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Romanian Journal of Internal Medicine

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Efficacy of long-term low-dose sulodexide in diabetic and non-diabetic nephropathies

Diana-Silvia Zilişteanu
  • Corresponding author
  • Center of Internal Medicine and Nephrology, Fundeni Clinical Institute, Bucharest
  • “Carol Davila” University of Medicine and Pharmacy, Bucharest
  • Email:
/ Teodora Atasie
  • Center of Internal Medicine and Nephrology, Fundeni Clinical Institute, Bucharest
/ M. Voiculescu
  • Center of Internal Medicine and Nephrology, Fundeni Clinical Institute, Bucharest
  • “Carol Davila” University of Medicine and Pharmacy, Bucharest
Published Online: 2015-10-14 | DOI: https://doi.org/10.1515/rjim-2015-0022

Abstract

Background and Aims. Sulodexide has been reported to have antiproteinuric and nephroprotective properties. We investigated the effects of long-term low-dose Sulodexide on proteinuria and renal function in patients with chronic kidney disease (CKD) caused by diabetic nephropathy (DN), hypertensive nephropathy (HN) and primary glomerulonephritis (GN).

Material and Methods. 100 patients with CKD received low-dose Sulodexide 50 mg/day for 12 months. Treatment efficacy was evaluated as proteinuria reduction compared to baseline; response was defined as a decline in proteinuria below 0.3 g/d. Renal function evolution was assessed by eGFR variation from baseline.

Results. All patients presented reduction of proteinuria, with global mean value of proteinuria decrease of 0.85 ± 1.34 g/d (p<0.0001). Patients with HN had the highest mean percentage of proteinuria reduction (73±29%) and the lowest mean time period to achieve responder status (6.6±2.4 months), compared to patients with DN (57±29%, 8±2.9 months) and GN (63±24%, 10.7±1.2 months). Renal function as mean eGFR remained stable or improved during the study; significant increase was found only in HN group (3.41 ± 6.38 ml/min/1.73m2, p=0.043). Multivariate regression analysis identified that responder status was significantly associated with gender, baseline eGFR, baseline proteinuria and etiology of CKD. Concomitant administration of ACEIs or/and ARBs did not influence the response to Sulodexide therapy.

Conclusions. Independently of ACEIs or/and ARBs therapy, long-term low-dose Sulodexide is efficient as antiproteinuric and renoprotective therapy in patients with CKD caused by DN, GN and HN. Better response is achieved in patients with lower degree of renal dysfunction.

Obiectivul studiului. Sulodexid a demonstrat că posedă proprietăţi antiproteinurice şi nefroprotectoare, motiv pentru care am decis să investigăm efectele unei doze mici de Sulodexid administrate pe termen lung asupra proteinuriei şi funcţiei renale la pacienţi cu boală cronică de rinchi (BCR) apărută ca urmare a nefropatiei diabetice (ND), hipertensive (NH) sau glomerulonefritelor primare (GN).

Material şi Metodă. 100 de pacienţi cu BCR au primit în fiecare zi câte o doză mică de Sulodexid (50 mg/zi) timp de 12 luni. Eficacitatea tratamentului a fost evaluată prin reducerea nivelurilor proteinuriei comparativ cu valorile iniţiale; răspunsul terapeutic a fost definit drept o scădere a proteinuriei la valori mai mici de 0.3 g/dl. Evoluţia funcţiei renale a fost evaluată prin calcularea variaţiei eGFR faţă de valoarea iniţială.

Rezultate. La finalul celor 12 luni de tratament cu Sulodexid, toţi pacienţii au înregistrat o scădere semnificativă a proteinuriei, cu o valoare globală medie a scăderii proteinuriei de 0.85 ± 1.34 g/dl (p<0.0001). Pacienţii cu NH au înregistrat cea mai ridicată valoare medie procentuală a scăderii proteinuriei (73±29%) şi cea mai redusă durată medie a tratamentului până la obţinerea răspunsului terapeutic (6.6±2.4 luni), comparativ cu pacienţii cu ND (57±29%, 8±2.9 luni) şi GN (63±24%, 10.7±1.2 luni). Funcţia renală ca şi medie eGFR a rămas nemodificată sau s-a ameliorat, o ameliorare semnificativă fiind înregistrată doar în grupul pacienţilor cu NH (3.41 ± 6.38 ml/min/1.73m2, p=0.043). Analiza regresiei multivariate a identificat că răspunsul terapeutic a fost semnificativ asociat cu sexul, valorile iniţiale ale GFR, proteinuriei şi cu etiologia BCR. Administrarea concomitentă de inhibitori ai enzimei de conversie (IEC) sau/şi blocanţi ai receptorilor angiotensinei (BRA) nu au influenţat răspunsul terapeutic al administrării de Sulodexid.

Concluzii. Sulodexid în doză mică pe termen lung a dovedit eficienţă terapeutică în ceea ce priveşte efectul său antiproteinuric şi renoprotectiv la pacienţii cu BCR cauzată de ND, NH sau GN, independent de administrarea de IEC/BRA. Un răspuns terapeutic mai bun a fost înregistrat la pacienţii aflaţi în stadii mai puţin avansate ale disfuncţiei renale.

Keywords: sulodexide; nephropathy; proteinuria; renal function; CKD progression

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About the article

Published Online: 2015-10-14

Published in Print: 2015-06-01


Citation Information: Romanian Journal Of Internal Medicine, ISSN (Online) 1220-4749, DOI: https://doi.org/10.1515/rjim-2015-0022. Export Citation

© 2015 Diana-Silvia Zilişteanu et al., published by De Gruyter Open. This chapter is distributed under the terms of the Creative Commons Attribution 4.0 Public License. (CC BY 4.0)

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