{"id":"background-statin-therapy","safety":{"commonSideEffects":[{"rate":"1-3%","effect":"Muscle pain or myalgia"},{"rate":"1-3%","effect":"Elevated liver enzymes"},{"rate":"<0.1%","effect":"Rhabdomyolysis"},{"rate":"1-2%","effect":"Headache"},{"rate":"1-2%","effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL4298181","moleculeType":"Gene"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Statins competitively inhibit HMG-CoA reductase, blocking the conversion of HMG-CoA to mevalonate in the cholesterol biosynthetic pathway. This leads to decreased intracellular cholesterol levels, upregulation of LDL receptors on hepatocytes, and increased clearance of LDL cholesterol from the bloodstream. In the context of Amgen's Phase 3 trials, background statin therapy is typically used as a control or baseline treatment to establish the additional benefit of investigational lipid-lowering agents.","oneSentence":"Background statin therapy reduces low-density lipoprotein (LDL) cholesterol by inhibiting HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:31.491Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia and cardiovascular risk reduction (used as background therapy in clinical trials)"}]},"trialDetails":[{"nctId":"NCT06863545","phase":"NA","title":"Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography","status":"RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2025-04-22","conditions":"Coronary Artery Disease, CT 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Inhibitors in Liver Transplant Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Medical Research Center for Therapy and Preventive Medicine","startDate":"2021-10-01","conditions":"Dyslipidemias, Hyperlipidemias, Liver Transplant Disorder","enrollment":59},{"nctId":"NCT04807400","phase":"PHASE3","title":"Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-07-07","conditions":"Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol","enrollment":892},{"nctId":"NCT03433755","phase":"PHASE3","title":"Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia","status":"TERMINATED","sponsor":"Amgen","startDate":"2019-05-09","conditions":"Primary Hypercholesterolemia, Mixed Dyslipidemia","enrollment":259},{"nctId":"NCT03175367","phase":"PHASE2","title":"Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia","status":"COMPLETED","sponsor":"Regeneron Pharmaceuticals","startDate":"2017-11-10","conditions":"Hypercholesterolemia","enrollment":272},{"nctId":"NCT03570697","phase":"PHASE3","title":"Imaging of Coronary Plaques in Participants Treated With Evolocumab","status":"COMPLETED","sponsor":"Amgen","startDate":"2018-11-19","conditions":"Coronary Artery Disease (CAD)","enrollment":164},{"nctId":"NCT02963311","phase":"PHASE2","title":"A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH)","status":"COMPLETED","sponsor":"The Medicines Company","startDate":"2016-12-13","conditions":"Homozygous Familial Hypercholesterolemia","enrollment":9},{"nctId":"NCT02571257","phase":"PHASE2","title":"Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin 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Therapy","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2018-09-24","conditions":"Cardiovascular Diseases","enrollment":23066},{"nctId":"NCT02659397","phase":"PHASE2","title":"A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg","status":"COMPLETED","sponsor":"Esperion Therapeutics, Inc.","startDate":"2015-12","conditions":"Hyperlipidemia","enrollment":68},{"nctId":"NCT02584504","phase":"PHASE3","title":"Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin","status":"COMPLETED","sponsor":"Sanofi","startDate":"2015-11-30","conditions":"Hypercholesterolemia","enrollment":163},{"nctId":"NCT02023879","phase":"PHASE3","title":"Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE 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Diseases","enrollment":72},{"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":"NCT00984750","phase":"PHASE3","title":"Acetyl-L-Carnitine in Type 2 Diabetes","status":"COMPLETED","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2008-04","conditions":"Diabetes Type 2, Hypertension","enrollment":229},{"nctId":"NCT00261352","phase":"PHASE3","title":"GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate","status":"TERMINATED","sponsor":"AstraZeneca","startDate":"2005-03","conditions":"Type 2 Diabetes","enrollment":1000}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":162,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Background Statin Therapy","genericName":"Background Statin Therapy","companyName":"Amgen","companyId":"amgen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Background statin therapy reduces low-density lipoprotein (LDL) cholesterol by inhibiting HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis. Used for Hypercholesterolemia and cardiovascular risk reduction (used as background therapy in clinical trials).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}