ARTOTEC

Opinions on drugs - Posted on Mar 12 2014

Reason for request

Re-assessment of the Actual Benefit of all systemically administered diclofenac-based medicines at the Committee’s request, in compliance with Article R-163-21 of the French Social Security Code

Clinical Benefit

Low

The actual benefit of ARTOTEC 50 mg/0.2 mg and 75 mg/0.2 mg tablets remains low in the symptomatic treatment of rheumatic diseases in at-risk patients (particularly those aged > 65 years, with a history of peptic ulcer or intolerance to NSAIDs) for whom anti-inflammatory treatment is essential.
It is insufficient in the subpopulation of patients who also have risk factors for cardiovascular events.

Insufficient

It is insufficient in the subpopulation of patients who also have risk factors for cardiovascular events.