REVERPLEG (argipressin) - Catecholamine-refractory hypotension following septic shock

The Committee deems that the clinical benefit of REVERPLEG (argipressin) 40 IU/2 mL concentrate for solution for infusion is moderate in the MA indication.

Considering:

• expert opinions, which highlight:
  • the role of vasopressin in international guidelines as a second-line therapy in patients with septic shock and inadequate mean blood pressure despite treatment with noradrenaline (weak recommendation, moderate level of evidence);
  • the value of limiting the catecholamine dose in order to reduce adrenergic stimulation in the context of prolonged treatment with noradrenaline in the event of septic shock;
  • the potential benefit of a multimodal approach using different vasopressors with the aim of creating a synergy of action mechanisms against vasoplegia and reducing the harmful effects of each vasoactive drug;

but in view of:

• the absence of data with a good level of evidence demonstrating an efficacy of vasopressin in terms of reducing mortality and morbidity in patients with catecholamine-refractory hypotension following septic shock;
• the absence of evidence of an additional advantage in terms of safety of adding low-dose vasopressin to noradrenaline compared to noradrenaline alone in the MA indication;
• uncertainties with respect to the dosages of REVERPLEG (argipressin) and noradrenaline that will be used in real-world conditions, in a context where high doses of REVERPLEG may cause skin and gut necrosis (in accordance with the information in the SmPC);

The Committee considers that REVERPLEG (argipressin) 40 IU/2 mL concentrate for solution for infusion provides no clinical added value (CAV V) in the current care pathway for the management of catecholamine-refractory hypotension following septic shock in adult patients.