Pharmacotherapeutic group: Vitamin B1, plain, ATC code: A11DA
Vitamin B1 is an essential medicinal substance. Fat-soluble thiamine derivatives are converted in the body into biologically active thiamine pyrophosphate (TPP, synonym: cocarboxylase). TPP 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. It also participates in the conversion of alpha-ketoglutarate to succinyl-CoA in the citric acid cycle. Due to the close metabolic interrelationships, interactions with other B-complex vitamins exist. Cocarboxylase is, among others, a coenzyme of pyruvate dehydrogenase, which plays a key role in the oxidative degradation of glucose. Since energy production in nerve cells occurs primarily through the oxidative degradation of glucose, an adequate supply of thiamine is essential for proper nerve function. Elevated glucose levels increase thiamine requirements. Insufficient cocarboxylase levels in the blood lead to the accumulation of intermediate degradation products such as pyruvate, lactate, and ketoglutarate in the blood and tissues, to which skeletal muscle, myocardium, and the central nervous system are particularly sensitive. Benfotiamine prevents the accumulation of these toxic substances.
To determine vitamin B1 status, measurement of thiamine pyrophosphate-dependent enzyme activity in erythrocytes is suitable, such as transketolase (ETK) and the degree of its activatability (activation coefficient α-ETK). Plasma ETK concentrations range between 2–4 µg/100 ml.
The antineuralgic effect of vitamin B1 (or 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 individuals.
The efficacy of high-dose vitamin B1 in the treatment of Wernicke's encephalopathy is well established and is regarded as evidence of a 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 therapy, significant improvement in neuropathy and vibration perception was achieved within three weeks. Neuropathy assessment showed a marked reduction in sensory disturbances. Regarding pain sensitivity, improvement was observed in 47% of patients receiving the active agent, 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 confirm this positive effect.
In a further double-blind, placebo-controlled study, significant improvement in neuropathy parameters was achieved following administration of a benfotiamine monotherapy preparation (internal company data, 1993).
⚠️ Warnings
Consultation with a physician is required if other vitamin B1-containing products are being taken concurrently.
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'.