biomarkers in the ed - useful or useless

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Bringing sexy back?

biomarkers - useful or useless?Katrin Hruska

No disclosures

N Engl J Med 2015; 373:1916-1925November 12, 2015

”in the near future, high suPAR levels probably will inform physician-patient conversations about

preventing kidney disease"

”rigorous NEJM study is a significant breakthrough in preventive medicine"

Groundbreaking blood test predicts kidney disease FIVE YEARS BEFORE symptoms appear

”Trisaq's product strategy has been designed to yield early proof-of-

concept as well as commercialization opportunities”

”Conservatively estimated, Trisaq's current pipeline of products can benefit about 15-25% of all CKD patients and their combined sales potential well

exceeds $1 billion.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Novel Blood Biomarker May Predict CKD RiskOutcomes studies necessary to prove clinical efficacy

suPAR: Strong and independent predictor of survival

Rather young and healthy than old and

sick

The primary endpoint was to create an accurate prognostication score of death by combining APACHE II score and serum suPAR.

💀14 ng/mL

3-70 ng/mL 1-65 ng/mL

😀9 ng/mL

suPAR levels and survival in sepsis

range:

Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.

suPAR

Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.

APACHE II

Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.

Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.

Mor

talit

y%

0

10

20

30

40

i ii iii iv

Apache II<17 Apache II≥17

suPAR≥12

suPAR≥12

”validated” in a Swedish cohort

Mor

talit

y%

0

10

20

30

40

i ii iii iv

suPAR≥12

suPAR≥12

the high mortality in stratum (ii) may be due to small number of patients in this group (n = 21) and chance variations in mortality. Apart from that

aberration, the findings validate those from the larger Greek study

”validated” in a Swedish cohort

”this strong discriminative prognostic score developed in Greek patients was validated in a cohort of Swedish patients”

”There is no doubt that suPAR has strong prognostic value in ICU patients. However, in many cases this knowledge may not lead to lifesaving interventions, as limited treatment options are efficient

in severely ill sepsis patients”

Prediction of 30 day mortality compared to Danish Emergency Process Triage

Agreement in 55% of cases

”additional biomarkers other than CT are needed"

”we acknowledge the editorial and statistical contribution of Leslie S. Prichep, PhD”

”we acknowledge the editorial and statistical contribution of Leslie S. Prichep, PhD”

A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a therapeutic intervention

A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions or survives

A surrogate endpoint is a biomarker that is intended to substitute for a clinical endpoint

A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions or survives

A surrogate endpoint is a biomarker that is intended to substitute for a critical endpoint

Image: Bengt Nyman

SNTF

photo: Michele di Trani

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