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ezetimibe AND randomized controlled trial

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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
#1
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
#2
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 15, 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28279967/ezetimibe-increases-endogenous-cholesterol-excretion-in-humans
#3
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...
March 9, 2017: Arteriosclerosis, Thrombosis, and Vascular Biology
https://www.readbyqxmd.com/read/28257594/ezetimibe-for-the-treatment-of-nonalcoholic-fatty-liver-disease-a-meta-analysis
#4
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 conducted; however, the results are inconsistent. We conducted 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
#5
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
#6
Dolezelova E, Stein E, Derosa G, Maffioli P, Nachtigal P, Sahebkar A
AIMS: Statins are known to influence status of adipokines, which play a key role in the pathophysiology of cardiometabolic diseases. As the effect of ezetimibe add-on to statin therapy on the impact of statins on plasma adipokines levels is unclear yet, the aim of this study was to answer this question through meta-analysis of controlled trials. METHODS: A systematic review followed by a bibliographic search in PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases was performed...
February 6, 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
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/27998714/a-nutraceutical-approach-armolipid-plus-to-reduce-total-and-ldl-cholesterol-in-individuals-with-mild-to-moderate-dyslipidemia-review-of-the-clinical-evidence
#10
REVIEW
Vivencio Barrios, Carlos Escobar, Arrigo Francesco Giuseppe Cicero, David Burke, Peter Fasching, Maciej Banach, Eric Bruckert
Compelling evidence supports the effectiveness of the reduction of total and LDL cholesterol (TC and LDL-C) in primarily preventing cardiovascular events, within the framework of life-long prevention programs mainly consisting in lifestyle changes. Pharmacological treatment should be introduced when lifestyle changes, including use of nutraceuticals, have failed. ESC/EAS guidelines list a number of nutraceutical compounds and functional foods which have been individually studied in randomized, controlled clinical trials (RCTs)...
February 2017: Atherosclerosis. Supplements
https://www.readbyqxmd.com/read/27932353/ezetimibe-in-combination-with-statins-ameliorates-endothelial-dysfunction-in-coronary-arteries-after-stenting-the-cuvic-trial-effect-of-cholesterol-absorption-inhibitor-usage-on-target-vessel-dysfunction-after-coronary-stenting-a-multicenter-randomized-controlled
#11
Susumu Takase, Tetsuya Matoba, Soichi Nakashiro, Yasushi Mukai, Shujiro Inoue, Keiji Oi, Taiki Higo, Shunsuke Katsuki, Masao Takemoto, Nobuhiro Suematsu, Kenichi Eshima, Kenji Miyata, Mitsutaka Yamamoto, Makoto Usui, Kenji Sadamatsu, Shinji Satoh, Toshiaki Kadokami, Kiyoshi Hironaga, Ikuyo Ichi, Koji Todaka, Junji Kishimoto, Kensuke Egashira, Kenji Sunagawa
OBJECTIVES: We sought to investigate whether treatment with ezetimibe in combination with statins improves coronary endothelial function in target vessels in coronary artery disease patients after coronary stenting. APPROACH AND RESULTS: We conducted a multicenter, prospective, randomized, open-label, blinded-end point trial among 11 cardiovascular treatment centers. From 2011 to 2013, 260 coronary artery disease patients who underwent coronary stenting were randomly allocated to 2 arms (statin monotherapy, S versus ezetimibe [10 mg/d]+statin combinational therapy, E+S)...
February 2017: Arteriosclerosis, Thrombosis, and Vascular Biology
https://www.readbyqxmd.com/read/27882214/efficacy-and-safety-of-different-doses-of-evolocumab-in-reducing-low-density-lipoprotein-cholesterol-levels-a-meta-analysis
#12
Cheng Cheng, Sijia Sun, Yafeng Zhou, Xiangjun Yang
Evolocumab has been considered as an efficacious, safe and promising therapeutic modality for hypercholesterolemia and is associated with cardiovascular diseases. The efficacy and safety of two different doses of evolocumab were evaluated and the safety of evolocumab was compared with that of a placebo and ezetimibe. PubMed and EMBASE databases were searched and randomized controlled trials that examined the effect and safety of evolomucab compared with a placebo and ezetimibe were retrieved. Two authors independently performed article reviews and study quality evaluations...
November 2016: Biomedical Reports
https://www.readbyqxmd.com/read/27792720/-effect-of-simvastatin-plus-inulin-in-comparison-with-simvastatin-plus-ezetimibe-on-the-treatment-of-mixed-dyslipidemia
#13
Esperanza Martínez-Abundis, Carmelita Barrera-Durán, Manuel González-Ortiz, Eduardo Hernández-Salazar
INTRODUCTION: Mixed dyslipidemia accelerates atherosclerosis and leads to cardiovascular disease and death. Non-soluble fibers such as inulin have been shown to have an effect on dyslipidemia. AIM: To assess the effect of the combination of simvastatin plus inulin in comparison with simvastatin plus ezetimibe in mixed dyslipidemia. MATERIAL AND METHODS: A randomized, double-blind, clinical trial with parallel control group was performed in 60 patients with mixed dyslipidemia, without drug treatment or failure to statins and lifestyle changes...
October 2016: Gaceta Médica de México
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
#14
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/27740972/effect-of-alirocumab-dose-increase-on-ldl-lowering-and-lipid-goal-attainment-in-patients-with-dyslipidemia
#15
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/27729106/safety-of-alirocumab-a-pcsk9-monoclonal-antibody-from-14-randomized-trials
#16
Peter H Jones, Harold E Bays, Umesh Chaudhari, Robert Pordy, Christelle Lorenzato, Kathryn Miller, Jennifer G Robinson
Previous individual trials of alirocumab (a PCSK9 monoclonal antibody) showed significant low-density lipoprotein cholesterol reductions with overall treatment-emergent adverse event (TEAE) rates comparable with controls. This analysis evaluated safety data from 14 trials (4 phase 2 and 10 phase 3, 8 to 104 weeks; n = 5,234), in 2 pools according to control (placebo/ezetimibe). Overall, 3,340 patients received alirocumab (4,029 patient-years' exposure), 1,276 received placebo, and 618 received ezetimibe. Incidence of deaths, serious TEAEs, discontinuations because of TEAEs, and overall TEAEs were similar between alirocumab and control groups...
December 15, 2016: American Journal of Cardiology
https://www.readbyqxmd.com/read/27701660/association-between-low-density-lipoprotein-cholesterol-lowering-genetic-variants-and-risk-of-type-2-diabetes-a-meta-analysis
#17
Luca A Lotta, Stephen J Sharp, Stephen Burgess, John R B Perry, Isobel D Stewart, Sara M Willems, Jian'an Luan, Eva Ardanaz, Larraitz Arriola, Beverley Balkau, Heiner Boeing, Panos Deloukas, Nita G Forouhi, Paul W Franks, Sara Grioni, Rudolf Kaaks, Timothy J Key, Carmen Navarro, Peter M Nilsson, Kim Overvad, Domenico Palli, Salvatore Panico, Jose-Ramón Quirós, Elio Riboli, Olov Rolandsson, Carlotta Sacerdote, Elena Salamanca-Fernandez, Nadia Slimani, Annemieke M W Spijkerman, Anne Tjonneland, Rosario Tumino, Daphne L van der A, Yvonne T van der Schouw, Mark I McCarthy, Inês Barroso, Stephen O'Rahilly, David B Savage, Naveed Sattar, Claudia Langenberg, Robert A Scott, Nicholas J Wareham
Importance: Low-density lipoprotein cholesterol (LDL-C)-lowering alleles in or near NPC1L1 or HMGCR, encoding the respective molecular targets of ezetimibe and statins, have previously been used as proxies to study the efficacy of these lipid-lowering drugs. Alleles near HMGCR are associated with a higher risk of type 2 diabetes, similar to the increased incidence of new-onset diabetes associated with statin treatment in randomized clinical trials. It is unknown whether alleles near NPC1L1 are associated with the risk of type 2 diabetes...
October 4, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27678439/efficacy-and-safety-of-gemcabene-as-add-on-to-stable-statin-therapy-in-hypercholesterolemic-patients
#18
Evan Stein, Harold Bays, Michael Koren, Rebecca Bakker-Arkema, Charles Bisgaier
BACKGROUND: Ezetimibe added to statin therapy further reduces LDL-C and clinical atherosclerotic cardiovascular disease compared to statin alone. However, the number of effective and safe oral agents for patients not at LDL-C goal is limited. In prior clinical trials, gemcabene reduced LDL-C and was generally well-tolerated in nearly 900 patients treated for up to 12 weeks. OBJECTIVE: To evaluate the LDL-C lowering and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients...
September 2016: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/27460541/ezetimibe-increases-intestinal-expression-of-the-ldl-receptor-gene-in-dyslipidaemic-men-with-insulin-resistance
#19
Jean-Philippe Drouin-Chartier, André J Tremblay, Valéry Lemelin, Marie-Claude Lépine, Benoît Lamarche, Patrick Couture
AIM: To gain further insight into intestinal cholesterol homeostasis in dyslipidaemic men with insulin resistance (IR) by examining the impact of treatment with ezetimibe on the expression of key genes involved in cholesterol synthesis and LDL receptor (R)-mediated uptake of lipoproteins. METHODS: A total of 25 men with dyslipidaemia and IR were recruited to participate in this double-blind, randomized, crossover, placebo-controlled trial. Participants received 10 mg/day ezetimibe or placebo for periods of 12 weeks each...
December 2016: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27412989/ezetimibe-statin-combination-therapy
#20
Barbara Nußbaumer, Anna Glechner, Angela Kaminski-Hartenthaler, Peter Mahlknecht, Gerald Gartlehner
BACKGROUND: To date, most clinical comparisons of ezetimibe-statin combination therapy versus statin monotherapy have relied entirely on surrogate variables. In this systematic review, we study the efficacy and safety of ezetimibe-statin combination therapy in comparison to statin monotherapy in terms of the prevention of cardiovascular events in hyperlipidemic patients with atherosclerosis and/or diabetes mellitus. METHODS: This review is based on a systematic literature search (1995 to July 2015) in PubMed, the Excerpta Medica Database (EMBASE), the Cochrane Library, and the ClinicalTrials...
July 1, 2016: Deutsches Ärzteblatt International
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