Mesoglicano: repairs damaged walls in superficial venous thrombosis

In the article Mesoglycan for long-term secondary prevention in patients with superficial vein thrombosis (METRO): a multicentre, randomised clinical trial in Italy, published in the scientific journal «eClinicalMedicine» of the «The Lancet» publishing group, researchers from the group coordinated by Giuseppe Camporese (Complex Operational Unit Medical Clinic 1 with a thrombotic-hemorrhagic focus of the Azienda Ospedale-University of Padua) and by Paolo Simioni (director of UOC Medical Clinic 1), demonstrated that treatment with mesoglycan in patients with a recent diagnosis of superficial vein thrombosis statistically significantly reduces the long-term recurrence rate. 

Mesoglycan is an active ingredient belonging to the class of antithrombotics, drugs that help prevent the formation of clots inside blood vessels (veins and arteries), used in the prevention and treatment of vascular diseases, including venous thrombosis and chronic ulcers.

The data support the hypothesis that the drug acts through accumulation and that the pharmacological “repair” effect on the venous wall damaged by thrombosis develops slowly over time, then persisting for a long time even after treatment has ended.

The study involved centers throughout Italy: Padua, Venezia, Mirano (VE), Conegliano (TV), Castelfranco Veneto (TV), Perugia, Roma, Napoli, Avellino, Palermo, Macerata, Ancona, Firenze, Bari, Avezzano (AQ), Varese. A total of 553 patients with a recent diagnosis of superficial vein thrombosis were recruited, treated for 45 days with fondaparinux 2.5 mg/day, in accordance with international Guidelines (fondaparinux is used to prevent the formation of blood clots and to treat thrombosis). At the end of this therapy, used for the acute phase of the disease, the patients were randomized (assigned by chance to different groups) and one group received mesoglycan 50 mg x 2/day, while the other group received the corresponding placebo, for 12 months. 

At the end of treatment, the patients were followed for a further 12 months of clinical follow-up, for a total study duration of 24 months. 

«To date, no international guideline reports recommendations or suggestions on how to prevent recurrences of superficial vein thrombosis, nor is the true long-term incidence rate of recurrences reported; in the literature only data from retrospective studies or registries are available, or from prospective studies with follow-up of at most 3 months after discontinuation of fondaparinux therapy - explains Giuseppe Camporese, first author of the publication -. The study demonstrated a statistically significant reduction in events (mainly recurrences of superficial vein thrombosis), of about 30%, at 24 months, in the group of patients treated with mesoglycan compared with those given placebo, thus confirming an effective and safe long-term treatment. The study also found a 24-month recurrence rate of venous thromboembolic events in untreated patients of 39%, much higher than what has been reported to date in previous studies».

«This study fills an important gap in knowledge on the management of superficial vein thrombosis after the acute phase of the disease - adds Paolo Simioni, co-author of the publication -.  The results indicate that mesoglycan is not limited to an antithrombotic effect, but appears to promote a progressive recovery of the functionality of the venous wall damaged, resulting in a reduction in long-term recurrences. This is an innovative approach, based on vessel protection and repair, which may help improve patients’ quality of life and serve as a reference point for future updates to international guidelines».