Contact us to report problems with: For Publishers For Researchers For Librarians LONG-TERM SAFETY AND EFFICACY OF ABINATION OF NIACIN EXTENDED RELEASE AND SIMVASTATIN IN PATIENTS WITH DYSLIPIDEMIA: THE OCEANS STUDY AUTHORS: Karas, Richard H.Moti L.Robert H.H.Daiva R.Michael H.SOURCE: , Volume 8, Number 2, 2008 , pp.PUBLISHER: Key: - Free Content - New Content - Subscribed Content - Free Trial Content ABSTRACT: INTRODUCTION: High-dose HMG-CoA reductase inhibitors (statins) fail to prevent approximately two-thirds of cardiovascular events.Fact has focused increased attention on treating abnormalities of non-high-density lipoprotein-cholesterol (non-HDL-C), HDL-C, and triglycerides in national guidelines and has intensified interest inbination therapy.OCEANS study (Open-label evaluation of the safety and efficacy of abination of niacin ER and simvAstatin in patieNts with dySlipidemia; ClinicalTrials.NCT00080275) evaluated the safety and efficacy of abination of niacin extended release and simvastatin (NER/S; SIMCOR(R)) over 52 weeks in 520 patients with mixed dyslipidemia.A 4-week run-in phase of diet modification and simvastatin 40 mg/day, median baseline values (mg/dL) were: non-HDL-C = 141, low-density lipoprotein-cholesterol (LDL-C) = 110, HDL-C = 45, and triglyceride = 151.Were randomized to an 8- or 12-week niacin titration scheme to a maximum NER/S dosage of 2000/40 mg/day.Between titration groups in tolerability, safety, and efficacy were minimal; therefore, all results are for pooled titration groups.Safety of NER/S was consistent with the safety profile of each individualponent.With NER/S was well tolerated: 71% of patients experienced flushing and 92% of flushing episodes were mild or moderate in intensity.61% of patients experienced flushing episodes that were rated as mild or moderate in intensity.Decreased over time: 40% of those who had flushing during titration experienced flushing during the final 12 weeks.Of 20% of patients discontinued treatment because of a treatment-related adverse event, including 7% who discontinued because of flushing.Changes from baseline (following the simvastatin 40 mg/day run-in phase) to 24 weeks were: non-HDL-C = -27.= -25.= +23.Triglycerides = -35.P 0.Baseline).Patients, NER/S 2000/40 mg/day decreased non-HDL-C, LDL-C, and triglycerides by approximately 50% and increased HDL-C by approximately 25% when week-24 lipid values werepared with lipid values obtained prior to the simvastatin 40 mg/day run-in.Therapeutic lipid targets (LDL-C , HDL-C 40 mg/dL, and triglycerides 150 mg/dL) were achieved concurrently by 65% of patients treated with NER/S.With NER/S 2000/40 mg/day is well tolerated, has no unanticipated adverse events, and provides additional, clinically relevant improvements in multiple lipid parameters beyond statin monotherapy.KEYWORDS: ; ; ; ; ; ; ; DOCUMENT TYPE: Research article AFFILIATIONS: 1: 1 Division of Cardiology, Molecular Cardiology Research Institute, Tufts Medical Center, Boston, Massachusetts, USA 2: 2 Department of Veterans Affairs Medical Center, Atherosclerosis Research Center, Long Beach, California, USA 3: 3 Division of Metabolism, Northwest Lipid Research Clinic, Endocrinology and Nutrition, University of Washington School of Medicine, Seattle, Washington, USA 4: 4 Abbott, Weston, Florida, USA 5: 5 Division of Cardiology, University of Chicago, Chicago, Illinois, USA This feature is in beta and some links may initially be displayed as numbers instead of article titles.On any of the links will take you to the rmended articles, regardless of the display of the link.The full text article is available for purchase $54.TAX Pressing the buy now button more than once may result in multiple purchases CREDIT/DEBIT CARD INSTITUTIONAL PAYMENT ACCOUNT OR Purchase later Key: - Free Content - New Content - Subscribed Content - Free Trial Content Website 2008 Ingenta.Read more [mechanisms of signal transduction] regulation of interleukin-6-induced hepatic insulin resistance by mammalian target of rapamycin through the stat3-socs3 pathway
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