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RASILEZ (aliskiren), RASILEZ HCT (aliskiren/hydrochlorothiazide), renin inhibitor, alone or in combination with a diuretic

Opinions on drugs - Posted on Mar 13 2017

Reason for request

Re-assessment of the actual benefit

Insufficient clinical benefit in the treatment of hypertension to justify continued reimbursement


  • 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.



Actual benefit



Therapeutic use


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