{"id":"irbesartan-atorvastatin-fixed-dose-combination","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Muscle pain (myalgia)"},{"rate":null,"effect":"Elevated liver enzymes"},{"rate":null,"effect":"Hyperkalemia"}]},"_chembl":{"chemblId":"CHEMBL1487","moleculeType":"Small molecule","molecularWeight":"558.65"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Irbesartan is an angiotensin II receptor blocker (ARB) that reduces vasoconstriction and aldosterone secretion, lowering blood pressure. Atorvastatin is a statin that inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, reducing LDL cholesterol and cardiovascular risk. The combination addresses two major cardiovascular risk factors in a single tablet.","oneSentence":"This fixed-dose combination lowers blood pressure by blocking angiotensin II receptors while simultaneously reducing cholesterol by inhibiting HMG-CoA reductase.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:50:11.910Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension with dyslipidemia in patients requiring both agents"},{"name":"Cardiovascular risk reduction in hypertensive patients with elevated cholesterol"}]},"trialDetails":[{"nctId":"NCT02842359","phase":"PHASE4","title":"Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension","status":"COMPLETED","sponsor":"Sanofi","startDate":"2016-08-23","conditions":"Type 2 Diabetes Mellitus","enrollment":11},{"nctId":"NCT04061824","phase":"PHASE4","title":"Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2016-05-24","conditions":"Hypertension, Dyslipidemias","enrollment":150}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Rovelito"],"phase":"marketed","status":"active","brandName":"Irbesartan/atorvastatin fixed dose combination","genericName":"Irbesartan/atorvastatin fixed dose combination","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This fixed-dose combination lowers blood pressure by blocking angiotensin II receptors while simultaneously reducing cholesterol by inhibiting HMG-CoA reductase. Used for Hypertension with dyslipidemia in patients requiring both agents, Cardiovascular risk reduction in hypertensive patients with elevated cholesterol.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}