{"id":"eze-simvastatin","safety":{"commonSideEffects":[{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Elevated liver enzymes"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ezetimibe selectively inhibits the Niemann-Pick C1-Like 1 (NPC1L1) transporter in the intestinal brush border, reducing dietary and biliary cholesterol absorption. Simvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis. Together, these complementary mechanisms provide additive LDL-cholesterol reduction beyond either agent alone.","oneSentence":"EZE/simvastatin combines ezetimibe (which blocks cholesterol absorption in the intestine) with simvastatin (which inhibits HMG-CoA reductase to reduce cholesterol synthesis) for dual lipid-lowering action.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:40:24.980Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia and mixed dyslipidemia"}]},"trialDetails":[{"nctId":"NCT00541697","phase":"PHASE3","title":"Eze/Simva Switch Study in Diabetics (0653A-807)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-01-19","conditions":"Diabetes Mellitus, Type 2","enrollment":648},{"nctId":"NCT00462748","phase":"PHASE3","title":"A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-03","conditions":"Hypercholesterolemia","enrollment":786},{"nctId":"NCT01763866","phase":"PHASE3","title":"LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2","status":"COMPLETED","sponsor":"Amgen","startDate":"2013-01-15","conditions":"Hyperlipidemia","enrollment":2067},{"nctId":"NCT03543774","phase":"PHASE4","title":"Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population","status":"UNKNOWN","sponsor":"Hue University of Medicine and Pharmacy","startDate":"2018-06-15","conditions":"Hypercholesterolemia, Chronic Kidney Diseases","enrollment":30},{"nctId":"NCT00817843","phase":"PHASE4","title":"The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study","status":"COMPLETED","sponsor":"dr.Frank L.J. Visseren","startDate":"2009-04","conditions":"Metabolic Syndrome","enrollment":100},{"nctId":"NCT00664469","phase":"PHASE3","title":"INdians Followed for INtensive Lipid Lowering Treatment and Its safetY","status":"TERMINATED","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2007-08","conditions":"Hypercholesterolemia","enrollment":64},{"nctId":"NCT00861731","phase":"PHASE4","title":"Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy","status":"UNKNOWN","sponsor":"Azienda Ospedaliero Universitaria di Sassari","startDate":"2008-11","conditions":"Hypercholesterolemia, Chronic Nephropathy","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"EZE/simvastatin","genericName":"EZE/simvastatin","companyName":"Azienda Ospedaliero Universitaria di Sassari","companyId":"azienda-ospedaliero-universitaria-di-sassari","modality":"Small molecule","firstApprovalDate":"","aiSummary":"EZE/simvastatin combines ezetimibe (which blocks cholesterol absorption in the intestine) with simvastatin (which inhibits HMG-CoA reductase to reduce cholesterol synthesis) for dual lipid-lowering action. Used for Hypercholesterolemia and mixed dyslipidemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}