In a nutritional study, APUXAN showed the following results after being studied for 16 weeks with respect to its safety:
- APUXAN is well tolerated and safe.
- APUXAN results compared to the placebo in no side effects.
to efficacy, the safety of a preparation is of central importance. Drugs or
drug combinations may also have negative effects on the body in addition to the
APUXAN was monitored in a nutritional study with respect to consumer safety. Over 16 weeks, relevant parameters of clinical chemistry (liver and kidney) were determined. None of the monitored blood values showed a statistical deviation from the standard value in the course of the study
It can be concluded that APUXAN has no negative effect on the liver and kidneys.
Results of the safety study: liver function test
The liver as a detoxification organ of the body is a first indicator for toxic effects. The monitoring of suitable liver enzymes is an effective way to test the possible toxic effects of new formulations.
This concerns various liver parameters, which are detectable in the blood. At the beginning and at the end of the clinical trial at 16 weeks under APUXAN - or placebo administration, the liver values alkaline phosphatase, glutamate-pyruvate transaminase, glutamate-oxaloacetate transaminase, glutamate dehydrogenase, gamma glutamyl transferase and bilirubin were checked.
Liver enzyme alkaline phosphatase
Alkaline phosphatases are an enzyme group, which cleave phosphoric acid monoesters in the body.
The laboratory medical determination of alkaline phosphatase is used primarily as an indicator of diseases of the liver and gallbladder.
The values of the alkaline phosphatase of APUXAN test subjects lie between the nationally defined limits and showed no deviations from the standard values during the study.
Liver enzyme GPT
Glutamate-pyruvate transaminase (GPT, alternative name: alanine aminotransferase, ALT) is an enzyme found mainly in the liver but also in the myocardium and the skeletal muscle. In disease-related destruction of liver cells, GPT is released and can be detected in the blood.
An elevated GPT value can thus point to liver damage in the course of a clinical study.
The GPT values of APUXAN test subjects showed no deviations from the standard values during the study.
Liver enzyme AST/GOT
As with GPT, glutamate-oxaloacetate transaminase (GOT, alternative name: aspartate aminotransferase, AST) is an enzyme found mainly in the liver, but also in the myocardium and the skeletal muscle. Dyeing cells release GOT, resulting in a detectable level in the blood.
Elevated GOT values may indicate liver toxication in the course of a clinical trial.
The GOT values of APUXAN test subjects showed no deviations from the standard values during the study.
Liver enzyme GGT
The enzyme gamma-glutamyl transferase (GGT) is present in many tissues and organs, such as in the liver, the kidneys, the pancreas, the small intestine and the spleen.
As the enzyme occurs in the membranes of cells of the liver and the gallbladder, increased levels of GGT in the blood point to a damage to these organs.
During a clinical trial, GGT is a particularly sensitive blood value indicator of liver and bile damage.
The GGT values of APUXAN test subjects showed no deviations from the standard values during the study.
Liver enzyme GLDH
Glutamate dehydrogenase (GLDH) is an enzyme found exclusively in the mitochondria and is essential for the production of the amino acid glutamate.
It is found in high concentrations in the mitochondria of the liver parenchymal cells. Therefore, an increase in GLDH blood values also often indicates liver damage.
The GLDH values of APUXAN test subjects showed no deviations from the standard values during the study.
Liver enzyme total Bilirubin
Bilirubin is a yellow dye created during the breakdown of the red blood cell pigment haemoglobin.
In blood, bilirubin binds to the blood protein albumin and is thereby transported to the liver. The bilirubin-albumin complex is referred to as "indirect bilirubin". In the liver, bilirubin is separated from the albumin. The resulting bile pigment is called "direct bilirubin". In the blood, both "indirect" and "direct bilirubin" are present. Both are collectively referred to as "total bilirubin".
An increase in "total bilirubin" in the course of a clinical trial may indicate liver and bile problems.
The bilirubin values of APUXAN test subjects showed no deviations from the standard value in the course of the study.
Results of the safety study: kidney values
The kidneys are the body's filtering organs. Active agents impeding this function can lead to serious health consequences.
The monitoring of the renal parameters albumin, urea nitrogen, serum creatinine, total protein, cystatin C and beta-2-microglobulin in the blood at the beginning and at end of the clinical trial after 16 weeks can exclude renal impairment through APUXAN.
Kidney enzyme albumin
Albumin is a protein in the blood. As a carrier for small molecules, it plays a central role in the bloodstream.
Laboratory medicine determines albumin in the blood as an indicator of inflammatory kidney disorders as well as liver damage. Low blood levels are critical.
The albumin values of APUXAN test subjects showed no deviations from the standard value in the course of the study.
kidney enzyme total protein
Laboratory medicine determines total protein in the blood as an indicator of inflammatory kidney disorders as well as liver damage. Here, just as the albumin alone, low blood levels are critical.
The total protein values of APUXAN test subjects showed no deviations from the standard value in the course of the study.
kidney enzyme urea nitrogen
Urea nitrogen refers to the urea-bound nitrogen in the blood, a degradation product of the protein metabolism. If protein degrades, urea is produced, which is filtered out by the kidneys and excreted in the urine.
Modified urea nitrogen values indicate a malfunction of the kidneys. Excessive blood levels may also occur in inflammatory processes. A follow-up in clinical trials is therefore important.
The urea nitrogen values of APUXAN test subjects showed no deviations from the standard values during the study.
Kidney enzyme creatinine
Creatinine is a degradation product of the muscle energy metabolism. The daily amount in the urine is in proportion to the muscle mass and is fairly constant. Therefore, the creatinine level in the blood provides information on the filtration capacity of the kidneys.
The creatinine values of APUXAN test subjects showed no deviations from the standard values during the study.
Kidney enzyme cystatin C
Cystatin C is one of the cysteine protease inhibitors present in all nucleated cells of the body. It is produced relatively stable and is, with the exception of some autoimmune diseases, hardly affected , by other processes in the body. Unlike creatinine, muscle mass has little effect on the blood concentration of Cystatin C. Excretion is via the kidneys. This allows a direct conclusion on the filtration capacity of the kidneys by the Cystatin C concentration in the blood.
The cystatin C value of APUXAN test subjects during the study showed no deviations from the standard value.
Kidney enzyme beta-2 microglobulin
Beta-2-microglobulin is a protein found in all nucleated cells. It is delivered continuously into the blood in small amounts.
Beta-2-microglobulin is filtered by the kidney and reabsorbed tubularly. Therefore, consistent levels in the blood can be found in healthy people.
An increased concentration in the blood can indicate a strong activation of the immune system, excessive cell death or decreased renal filtration.
The beta-2 microglobulin value of APUXAN test subjects showed no increase compared with the standard value.