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https://www.readbyqxmd.com/read/28919772/anti-pcsk9-antibodies-for-the-treatment-of-heterozygous-familial-hypercholesterolemia-patient-selection-and-perspectives
#1
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/28905478/efficacy-and-safety-of-alirocumab-in-insulin-treated-individuals-with-type-1-or-type-2-diabetes-and-high-cardiovascular-risk-the-odyssey-dm-insulin-randomized-trial
#2
Lawrence A Leiter, Bertrand Cariou, Dirk Müller-Wieland, Helen M Colhoun, Stefano Del Prato, Francisco J Tinahones, Kausik K Ray, Maja Bujas-Bobanovic, Catherine Domenger, Jonas Mandel, Rita Samuel, Robert R Henry
AIMS: To investigate efficacy and safety of alirocumab in participants with type 2 or type 1 diabetes treated with insulin and with elevated low-density lipoprotein cholesterol (LDL-C) despite maximally tolerated statin therapy. MATERIALS AND METHODS: Participants at high cardiovascular risk with type 2 (n = 441) or type 1 diabetes (n = 76) and LDL-C ≥70 mg/dL (≥1.8 mmol/L) were randomized 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks (Q2W), for 24 weeks' double-blind treatment...
September 14, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28862926/alirocumab-treatment-and-achievement-of-non-high-density-lipoprotein-cholesterol-and-apolipoprotein-b-goals-in-patients-with-hypercholesterolemia-pooled-results-from-10-phase-3-odyssey-trials
#3
Harold E Bays, Lawrence A Leiter, Helen M Colhoun, Desmond Thompson, Laurence Bessac, Robert Pordy, Peter P Toth
BACKGROUND: Non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein (apo) B are better predictors of atherosclerotic cardiovascular disease risk than low-density lipoprotein cholesterol alone. US and European lipid management guidelines support non-HDL-C and apoB as targets for lipid-lowering therapy. METHODS AND RESULTS: This analysis evaluated the efficacy of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, on non-HDL-C and apoB...
August 8, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28854074/implementation-of-a-new-clinic-based-pharmacist-managed-pcsk9-inhibitor-consultation-service
#4
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/28817679/increased-half-life-and-enhanced-potency-of-fc-modified-human-pcsk9-monoclonal-antibodies-in-primates
#5
Yijun Shen, Hua Li, Li Zhao, Gang Li, Ben Chen, Qingsong Guo, Bei Gao, Jinsong Wu, Tong Yang, Li Jin, Yong Su
Blocking proprotein convertase subtilisin kexin type 9 (PCSK9) binding to low-density lipoprotein receptor (LDLR) can profoundly lower plasma LDL levels. Two anti-PCKS9 monoclonal antibodies (mAbs), alirocumab and evolocumab, were approved by the FDA in 2015. The recommended dose is 75 mg to 150 mg every two weeks for alirocumab and 140mg every two weeks or 420 mg once a month for evolocumab. This study attempted to improve the pharmacokinetic properties of F0016A, an IgG1 anti-PCKS9 mAb, to generate biologically superior molecules...
2017: PloS One
https://www.readbyqxmd.com/read/28804243/a-quantitative-systems-pharmacology-platform-to-investigate-the-impact-of-alirocumab-and-cholesterol-lowering-therapies-on-lipid-profiles-and-plaque-characteristics
#6
Jeffrey E Ming, Ruth E Abrams, Derek W Bartlett, Mengdi Tao, Tu Nguyen, Howard Surks, Katherine Kudrycki, Ananth Kadambi, Christina M Friedrich, Nassim Djebli, Britta Goebel, Alex Koszycki, Meera Varshnaya, Joseph Elassal, Poulabi Banerjee, William J Sasiela, Michael J Reed, Jeffrey S Barrett, Karim Azer
Reduction in low-density lipoprotein cholesterol (LDL-C) is associated with decreased risk for cardiovascular disease. Alirocumab, an antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduces LDL-C. Here, we report development of a quantitative systems pharmacology (QSP) model integrating peripheral and liver cholesterol metabolism, as well as PCSK9 function, to examine the mechanisms of action of alirocumab and other lipid-lowering therapies, including statins. The model predicts changes in LDL-C and other lipids that are consistent with effects observed in clinical trials of single or combined treatments of alirocumab and other treatments...
2017: Gene Regulation and Systems Biology
https://www.readbyqxmd.com/read/28799203/efficacy-and-safety-of-alirocumab-in-people-with-prediabetes-vs-those-with-normoglycaemia-at-baseline-a-pooled-analysis-of-10-phase-iii-odyssey-clinical-trials
#7
L A Leiter, D Müller-Wieland, M T Baccara-Dinet, A Letierce, R Samuel, B Cariou
AIM: To assess the lipid-lowering efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in people with hypercholesterolaemia and prediabetes at baseline vs people with normoglycaemia at baseline in a pooled analysis of 10 ODYSSEY phase III trials. METHODS: People classified as having prediabetes had baseline HbA1c ≥39 mmol/mol (5.7%) and <48 mmol/mol (6.5%), or two baseline fasting plasma glucose values ≥5.6 mmol/l (100 mg/dl) but no more than one fasting plasma glucose value ≥7...
August 11, 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28798072/the-roles-of-apo-a-size-phenotype-and-dominance-pattern-in-pcsk9-inhibition-induced-reduction-in-lp-a-with-alirocumab
#8
Byambaa Enkhmaa, Erdembileg Anuurad, Wei Zhang, Kun Yue, Ching-Shang Li, Lars Berglund
An elevated level of lipoprotein(a) [Lp(a)] is a risk factor for cardiovascular disease. Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9, is reported to reduce Lp(a) levels. The relationship of Lp(a)-reduction with apolipoprotein(a) [apo(a)] size polymorphism, phenotype, and dominance pattern and LDL-C-reduction was evaluated in a pooled analysis of 155 hypercholesterolemic patients (75 with heterozygous familial hypercholesterolemia) from 2 clinical trials. Alirocumab significantly reduced total Lp(a) (pooled median: -21%, p=0...
August 10, 2017: Journal of Lipid Research
https://www.readbyqxmd.com/read/28768335/simulation-of-lipid-lowering-therapy-intensification-in-a-population-with-atherosclerotic-cardiovascular-disease
#9
Christopher P Cannon, Irfan Khan, Alexa C Klimchak, Matthew R Reynolds, Robert J Sanchez, William J Sasiela
Importance: In patients with atherosclerotic cardiovascular disease (ASCVD), guidelines recommend optimizing statin treatment, and consensus pathways suggest use of ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in patients with persistently elevated low-density lipoprotein cholesterol (LDL-C) levels despite use of statins. Recent trials have provided evidence of benefit in reduction of cardiovascular events with these agents. Objective: To estimate the percentage of patients with ASCVD who would require a PCSK9 inhibitor when oral lipid-lowering therapy (LLT) is intensified first...
August 2, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28750828/efficacy-and-safety-of-alirocumab-versus-ezetimibe-over-2-years-from-odyssey-combo-ii
#10
RANDOMIZED CONTROLLED TRIAL
Mahfouz El Shahawy, Christopher P Cannon, Dirk J Blom, James M McKenney, Bertrand Cariou, Guillaume Lecorps, Robert Pordy, Umesh Chaudhari, Helen M Colhoun
The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab has been shown to substantially reduce low-density lipoprotein cholesterol (LDL-C). Demonstrating whether efficacy and safety are maintained over a long duration of exposure is vital for clinical decision-making. The COMBO II trial compared the efficacy and safety of alirocumab versus ezetimibe over 2 years. A prespecified first analysis was reported at 52 weeks. Here we report the final end-of-study data (on-treatment) and evaluate post hoc the safety profile with longer versus shorter duration of alirocumab exposure...
September 15, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28750477/anti-pcsk9-antibodies-for-hypercholesterolaemia-overview-of-clinical-data-and-implications-for-primary-care
#11
REVIEW
Olivier S Descamps, Uwe Fraass, Ricardo Dent, Winfried März, Ioanna Gouni-Berthold
OBJECTIVES: To put data from our recent systematic review of phase 3 studies of anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies into the context of clinical practice. METHODS: Data from studies previously identified by a systematic review of phase 3 studies of alirocumab and evolocumab and additional references from non-systematic literature searches were used. We evaluated the hypothetical cardiovascular (CV) benefit in cases of typical patients in whom anti-PCSK9 antibodies may be recommended, using preliminary major CV event (CVE) rates from long-term clinical trials of anti-PCSK9 antibodies and from extrapolations derived from correlation between low-density lipoprotein cholesterol (LDL-C) reduction and CV benefit with other lipid-lowering therapies (LLTs)...
July 27, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28740397/eligibility-for-alirocumab-or-evolocumab-treatment-in-1090-hypercholesterolemic-patients-referred-to-a-regional-cholesterol-treatment-center-with-ldl-cholesterol-%C3%A2-70-mg-dl-despite-maximal-tolerated-ldl-cholesterol-lowering-therapy
#12
Vybhav Jetty, Charles J Glueck, Kevin Lee, Naila Goldenberg, Marloe Prince, Ashwin Kumar, Michael Goldenberg, Ishan Anand, Ping Wang
BACKGROUND: Proprotein convertase subtilisin/kexin type 9 inhibitors, Praluent (alirocumab [ALI]) and Repatha (evolocumab [EVO]) have been approved as adjuncts to the standard-of-care maximal-tolerated dose (MTD) of low-density lipoprotein cholesterol (LDLC)-lowering therapy (LLT), statin therapy, in heterozygous (HeFH) (ALI or EVO) or homozygous (EVO) familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease (CVD) where LDLC lowering is insufficient (both). Since LDLC lowering has been revolutionized by ALI and EVO, specialty pharmaceutical pricing models will be applied to a mass market...
2017: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/28738813/efficacy-and-safety-of-proprotein-convertase-subtilisin-kexin-type-9-pcsk9-inhibitors-alirocumab-and-evolocumab-a-post-commercialization-study
#13
Joshua Choi, Amir M Khan, Michael Jarmin, Naila Goldenberg, Charles J Glueck, Ping Wang
BACKGROUND: Efficacy-safety of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, alirocumab (ALI) and evolocumab (EVO), have previously been evaluated through controlled clinical trials with selective patient groups. Post-commercially, in 69 patients with heterozygous familial hypercholesterolemia (HeFH) and/or cardiovascular disease (CVD) with suboptimal LDL cholesterol (LDLC) lowering on maximal tolerated LDLC therapy, we assessed efficacy and safety of ALI and EVO. METHODS: Post-commercially, we started 29 patients on ALI 75 mg, 18 on ALI 150 mg, and 22 on EVO 140 mg every 2 weeks added to a maximally tolerated LDLC-lowering regimen...
July 24, 2017: Lipids in Health and Disease
https://www.readbyqxmd.com/read/28721159/pcsk9-inhibitors-from-discovery-of-a-single-mutation-to-a-groundbreaking-therapy-of-lipid-disorders-in-one-decade
#14
Krzysztof Jaworski, Piotr Jankowski, Dariusz A Kosior
Hypercholesterolemia is one of the main risk factors for coronary heart disease and significantly contributes to the high mortality associated with cardiovascular diseases. Statin therapy represents the gold standard in the reduction of low-density lipoprotein cholesterol concentration. Nevertheless, many patients still cannot achieve the recommended target levels, due to either inadequate effectiveness or intolerance of these drugs. Monoclonal antibodies that inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9) have emerged as a promising option in lipid-lowering treatment...
June 2017: Archives of Medical Science: AMS
https://www.readbyqxmd.com/read/28693998/long-term-treatment-adherence-to-the-proprotein-convertase-subtilisin-kexin-type-9-inhibitor-alirocumab-in-6-odyssey-phase-iii-clinical-studies-with-treatment-duration-of-1-to-2%C3%A2-years
#15
Michel Farnier, Helen M Colhoun, William J Sasiela, Jay M Edelberg, Gaëlle Asset, Jennifer G Robinson
BACKGROUND: Nonadherence to cardiovascular medications, including daily, oral statin therapy, negatively impacts outcomes in patients requiring low-density lipoprotein cholesterol (LDL-C)-lowering therapy. The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab also reduces LDL-C, but has a different mode of administration (subcutaneous injection). OBJECTIVE: The objective of the study was to assess long-term adherence to alirocumab 75 or 150 mg, given every 2 weeks, in phase III trials of patients with sub-optimally controlled hypercholesterolemia...
June 8, 2017: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/28623954/efficacy-and-safety-of-alirocumab-in-patients-with-hypercholesterolemia-not-adequately-controlled-with-non-statin-lipid-lowering-therapy-or-the-lowest-strength-of-statin-odyssey-nippon-study-design-and-rationale
#16
Tamio Teramoto, Akira Kondo, Arihiro Kiyosue, Mariko Harada-Shiba, Yasushi Ishigaki, Kimimasa Tobita, Yumiko Kawabata, Asuka Ozaki, Marie T Baccara-Dinet, Masataka Sata
BACKGROUND: Statins are generally well-tolerated and serious side effects are infrequent, but some patients experience adverse events and reduce their statin dose or discontinue treatment altogether. Alirocumab is a highly specific, fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), which can produce substantial and sustained reductions of low-density lipoprotein cholesterol (LDL-C). METHODS: The randomized, double-blind, placebo-controlled, parallel-group, phase 3 ODYSSEY NIPPON study will explore alirocumab 150 mg every 4 weeks (Q4W) in 163 Japanese patients with hypercholesterolemia who are on the lowest-strength dose of atorvastatin (5 mg/day) or are receiving a non-statin lipid-lowering therapy (LLT) (fenofibrate, bezafibrate, ezetimibe, or diet therapy alone)...
June 17, 2017: Lipids in Health and Disease
https://www.readbyqxmd.com/read/28618994/role-of-anti-pcsk9-antibodies-in-the-treatment-of-patients-with-statin-intolerance
#17
Julia Schreml, Ioanna Gouni-Berthold
Statin intolerance is usually defined as the inability of a patient to tolerate statin-treatment due to muscle-related complaints. While randomised trials show that these complaints occure with similar frequency in patients receiving placebo, namely in up to ~5% of the subjects, data from registries as well as clinical experience indicate a much higher frequency of up to ~30%. The lack of standard definition or of a diagnostic marker of statin intolerance confounds the problem. The diagnosis remains subjective based on the symptoms the patient reports...
June 16, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28596304/pcsk9-inhibition-and-atherosclerotic-cardiovascular-disease-prevention-does-reality-match-the-hype
#18
REVIEW
Savvas Hadjiphilippou, Kausik K Ray
Within this review we look at whether the potential provided by proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition for prevention of atherosclerotic cardiovascular disease matches the excitement generated. Two fully human monoclonal antibodies to PCSK9 are currently licenced for clinical use both in the USA and the European Union: evolocumab and alirocumab. These reduce low-density lipoprotein cholesterol by over 50% across a range of populations and were generally found to have a safety profile comparable with placebo...
June 8, 2017: Heart: Official Journal of the British Cardiac Society
https://www.readbyqxmd.com/read/28572002/toward-an-international-consensus-integrating-lipoprotein-apheresis-and-new-lipid-lowering-drugs
#19
REVIEW
Claudia Stefanutti, Ulrich Julius, Gerald F Watts, Mariko Harada-Shiba, Maria Cossu, Volker J Schettler, Giustina De Silvestro, Handrean Soran, Jeanine Roeters Van Lennep, Livia Pisciotta, Hans U Klör, Kurt Widhalm, Patrick M Moriarty
BACKGROUND: Despite advances in pharmacotherapy of lipid disorders, many dyslipidemic patients do not attain sufficient lipid lowering to mitigate risk of atherosclerotic cardiovascular disease. Several classes of novel lipid-lowering agents are being evaluated to reduce atherosclerotic cardiovascular disease risk. Lipoprotein apheresis (LA) is effective in acutely lowering the plasma concentrations of atherogenic lipoproteins including low-density lipoprotein cholesterol and lipoprotein(a), and novel lipid-lowering drugs may dampen the lipid rebound effect of LA, with the possibility that LA frequency may be decreased, in some cases even be discontinued...
April 25, 2017: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/28555526/statin-intolerance-in-heterozygous-familial-hypercolesterolemia-with-cardiovascular-disease-after-pcsk-9-antibodies-what-else
#20
Francesco Sbrana, Beatrice Dal Pino, Federico Bigazzi, Andrea Ripoli, Claudio Passino, Alessandra Gabutti, Emilio M Pasanisi, Christina Petersen, Alessandro Valleggi, Giancarlo Todiere, Andrea Barison, Alberto Giannoni, Luca Panchetti, Francesco Becherini, Mascia Pianelli, Roberta Luciani, Tiziana Sampietro
Background Familial hypercholesterolemia is the elective clinical condition that deserves the maximal personalisation in lipid-lowering therapy, especially in the presence of statin intolerance. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors represent a promising approach to lower low-density lipoprotein (LDL) cholesterol. Methods We enrolled 18 patients (mean age 62 ± 8 years, 72% men) affected by heterozygous familial hypercholesterolemia and cardiovascular disease, with a history of statin intolerance assigned to PCSK9 inhibitors...
January 1, 2017: European Journal of Preventive Cardiology
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