{"id":"abt-335-and-simvastatin","safety":{"commonSideEffects":[{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Elevated liver enzymes"},{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Rhabdomyolysis (rare with fibrate-statin combination)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ABT-335 is a peroxisome proliferator-activated receptor alpha (PPARα) agonist that lowers triglycerides and raises HDL cholesterol, while simvastatin is an HMG-CoA reductase inhibitor that reduces LDL cholesterol. Together, they provide complementary lipid management in patients with dyslipidemia who require both triglyceride and cholesterol reduction.","oneSentence":"ABT-335 (fenofibrate) combined with simvastatin works by reducing triglycerides and LDL cholesterol through dual lipid-lowering pathways.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:58:46.061Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dyslipidemia with elevated triglycerides and LDL cholesterol"}]},"trialDetails":[{"nctId":"NCT00491530","phase":"PHASE3","title":"A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia","status":"COMPLETED","sponsor":"Abbott","startDate":"2007-06","conditions":"Mixed Dyslipidemia","enrollment":310},{"nctId":"NCT00300430","phase":"PHASE3","title":"Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.","status":"COMPLETED","sponsor":"Abbott","startDate":"2006-09","conditions":"Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia","enrollment":1911},{"nctId":"NCT00300456","phase":"PHASE3","title":"Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood","status":"COMPLETED","sponsor":"Abbott","startDate":"2006-03","conditions":"Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia","enrollment":657}],"_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-335","TRILIPIX"],"phase":"phase_3","status":"active","brandName":"ABT-335 and simvastatin","genericName":"ABT-335 and simvastatin","companyName":"Abbott","companyId":"abbott","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ABT-335 (fenofibrate) combined with simvastatin works by reducing triglycerides and LDL cholesterol through dual lipid-lowering pathways. Used for Dyslipidemia with elevated triglycerides and LDL cholesterol.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}