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ezetimibe AND randomized controlled trial

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
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])...
December 8, 2016: Arteriosclerosis, Thrombosis, and Vascular Biology
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
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
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
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
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...
September 14, 2016: American Journal of Cardiology
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
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
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
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
Jung Hee Lee, Dong Ho Shin, Byeong Keuk Kim, Young Guk Ko, Donghoon Choi, Yangsoo Jang, Myeong Ki Hong
PURPOSE: The effects of short-term intensive lipid-lowering treatment on coronary plaque composition have not yet been sufficiently evaluated. We investigated the influence of short-term intensive lipid-lowering treatment on quantitative and qualitative changes in plaque components of non-culprit lesions in patients with acute coronary syndrome. MATERIALS AND METHODS: This was a prospective, randomized, open-label, single-center trial. Seventy patients who underwent both baseline and three-month follow-up virtual histology intravascular ultrasound were randomly assigned to either an intensive lipid-lowering treatment group (ezetimibe/simvastatin 10/40 mg, n=34) or a control statin treatment group (pravastatin 20 mg, n=36)...
September 2016: Yonsei Medical Journal
Erisa Kawada-Watanabe, Hiroshi Ogawa, Ryo Koyanagi, Hiroyuki Arashi, Junichi Yamaguchi, Kunihiko Matsui, Nobuhisa Hagiwara
BACKGROUND: In contrast to current guidelines in Western countries, moderate reduction of low-density lipoprotein cholesterol (LDL-C) is recommended for Japanese patients with atherosclerotic cardiovascular disease and dyslipidemia even in secondary prevention. HIJ-PROPER (Heart Institute of Japan-PRoper level of lipid lOwering with Pitavastatin and Ezetimibe in acute coRonary syndrome) is a prospective, randomized, open-label, blinded endpoint multicenter trial designed to assess whether closely controlled LDL-C lowering with a standard statin dose plus ezetimibe, targeting LDL-C of <70mg/dL, would reduce cardiovascular events more than standard statin monotherapy targeting LDL-C of <100mg/dL as per the Japan Atherosclerotic Society guideline in patients with acute coronary syndrome (ACS) and dyslipidemia...
June 24, 2016: Journal of Cardiology
Kenichi Tsujita, Kenshi Yamanaga, Naohiro Komura, Kenji Sakamoto, Seigo Sugiyama, Hitoshi Sumida, Hideki Shimomura, Takuro Yamashita, Hideki Oka, Koichi Nakao, Sunao Nakamura, Masaharu Ishihara, Kunihiko Matsui, Naritsugu Sakaino, Natsuki Nakamura, Nobuyasu Yamamoto, Shunichi Koide, Toshiyuki Matsumura, Kazuteru Fujimoto, Ryusuke Tsunoda, Yasuhiro Morikami, Koushi Matsuyama, Shuichi Oshima, Koichi Kaikita, Seiji Hokimoto, Hisao Ogawa
BACKGROUND: The IMPROVE-IT trial showed that the clinical benefit of statin/ezetimibe combination appeared to be pronounced in patients with prior statin therapy. We hypothesized that the antiatherosclerotic effect of atorvastatin/ezetimibe combination was pronounced in patients with statin pretreatment. METHODS: In the prospective, randomized, controlled, multicenter PRECISE-IVUS trial, 246 patients undergoing intravascular ultrasound-guided percutaneous coronary intervention were randomized to atorvastatin/ezetimibe combination or atorvastatin alone...
September 2016: European Journal of Preventive Cardiology
Steven E Nissen, Ricardo E Dent-Acosta, Robert S Rosenson, Erik Stroes, Naveed Sattar, David Preiss, G B John Mancini, Christie M Ballantyne, Alberico Catapano, Ioanna Gouni-Berthold, Evan A Stein, Allen Xue, Scott M Wasserman, Rob Scott, Paul D Thompson
Statins are the accepted standard for lowering low-density lipoprotein cholesterol (LDL-C). However, 5% to 10% of statin-treated patients report intolerance, mostly due to muscle-related adverse effects. Challenges exist to objective identification of statin-intolerant patients. Evolocumab is a monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9), resulting in marked LDL-C reduction. We report the design of Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin-Intolerant Subjects 3 (GAUSS-3), a phase 3, multicenter, randomized, double-blind, ezetimibe-controlled study to compare effectiveness of 24 weeks of evolocumab 420 mg monthly vs ezetimibe 10 mg daily in hypercholesterolemic patients unable to tolerate an effective statin dose...
March 2016: Clinical Cardiology
Leslie Cho, Michael Rocco, David Colquhoun, David Sullivan, Robert S Rosenson, Ricardo Dent, Allen Xue, Rob Scott, Scott M Wasserman, Erik Stroes
PURPOSE: Recent evidence suggests that statin intolerance may be more common than reported in randomized trials. However, the statin-intolerant population is not well characterized. The goal of this report is to characterize the population enrolled in the phase 3 Goal Achievement after Utilizing an anti-PCSK9 antibody in Statin Intolerant Subjects Study (GAUSS-2; NCT 01763905). METHODS: GAUSS-2 compared evolocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9) to ezetimibe in hypercholesterolemic patients who discontinued statin therapy due to statin-associated muscle symptoms (SAMS)...
June 2016: Cardiovascular Drugs and Therapy
Steven C Lin, Brandon Ang, Carolyn Hernandez, Ricki Bettencourt, Rashmi Jain, Joanie Salotti, Lisa Richards, Yuko Kono, Archana Bhatt, Hamed Aryafar, Grace Y Lin, Mark A Valasek, Claude B Sirlin, Sharon Brouha, Rohit Loomba
BACKGROUND: Nonalcoholic steatohepatitis (NASH) is associated with increased cardiovascular risk and mortality. No US Food and Drug Administration (FDA) approved therapies for NASH are available; clinical trials to date have not yet systematically assessed for changes in cardiovascular risk. This study examines the prospective utility of cardiovascular risk assessments, the Framingham risk score (FRS) and coronary artery calcium (CAC) score, as endpoints in a NASH randomized clinical trial, and assesses whether histologic improvements lead to lower cardiovascular risk...
March 2016: Therapeutic Advances in Gastroenterology
Borislava Mihaylova, Iryna Schlackow, William Herrington, Jingky Lozano-Kühne, Seamus Kent, Jonathan Emberson, Christina Reith, Richard Haynes, Alan Cass, Jonathan Craig, Alastair Gray, Rory Collins, Martin J Landray, Colin Baigent
BACKGROUND: Simvastatin, 20mg, plus ezetimibe, 10mg, daily (simvastatin plus ezetimibe) reduced major atherosclerotic events in patients with moderate to severe chronic kidney disease (CKD) in the Study of Heart and Renal Protection (SHARP), but its cost-effectiveness is unknown. STUDY DESIGN: Cost-effectiveness of simvastatin plus ezetimibe in SHARP, a randomized controlled trial. SETTING & POPULATION: 9,270 patients with CKD randomly assigned to simvastatin plus ezetimibe versus placebo; participants in categories by 5-year cardiovascular risk (low, <10%; medium, 10%-<20%; or high, ≥20%) and CKD stage (3, 4, 5 not on dialysis, or on dialysis therapy)...
April 2016: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
Robert A Hegele, Samuel S Gidding, Henry N Ginsberg, Ruth McPherson, Frederick J Raal, Daniel J Rader, Jennifer G Robinson, Francine K Welty
Pharmacological reduction of low-density lipoprotein (LDL) cholesterol using statin drugs is foundational therapy to reduce cardiovascular disease (CVD) risk. Here, we consider the place of nonstatin therapies that also reduce LDL cholesterol in prevention of CVD. Among conventional nonstatins, placebo-controlled randomized clinical trials showed that bile acid sequestrants, niacin, and fibrates given as monotherapy each reduce CVD end points. From trials in which patients' LDL cholesterol was already well controlled on a statin, adding ezetimibe incrementally reduced CVD end points, whereas adding a fibrate or niacin showed no incremental benefit...
November 2015: Arteriosclerosis, Thrombosis, and Vascular Biology
Gianluigi Savarese, Gaetano M De Ferrari, Giuseppe M C Rosano, Pasquale Perrone-Filardi
BACKGROUND: The addition of ezetimibe to statin therapy has been widely demonstrated to significantly reduce low-density lipoprotein cholesterol levels. However, the efficacy of ezetimibe in reducing CV events and its safety has been less investigated. The aim of the current meta-analysis was to report efficacy and safety of ezetimibe from randomized clinical trials. METHODS: Randomized clinical trials with a follow-up of at least 24 weeks, enrolling more than 200 patients, comparing ezetimibe versus placebo or ezetimibe plus another hypolipidemic agent versus the same hypolipidemic drug alone and reporting at least one event among all-cause and CV mortality, myocardial infarction (MI), stroke and new onset of cancer were included in the analysis...
December 15, 2015: International Journal of Cardiology
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