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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

Changes from baseline in urinary protein-to-creatinine ratio (UPCR) according to study group. The change from the baseline, in the geometric mean, with 95% confidence intervals, is shown for UPCR.
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Figure 2: Changes from baseline in urinary protein-to-creatinine ratio (UPCR) according to study group. The change from the baseline, in the geometric mean, with 95% confidence intervals, is shown for UPCR.

Mentions: The secondary end point of the study was within-group change in log UPCR for 6 months. Treatment with sulodexide 150 mg daily for 6 months significantly reduced log UPCR from 6.38±0.77 at T0 to 5.98±0.94 at T6 (p=0.045). However, treatment with sulodexide 75 mg daily and the placebo did not show a significant reduction in logUPCR (75 mg group, logUPCR from 6.47±0.79 at T0 to 6.63±0.74 at T6, p=0.487; placebo group, logUPCR from 6.38±0.53 at T0 to 6.29±0.70 at T6, p=0.190) (Table 4). By the end of the study period, treatment with sulodexide 150 mg daily for 6 months had reduced the geometric mean in UPCR by 33%, as compared to the baseline (p=0.045) and showed a tendency to increase the time-dependent anti-proteinuric effect (Fig. 2). There were no significant differences between either of the sulodexide groups and the placebo group in the change in the logUPCR to any of the follow-up time points (Table 4, Fig. 2).


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)

Changes from baseline in urinary protein-to-creatinine ratio (UPCR) according to study group. The change from the baseline, in the geometric mean, with 95% confidence intervals, is shown for UPCR.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 2: Changes from baseline in urinary protein-to-creatinine ratio (UPCR) according to study group. The change from the baseline, in the geometric mean, with 95% confidence intervals, is shown for UPCR.
Mentions: The secondary end point of the study was within-group change in log UPCR for 6 months. Treatment with sulodexide 150 mg daily for 6 months significantly reduced log UPCR from 6.38±0.77 at T0 to 5.98±0.94 at T6 (p=0.045). However, treatment with sulodexide 75 mg daily and the placebo did not show a significant reduction in logUPCR (75 mg group, logUPCR from 6.47±0.79 at T0 to 6.63±0.74 at T6, p=0.487; placebo group, logUPCR from 6.38±0.53 at T0 to 6.29±0.70 at T6, p=0.190) (Table 4). By the end of the study period, treatment with sulodexide 150 mg daily for 6 months had reduced the geometric mean in UPCR by 33%, as compared to the baseline (p=0.045) and showed a tendency to increase the time-dependent anti-proteinuric effect (Fig. 2). There were no significant differences between either of the sulodexide groups and the placebo group in the change in the logUPCR to any of the follow-up time points (Table 4, Fig. 2).

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