Reason for request

re-assessment of actual benefit

The Committee recommends the continuation of reimbursement in the treatment of arterial hypertension.

 

  • ALPRESS and MINIPRESS have Marketing Authorisation in the treatment of arterial hypertension.
  • The efficacy of prazosin in patients with mild to moderate essential arterial hypertension has only been demonstrated on the basis of a surrogate endpoint, the reduction in blood pressure. No studies of the efficacy of prazosin in terms of morbidity and mortality are currently available.
  • In view of the more frequent observation of hypotension under immediate-release (IR) prazosin (MINIPRESS) than under the prolonged-release (PR) form, ALPRESS, the latter is recommended for the long-term treatment of patients with arterial hypertension. MINIPRESS is no longer used in the care of patients with hypertension.

Clinical Benefit

Insufficient

The actual benefit of MINIPRESS remains insufficient in the "hypertension" indication.


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