Angiotensin-II-Acetat (1) – Giapreza®

• Clinical trials
  • For the benefit assessment, the pharmaceutical manufacturer has submitted the multicentre, randomised, double-blind ATHOS-3 trial, in which angiotensin II acetate is compared with placebo, in each case in addition to vasopressor therapy.

Adults with septic or other distributive shock who remain hypotensive despite adequate volume replacement and the use of catecholamines and other available vasoconstrictive therapies

• The additional benefit is not proven.
• Overall, there are neither benefits nor disadvantages for angiotensin II acetate compared with optimised standard therapy. It is concluded that an additional benefit is not proven.
• mortality
  • With regard to overall mortality at day 28, there were no statistically significant differences between the treatment groups in the overall population.
• Morbidity – discharge from the intensive care unit
  • With regard to morbidity, there were no statistically significant differences between the treatment groups in the overall population for the endpoint ‘discharge from the intensive care unit’.
• Morbidity – Weaning from mechanical ventilation
  • The endpoint ‘discontinuation of mechanical ventilation’ is defined as the period between the start of treatment and the end of mechanical ventilation. The dossier contains analyses covering an observation period of 7 days. These results show, however, that after 7 days a large proportion of patients were still on mechanical ventilation, meaning that the median was not reached in this analysis. The 7-day observation period is therefore too short to yield meaningful results.
• Morbidity – Discontinuation of renal replacement therapy
  • The results submitted by the pharmaceutical manufacturer show that, after 7 days, a large proportion of patients still required renal replacement therapy, meaning that the median was not reached in this analysis. The 7-day observation period is therefore too short to yield meaningful results.
• Side effects
  • In the category of side effects, no statistically significant differences were observed between the treatment arms.
• Overall view
  • No statistically significant difference in mortality was observed between the treatment groups.
  • In the morbidity category, no statistically significant difference was demonstrated for the endpoint ‘discharge from the intensive care unit’. No usable data were available for the endpoints ‘weaning from mechanical ventilation’ and ‘discontinuation of renal replacement therapy’.
  • No data were collected in the quality of life category.
  • In the category of side effects, no statistically significant differences were observed between the treatment arms.
  • Overall, there are neither advantages nor disadvantages to angiotensin II acetate compared with optimised standard therapy. It is concluded that an additional benefit is not proven.

Courtesy translation only, please refer to the German original.