KARDEGIC (acetylsalicylate de DL-lysine)
Reason for request
Key points
Favourable opinion for reimbursement in the prevention of atherosclerosis-related cardiovascular and cerebrovascular complications in patients with a high vascular risk with confirmed peripheral arterial disease (PAD).
What therapeutic improvement?
No clinical added value in the therapeutic strategy.
Role in the care pathway?
The management of patients with PAD depends on the disease stage. Whether patients are asymptomatic or symptomatic, it is based on:
- control of cardiovascular risk factors (smoking, hypertension, dyslipidemia, diabetes),
- the implementation of lifestyle and dietary measures,
- regular physical exercise (walking),
- preventive treatment of cardio- and cerebrovascular complications, including a statin (even in the absence of lipid assessment abnormalities) and in the event of concomitant hypertension, an angiotensin converting enzyme inhibitor / angiotensin receptor blocker (depending on the existence and severity of hypertension).
According to the various national and international guidelines, long-term antiplatelet therapy with aspirin (75 to 325 mg/day) or clopidogrel (75 mg/day), should be added in symptomatic patients (grade IA). This treatment is also recommended in patients having undergone a revascularisation procedure. Following percutaneous transluminal coronary angioplasty with stent insertion, dual therapy combining low-dose aspirin and clopidogrel is recommended for 1 month. Beyond this period, due to the arterial disease and the high cardiovascular risk, antiplatelet therapy (aspirin or clopidogrel) is continued in the long term. In patients with an endoprosthesis unrelated to atheroma, no guidelines have been established.
Role of the medicinal product in the care pathway
KARDEGIC (acetylsalicylic acid) proprietary medicinal products can be used as first-line treatment in patients with symptomatic confirmed PAD or having undergone a revascularisation procedure. In the event of asymptomatic PAD, there is no indication for the systematic prescription of KARDEGIC (acetylsalicylic acid) as first-line therapy.
Clinical Benefit
Moderate |
The Committee deems that the clinical benefit of KARDEGIC (acetylsalicylic acid) powder for oral suspension in single-dose sachets is moderate in the prevention of cardiovascular and cerebrovascular complications related to atherosclerosis in patients with a high vascular with confirmed PAD. |
Clinical Added Value
no clinical added value |
Considering:
but:
the Transparency Committee considers that KARDEGIC (acetylsalicylic acid) provides no clinical added value (CAV V) in the care pathway for confirmed PAD.
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