Proprietary medicinal products based on olmesartan, angiotensin II antagonists: AXELER (olmesartan/amlodipine)
CARDIOLOGY - Focus
Opinions on drugs - Posted on Sep 14 2015
Reason for request
Renewal of inclusion
Does not recommend the continuation of reimbursement, because its efficacy has been demonstrated only in terms of a reduction in blood pressure readings, no effect on morbidity and mortality has been demonstrated unlike that of certain active ingredients of the same class (except in uncomplicated essential arterial hypertension), and because of the increased risk of serious enteropathies, even though they are very rare
- Olmesartan is indicated, in monotherapy or in combination, in the treatment of essential arterial hypertension (AH).
- The efficacy of olmesartan, unlike that of the majority of other sartans, has been demonstrated only in terms of a reduction in blood pressure readings and not in terms of morbidity and mortality (except in uncomplicated essential AH).
- Unlike the other sartans that are available, olmesartan carries an increased risk of serious enteropathies, even though they are very rare (< 1/10,000).
- The results of a study by CNAMTS confirmed an increased risk of hospitalisation for intestinal malabsorption with olmesartan compared with angiotensin-converting enzyme (ACE) inhibitors, which was not found for other sartans.
- Prescription of olmesartan instead of another sartan could be a missed opportunity for patients. These proprietary medicinal products thus no longer have a role in the therapeutic strategy for patients with hypertension.
Évaluation des médicaments