Argipressin: New therapy for septic shock now approved for 26 EU countries

World Sepsis Day on 13 September 2018

A new therapeutic option for septic shock has now been approved for and is available in 26 European countries. Sepsis affects 27 to 30 million people worldwide and leads to eight million deaths every year. Septic shock is caused by generalized infection and is associated with higher morbidity, mortality, and extended disability. Most importantly, sepsis has negative effects on the cardiovascular system. Blood pressure drops, consciousness is impaired, the heart and respiratory rates increase. Deteriorated macro and micro-circulation lead to decrease of blood flow to organs and ultimately to organ failure.

AMOMED has received marketing authorization for a new drug to stabilize the cardiovascular system in the event of septic shock in a Europe-wide approval process covering 26 European countries. The active ingredient is Argipressin, also known as arginine-vasopressin or antidiuretic hormone. It contracts the smooth muscle cells in very small vessels, leading to increased peripheral vascular resistance and higher blood pressure.

Septic shock – every minute counts!

Prof. Dr. Heinrich V. Groesdonk, Chief Physician of the Interdisciplinary Surgical Intensive Care Unit at Saarland University Medical Center: “The chances for surviving septic shock depend essentially on how quickly a successful therapy is started to fight the infection causing sepsis. In addition, it is crucial to stabilize the cardiovascular situation as quickly as possible to prevent organ damage. Vasopressors help to establish high blood pressure sufficiently to supply the organs with adequate amounts of oxygen. If added early to norepinephrine, Argipressin is highly effective in stabilizing the cardiovascular function, on the one hand in curbing the toxic effects of high dose of catecholamines, e.g. arrhythmias, ischemias or damaging myocardial cells, and on the other hand in increasing chances for survival of certain patients.

Sepsis in the intensive care unit: a widespread and life-threatening disorder

Sepsis cases are on the rise worldwide. An estimated incidence of approx. 440 cases per 100,000 inhabitants and year was reported from 2005 to 2015 (Crit Care Clin 2018;34:15-27). In the course of the disease, 10 to 20 percent of sepsis patients admitted to intensive care units develop organ dysfunctions with or without cardiovascular failure. More than half of all generalized infections are acquired outside the hospital, with the lungs and the gastrointenstinal tract being the most frequent sites of infection.

The German INESP study covered 11,883 patients in 133 German intensive care units. Severe sepsis (sepsis-1 criteria) was diagnosed in 218 patients (intensive care unit mortality rate of 16.7 percent, hospital mortality rate of 23.4 percent) and septic shock in 1,285 cases (intensive care unit mortality rate of 37.3 percent, hospital mortality rate of 43.3). The point prevalence of patients with sepsis or septic shock on any given day amounted to 17.9 percent of the total population in the intensive care units. (Intensive Care Med 2016; 42: 1980-1989)

Prof. Groesdonk: “Severe sepsis and septic shock still mean a heavy burden of disease with high mortality rate and extended disability. Those burdens not only affect the patients and their loved ones emotionally, but also the health care systems financially. Correctly used, Argipressin can reduce morbidity and mortality.”

Study results on Argipressin

Here are some study results: As part of the VASST study, 800 patients with documented septic shock requiring vasopressor therapy over the course of six hours were randomly treated with Argipressin or noradrenaline in addition to the standard therapy. Patients with moderate shock who were given Argipressin showed a significantly lower mortality rate and also exhibited a significant decrease in atrial fibrillation compared to patients treated with noradrenaline alone. At the same time, the stroke volume index between the two study arms did not differ.

A further analysis of the VASST study showed that the probability for progression to kidney failure in patients with a corresponding risk nearly halved by Argipressin.

Data from the VANISH study, which compared Argipressin and noradrenaline within six hours after the manifestation of a septic shock, confirmed these results. When Argipressin was administered, kidney failure occurred less frequently (minus 11%); the Argipressin group exhibited a relative reduction in the need for renal replacement therapy up to 30 percent. Moreover, Argipressin had a catecholamine-saving effect. (Wien klin Mag; DOI 10.1007/s00740-016-0159-5; ESICM Congress, Satellite Symposium of Amomed Pharma, 4 October 2016, Milan)

AMOMED supports World Sepsis Day on 13 September

Despite these alarming figures, there is an amazingly low awareness of sepsis depending on country and level of education. “AMOMED supports World Sepsis Day, which is intended to increase knowledge of this still largely unknown syndrome and its fateful consequences,” explained Dr. med. Houman Kamali, Head of International Medical Affairs at the company. “At the same time, this day is a gesture of solidarity and support to all those millions of people who have lost their loved ones or who themselves suffer as survivors from the long-term effects of sepsis. Sepsis and septic shock rank third among the most frequent causes of death in the world after heart attacks and strokes. Through early diagnosis and prompt treatment, we can dramatically improve the outcome of sepsis and septic shock. Our new therapy option enables us to wage the daily battle against sepsis and septic shock with good prospects for success.