ILTRIA (acetylsalicylic acid/atorvastatin/ramipril), platelet aggregation inhibiting drug, statin and ACE inhibitor in combination

Insufficient clinical benefit in secondary prevention of stroke           

• ILTRIA has Marketing Authorisation for secondary prevention of strokes as well as a substitution therapy in adults who are sufficiently controlled by the combination of acetylsalicylic acid, atorvastatin and ramipril, in the form of three components alone, at equivalent therapeutic doses.
• It has not shown its clinical benefit in terms of morbidity, mortality, adherence or quality of life. Only bioequivalence data between the fixed combination ILTRIA (100 mg acetylsalicylic acid, 20 mg atorvastatin and 10 mg ramipril) and each of its three active ingredients taken separately at the same doses are available.
• The recommended dosages of aspirin range from 75 to 160 mg/day as secondary prevention. In patients whose cholesterol level is high, the 20 mg/day dosage may be insufficient to achieve the therapeutic target in terms of LDL cholesterol. ILTRIA is therefore not suitable for treatment of all patients due to the fixed doses of acetylsalicylic acid (100 mg) and atorvastatin (20 mg) proposed.