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Peter P Toth, Jamie P Dwyer, Christopher P Cannon, Helen M Colhoun, Daniel J Rader, Ashish Upadhyay, Michael J Louie, Andrew Koren, Alexia Letierce, Jonas Mandel, Maciej Banach
Individuals with chronic kidney disease are at increased risk of premature cardiovascular disease. Among them, many with elevated low-density lipoprotein cholesterol (LDL-C) are unable to achieve optimal LDL-C on statins and require additional lipid-lowering therapy. To study this, we compared the LDL-C-lowering efficacy and safety of alirocumab in individuals with hypercholesterolemia with impaired renal function, defined as eGFR 30-59 ml/min/1.73 m2 , to those without impaired renal function eGFR ≥60 ml/min/1...
March 8, 2018: Kidney International
Charles J Glueck, Alan Brown, Anne C Goldberg, James M McKenney, Louis Kantaros, John Stewart, Joseph Elassal, Andrew Koren
BACKGROUND: The alirocumab expanded use program provided open-label access to alirocumab before its commercial availability to patients with severe hypercholesterolemia not controlled with maximally tolerated doses of standard-of-care lipid-lowering therapy. OBJECTIVE: To describe the safety and lipid-lowering efficacy of alirocumab in high-risk patients who were likely to be early users of proprotein convertase subtilisin/kexin type 9 inhibitors after approval...
February 7, 2018: Journal of Clinical Lipidology
Vladimír Bláha, Milan Bláha, Miriam Lánská, Eduard Havel, Pavel Vyroubal, Zdeněk Zadák, Pavel Žák
PCSK9-inhibitors belong to the new class of hypolipidemic agents. They enhance catabolism of low density lipoprotein cholesterol (LDL-C) through inhibiting activity of proprotein convertase subtilisin/kexin type 9 (PCSK9). They are monoclonal antibodies (alirocumab, evolocumab etc). Under clinical development are also other types of PCSK9-inhibitors which act at a subcellular level. The treatment with PCSK9-inhibitors can be beneficially combined with lipoprotein apheresis (LA). If such treatment using PCSK9-inhibitors is possible with regard to an individual patients genotype, the combination of LA and PCSK9-inhibitors leads to slowing the space of LDL-C increase between individual procedures of apheresis and enables attaining of the lowest possible values of LDL-cholesterolemia for the longest possible period of time...
2018: Vnitr̆ní Lékar̆ství
Robert R Henry, Dirk Müller-Wieland, Pam R Taub, Maja Bujas-Bobanovic, Michael J Louie, Alexia Letierce, Henry N Ginsberg
AIMS: This analysis assessed efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, in patients with or without metabolic syndrome (MetS) using pooled data from 10 phase 3 ODYSSEY trials. MATERIALS AND METHODS: Data from 4983 randomized patients (1940 with MetS; 1642 with diabetes excluded) were assessed in subgroups by MetS status. Efficacy data were analysed in 4 pools per study design: 2 placebo-controlled pools (1 using alirocumab 150 mg every 2 weeks [Q2W], 1 using 75/150 mg Q2W) with background statin, and 2 ezetimibe-controlled pools (both alirocumab 75/150 mg Q2W), 1 with and 1 without background statin...
March 1, 2018: Diabetes, Obesity & Metabolism
Baris Gencer, David Nanchen, Tinh-Hai Collet, Nicolas Rodondi, François Mach
PCSK9 (proprotein convertase subtilisin kexin 9) monoclonal antibodies (mAb) are new therapeutic agents to lower efficiently LDL-cholesterol levels. New data from large clinical trials suggest that the addition of PCSK9 mAb to statins can reduce the incidence of major adverse cardiovascular events in very high risk patients. Alirocumab and evolocumab are two agents available in Switzerland with specific limitations for reimbursement. PCSK9 mAb should be considered in patients with clinical atherosclerotic cardiovascular disease (ASCVD), as well as in patients with familial hypercholesterolemia without ASCVD who have substantially high LDL-cholesterol levels despite the use of statin at maximally tolerated dose with or without ezetimibe, or intolerance to appropriate doses of several statins...
February 28, 2018: Revue Médicale Suisse
Peter A McCullough, Christie M Ballantyne, Santosh K Sanganalmath, Gisle Langslet, Seth J Baum, Prediman K Shah, Andrew Koren, Jonas Mandel, Michael H Davidson
Patients with previous atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) are at high risk of future cardiovascular events. Despite maximally tolerated doses of statins, many patients still have elevated low-density lipoprotein cholesterol (LDL-C) levels. We evaluated the efficacy and safety of alirocumab in patients with ASCVD and/or HeFH on a maximally tolerated dose of statin (rosuvastatin 20 or 40 mg, atorvastatin 40 or 80 mg, or simvastatin 80 mg, or lower doses with an investigator-approved reason) ± other lipid-lowering therapies from 5 placebo-controlled phase 3 trials (52 to 78 weeks)...
February 2, 2018: American Journal of Cardiology
Kausik K Ray, Lawrence A Leiter, Dirk Müller-Wieland, Bertrand Cariou, Helen M Colhoun, Robert R Henry, Francisco J Tinahones, Maja Bujas-Bobanovic, Catherine Domenger, Alexia Letierce, Rita Samuel, Stefano Del Prato
AIMS: Individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia represent a high-risk and difficult-to-treat population. ODYSSEY DM-DYSLIPIDEMIA (NCT02642159) compared alirocumab, a proprotein convertase subtilisin-kexin type 9 inhibitor, with usual care (UC) in individuals with T2DM and mixed dyslipidaemia not optimally managed by maximally-tolerated statins. MATERIALS AND METHODS: UC options (no additional lipid-lowering therapy; fenofibrate; ezetimibe; omega-3 fatty acid; nicotinic acid) were selected prior to stratified randomization to open-label alirocumab 75 mg every 2 weeks (Q2W; with increase to 150 mg Q2W at Week [W]12 if W8 non-high-density lipoprotein cholesterol [non-HDL-C] was ≥2...
February 13, 2018: Diabetes, Obesity & Metabolism
Gregory S Pokrywka
Elevated low-density lipoprotein cholesterol (LDL-C) plays a major role in the development of atherosclerotic cardiovascular disease. Statins are the first-line treatment to lower LDL-C in patients with hypercholesterolemia; however, some high cardiovascular risk patients may have inadequate responses to statin therapy or are intolerant to statins, and may need additional and/or alternative non-statin therapies to further reduce their LDL-C levels. Monoclonal antibodies that inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), a key regulator of circulating LDL-C levels, have received considerable attention as promising non-statin therapeutic options for the management of hypercholesterolemia...
February 7, 2018: Postgraduate Medicine
Felice Gragnano, Paolo Calabrò
Despite recent therapeutic advances, there is an unmet need in cardiovascular disease prevention. Clinical trials and meta-analyses have established that LDL-C lowering, particularly by statin therapy, reduces the progression of coronary atherosclerosis and the risk of coronary events. Insufficient LDL-C reduction and high residual risk in a significant proportion of statin-treated patients signify that additional therapies are required to deliver more effective coronary care. Pharmacological inhibition of cholesterol absorption (with ezetimibe) and PCSK9 activity (with evolocumab or alirocumab) provides potentially useful approaches for the therapeutic modulation of LDL-C metabolism in statin-treated patients...
February 2018: Atherosclerosis
Merel L Hartgers, Joep C Defesche, Gisle Langslet, Paul N Hopkins, John J P Kastelein, Marie T Baccara-Dinet, Werner Seiz, Sara Hamon, Poulabi Banerjee, Claudia Stefanutti
BACKGROUND: Mutations in the genes for the low-density lipoprotein receptor (LDLR), apolipoprotein B, and proprotein convertase subtilisin/kexin type 9 have been reported to cause heterozygous and homozygous familial hypercholesterolemia (FH). OBJECTIVE: The objective is to examine the influence of double heterozygous, compound heterozygous, or homozygous mutations underlying FH on the efficacy of alirocumab. METHODS: Patients from 6 alirocumab trials with elevated low-density lipoprotein cholesterol (LDL-C) and FH diagnosis were sequenced for mutations in the LDLR, apolipoprotein B, proprotein convertase subtilisin/kexin type 9, LDLR adaptor protein 1 (LDLRAP1), and signal-transducing adaptor protein 1 genes...
December 28, 2017: Journal of Clinical Lipidology
Ye-Xuan Cao, Hui-Hui Liu, Qiu-Ting Dong, Sha Li, Jian-Jun Li
AIMS: To investigate the effect of two clinically applied proprotein convertase subtilisin/kexin type 9 monoclonal antibody (PCSK9-mAb) on glycaemia and new-onset diabetes mellitus (NODM). MATERIALS AND METHODS: PubMed, MEDLINE, Embase, Cochrane databases and websites were systematically searched for randomized controlled trials that reported the fasting plasma glucose (FPG), Hemoglobin A1c (HbA1c) or NODM incidence. Risk ratios (RR) for NODM and Mean Difference (MD) for FPG and HbA1c with 95% confidence intervals (CI) were calculated using a fixed-effect model...
January 27, 2018: Diabetes, Obesity & Metabolism
Aurora Gonzalez-Estrada, Jose Carlos Alarcon-Garcia, Paula Garcia-Ocaña, Ana Camacho-Carrasco, Maria Del Carmen Alarcon-Garcelan, Fatima Espinosa-Torre, Veronica Alfaro-Lara, Ovidio Muñiz-Grijalvo
No abstract text is available yet for this article.
August 2017: Atherosclerosis
Mikaël Croyal, Thi-Thu-Trang Tran, Rose-Hélène Blanchard, Jean-Chistophe Le Bail, Elise Villard, Bruno Poirier, Aurélie Thédrez, Michel Krempf, Christophe Boixel, Gilles Lambert, Etienne Guillot
No abstract text is available yet for this article.
August 2017: Atherosclerosis
Alan Jones, Kate Peers, Sud Ramachandran, Ateeq Syed
No abstract text is available yet for this article.
August 2017: Atherosclerosis
Francesca Simonelli, Cristiano Miotti, Barbara Fausta Filice, Giovanna Gallo, Simone Burocchi, Vivanne Presta, Gerardo Salerno, Sofia Abbolito, Massimo Volpe, Luciano De Biase
No abstract text is available yet for this article.
August 2017: Atherosclerosis
Antonio J Vallejo-Vaz, Eli M Roth, G Kees Hovingh, L Veronica Lee, Joseph Gervasio, Alexia Letierce, Kausik K Ray
No abstract text is available yet for this article.
August 2017: Atherosclerosis
Eli Roth, Patrick M Moriarty, Jean Bergeron, Gisle Langslet, Garen Manvelian, Jian Zhao, Marie T Baccara-Dinet, Daniel J Rader
No abstract text is available yet for this article.
August 2017: Atherosclerosis
Donatella Zodda, Rosario Giammona, Silvia Schifilliti
Prevention and treatment of dyslipidemia should be considered as an integral part of individual cardiovascular prevention interventions, which should be addressed primarily to those at higher risk who benefit most. To date, statins remain the first-choice therapy, as they have been shown to reduce the risk of major vascular events by lowering low-density lipoprotein cholesterol (LDL-C). However, due to adherence to statin therapy or statin resistance, many patients do not reach LDL-C target levels. Ezetimibe, fibrates, and nicotinic acid represent the second-choice drugs to be used in combination with statins if lipid targets cannot be reached...
January 21, 2018: Pharmacy (Basel, Switzerland)
Yu-Sheng Zhang, Ye-Hua Hao, Hou-Long Luo, Bao-Cheng Xie, Jian-Ying Fu, Zhi-Kun Zhou
INTRODUCTION: Low high-density lipoprotein cholesterol (HDL-C) and high low-density lipoprotein cholesterol (LDL-C) levels are associated with incidence of cardiovascular disease (CVD). Alirocumab has been considered as an efficacious, safe and promising therapeutic modality for hypercholesterolemia. The purpose of this study is to compare the differences of the three different doses of alirocumab in patients with hypercholesterolaemia. EVIDENCE ACQUISITION: Randomized controlled trials were identified from PubMed, EMBASE, PMC and Cochrane-library databases...
January 11, 2018: Minerva Medica
BinBin Zheng-Lin, Alberto Ortiz
Cardiovascular disease is the leading cause of death in patients with chronic kidney disease (CKD) and CKD is considered a coronary artery disease risk equivalent. So far, statins have been the mainstay of primary and secondary prevention of cardiovascular disease in the general population. However, their benefit on outcomes is limited and controversial in CKD patients and new therapeutic approaches to reduce cardiovascular risk are needed. Monoclonal antibodies targeting proprotein convertase subtilisin/kexin 9 (PCSK9) reduce low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) in high-risk populations and cardiovascular events in secondary prevention...
January 3, 2018: Drugs
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