AGE Reader

Non-invasive cardiovascular risk assessment

Patient friendly diagnosis, Personalized care & Preventing disease

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Clinical validation

The comfortable and safe AGE Reader measurement offers crucial clinical information to clinicians and researchers. The AGE Reader has been validated against the gold standard for measuring AGEs (skin biopsies). It was shown that skin AF is strongly correlated with AGEs.

The device has been clinically validated in multiple large-scale, clinical trials over the last few years involving tens of thousands of healthy controls, diabetics, cardiovascular and renal patients. The clinical studies demonstrate that skin autofluorescence is a strong and independent risk predictor for mortality, diabetic complications and cardiovascular events. In particular, it can independently predict cardiovascular co-morbidity and mortality in diabetes, renal failure and dialysis patients.

Diabetes
Initial clinical studies were performed in diabetes mellitus, because it is the classical example of increased formation and accumulation of AGEs. Skin AF was indeed found to be approximately 30% higher in patients with type 1 or type 2 diabetes mellitus compared with age-matched controls. In a large cohort of well controlled primary care patients with type 2 diabetes, the presence and degree of microvascular and macrovascular complications were associated with a graded increase in skin AF (Lutgers 2006). Gerrits et al. (2008) reported that skin AF is not only associated with diabetic nephropathy and neuropathy, but is also a predictor of its development.

The UK Prospective Diabetes Study (UKPDS) risk score has emerged as the most widely used tool to predict complications in type 2 diabetes. Although many type 2 diabetes patients are nowadays controlled tightly according to guidelines for their classic risk factors (for example cholesterol, blood pressure, smoking and HbA1c), they still develop cardiovascular complications. Additionally, risk calculators may underestimate CV risk in patients already treated with antihypertensive or lipid-lowering drugs. Consequently there is a need for additional markers among clinicians to identify patients at high risk for developing CV complications.

The publication by Lutgers et al. (2009) in Diabetologia showed that the AGE Reader is of additional value in determining CV risk besides the classic risk factors. Within a group of almost 1000 well controlled (HbA1c: 7%) type 2 diabetes patients in primary care it was shown that the AGE Reader measurement, apart from age, was the best single predictor of CV mortality and total mortality. Furthermore this publication demonstrated that the AGE Reader measurement in combination with the UKPDS risk score adds prognostic information and often leads to reclassification from low-intermediate risk to high risk (27%) and vice versa. Thus, without using the AGE Reader, 27% of the patients was incorrectly classified and therefore possibly not treated as desired.

Renal disease
The AGE Reader has also been extensively tested in renal disease which led to the following important conclusions:

  • Skin AF is an independent predictor of cardiovascular disease associated mortality in hemodialysis patients.
  • Skin AF is a strong and independent predictor of mortality and chronic graft loss in renal transplant recipients.
  • Skin AF correlates to arterial elasticity and diastolic function in both hemodialysis and peritoneal dialysis patients.

Cardiovascular disease
Clinical research on the AGE Reader in cardiovascular led to the following findings:

Since the introduction of the AGE Reader over 145 peer reviewed papers have been published. These papers supply an extensive clinical validation. You can find the key publications here and the most recent publications regarding the AGE Reader here. If you would like to see the complete list of publication, please download our publication list.

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The AGE Reader App!
The new AGE Reader App allows you to generate a comprehensive Cardiovascular Risk Report based on the AGE Reader measurement. For each patient all visits can be documented and consulted in the easy to use App.
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