RASILEZ (aliskiren), RASILEZ HCT (aliskiren/hydrochlorothiazide), renin inhibitor, alone or in combination with a diuretic
CARDIOLOGY - Update
Opinions on drugs - Posted on Mar 13 2017
Reason for request
Re-assessment of the actual benefit
- RASILEZ has a Marketing Authorisation in the treatment of essential hypertension in adults.
- RASILEZ HCT has a Marketing Authorisation in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide used alone.
- New data confirm the absence of benefit of aliskiren relative to placebo in terms of cardiovascular prevention, associated with an increased risk of adverse events (hyperkalaemia, renal impairment, hypotension) regardless of the patient population studied (heart or renal failure patients, elderly patients with other risk factors).
- Aliskiren’s safety profile has been regularly re-evaluated in light of the adverse effects observed in studies, with the recent addition of dyspnoea and hyponatremia.
Évaluation des médicaments