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ezetimibe AND randomized controlled trial

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https://www.readbyqxmd.com/read/29106532/using-genetics-to-explore-whether-the-cholesterol-lowering-drug-ezetimibe-may-cause-an-increased-risk-of-cancer
#1
Bo Kobberø Lauridsen, Stefan Stender, Ruth Frikke-Schmidt, Børge G Nordestgaard, Anne Tybjærg-Hansen
Background: Results from randomized controlled trials (RCTs) have raised concern that the cholesterol-lowering drug ezetimibe might increase the risk of cancer. We tested the hypothesis that genetic variation in NPC1L1 , mimicking treatment with ezetimibe, was associated with an increased risk of cancer. Methods: We included 67 257 individuals from the general population. Of these, 8333 developed cancer and 2057 died of cancer from 1968 to 2011. To mimic the effect of ezetimibe, we calculated weighted allele scores based on the low-density lipoprotein (LDL) cholesterol-lowering(= NPC1L1-inhibitory) effect of each variant...
June 30, 2017: International Journal of Epidemiology
https://www.readbyqxmd.com/read/29069377/effect-of-statins-and-non-statin-ldl-lowering-medications-on-cardiovascular-outcomes-in-secondary-prevention-a-meta-analysis-of-randomized-trials
#2
Konstantinos C Koskinas, George C M Siontis, Raffaele Piccolo, Dimitris Mavridis, Lorenz Räber, François Mach, Stephan Windecker
Aims: Current evidence on dyslipidaemia management has expanded to novel treatments and very low achieved levels of low-density lipoprotein cholesterol (LDL-C). We sought to compare the clinical impact of more-intensive vs. less-intensive LDL-C lowering by means of statins and currently recommended non-statin medications in secondary prevention. Methods and results: We searched Medline, EMBASE, and Cochrane databases for randomized controlled trials of statins, ezetimibe, proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, or bile acid sequestrants with >500 patients followed for ≥1 year...
October 23, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28971955/systematic-review-and-network-meta-analysis-on-the-efficacy-of-evolocumab-and-other-therapies-for-the-management-of-lipid-levels-in-hyperlipidemia
#3
REVIEW
Peter P Toth, Gillian Worthy, Shravanthi R Gandra, Naveed Sattar, Sarah Bray, Lung-I Cheng, Ian Bridges, Gavin M Worth, Ricardo Dent, Carol A Forbes, Sohan Deshpande, Janine Ross, Jos Kleijnen, Erik S G Stroes
BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors evolocumab and alirocumab substantially reduce low-density lipoprotein cholesterol (LDL-C) when added to statin therapy in patients who need additional LDL-C reduction. METHODS AND RESULTS: We conducted a systematic review and network meta-analysis of randomized trials of lipid-lowering therapies from database inception through August 2016 (45 058 records retrieved). We found 69 trials of lipid-lowering therapies that enrolled patients requiring further LDL-C reduction while on maximally tolerated medium- or high-intensity statin, of which 15 could be relevant for inclusion in LDL-C reduction networks with evolocumab, alirocumab, ezetimibe, and placebo as treatment arms...
October 2, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28928170/effect-of-adding-bezafibrate-to-standard-lipid-lowering-therapy-on-post-fat-load-lipid-levels-in-patients-with-familial-dysbetalipoproteinemia-a-randomized-placebo-controlled-crossover-trial
#4
Charlotte Koopal, A David Marais, Jan Westerink, Yolanda van der Graaf, Frank L J Visseren
Familial dysbetalipoproteinemia (FD) is a genetic disorder associated with impaired postprandial lipid clearance. The effect of adding bezafibrate to standard lipid-lowering therapy on postprandial and fasting lipid levels in patients with FD is unknown. In this randomized placebo-controlled double-blind crossover trial, 15 patients with FD received bezafibrate and placebo for 6 weeks in randomized order in addition to standard lipid-lowering therapy (statin, ezetimibe, and/or lifestyle). We assessed post-fat load lipids, expressed as incremental area under the curve (iAUC) and area under the curve (AUC), as well as fasting levels and safety, and found that adding bezafibrate did not reduce post-fat load non-HDL-cholesterol (non-HDL-C) iAUC (1...
November 2017: Journal of Lipid Research
https://www.readbyqxmd.com/read/28923989/competing-risks-of-cardiovascular-versus-noncardiovascular-death-during-long-term-follow-up-after-acute-coronary-syndromes
#5
Alexander C Fanaroff, Matthew T Roe, Robert M Clare, Yuliya Lokhnygina, Ann Marie Navar, Robert P Giugliano, Stephen D Wiviott, Andrew M Tershakovec, Eugene Braunwald, Michael A Blazing
BACKGROUND: Understanding the relative risk of cardiovascular versus noncardiovascular death is important for designing clinical trials. These risks may differ depending on patient age, sex, and type of acute coronary syndrome (ACS). METHODS AND RESULTS: IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) was a randomized controlled trial of simvastatin plus either ezetimibe or placebo following stabilized ACS. Cause of death was adjudicated by an independent committee...
September 18, 2017: Journal of the American Heart Association
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
#6
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/28697767/the-impact-of-the-time-of-drug-administration-on-the-effectiveness-of-combined-treatment-of-hypercholesterolemia-with-rosuvastatin-and-ezetimibe-roseze-study-protocol-for-a-randomized-controlled-trial
#7
Karolina Obońska, Michał Kasprzak, Joanna Sikora, Ewa Obońska, Krzysztof Racki, Natalia Goździkiewicz, Magdalena Krintus, Jacek Kubica
BACKGROUND: Hypercholesterolemia is one of the main risk factors for cardiovascular disease. The first line treatment for hypercholesterolemia is statin therapy. When the expected low-density lipoprotein cholesterol (LDL-C) concentration is not achieved, the pharmacotherapy may be extended by combining the statin with the cholesterol absorption inhibitor ezetimibe. METHODS/DESIGN: The study is designed as a randomized, open-label, single-center, crossover study evaluating the effectiveness of combined therapy with rosuvastatin and ezetimibe for hypercholesterolemia...
July 11, 2017: Trials
https://www.readbyqxmd.com/read/28509674/evidence-for-more-intensive-cholesterol-lowering
#8
Handrean Soran, See Kwok, Safwaan Adam, Jan Hoong Ho, Paul N Durrington
PURPOSE OF REVIEW: In randomized clinical trials, reduction in cardiovascular disease (CVD) risk with cholesterol-lowering drugs correlates with the LDL cholesterol decrease. However, because the majority have investigated a fixed statin dose, current guidelines disagree about the use of statin dose titration or non-statin adjunctive cholesterol-lowering drugs. RECENT FINDINGS: We conducted a meta-analysis of all randomized controlled trials with CVD end-points, comparing two intensities of lipid-lowering regimens within the same population, using varying statins doses and/or potency, ezetimibe or PCSK9 inhibitors and compared the observed number of patients needed to be treated for 10 years to prevent one CVD event (NNT) with NNT predicted from trials of predominantly single-dose statin...
August 2017: Current Opinion in Lipidology
https://www.readbyqxmd.com/read/28430910/low-density-lipoprotein-cholesterol-targeting-with-pitavastatin-ezetimibe-for-patients-with-acute-coronary-syndrome-and-dyslipidaemia-the-hij-proper-study-a-prospective-open-label-randomized-trial
#9
Nobuhisa Hagiwara, Erisa Kawada-Watanabe, Ryo Koyanagi, Hiroyuki Arashi, Junichi Yamaguchi, Koichi Nakao, Tetsuya Tobaru, Hiroyuki Tanaka, Toshiaki Oka, Yasuhiro Endoh, Katsumi Saito, Tatsuro Uchida, Kunihiko Matsui, Hiroshi Ogawa
Aims: To elucidate the effects of intensive LDL-C lowering treatment with a standard dose of statin and ezetimibe in patients with dyslipidaemia and high risk of coronary events, targeting LDL-C less than 70 mg/dL (1.8 mmol/L), compared with standard LDL-C lowering lipid monotherapy targeting less than 100 mg/dL (2.6 mmol/L). Methods and results: The HIJ-PROPER study is a prospective, randomized, open-label trial to assess whether intensive LDL-C lowering with standard-dose pitavastatin plus ezetimibe reduces cardiovascular events more than standard LDL-C lowering with pitavastatin monotherapy in patients with acute coronary syndrome (ACS) and dyslipidaemia...
August 1, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28394933/the-acute-impact-of-high-dose-lipid-lowering-treatment-on-endothelial-progenitor-cells-in-patients-with-coronary-artery-disease-the-remedy-epc-early-substudy
#10
RANDOMIZED CONTROLLED TRIAL
Rosalinda Madonna, Francesca Vera Renna, Paola Lanuti, Matteo Perfetti, Marco Marchisio, Carlo Briguori, Gerolama Condorelli, Lamberto Manzoli, Raffaele De Caterina
RATIONALE AND OBJECTIVE: Endothelial progenitor cells (EPCs) play a role in vascular repair, while circulating endothelial cells (CECs) are biomarkers of vascular damage and regeneration. Statins may promote EPC/CEC mobilization in the peripheral blood. We evaluated whether pre-procedural exposure to different lipid-lowering drugs (statins±ezetimibe) can acutely increase levels/activity of EPCs/CECs in patients with stable coronary artery disease (CAD). METHODS: In a planned sub-analysis of the Rosuvastatin For REduction Of Myocardial DamagE During Coronary AngioplastY (REMEDY) trial, 38 patients with stable CAD on chronic low-dose statin therapy were randomized, in a double-blind, placebo-controlled design, into 4 groups before PCI: i...
2017: PloS One
https://www.readbyqxmd.com/read/28378336/review-of-treatment-for-alopecia-totalis-and-alopecia-universalis
#11
REVIEW
Sama Kassira, Dorota Z Korta, Lance W Chapman, Francis Dann
Alopecia areata (AA) is an autoimmune disease directed at the hair follicle. Although usually limited to patchy hair loss over the scalp (focalis), AA can present as total loss of scalp hair (totalis; AT) or as total loss of both scalp and body hair (universalis; AU). Management of AT and AU can be challenging, and although multiple treatment modalities have been explored, no therapy is currently FDA-approved. This review focuses on the evidence for current treatment options for AT and AU. The PubMed database was searched from January 1, 2000, to September 1, 2016, for clinical trials, retrospective studies, and case reports of treatments for AT and AU...
August 2017: International Journal of Dermatology
https://www.readbyqxmd.com/read/28316281/are-potentially-clinically-meaningful-benefits-misinterpreted-in-cardiovascular-randomized-trials-a-systematic-examination-of-statistical-significance-clinical-significance-and-authors-conclusions
#12
G Michael Allan, Caitlin R Finley, James McCormack, Vivek Kumar, Simon Kwong, Emelie Braschi, Christina Korownyk, Michael R Kolber, Adriennne J Lindblad, Oksana Babenko, Scott Garrison
BACKGROUND: While journals and reporting guidelines recommend the presentation of confidence intervals, many authors adhere strictly to statistically significant testing. Our objective was to determine what proportions of not statistically significant (NSS) cardiovascular trials include potentially clinically meaningful effects in primary outcomes and if these are associated with authors' conclusions. METHODS: Cardiovascular studies published in six high-impact journals between 1 January 2010 and 31 December 2014 were identified via PubMed...
March 20, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28294373/rationale-and-design-of-reduce-it-reduction-of-cardiovascular-events-with-icosapent-ethyl-intervention-trial
#13
RANDOMIZED CONTROLLED TRIAL
Deepak L Bhatt, Ph Gabriel Steg, Eliot A Brinton, Terry A Jacobson, Michael Miller, Jean-Claude Tardif, Steven B Ketchum, Ralph T Doyle, Sabina A Murphy, Paresh N Soni, Rene A Braeckman, Rebecca A Juliano, Christie M Ballantyne
Residual cardiovascular risk persists despite statins, yet outcome studies of lipid-targeted therapies beyond low-density lipoprotein cholesterol (LDL-C) have not demonstrated added benefit. Triglyceride elevation is an independent risk factor for cardiovascular events. High-dose eicosapentaenoic acid (EPA) reduces triglyceride-rich lipoproteins without raising LDL-C. Omega-3s have postulated pleiotropic cardioprotective benefits beyond triglyceride-lowering. To date, no large, multinational, randomized clinical trial has proved that lowering triglycerides on top of statin therapy improves cardiovascular outcomes...
March 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28279967/ezetimibe-increases-endogenous-cholesterol-excretion-in-humans
#14
RANDOMIZED CONTROLLED TRIAL
Xiaobo Lin, Susan B Racette, Lina Ma, Michael Wallendorf, Richard E Ostlund
OBJECTIVE: Ezetimibe improves cardiovascular outcomes when added to optimum statin treatment. It lowers low-density lipoprotein cholesterol and percent intestinal cholesterol absorption, but the exact cardioprotective mechanism is unknown. We tested the hypothesis that the dominant effect of ezetimibe is to increase the reverse transport of cholesterol from rapidly mixing endogenous cholesterol pool into the stool. APPROACH AND RESULTS: In a randomized, placebo-controlled, double-blind parallel trial in 24 healthy subjects with low-density lipoprotein cholesterol 100 to 200 mg/dL, we measured cholesterol metabolism before and after a 6-week treatment period with ezetimibe 10 mg/d or placebo...
May 2017: Arteriosclerosis, Thrombosis, and Vascular Biology
https://www.readbyqxmd.com/read/28257594/ezetimibe-for-the-treatment-of-non-alcoholic-fatty-liver-disease-a-meta-analysis
#15
Yukiomi Nakade, Kenta Murotani, Tadahisa Inoue, Yuji Kobayashi, Takaya Yamamoto, Norimitsu Ishii, Tomohiko Ohashi, Kiyoaki Ito, Yoshitaka Fukuzawa, Masashi Yoneda
AIM: Several studies on the efficacy of ezetimibe, a potent inhibitor of cholesterol absorption, in treating non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) have been published; however, the results are inconsistent. We undertook a meta-analysis to evaluate the efficacy of ezetimibe in treating NAFLD and NASH. METHODS: PubMed, Medline, and Cochrane Library Full Text Database were searched until June 2016. The main inclusion criteria included original studies investigating the use of ezetimibe for the treatment of NAFLD and NASH...
March 3, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28191471/lipids-a-suitable-therapeutic-target-in-diabetic-neuropathy
#16
REVIEW
M C Perez-Matos, M C Morales-Alvarez, C O Mendivil
Diabetic polyneuropathy (DPN) encompasses multiple syndromes with a common pathogenesis. Glycemic control shows a limited correlation with DPN, arguing in favor of major involvement of other factors, one of which is alterations of lipid and lipoprotein metabolism. Consistent associations have been found between plasma triglycerides/remnant lipoproteins and the risk of DPN. Studies in cultured nerve tissue or in murine models of diabetes have unveiled mechanisms linking lipid metabolism to DPN. Deficient insulin action increases fatty acids flux to nerve cells, inducing mitochondrial dysfunction, anomalous protein kinase C signaling, and perturbations in the physicochemical properties of the plasma membrane...
2017: Journal of Diabetes Research
https://www.readbyqxmd.com/read/28166606/effect-of-ezetimibe-on-plasma-adipokines-a-systematic-review-and-meta-analysis
#17
Eva Dolezelova, Evan Stein, Giuseppe Derosa, Pamela Maffioli, Petr Nachtigal, Amirhossein Sahebkar
AIMS: Statins are known to influence the status of adipokines, which play a key role in the pathophysiology of cardiometabolic diseases. As the effect of ezetimibe as an add-on to statin therapy on the impact of statins on plasma adipokines levels is currently unclear, the aim of the present study was to investigate this through a meta-analysis of controlled trials. METHODS: A systematic review was performed, followed by a bibliographic search in PubMed, Medline, SCOPUS, Web of Science and Google Scholar databases...
July 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28153102/safety-of-very-low-low-density-lipoprotein-cholesterol-levels-with%C3%A2-alirocumab-pooled-data-from-randomized-trials
#18
RANDOMIZED CONTROLLED TRIAL
Jennifer G Robinson, Robert S Rosenson, Michel Farnier, Umesh Chaudhari, William J Sasiela, Laurence Merlet, Kathryn Miller, John J P Kastelein
BACKGROUND: Proprotein convertase subtilisin/kexin type 9 monoclonal antibodies can reduce low-density lipoprotein cholesterol (LDL-C) to very low levels when added to background lipid-lowering therapy. OBJECTIVES: The safety of alirocumab was evaluated in patients with at least 2 consecutive LDL-C values <25 or <15 mg/dl in the ODYSSEY program, with follow-up as long as 104 weeks. METHODS: Pooled data from 14 trials were analyzed (double-blind treatment 8 to 104 weeks; n = 3,340 alirocumab, n = 1,894 control [placebo or ezetimibe]; representing 4,029 [alirocumab] and 2,114 [control] double-blind patient-years' exposure)...
February 7, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28098515/a-randomized-open-label-trial-to-assess-the-effect-of-plant-sterols-associated-with-ezetimibe-in-low-density-lipoprotein-levels-in-patients-with-coronary-artery-disease-on-statin-therapy
#19
RANDOMIZED CONTROLLED TRIAL
Gisane Biacchi Gomes, Ana Denise Zazula, Leonardo Seidi Shigueoka, Rosangela Alquieri Fedato, Ana Beatriz Brenner Affonso da Costa, Luiz Cesar Guarita-Souza, Cristina Pellegrino Baena, Marcia Olandoski, José Rocha Faria-Neto
Consumption of food products enriched with plant sterols and the use of ezetimibe reduce cholesterol absorption in the intestine and effectively reduce low-density lipoprotein (LDL) plasma levels. We evaluated the therapeutic effect of the ezetimibe+plant sterol association in patients with coronary artery disease still not reaching recommended lipid levels despite the use of statins. We performed a prospective open-label study with 41 patients with stable coronary disease and LDL >70 mg/dL. Patients were randomized into four groups for a 6-week treatment: the control (CT) group remained on the same statin therapy, the ezetimibe (EZ) group received 10 mg/day of ezetimibe, the plant sterol (PS) group received spread enriched with 2 g of plant sterols, and the ezetimibe+PS (EZ+PS) group received 10 mg/day EZ +2 g PS...
January 2017: Journal of Medicinal Food
https://www.readbyqxmd.com/read/28090731/addition-of-ezetimibe-to-statins-for-patients-at-high-cardiovascular-risk-systematic-review-of-patient-important-outcomes
#20
REVIEW
Yutong Fei, Gordon Henry Guyatt, Paul Elias Alexander, Regina El Dib, Reed A C Siemieniuk, Per Olav Vandvik, Mark E Nunnally, Huda Gomaa, Rebecca L Morgan, Arnav Agarwal, Ying Zhang, Neera Bhatnagar, Frederick A Spencer
Ezetimibe is widely used in combination with statins to reduce low-density lipoprotein. We sought to examine the impact of ezetimibe when added to statins on patient-important outcomes. Medline, EMBASE, CINAHL, and CENTRAL were searched through July, 2016. Randomized controlled trials (RCTs) of ezetimibe combined with statins versus statins alone that followed patients for at least 6 months and reported on at least one of all-cause mortality, cardiovascular deaths, non-fatal myocardial infarctions (MI), and non-fatal strokes were included...
January 16, 2017: Journal of Evaluation in Clinical Practice
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