PRITOR

Opinions on drugs - Posted on Dec 18 2013

Reason for request

Renewal of inclusion. Extension of indication "Cardiovascular prevention"

Clinical Benefit

Substantial

The Committee considers that the actual benefit of PRITOR remains substantial in the indication "arterial hypertension".

The Committee considers that the actual benefit of PRITOR is substantial in the indication " Cardiovascular prevention : Reduction of cardiovascular morbidity in adults with : manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease)."

Comments

Given the above-mentioned elements, especially uncertainties in terms of increased cardiovascular risk observed in type 2 diabetic patients being assessed by the EMA, the Committee considers that in the current state of knowledge it cannot rule on the actual benefit of PRITOR in the indication " Cardiovascular prevention : Reduction of cardiovascular morbidity in adults with type 2 diabetes mellitus with documented target organ damage. "