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https://www.readbyqxmd.com/read/27697814/european-drug-market-entries-2015-with-new-mechanisms-of-action
#1
Titus W P van den Heuvel, Adam F Cohen, Robert Rissmann
In this article, we consider the new drugs approved for the European market in 2015. We present a summary of the new mechanisms of action introduced and highlight three new mechanisms of action with a potentially high future impact: PCSK9 inhibition (alirocumab (Praluent®) and evolocumab (Repatha®)) for hypercholesterolaemia, neprilysin inhibition (sacubitril in combination with valsartan (Entresto®)) for heart failure, and interleukin-5 inhibition (mepolizumab (Nucala®)) for asthma.
October 2016: Clinical Medicine: Journal of the Royal College of Physicians of London
https://www.readbyqxmd.com/read/27668059/praluent-alirocumab-first-pcsk9-inhibitor-approved-by-the-fda-for-hypercholesterolemia
#2
Lisa A Raedler
No abstract text is available yet for this article.
March 2016: American Health & Drug Benefits
https://www.readbyqxmd.com/read/27548598/alirocumab-praluent-for-treatment-of-hyperlipidemia
#3
Patrick L Turner, Kathleen A Barry
No abstract text is available yet for this article.
August 15, 2016: American Family Physician
https://www.readbyqxmd.com/read/27359211/proprotein-convertase-subtilisin-kexin-9-pcsk9-inhibitors-and-the-future-of-dyslipidemia-therapy-an-updated-patent-review-2011-2015
#4
Sandy Elbitar, Petra El Khoury, Youmna Ghaleb, Jean-Pierre Rabès, Mathilde Varret, Nabil G Seidah, Catherine Boileau, Marianne Abifadel
The identification by Abifadel et al. in 2003 of the first mutations of PCSK9 was the major breakthrough in the cholesterol field that led to a new therapeutic target. This discovery paved the way to new lipid lowering drugs reducing LDL-cholesterol levels through the inhibition of PCSK9. Two anti-PCSK9 monoclonal antibodies have received FDA and EMA approvals: Alirocumab and Evolocumab. Areas covered: This article reviews the different strategies that are pursued to modulate the functional activity of PCSK9 for lowering LDL-cholesterol levels...
December 2016: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/27215418/-pcsk9-inhibitors-new-treatment-option-in-clinical-practice
#5
D Müller-Wieland, N Marx
Proprotein convertase subtilisin/kexin type 9 (PCSK9) binds to low-density lipoprotein (LDL) receptors leading to their degradation in the liver. Inhibition of PCSK9 leads to an increase in LDL receptors and as a result to a reduction of LDL cholesterol in blood. Currently, two antibodies against PCSK9 are available for clinical treatment in Germany, evolocumab (Repatha®) and alirocumab (Praluent®). Clinical studies have shown that treatment with these antibodies, which must be subcutaneously injected by patients every 2 or 4 weeks, in addition to an already existing lipid therapy can lower the LDL cholesterol level in blood by an average of 50-60 %...
June 2016: Herz
https://www.readbyqxmd.com/read/27186592/pcsk9-inhibitors-monoclonal-antibodies-for-the-treatment-of-hypercholesterolemia
#6
REVIEW
D M Paton
In 2015 the U.S. Food and Drug Administration approved the first two proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, alirocumab (Praluent®; Sanofi/ Regeneron) and evolocumab (Repatha®; Amgen), for use in patients with heterozygous and homozygous familial hypercholesterolemia and for patients intolerant of statins or those with a major risk of cardiovascular disease (CVD) but unable to lower their LDL cholesterol (LDL-C) to optimal levels with statins and ezetimibe. Numerous randomized clinical trials have demonstrated that these inhibitors cause a fall in LDL-C levels of 50-60% as well as causing a decline in lipoprotein(a) and an increase in HDL cholesterol...
March 2016: Drugs of Today
https://www.readbyqxmd.com/read/27096698/the-new-face-of-hyperlipidemia-management-proprotein-convertase-subtilisin-kexin-inhibitors-pcsk-9-and-their-emergent-role-as-an-alternative-to-statin-therapy
#7
Lillian Smith, Juan Mosley, Jarah Yates, Luke Caswell
This review analyzes Proprotein Convertase Subtilisin/Kexin 9 inhibitors (PCSK-9), a new medication class that has arisen in the last year to combat hypercholesterolemia. They are targeted towards patients who are unable to achieve acceptable low density lipoprotein (LDL) levels despite maximum statin therapy, as well as those who are unable to tolerate maximum statin therapy due to side effects such as myopathy or myalgia. Two of these medications have been released in the last year: alirocumab (Praluent) and evolocumab (Repatha)...
2016: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/26968977/eligibility-for-pcsk9-treatment-in-734-hypercholesterolemic-patients-referred-to-a-regional-cholesterol-treatment-center-with-ldl-cholesterol-%C3%A2-70-mg-dl-despite-maximal-tolerated-cholesterol-lowering-therapy
#8
Charles J Glueck, Parth Shah, Naila Goldenberg, Marloe Prince, Kevin Lee, Vybhav Jetty, Ashwin Kumar, Michael Goldenberg, Ping Wang
BACKGROUND: LDL cholesterol (LDLC) lowering has been revolutionized by PCSK9 inhibitors, Alirocumab (Praluent) and Evolocumab (Repatha), approved as adjuncts to maximally tolerated cholesterol lowering therapy in heterozygous (HeFH) or homozygous (HoFH) familial hypercholesterolemia, and/or clinical atherosclerotic cardiovascular disease (CVD) where LDLC lowering is insufficient. METHODS: We applied FDA and insurance eligibility criteria for PCSK9 inhibitor use in 734 hypercholesterolemic patients serially referred over 3 years who then received ≥ 2 months maximally tolerated LDLC lowering therapy with follow up LDLC ≥ 70 mg/dl, and in 50 patients approved by insurance for PCSK9 inhibitors...
2016: Lipids in Health and Disease
https://www.readbyqxmd.com/read/26935836/alirocumab-a-review-in-hypercholesterolemia
#9
Sarah L Greig, Emma D Deeks
Alirocumab (Praluent(®)) is a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9) that is administered via subcutaneous injection every 2 weeks. Across ten phase III studies from the ODYSSEY clinical trial program in patients with heterozygous familial hypercholesterolemia (heFH) or nonfamilial hypercholesterolemia (nonFH), including some with mixed dyslipidemia, subcutaneous alirocumab 75 or 150 mg every 2 weeks was significantly more effective with regard to reducing low-density lipoprotein-cholesterol (LDL-C) over 24 weeks than comparator agents (i...
April 2016: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/26911710/pcsk9-inhibitors-and-their-role-in-high-risk-patients-in-reducing-ldl-cholesterol-levels-alirocumab
#10
Chanukya Dahagam, Aditya Goud, Abdelhai Abdelqader, Aditya Hendrani, Matthew J Feinstein, Arman Qamar, Parag H Joshi, Kristopher J Swiger, Kathleen Byrne, Renato Quispe, Steven R Jones, Roger S Blumenthal, Seth S Martin
In this review, we examine alirocumab (Praluent(®)), a monoclonal antibody to PCSK9 and its role in reducing LDL-C levels. By comparing the results of various studies and trials we discuss the efficacy and safety of alirocumab. We aim to guide clinicians of the role of alirocumab in clinical practice. Overall, PCSK9 inhibitors are promising new agents in further reducing LDL-C levels in addition to diet and maximally tolerated statin therapy. Long-term outcome studies are currently ongoing and will further delineate the role of PCSK9 inhibitors...
March 2016: Future Cardiology
https://www.readbyqxmd.com/read/26886466/pcsk9-inhibitors-an-innovative-approach-to-treating-hyperlipidemia
#11
Alexandra M Sible, James J Nawarskas, Joe R Anderson
Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors are novel agents indicated for the treatment of hyperlipidemia. Inhibition of PCSK9 produces an increase in surface low-density lipoprotein (LDL) receptors and increases removal of LDL from the circulation. Alirocumab (Praluent; Sanofi/Regeneron, Bridgewater, NJ) and evolocumab (Repatha; Amgen, Thousand Oaks, CA) are currently available and approved for use in patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, and clinical atherosclerotic cardiovascular disease...
May 2016: Cardiology in Review
https://www.readbyqxmd.com/read/26868931/two-new-lipid-regulating-drugs
#12
(no author information available yet)
▼Evolocumab (Repatha-Amgen Ltd) and ▼alirocumab (Praluent-Sanofi) are the first in a novel class of lipid-regulating drugs, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, to be licensed in the UK. Both drugs have marketing authorisation for the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and are administered by subcutaneous injection. Here we consider the evidence for evolocumab and alirocumab in the management of primary hypercholesterolaemia and dyslipidaemias...
February 2016: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/26785741/alirocumab-for-hyperlipidemia-odyssey-phase-iii-clinical-trial-results-and-us-fda-approval-indications
#13
Eli M Roth
A new class of lipid-lowering drugs, inhibitors of PCSK9 has been generating impressive clinical trial data over the last several years, and alirocumab (Praluent) has become the first to be approved by the US FDA. Alirocumab has been shown to lower low density lipoprotein cholesterol by 45-62% with a safety profile generally comparable to placebo. Alirocumab is a monoclonal antibody to PCSK9 administered subcutaneously and has been evaluated in 16 Phase III clinical trials, the majority of which have been enrolled or completed...
March 2016: Future Cardiology
https://www.readbyqxmd.com/read/26766888/alirocumab-praluent-first-in-the-new-class-of-pcsk9-inhibitors
#14
Marina Manniello, Michele Pisano
Alirocumab (Praluent): first in the new class of PCSK9 inhibitors.
January 2016: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/26692765/low-high-density-lipoprotein-and-risk-of-myocardial-infarction
#15
REVIEW
A Ramirez, P P Hu
Low HDL is an independent risk factor for myocardial infarction. This paper reviews our current understanding of HDL, HDL structure and function, HDL subclasses, the relationship of low HDL with myocardial infarction, HDL targeted therapy, and clinical trials and studies. Furthermore potential new agents, such as alirocumab (praluent) and evolocumab (repatha) are discussed.
2015: Clinical Medicine Insights. Cardiology
https://www.readbyqxmd.com/read/26684558/therapeutic-management-of-familial-hypercholesterolemia-current-and-emerging-drug-therapies
#16
REVIEW
Roshni S Patel, Emily M Scopelliti, Julie Savelloni
Familial hypercholesterolemia (FH) is a genetic disorder characterized by significantly elevated low-density lipoprotein cholesterol (LDL-C) concentrations that result from mutations of the LDL receptor, apolipoprotein B (apo B-100), and proprotein convertase subtilisin/kexin type 9 (PCSK9). Early and aggressive treatment can prevent premature atherosclerotic cardiovascular disease in these high-risk patients. Given that the cardiovascular consequences of FH are similar to typical hypercholesterolemia, traditional therapies are utilized to decrease LDL-C levels...
December 2015: Pharmacotherapy
https://www.readbyqxmd.com/read/26652782/-pcsk9-inhibition-as-the-new-hope-for-patients-with-familial-hypercholesterolemia-statin-intolerance-and-eventually-for-those-at-the-highest-cardiovascular-risk-focused-on-alirocumab-praluent%C3%A2
#17
REVIEW
Richard Češka
At the present time there are novel hypolipidemics registered globally (alirocumab was the first drug of this group in the world registered by an American drug agency FDA) and in Europe, which in many ways differ from the medicines administered until now. They are bringing another advancement in the treatment of disorders of lipid metabolism and in preventive cardiology. Alirocumab is a fully human monoclonal antibody to PCSK-9 enzyme (proprotein convertase subtilisin kexin-9). PCSK-9 enzyme plays an important role in the metabolism of LDL-cholesterol through affecting the breakdown and eventually the amount and activity of LDL-receptors...
November 2015: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/26651519/antibodies-to-watch-in-2016
#18
Janice M Reichert
The number of novel antibody therapeutics that received first marketing approvals in 2015 met expectations, with 6 (alirocumab (Praluent®), evolocumab (Repatha®), daratumumab (Darzalex®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®)) granted first approvals as of mid-November*. Seven novel antibody therapeutics (begelomab, brodalumab, elotuzumab, ixekizumab, necitumumab, obiltoxaximab, reslizumab) are in regulatory review, and thus a similar number, if not more, are projected to gain first approvals in 2016...
2016: MAbs
https://www.readbyqxmd.com/read/26535020/pharmaceutical-approval-update
#19
Kunj Gohil
Alirocumab (Praluent) for high cholesterol; flibanserin (Addyi) for sexual desire disorder in women; daclatasvir (Daklinza) for chronic hepatitis C virus (HCV) genotype 3 infection; and ombitasvir/paritaprevir/ritonavir (Technivie) for genotype 4 HCV infection without cirrhosis.
October 2015: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/26445204/evolocumab-repatha-a-second-pcsk9-inhibitor-to-lower-ldl-cholesterol
#20
REVIEW
(no author information available yet)
The second FDA-approved PCSK9 inhibitor evolocumab (Repatha) appears to be similar in efficacy and safety to alirocumab (Praluent), but no comparative studies are available. Given by subcutaneous injection every 2 weeks or once monthly, evolocumab can further lower LDL-cholesterol levels by about 60% in patients at high risk for atherosclerotic cardiovascular disease already taking maximal statin therapy. Its effect on cardiovascular outcomes remains to be established. The long-term efficacy and safety of both evolocumab and alirocumab are unknown, and they are expensive...
October 12, 2015: Medical Letter on Drugs and Therapeutics
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