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Órgano Oficial de la Sociedad Mexicana de Angiología y Cirugía Vascular

2014, Number 1

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Rev Mex Angiol 2014; 42 (1)

Sulodexida para la enfermedad venosa crónica. Experiencia clínica en México

Flota-Cervera LF, Paz-Janeiro JL, Guevara-Saldívar MI, Muñoz-Martínez TC, Nuricumbo-Vázquez A, Santana-Vega D, Ibáñez-Rodríguez JF, Cardoso-Villaseñor A, Estrada-Guerrero JG, Chew-Salas E, Frati-Munari AC

Language: Spanish
References: 48
Page: 28-37
PDF size: 211.83 Kb.


ABSTRACT

Background. Sulodexide is a glycosaminoglycan used in the treatment of venous chronic disease (CVD) which has been recently introduced as a therapeutic tool in México.
Objective. To collect Mexican experience using sulodexide in the treatment of CVD.
Material and methods. From September 2012 to May 2013, angiologist and internist of 20 Mexican cities were invited to fulfill a structured form with demographic and clinical data of their patients treated for CVD. Those receiving sulodexide were analyzed, as well as the clinical data in the following visits.
Results. 104 specialists participated with 1,013 patients, most of them (76%) were classified as C3 to C6, 35% as C6. They were previously treated with surgery, sclerotherapy, flebotonics or pentoxifylline. Combined with venous hygiene measures and compressive therapy, sulodexide was prescribed mostly (81%) by oral route, 19% by intramuscular alone or combined with oral route. 768 patients (75.8%) were followed one to four visits (median between visits 30 days). A significant improvement of symptoms (p ‹ 0.001) were noticed during the follow up, while a tendency of objective improvement occurred (p = NS). By the fourth visit leg ulcers either cured or had a great improvement (76-100% of size reduction respect to the initial) in 84.8% of the cases. Opinions of patients and doctors resulted in better or much better in 91.2%, and good or very good results in 92.5% of the cases respectively. Adverse effects were reported in 12 cases (1.56%), they were mild and resolved spontaneously.
Conclusion. Sulodexide is effective and safe, with a high grade of satisfaction for both patients and doctors, in the treatment of any stage of CVD and specially in most severe cases with active leg ulcers.


REFERENCES

  1. Sigler Morales L, Castañeda Gaxiola R, Rish Fein L. Insuficiencia venosa crónica en la RePública Mexicana. Rev Mex Angiol 2004; 32: 44-6.

  2. Chiesa R, Marone EM, Limoni C, Volonté M, Schaefer E, Petrini O. Chronic venous insufficiency in Italy: the 24- cities cohort study. Eur J Vasc Endovasc Surg 2005; 30: 422-9.

  3. Zahariev T, Anastassov V, Girov K, Goranova E, Grozdinski L, Kniajev V, Stankev M. Prevalence of primary chronic venous disease: the Bulgarian experience. Int Angiol 2009; 28: 303-10.

  4. Rabe E, Guex JJ, Puskas A, Scuderi A, Fernandez Quesada F, The VCP coordinators. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol 2012; 31: 105-15.

  5. Andreozzi GM. Prevalence of patients with chronic venous disease-related symptoms but without visible signs (described as C0s in the CEAP classification): the Italian experience. Phlebolymphology 2006; 13: 28-35.

  6. Andreozzi GM, Cordova RM, Scomparin A, et al. Quality of life in chronic venous insufficiency. An Italian pilot study of the Triveneto Region. Int Angiol 2005; 24: 272-7.

  7. Bergan JJ, Schmid Schönbein GW, Coleridge Smith PD, Nicolaides AN, Boisseau MR, Ekloff B. Chronic venous disease. N Engl J Med 2006; 355: 488-98.

  8. Gloviczki P, Comerota AJ, Dalsing MG, Eklof BG, Gillespie DL, Gloviczki ML, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011; 53(5 Suppl.): 2S-48S.

  9. Andreozzi GM. Sulodexide in the treatment of chronic venous disease. Am J Cardiovasc Drugs 2012; 12: 73-81.

  10. Agus GB, Mattana P, Carelli F. Monitor 2010: italian epidemiological survey on chronic venous diseases. Acta Phlebol 2012; 13: 9-17.

  11. Lohr JM, Bush RL. Venous disease in women: epidemiology, manifestations, and treatment. J Vasc Surg 2013; 57 (4 Suppl.): 37S-45S.

  12. Karathanos Ch, Sfyroeras G, Drakon A, Roussas N, Exarchou M, Kyriakou D, Giannoukas AD. Superficial vein thrombosis in patients with varicose veins: role of thrombophilia factors, age and body mass. Eur J Vasc Endovasc Surg 2012; 43: 355-8.

  13. Danielsson G, Eklof B, Grandinetti A, Kistner RL. The influence of obesity on chronic venous disease. Vasc Endovasc Surg 2002; 36: 271-6.

  14. García-Gimeno M, Rodríguez-Camarero S, Tagarro- Villalba S, Ramalle-Gomara E, Ajona García JA, González Arranz MA, et al. Reflux patterns and risk factors of primary varicose veins’ clinical severity. Phlebology 2012; 27; 1-9.

  15. Vlajinac HD, Marinkovic JM, Maksimovic MZ, Matic PA, Radak DJ. Body mass index and primary chronic venous disease—a cross-sectional study. Eur J Vasc Endovasc Surg 2013; 45: 293-8.

  16. Barquera Cervera S, Campos-Nonato I, Rojas R, Rivera J. Obesidad en México: epidemiología y política de salud para su control y prevención. Gac Med Mex 2010; 146: 397-407.

  17. Lozano Sánchez FS, González-Porras JR, Díaz Sánchez S, Marinel Lo Roura J, Sánchez Nevarez J, Carrasco EC, et al. Negative impact of deep venous thrombosis on chronic venous disease. Thromb Res 2013; 131: e123- e126. Flota-Cervera LF y cols. Sulodexida para la enfermedad venosa crónica. Rev Mex Angiol 2014; 42(1): 28-37 37

  18. Nicolaides AN, Allegra C, Bergan J, Bradbury A, Cairols M, Carpentier P, et al. Management of chronic venous disorders of the lower limbs. Guidelines according to scientific evidence. Int Angiol 2008; 27: 1-59.

  19. Martínez MJ, Bonfil X, Moreno RM, Vargas E, Capella D. Flebotónicos para la insuficiencia venosa (versión Cochrane traducida). La Biblioteca Cochrane Plus 2008; N 4. Disponible en: http;//www.update-software.com

  20. Jull AB, Waters J, Arroll B. Pentoxifylline for treating venous leg ulcers. Cochrane Database Syst Rev 2002; (1): CD001733.

  21. Saharay M, Shields DA, Georgiannos SN, Porter JB, Scurr JH, Coleridge Smith PD. Endothelial activation in patients with chronic venous disease. Eur J Vasc Endovasc Surg 1998; 15: 342-9.

  22. Chiu J-J, Chien S. Effects of disturbed flow on vascular endothelium: pathophysiological basis and clinical perspectives. Physiol Rev 2011; 91: 327-87.

  23. Ono T, Bergan JJ, Schmid-Schönbeim GW, Takase S. Monocyte infiltration into venous valves. J Vasc Surg 1998; 27: 158-66.

  24. Nicolaides AN. Chronic venous disease and the leukocyteendothelium interaction: from symptoms to ulceration. Angiology 2005; 56(Suppl. 1): S11-S19.

  25. Bergan JJ, Schmid-Schönbeim GW, Coleridge-Smith PD, Nicolaides AN, Boisseau MR, Eklof B. Chronic venous disease. N Engl J Med 2006; 355: 488-98.

  26. Broekhuisen LN, Meuwese MC, Mooij HL, Stroes ESG, Vink H, Gouverneur M. Sulfated glycosaminoglycans restore barrier of cultured endothelial cells under hyperglycemic conditions. In Meuwese MC. Targeting the vessel wall in cardiovascular prevention. Amsterdam Univ. Amsterdam; 2008, p. 46-54. Disponible en: http:// dare.uva.n/document/112476

  27. Broekhuisen LN, Lemkes BA, Mooij HL, Meuwese MC, Verberne H, Holleman F, et al. Effect of sulodexide on endotelial glycocalyx and vascular permeability in patients with type 2 diabetes mellitus. Diabetologia 2010; 53: 2646-55.

  28. Mathison Y, Garrido MR, Israel A, et al. Efecto del glicosaminoglicano sulodexida sobre la actividad de la sintasa de óxido nítrico en la corteza renal de ratas con diabetes tipo 1. Rev Latinoamer Hipert 2008; 3: 182-9.

  29. Kristová V, Lisková S, Sotniková R, et al. Sulodexide improves endothelial dysfunction in streptozotocin-induced diabetes in rats. Physiol Res 2008; 57: 491-4.

  30. Vasquez J, Mathison Y, Romero-Vecchione E, et al. Efecto del sulodexide sobre la capacidad de relajación y alteraciones estructurales de la arteria aorta en ratas diabéticas por estreptozotocina. Invest Clin 2010; 51: 467-77.

  31. Park HY, Kang S, Kim GY, et al. Inhibition of neointimal proliferation of rat carotid artery by sulodexide. J Korean Med Sci 1997; 12: 210-4.

  32. Mattana P, Mannello F, Ferrari P, Agus GB. Vascular pathologies and inflammation: the anti-inflammatory properties of sulodexide. J Vasc Endovasc Surg 2012; 19(Suppl. 2): 1-7.

  33. Uemura S, Mastsushita H, Glassford AJ, Asagami T, Lee KH, Harrison DG, Tsao PS. Diabetes mellitus enhances vascular matrix metalloproteinase activity: role of oxidative stress. Circ Res 2001; 88: 1291-8.

  34. Harenberg J. Review of pharmacodynamics, pharmacokinetics. And therapeutic properties of sulodexide. Med Res Rev 1998; 18: 1-20.

  35. Cospite M, Miglio G, Ferrara F, Cospite V, Palazzini E. Haemodynamic effects of sulodexide in post-thrombophlebitic syndromes. Acta Ther 1992; 18: 149-61.

  36. Cospite M, Ferrara F, Cospite V, Palazzini E. Sulodexide and the microcirculatory component in microphlebopathies. Curr Med Res Opin 1992; 13: 56-60.

  37. Allegra C. Ruolo attuale dei glicosaminoglicani e prospettive in terapia. Minerva Angiol 1993; 18(Suppl. 3 al N. 1): 45-9.

  38. Scondotto G, Aloisi D, Ferrari P, Martini L. Treatment of venous leg ulcers with sulodexide. Angiology 1999; 50: 883-9.

  39. Coccheri S, Scondotto G, Agnelli G, Aloisi D, Palazzini E, Zamboni V. Randomized, double-blind, multicentre, placebo controlled study of sulodexide in the treatment of venous leg ulcers. Thromb Haemost 2002; 87: 947-52.

  40. Kucharzevski M, Franec A, HozioleK H. Treatment of venous leg ulcers with sulodexide. Phlebologie 2003; 32: 115-20.

  41. Apollonio A, Mosti G, Ricci E. Microcircolo e ulcere venose. Acta Vulnol 2008; 6: 125-32.

  42. Deutsche Geselleschaft FÜr Phlebologie (DGP). Guidelines for the diagnosis and therapy of venous ulcers (version 8 2008). Phlebologie 2008; 37: 308-29.

  43. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians evidence-based clinical practice guidelines. 8th ed. Chest 2008; 133: 454S-545S.

  44. Nelson EA. Clinical evidence. Venous leg ulcers. BMJ Clinical Evidence 2011; 212: 1901.

  45. Jawien A, Szewczyk MT, Kaszuba A, Gaciong Z, Krasinski Z, Wronski J, et al. Guidelines for the management of chronic venous ulceration. Recommendation of a multidisciplinary expert group. Leczenie Ran 2011; 8: 59-80.

  46. Saviano M, Maleta O, Liguori L. Double-blind, double dummy, randomized, multi-centre clinical assessment of efficacy, tolerability and dose-effect relationship of sulodexide in chronic venous insufficiency. Curr Med Res Opin 1993; 13: 96-108.

  47. Cirujeda JL, Granado PC. A study of safety, efficacy, and efficiency of sulodexide compared with acenocumarol in secondary prophylaxis in patients with deep venous thrombosis. Angiology 2006; 57: 53-64.

  48. La Sierra-Cirujeda, Coronel P, Aza MJ, Gimeno M. Use of sulodexide in patients with peripheral vascular disease. J Blood Med 2010; 1: 105-15.




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