Pharmacotherapeutic group: Vitamin B1, plain, ATC code: A11DA
Vitamin B1 is an essential therapeutic substance. Fat-soluble thiamine derivatives are converted in the body into the biologically active thiamine pyrophosphate (TPP, synonym: cocarboxylase). TPP then influences important functions in carbohydrate metabolism. TPP acts as a coenzyme in the conversion of pyruvate to acetyl-CoA and in transketolase reactions in the pentose phosphate cycle. In addition, it is involved in the conversion of alpha-ketoglutarate to succinyl-CoA in the citric acid cycle. Due to the close metabolic interrelationships, interactions exist with other B-complex vitamins. Cocarboxylase is, among other things, a coenzyme of pyruvate dehydrogenase, which plays a key role in the oxidative degradation of glucose. Since energy production in nerve cells primarily relies on the oxidative degradation of glucose, an adequate supply of thiamine is essential for proper nerve function. Elevated glucose levels increase the requirement for thiamine. Insufficient levels of cocarboxylase in the blood lead to accumulation of intermediate degradation products such as pyruvate, lactate, and ketoglutarate in the blood and tissues, to which skeletal muscle, the myocardium, and the central nervous system are particularly sensitive. Benfotiamine prevents the accumulation of these toxic substances.
The thiamine pyrophosphate-dependent enzyme activity in erythrocytes, such as transketolase (ETK) and the degree of its activatability (activation coefficient α-ETK), is suitable for determining vitamin B1 status. Plasma ETK concentrations range between 2–4 µg/100 ml.
The antineuralgic effect of vitamin B1 (and benfotiamine) has been demonstrated in animal experiments. A positive effect on transketolase as an activation factor has also been observed in the treatment of alcohol-dependent patients.
The efficacy of high-dose vitamin B1 in the treatment of Wernicke's encephalopathy has been established and is regarded as evidence of the direct effect of the vitamin on the central nervous system.
The efficacy of benfotiamine in diabetic polyneuropathy has been documented in several double-blind, placebo-controlled studies. In the Ledermann study (1989), a combination preparation containing benfotiamine, vitamin B6, and vitamin B12 was used. During the course of therapy, significant improvement in neuropathy and vibration perception was achieved within three weeks. In the neuropathy assessment, a marked reduction in sensory disturbances was observed. Regarding pain sensitivity, improvement was achieved in 47% of patients receiving the active treatment, compared to only 10% in the placebo group. The Stracke and Federlin study (1996) demonstrates the effects of a combination preparation containing benfotiamine on diabetic polyneuropathy based on the objective parameter of nerve conduction velocity. Long-term observations over a total period of 12 months also confirmed this positive effect.
In another double-blind, placebo-controlled study, significant improvement in neuropathy parameters was achieved following administration of a benfotiamine monopreparation (internal company data, 1993).
⚠️ Warnings
If other vitamin B1-containing preparations are being taken concurrently, a physician should be consulted.
Benfogamma contains sucrose and liquid glucose syrup. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicinal product.
This medicinal product contains less than 1 mmol (23 mg) sodium per coated tablet, i.e., it is essentially 'sodium-free'.