{"id":"lapaquistat-acetate-and-atorvastatin","safety":{"commonSideEffects":[{"rate":null,"effect":"Elevated liver transaminases"},{"rate":null,"effect":"Muscle-related adverse events (myalgia, myopathy)"},{"rate":null,"effect":"Gastrointestinal effects"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This combination targets two key steps in cholesterol metabolism: lapaquistat acetate blocks the intestinal enzyme ACAT2, which is responsible for cholesterol esterification and absorption in the gut, thereby reducing dietary cholesterol uptake. Atorvastatin simultaneously inhibits HMG-CoA reductase in the liver, the rate-limiting enzyme in endogenous cholesterol synthesis. Together, these complementary mechanisms provide dual reduction of both exogenous and endogenous cholesterol pathways.","oneSentence":"Lapaquistat acetate inhibits ACAT2 (acyl-CoA:cholesterol acyltransferase 2) to reduce intestinal cholesterol absorption, while atorvastatin inhibits HMG-CoA reductase to reduce hepatic cholesterol synthesis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:20.145Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia / dyslipidemia (in combination therapy)"}]},"trialDetails":[{"nctId":"NCT00532311","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate Co-Administered With Statins in Subjects With Hypercholesterolemia","status":"TERMINATED","sponsor":"Takeda","startDate":"2007-07","conditions":"Hypercholesterolemia","enrollment":411},{"nctId":"NCT00487994","phase":"PHASE3","title":"Safety and Efficacy of Lapaquistat Acetate Taken Alone and With Atorvastatin in Subjects With Primary Dyslipidemia","status":"COMPLETED","sponsor":"Takeda","startDate":"2004-11","conditions":"Dyslipidemia","enrollment":2130},{"nctId":"NCT00251680","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy.","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-10","conditions":"Type 2 Diabetes","enrollment":400},{"nctId":"NCT00868127","phase":"PHASE3","title":"Safety of Lapaquistat Acetate in Subjects With Hypercholesterolemia","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-12","conditions":"Hypercholesterolemia","enrollment":574},{"nctId":"NCT00249899","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate Alone or Combined With High-Dose Statin Therapy in Subjects With Hypercholesterolemia","status":"TERMINATED","sponsor":"Takeda","startDate":"2005-11","conditions":"Hypercholesterolemia","enrollment":649},{"nctId":"NCT00864643","phase":"PHASE2","title":"Efficacy and Safety of Lapaquistat Acetate Coadministered With Atorvastatin in Subjects With Hypercholesterolemia","status":"COMPLETED","sponsor":"Takeda","startDate":"2004-09","conditions":"Hypercholesterolemia","enrollment":172},{"nctId":"NCT00143676","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate and Atorvastatin on Blood Cholesterol Levels in Subjects With Primary Hypercholesterolemia","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-08","conditions":"Hypercholesterolemia","enrollment":448}],"_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":["Lapaquistat acetate","Lipitor","TAK-475","Lapaquistat","TAK475"],"phase":"phase_3","status":"active","brandName":"Lapaquistat acetate and atorvastatin","genericName":"Lapaquistat acetate and atorvastatin","companyName":"Takeda","companyId":"takeda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lapaquistat acetate inhibits ACAT2 (acyl-CoA:cholesterol acyltransferase 2) to reduce intestinal cholesterol absorption, while atorvastatin inhibits HMG-CoA reductase to reduce hepatic cholesterol synthesis. Used for Hypercholesterolemia / dyslipidemia (in combination therapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}