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Article

Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases

1
Department of Vascular Surgery, Pugliese Ciaccio Hospital, 88100 Catanzaro, Italy
2
Forensic Medicine, Department of Law, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy
3
Department of Health Science, School of Medicine, University of Catanzaro, Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini University Hospital, 88100 Catanzaro, Italy
4
Department of Neurology and Stroke Unit, Annunziata Hospital of Cosenza, 87100 Cosenza, Italy
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Department of General Medicine, ASP 7 Catanzaro, 88100 Catanzaro, Italy
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Department of Pharmacy Helath and Nutritional Sciences, Department of Excellence 2018-2022, University of Calabria, 87036 Rende, Italy
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Department of Medical, Surgical and Advanced Technologies “G.F. Ingrassia”, University of Catania, 95041 Catania, Italy
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Department of Health Science, School of Medicine, Clinical Pharmacology Research Center [email protected], University of Catanzaro, 88100 Catanzaro, Italy
*
Author to whom correspondence should be addressed.
Both authors contributed equally to this manuscript.
Academic Editor: Herminia González Navarro
Nutrients 2021, 13(6), 2031; https://doi.org/10.3390/nu13062031
Received: 3 May 2021 / Revised: 8 June 2021 / Accepted: 9 June 2021 / Published: 13 June 2021
(This article belongs to the Section Clinical Nutrition)
Nattokinase (NK) is a serine protease enzyme with fibrinolytic activity. Even if it could be used for the treatment of several diseases, no data have been published supporting its use patients who underwent vascular surgery. In this study, we evaluated both the efficacy and the safety of nattokinase (100 mg/day per os) in patients admitted to vascular surgery. Patients were of both sexes, >18 years of age, with vascular diseases (i.e., deep vein thrombosis, superficial vein thrombosis, venous insufficiency), and naïve to specific pharmacological treatments (anticoagulants or anti-platelets). Patients were divided into three groups. Group 1: patients with deep vein thrombosis, treated with fondaparinux plus nattokinase. Group 2: patients with phlebitis, treated with enoxaparin plus nattokinase. Group 3: patients with venous insufficiency after classical surgery, treated with nattokinase one day later. During the study, we enrolled 153 patients (age 22–92 years), 92 females (60.1%) and 61 males (39.9%;), and documented that nattokinase was able to improve the clinical symptoms (p < 0.01) without the development of adverse drug reactions or drug interactions. Among the enrolled patients, during follow-up, we did not record new cases of vascular diseases. Attention to patients’ clinical evolution, monitoring of the INR, and timely and frequent adjustment of dosages represent the cornerstones of the safety of care for patients administered fibrinolytic drugs as a single treatment or in pharmacological combination. Therefore, we can conclude that the use of nattokinase represents an efficient and safe treatment able to both prevent and treat patients with vascular diseases. View Full-Text
Keywords: nattokinase; vascular diseases; clinical trial; low-molecular-weight heparin; Clinical Risk Management; safety of care in pharmacological treatments nattokinase; vascular diseases; clinical trial; low-molecular-weight heparin; Clinical Risk Management; safety of care in pharmacological treatments
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MDPI and ACS Style

Gallelli, G.; Di Mizio, G.; Palleria, C.; Siniscalchi, A.; Rubino, P.; Muraca, L.; Cione, E.; Salerno, M.; De Sarro, G.; Gallelli, L. Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases. Nutrients 2021, 13, 2031. https://doi.org/10.3390/nu13062031

AMA Style

Gallelli G, Di Mizio G, Palleria C, Siniscalchi A, Rubino P, Muraca L, Cione E, Salerno M, De Sarro G, Gallelli L. Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases. Nutrients. 2021; 13(6):2031. https://doi.org/10.3390/nu13062031

Chicago/Turabian Style

Gallelli, Giuseppe, Giulio Di Mizio, Caterina Palleria, Antonio Siniscalchi, Paolo Rubino, Lucia Muraca, Erika Cione, Monica Salerno, Giovambattista De Sarro, and Luca Gallelli. 2021. "Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases" Nutrients 13, no. 6: 2031. https://doi.org/10.3390/nu13062031

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