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Irbesartan/atorvastatin fixed dose combination

Irbesartan/atorvastatin fixed dose combination is a ARB/statin combination Small molecule drug developed by Sanofi. It is currently FDA-approved for Hypertension with dyslipidemia in patients requiring both agents, Cardiovascular risk reduction in hypertensive patients with elevated cholesterol. Also known as: Rovelito.

This fixed-dose combination lowers blood pressure by blocking angiotensin II receptors while simultaneously reducing cholesterol by inhibiting HMG-CoA reductase.

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.

At a glance

Mechanism of action

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.

Approved indications

• Hypertension with dyslipidemia in patients requiring both agents
• Cardiovascular risk reduction in hypertensive patients with elevated cholesterol

Common side effects

• Dizziness
• Fatigue
• Muscle pain (myalgia)
• Elevated liver enzymes
• Hyperkalemia

Key clinical trials

• Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension (PHASE4)
• Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia (PHASE4)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Irbesartan/atorvastatin fixed dose combination CI brief — competitive landscape report
• Irbesartan/atorvastatin fixed dose combination updates RSS · CI watch RSS
• Sanofi portfolio CI

Frequently asked questions about Irbesartan/atorvastatin fixed dose combination

Related

• Drug class: All ARB/statin combination drugs
• Target: All drugs targeting Angiotensin II type 1 receptor (AT1R) and HMG-CoA reductase
• Manufacturer: Sanofi — full pipeline
• Therapeutic area: All drugs in Cardiovascular
• Indication: Drugs for Hypertension with dyslipidemia in patients requiring both agents
• Indication: Drugs for Cardiovascular risk reduction in hypertensive patients with elevated cholesterol
• Also known as: Rovelito
• Compare: Irbesartan/atorvastatin fixed dose combination vs similar drugs
• Pricing: Irbesartan/atorvastatin fixed dose combination cost, discount & access