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«Grindeks»: Meldonium should not be included in the Prohibited list [0]


09.03.2016

Despite «Grindeks»’s submitted arguments, evidence and justifications, the World Anti-Doping Agency (WADA) included meldonium in the Prohibited list. In accordance with the results of the extended research, «Grindeks» has a firm conviction that meldonium should not be included in the Prohibited list. It is unclear to «Grindeks» why the WADA included meldonium in the Prohibited list, because it never gave any explanation of this decision. The company will continue to use all the options and will stand up for to the exclusion of meldonium from the WADA’s Prohibited list.

Mildronate® is a registered trademark of the JSC «Grindeks». Its active pharmaceutical ingredient (or active substance) is meldonium which is responsible for the pharmacological and therapeutic effects of Mildronate®. It should be noticed that inclusion of meldonium (Mildronate®) in the Prohibited list doesn’t change the fact that it is a medicine of high quality, safety and efficacy. Until now it has been available to everyone, including athletes, to prevent the negative effects caused by physical and psycho-emotional overload.

Mildronate® is widely used in the clinical practice. During increased physical activity, it restores the oxygen balance of tissue cells as well as activating the metabolic processes that result in lower requirements of oxygen consumption for energy production. Mildronate® is widely recognized by health care professionals and patients, and this may include athletes as well.

Mildronate® is mostly prescribed for patients to treat heart and cardiovascular diseases, including stable angina pectoris, chronic heart failure (NYHA I-III functional class), cardiomyopathy, functional cardiovascular disorders; also when there are acute and chronic ischemic brain blood circulation disorders, reduced working capacity, physical and psycho-emotional overload as well as during the recovery period after cerebrovascular disorders, head injury and encephalitis.

Depending on the patient’s health condition, the treatment course of meldonium preparations may vary from 4 to 6 weeks. The treatment course can be repeated twice or thrice a year. Only physicians can follow and evaluate patient health condition and state whether the patient should use meldonium for a longer period of time or not according to the information provided in the patient leaflet and summary of product characteristics.

Meldonium is a cytoprotective substance, which is used to prevent death of ischemic cells, and not to increase performance of normal cells. The mechanism of action of meldonium is based on limitation of carnitine biosynthesis, which leads to deceleration of fatty acid oxidation and activation of glycolysis. Unlike carnitine, meldonium doesn’t cause increase of muscle mass and physical properties. Meldonium decreases cellular damage from ischemia by reducing accumulation of detergent substances (acylcarnitine and acyl-coenzyme A) in the mitochondria. It means that meldonium reduces the ability of an organism to use fatty acids as its energy source. This is important in the treatment of pathologies associated with heart muscle ischemia (stenocardia, heart failure), because in these cases the heart is not getting enough oxygen and nutrients. Consequently, meldonium is a cytoprotective substance, which is used to prevent death of ischemic cells, and not to increase performance of normal cells. It means that meldonium cannot improve athletic performance, but it can stop tissue damage in the case of ischemia. That is why this therapeutic drug is not a doping agent.

Good safety profile of Mildronate® should be particularly emphasized. This is one of the key factors explaining its wide recognition among the doctors and patients. The Mildronate®’s safety is confirmed by its periodic safety update records and the results of published clinical studies. Based on available data, no adverse reactions related to Mildronate®’s use in athletes have been registered.

 






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