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Anti-proteinuric effect of sulodexide in immunoglobulin a nephropathy.

Bang K, Chin HJ, Chae DW, Joo KW, Kim YS, Kim S, Ju KD, Kim H, Ahn C, Oh KH - Yonsei Med. J. (2011)

Bottom Line: At 6 months, the primary end point was achieved by 12.5% of the patients assigned to the placebo, 4.0% of the patients assigned to sulodexide 75 mg daily and 21.4% of those assigned to 150 mg (p=0.308).Treatment with sulodexide 150 mg daily for 6 months significantly reduced log UPCR from 6.38±0.77 at baseline to 5.98±0.94 at 6 months (p=0.045), while treatment with sulodexide 75 mg daily and placebo did not.A 6-month treatment with sulodexide did not achieve 50% reduction of urinary protein excretion in IgA nephropathy patients, but showed a tendency to increase the time-dependent anti-proteinuric effect.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Transplantation Research Institute, 101 Daehak-ro, Jongno-gu, Seoul 110-744, Korea.

ABSTRACT

Purpose: We conducted a multi-center randomized double-blind study to determine the effects of 6-month therapy with sulodexide on urinary protein excretion in patients with idiopathic Immunoglobulin A (IgA) nephropathy.

Materials and methods: A total of seventy-seven patients participated in the study. They were randomly allocated to one of three groups: sulodexide 75 mg or 150 mg daily or the placebo for 6 months. The primary end point was the achievement, at 6 months, of at least 50% reduction in urine protein/creatinine ratio (UPCR) from the baseline value.

Results: At 6 months, the primary end point was achieved by 12.5% of the patients assigned to the placebo, 4.0% of the patients assigned to sulodexide 75 mg daily and 21.4% of those assigned to 150 mg (p=0.308). Treatment with sulodexide 150 mg daily for 6 months significantly reduced log UPCR from 6.38±0.77 at baseline to 5.98±0.94 at 6 months (p=0.045), while treatment with sulodexide 75 mg daily and placebo did not.

Conclusion: A 6-month treatment with sulodexide did not achieve 50% reduction of urinary protein excretion in IgA nephropathy patients, but showed a tendency to increase the time-dependent anti-proteinuric effect. Therefore, long-term clinical trials on a larger scale are warranted to elucidate the hypothesis that sulodexide affords renal protection in IgA nephropathy patients.

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Related in: MedlinePlus

Patient profiles; the number of patients who were screened for the study, underwent randomization, and completed the study. Some patients were excluded for more than one reason.
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Figure 1: Patient profiles; the number of patients who were screened for the study, underwent randomization, and completed the study. Some patients were excluded for more than one reason.

Mentions: Between March 2007 and April 2009, 209 patients with IgA nephropathy were screened for study. One hundred and four patients were randomly assigned with equal allocation to treatment with the placebo, a single dose of sulodexide 75 mg daily, or sulodexide 150 mg daily in two divided doses. The profiles of these patients are summarized in Fig. 1. Of the 104 randomized patients, 77 completed the study. Twenty-seven patients discontinued participation due to adverse effects, were lost to follow-up, or spontaneously withdrew from the study.


Anti-proteinuric effect of sulodexide in immunoglobulin a nephropathy.

Bang K, Chin HJ, Chae DW, Joo KW, Kim YS, Kim S, Ju KD, Kim H, Ahn C, Oh KH - Yonsei Med. J. (2011)

Patient profiles; the number of patients who were screened for the study, underwent randomization, and completed the study. Some patients were excluded for more than one reason.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3104455&req=5

Figure 1: Patient profiles; the number of patients who were screened for the study, underwent randomization, and completed the study. Some patients were excluded for more than one reason.
Mentions: Between March 2007 and April 2009, 209 patients with IgA nephropathy were screened for study. One hundred and four patients were randomly assigned with equal allocation to treatment with the placebo, a single dose of sulodexide 75 mg daily, or sulodexide 150 mg daily in two divided doses. The profiles of these patients are summarized in Fig. 1. Of the 104 randomized patients, 77 completed the study. Twenty-seven patients discontinued participation due to adverse effects, were lost to follow-up, or spontaneously withdrew from the study.

Bottom Line: At 6 months, the primary end point was achieved by 12.5% of the patients assigned to the placebo, 4.0% of the patients assigned to sulodexide 75 mg daily and 21.4% of those assigned to 150 mg (p=0.308).Treatment with sulodexide 150 mg daily for 6 months significantly reduced log UPCR from 6.38±0.77 at baseline to 5.98±0.94 at 6 months (p=0.045), while treatment with sulodexide 75 mg daily and placebo did not.A 6-month treatment with sulodexide did not achieve 50% reduction of urinary protein excretion in IgA nephropathy patients, but showed a tendency to increase the time-dependent anti-proteinuric effect.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Transplantation Research Institute, 101 Daehak-ro, Jongno-gu, Seoul 110-744, Korea.

ABSTRACT

Purpose: We conducted a multi-center randomized double-blind study to determine the effects of 6-month therapy with sulodexide on urinary protein excretion in patients with idiopathic Immunoglobulin A (IgA) nephropathy.

Materials and methods: A total of seventy-seven patients participated in the study. They were randomly allocated to one of three groups: sulodexide 75 mg or 150 mg daily or the placebo for 6 months. The primary end point was the achievement, at 6 months, of at least 50% reduction in urine protein/creatinine ratio (UPCR) from the baseline value.

Results: At 6 months, the primary end point was achieved by 12.5% of the patients assigned to the placebo, 4.0% of the patients assigned to sulodexide 75 mg daily and 21.4% of those assigned to 150 mg (p=0.308). Treatment with sulodexide 150 mg daily for 6 months significantly reduced log UPCR from 6.38±0.77 at baseline to 5.98±0.94 at 6 months (p=0.045), while treatment with sulodexide 75 mg daily and placebo did not.

Conclusion: A 6-month treatment with sulodexide did not achieve 50% reduction of urinary protein excretion in IgA nephropathy patients, but showed a tendency to increase the time-dependent anti-proteinuric effect. Therefore, long-term clinical trials on a larger scale are warranted to elucidate the hypothesis that sulodexide affords renal protection in IgA nephropathy patients.

Show MeSH
Related in: MedlinePlus