{"id":"niacin-er-simvastatin-tablets","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Flushing"},{"rate":"10-20","effect":"Pruritus"},{"rate":"5-15","effect":"Nausea"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Myalgia"},{"rate":"3-5","effect":"Elevated liver enzymes"},{"rate":"2-5","effect":"Hyperglycemia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Simvastatin blocks HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol production and hepatic VLDL secretion. Niacin ER acts through multiple mechanisms including inhibition of hepatic diacylglycerol acyltransferase-2 (DGAT2) and activation of GPR109A, leading to increased HDL cholesterol and reduced triglycerides. Together, they provide complementary lipid-modifying effects for cardiovascular risk reduction.","oneSentence":"Niacin ER/Simvastatin combines extended-release niacin (which increases HDL and lowers triglycerides) with simvastatin (a statin that inhibits HMG-CoA reductase to lower LDL cholesterol).","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:23:06.954Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hyperlipidemia and mixed dyslipidemia in patients requiring both statin and niacin therapy"},{"name":"Reduction of cardiovascular risk in patients with coronary heart disease"}]},"trialDetails":[{"nctId":"NCT00271817","phase":"PHASE3","title":"To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-12","conditions":"Hypercholesterolemia","enrollment":1220},{"nctId":"NCT00479882","phase":"PHASE3","title":"MK-0524B Lipid Study (MK-0524B-063)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-06-15","conditions":"Primary Hypercholesterolemia, Mixed Dyslipidemia","enrollment":2414},{"nctId":"NCT01335997","phase":"PHASE3","title":"Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-05-01","conditions":"Primary Hypercholesterolemia, Mixed Dyslipidemia","enrollment":1139},{"nctId":"NCT00289900","phase":"PHASE3","title":"Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-01-24","conditions":"Mixed Hyperlipidemia","enrollment":2340},{"nctId":"NCT01294683","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-02-04","conditions":"Primary Hypercholesterolemia, Dyslipidemia","enrollment":977},{"nctId":"NCT00804843","phase":"PHASE2","title":"Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-04","conditions":"Carotid Atherosclerosis","enrollment":100},{"nctId":"NCT00943124","phase":"PHASE1","title":"MK0524B Bioequivalence Study (0524B-070)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-07","conditions":"Dyslipidemia","enrollment":220},{"nctId":"NCT00479388","phase":"PHASE3","title":"Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-07","conditions":"Primary Hypercholesterolemia, Mixed Dyslipidemia","enrollment":1216},{"nctId":"NCT00461630","phase":"PHASE3","title":"Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2007-01","conditions":"Cardiovascular Disease, Peripheral Arterial Disease, Diabetes Mellitus","enrollment":25673},{"nctId":"NCT00465088","phase":"PHASE3","title":"An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)","status":"COMPLETED","sponsor":"Abbott","startDate":"2007-04","conditions":"Hyperlipidemia, Mixed Dyslipidemia","enrollment":199},{"nctId":"NCT00080275","phase":"PHASE3","title":"Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)","status":"COMPLETED","sponsor":"Kos Pharmaceuticals","startDate":"2004-03","conditions":"Hypercholesterolemia","enrollment":600},{"nctId":"NCT00082251","phase":"PHASE3","title":"Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST","status":"COMPLETED","sponsor":"Kos Pharmaceuticals","startDate":"","conditions":"Hypercholesterolemia","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ABT-919/483","Niacin ER/Simvastatin","Simcor"],"phase":"phase_3","status":"active","brandName":"Niacin ER/Simvastatin Tablets","genericName":"Niacin ER/Simvastatin Tablets","companyName":"Abbott","companyId":"abbott","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Niacin ER/Simvastatin combines extended-release niacin (which increases HDL and lowers triglycerides) with simvastatin (a statin that inhibits HMG-CoA reductase to lower LDL cholesterol). Used for Hyperlipidemia and mixed dyslipidemia in patients requiring both statin and niacin therapy, Reduction of cardiovascular risk in patients with coronary heart disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}