German diagnostics company Sphingotec GmbH, Hennigsdorf, reports that key opinion leaders have confirmed the clinical utility of biologically active adrenomedullin (bio-ADM), as a marker for vascular leakage (endothelial dysfunction), in patients with congestive heart failure and in patients with severe sepsis.
New clinical data presented by Alexandre Mebazaa, MD, PhD, professor of anesthesiology and critical care medicine at the Hôpital Lariboisière, demonstrates that high bio-ADM levels can identify patients with acute heart failure that require immediate diuretics therapy because they are at high risk of developing lung edema.1 Furthermore, bio-ADM levels above 45 pg/mL indicate congestion, both in acute heart failure and decompensated chronic heart failure.
Study data also demonstrate that elevated bio-ADM blood levels can reliably identify residual congestion at discharge, a major cause of rehospitalization and post-discharge mortality among heart failure patients that physicians have previously been unable to diagnose.2
In a separate study, Inder Anand, MD, DPhil, FCRP, a professor of medicine at the University of Minnesota, has reported that elevated bio-ADM levels are a strong indicator of 12-month mortality among patients with chronic heart failure. And Hans-Dirk Duengen, MD, MBA, associate professor of internal medicine at Charité University Hospital, has shown that bio-ADM reliably identifies high-risk patients with worsening heart failure requiring immediate diuretics therapy to improve outcomes.
Further, clinical data indicate that rising bio-ADM blood concentrations above 70 pg/mL precede septic and cardiogenic shock, helping to improve outcomes by reducing the time to diagnosis and therapeutic intervention.3,4 Among sepsis patients, falling bio-ADM levels after admission indicated a response to vasopressor therapy and subsequent survival, while rising levels above the cut-off value correlated with blood pressure breakdown and mortality. Data from routine clinical monitoring of bio-ADM support findings from clinical studies that bio-ADM is independent of inflammation and allows the monitoring of treatment success in patients with septic shock for early decisionmaking in intensive care.
“Bio-ADM provides clinical utility by reducing the time to appropriate clinical decisionmaking in both sepsis and in heart failure patients,” says Salvatore Di Somma, MD, associate professor of medicine at University La Sapienza. “In septic shock, bio-ADM is able to mirror the relaxation of vascular tone before the clinical signs of shock appear. In acute heart failure patients the biomarker provides important information in therapeutic decisionmaking in order to reduce mortality, length of stay in hospital, and rehospitalization rate,” he notes.
Allan S. Jaffe, MD, chair of the division of clinical core laboratory services in the department of laboratory medicine and pathology at the Mayo Clinic, adds that the situation might further improve in the future if a therapeutic antibody becomes available that targets bio-ADM in order to restore the impaired vascular barrier function.
By the middle of 2019, Sphingotec expects to launch bio-ADM testing, along with testing for other acute care biomarkers, to physicians in intensive care units and emergency departments. The tests will be available on the company’s fully automated IB 10 point-of-care testing platform, which is currently in use in more than 1,000 emergency departments, intensive care units, larger practices, and smaller hospitals in Europe and the Middle East. Sphingotec acquired the platform last summer from Samsung to measure a panel of acute diagnostic blood biomarkers on a regular basis, with more than 100,000 tests being performed per year.
“Backed by a €20 million investment of HBM Healthcare Investments, HBM BioCapital II LP, and Wellington Partners, we will push marketing of the IB 10 POC testing platform in 2019 to create a market monopoly for fully automated onsite testing of acute biomarkers at ICUs and EDs that support timely and valid clinical decisionmaking,” says Andreas Bergmann, PhD, founder and CEO of Sphingotec.
For further information, visit Sphingotec.
- Mebazaa A. XXXXX. Presentation at the 2018 symposium on Endothelial Dysfunction: Adrenomedullin as a Diagnostic and Therapeutic Target. Berlin: Adrenomed, 2018. Available at: XXXXX. Accessed XXXXX.
- Voors AA, Kremer D, Geven C, et al. Adrenomedullin in heart failure: pathophysiology and therapeutic application. J Heart Fail. 2019;21(2):163–171; doi: 10.1002/ejhf.1366.
- Mebazaa A, Geven C, Hollinger A, et al. Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational adrenomedullin and outcome in sepsis and septic shock-1 (AdrenOSS-1) study. Crit Care. 2018;22(1):354; doi: 10.1186/s13054-018-2243-2.
- Geven C, Bergmann A, Kox M, Pickkers P. Vascular effects of adrenomedullin and the anti-adrenomedullin antibody adrecizumab in sepsis. Shock. 2018;50(2):132–140; doi: 10.1097/shk.0000000000001103.