cholesterol (LDLc) levels such as persons with familial hypercholesterolemia. The proportion of statin-intolerant patients is between 7% and 29%. Alternative lipid-lowering drugs (including ezetimibe) are less effective and are not free from adverse effects. Both alirocumab, with the ODYSSEY ALTERNATIVE study, and evolocumab, with the GAUSS study, have shown strong lipid-lowering efficacy, with much greater tolerability than currently available alternatives, with the result that a larger number of patients achieve therapeutic targets...
May 2016: Clínica e Investigación en Arteriosclerosis
https://www.readbyqxmd.com/read/27886619/open-label-therapy-with-alirocumab-in-patients-with-heterozygous-familial-hypercholesterolemia-results-from-three-years-of-treatment
#11
Robert Dufour, Jean Bergeron, Daniel Gaudet, Robert Weiss, G Kees Hovingh, Zhizhi Qing, Feng Yang, Matthew Andisik, Albert Torri, Robert Pordy, Daniel A Gipe
BACKGROUND: PCSK9 inhibition with alirocumab significantly reduced LDL-C levels in trials of up to 78weeks' duration in patients with heterozygous familial hypercholesterolemia (HeFH). We report results from 3years of an ongoing open-label treatment extension (NCT01576484) to a 12-week double-blind trial in HeFH patients (NCT01266876). METHODS: Patients who completed the parent study and were receiving stable daily statin±ezetimibe could enter the open-label extension, where they received alirocumab 150mg every 2 weeks (Q2W) subcutaneously (n=58)...
February 1, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/27877050/development-of-proprotein-convertase-subtilisin-kexin-type-9-inhibitors-and-the-clinical-potential-of-monoclonal-antibodies-in-the-management-of-lipid-disorders
#12
REVIEW
Sanjiv Gupta
The aim of this manuscript is to review available data to evaluate the present status of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in the treatment of hypercholesterolemia. Relevant literature since 2003 is reviewed. The effectiveness of PCSK9 inhibitors in lowering low-density lipoprotein cholesterol and other atherogenic lipid fractions was studied in various Phase 2 and Phase 3 trials of Alirocumab, Evolocumab, and Bococizumab. The results of published long-term ODYSSEY and OSLER studies are summarized...
2016: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/27797643/modern-management-of-familial-hypercholesterolemia
#13
P Barton Duell, Ishwarlal Jialal
Familial hypercholesterolemia (FH) is a common genetic disorder that can manifest clinically as both the severe homozygous (HoFH) form that often presents in childhood and the commoner heterozygous (HeFH) form that is typically identified in adults. The majority of genetic causes are due to defects in low-density lipoprotein (LDL) receptor synthesis and action. Until recently, it was exceedingly difficult to achieve the goal of a 50% reduction in LDL-cholesterol or LDL-C < 70-100 in these patients. Established therapies include statins, niacin, bile-acid sequestrants, and ezetimibe in various combinations...
December 2016: Metabolic Syndrome and related Disorders
https://www.readbyqxmd.com/read/27793396/effect-of-alirocumab-on-lipoprotein-a-over-%C3%A2-1-5%C3%A2-years-from-the-phase-3-odyssey-program
#14
Daniel Gaudet, Gerald F Watts, Jennifer G Robinson, Pascal Minini, William J Sasiela, Jay Edelberg, Michael J Louie, Frederick J Raal
Elevated lipoprotein(a) [Lp(a)] is independently associated with increased cardiovascular risk. However, treatment options for elevated Lp(a) are limited. Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9, reduced low-density lipoprotein cholesterol (LDL-C) by up to 62% from baseline in phase 3 studies, with adverse event rates similar between alirocumab and controls. We evaluated the effect of alirocumab on serum Lp(a) using pooled data from the phase 3 ODYSSEY program: 4,915 patients with hypercholesterolemia from 10 phase 3 studies were included...
January 1, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/27784878/corrigendum-efficacy-and-safety-of-alirocumab-in-japanese-patients-with-heterozygous-familial-hypercholesterolemia-or-at-high-cardiovascular-risk-with-hypercholesterolemia-not-adequately-controlled-with-statins%C3%A3-odyssey-japan-randomized-controlled-trial
#15
Tamio Teramoto, Masahiko Kobayashi, Hiromi Tasaki, Hiroaki Yagyu, Toshinori Higashikata, Yoshiharu Takagi, Kiyoko Uno, Marie T Baccara-Dinet, Atsushi Nohara
No abstract text is available yet for this article.
2016: Circulation Journal: Official Journal of the Japanese Circulation Society
https://www.readbyqxmd.com/read/27777279/reductions-in-atherogenic-lipids-and-major-cardiovascular-events-a-pooled-analysis-of-10-odyssey-trials-comparing-alirocumab-with-control
#16
Kausik K Ray, Henry N Ginsberg, Michael H Davidson, Robert Pordy, Laurence Bessac, Pascal Minini, Robert H Eckel, Christopher P Cannon
BACKGROUND: A continuous relationship between reductions in low-density lipoprotein cholesterol (LDL-C) and major adverse cardiovascular events (MACE) has been observed in statin and ezetimibe outcomes trials down to achieved levels of 54 mg/dL. However, it is uncertain whether this relationship extends to LDL-C levels <50 mg/dL. We assessed the relationship between additional LDL-C, non-high-density lipoprotein cholesterol, and apolipoprotein B100 reductions and MACE among patients within the ODYSSEY trials that compared alirocumab with controls (placebo/ezetimibe), mainly as add-on therapy to maximally tolerated statin...
December 13, 2016: Circulation
https://www.readbyqxmd.com/read/27755114/proprotein-convertase-subtilisin-kexin-type-9-inhibitors-update-from-clinical-trials-to-real-world-experience
#17
Michel Farnier
PURPOSE OF REVIEW: After the approval of alirocumab and evolocumab, the first two monoclonal antibodies (mAbs) targeting proprotein convertase subtilisin kexin type 9 (PCSK9), this review provides an update on recent PCSK9 inhibitors data and describes recommendations for the use before the results of the ongoing cardiovascular endpoint trials. RECENT FINDINGS: New studies and complementary analysis of phase III trials have consistently shown that alirocumab and evolocumab are highly effective in reducing LDL-cholesterol and to some extent lipoprotein (a)...
December 2016: Current Opinion in Lipidology
https://www.readbyqxmd.com/read/27740972/effect-of-alirocumab-dose-increase-on-ldl-lowering-and-lipid-goal-attainment-in-patients-with-dyslipidemia
#18
John J P Kastelein, Dean J Kereiakes, Christopher P Cannon, Harold E Bays, Pascal Minini, L Veronica Lee, Jaman Maroni, Michel Farnier
OBJECTIVES: The objective of this study is to report the dose response in ODYSSEY phase 3 clinical trials of proprotein convertase subtilisin kexin type 9 inhibition with alirocumab in patients not at prespecified lipid goals who received a per-protocol dose increase from 75 every 2 weeks (Q2W) to 150 mg Q2W. METHODS: Patients (n=2181) receiving statins were enrolled in six phase 3 randomized, double-blind, double-dummy trials (24-104 weeks): alirocumab versus placebo or ezetimibe 10 mg/day...
October 12, 2016: Coronary Artery Disease
https://www.readbyqxmd.com/read/27739167/very-low-ldl-c-levels-may-safely-provide-additional-clinical-cardiovascular-benefit-the-evidence-to-date
#19
REVIEW
Terry McCormack, Ricardo Dent, Mark Blagden
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in Europe and increased low-density lipoprotein cholesterol (LDL-C) is a major contributor to CVD risk. Extensive evidence from clinical studies of statins has demonstrated a linear relationship between LDL-C levels and CVD risk. It has been proposed that lower LDL-C levels than those currently recommended may provide additional clinical benefit to patients. AIM: This review summarises the genetic and clinical evidence on the efficacy and safety of achieving very low LDL-C levels...
November 2016: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/27729681/cangrelor
#20
EDITORIAL
Danial E Baker, Kyle T Ingram
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
November 2015: Hospital Pharmacy
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