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Effects of pentoxifylline on proteinuria and glucose control in patients with type 2 diabetes: a prospective randomized double-blind multicenter study.

Han SJ, Kim HJ, Kim DJ, Sheen SS, Chung CH, Ahn CW, Kim SH, Cho YW, Park SW, Kim SK, Kim CS, Kim KW, Lee KW - Diabetol Metab Syndr (2015)

Bottom Line: The percentage changes in proteinuria from baseline in the pentoxifylline and placebo groups were a decrease of 23 % and 4 %, respectively (p = 0.012).However there was no significant difference in serum tumor necrosis factor (TNF)-α between the groups.NCT01382303.

View Article: PubMed Central - PubMed

Affiliation: Department of Endocrinology and Metabolism, Ajou University School of Medicine, 164, World Cup-ro, Yeongtong-gu, Suwon, 443-380 Korea.

ABSTRACT

Background: Pentoxifylline is a methylxanthine derivative with significant anti-inflammatory, anti-fibrotic, and anti-proliferative properties. Studies have shown that pentoxifylline may have renoprotective effects in patients with diabetic nephropathy. However, most of these studies were limited by small sample sizes. Therefore, we investigated whether pentoxifylline could reduce proteinuria in patients with diabetic nephropathy and residual proteinuria who received an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB). We also studied the effects of pentoxifylline on glycemic control, insulin resistance, and inflammatory parameters.

Methods: This was a prospective, randomized double-blind, placebo-controlled, multi-center study. A total of 174 patients with type 2 diabetes and albuminuria (>30 mg/g of creatinine) who were taking the recommended dosage of ACEI or ARB for > 6 months and receiving conventional therapy for diabetes were randomly assigned to receive pentoxifylline (1200 mg, daily; n = 87) or a placebo (n = 87) for 6 months. The endpoints were the effects of pentoxifylline on proteinuria, renal function, glucose control, and inflammatory parameters.

Results: The percentage changes in proteinuria from baseline in the pentoxifylline and placebo groups were a decrease of 23 % and 4 %, respectively (p = 0.012). In addition, significant reductions in fasting plasma glucose, glycated hemoglobin, and insulin resistance according to the homeostasis model assessment were observed in the pentoxifylline group compared to those in the placebo group. However there was no significant difference in serum tumor necrosis factor (TNF)-α between the groups.

Conclusions: Pentoxifylline therapy reduced proteinuria and improved glucose control and insulin resistance without significant change of serum TNF-α in patients with type 2 diabetic nephropathy. Therefore, pentoxifylline is a potential therapeutic alternative for treating diabetes and diabetic nephropathy.

Trial registration: NCT01382303.

No MeSH data available.


Related in: MedlinePlus

Flow diagram of the study
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Fig1: Flow diagram of the study

Mentions: The disposition of the patients in the trial is shown in Fig. 1. A total of 174 of the 196 initially screened patients met the eligibility criteria and were randomly assigned to either the placebo or pentoxifylline group. Eight patients in the placebo and seven in the pentoxifylline group were lost to follow-up. Five subjects in the placebo group discontinued the study due to adverse events (AEs), and one subject withdrew for personal reasons. Thirteen subjects discontinued the study due to AEs in the pentoxifylline group; one subject was removed due to an overdose violation, and nine subjects withdrew for personal reasons. In total, 8 patients were excluded because urine data were unavailable and the 122 remaining were evaluated. The baseline demographic and clinical characteristics of the two groups were similar (Tables 1 and 2). No significant differences were observed in BP, renal function, urinary protein and albumin excretion, or metabolic parameters, except HbA1c. The pentoxifylline group had a higher HbA1c level than the placebo group (7.5 ± 0.9 vs. 7.2 ± 0.8 % (59 ± 10 vs. 56 ± 9 mmol/mol), p = 0.043). The urinary TNF-α concentration was below or just at the threshold of detection in all patients at baseline and remained so throughout the study (data not shown).Fig. 1


Effects of pentoxifylline on proteinuria and glucose control in patients with type 2 diabetes: a prospective randomized double-blind multicenter study.

Han SJ, Kim HJ, Kim DJ, Sheen SS, Chung CH, Ahn CW, Kim SH, Cho YW, Park SW, Kim SK, Kim CS, Kim KW, Lee KW - Diabetol Metab Syndr (2015)

Flow diagram of the study
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4546105&req=5

Fig1: Flow diagram of the study
Mentions: The disposition of the patients in the trial is shown in Fig. 1. A total of 174 of the 196 initially screened patients met the eligibility criteria and were randomly assigned to either the placebo or pentoxifylline group. Eight patients in the placebo and seven in the pentoxifylline group were lost to follow-up. Five subjects in the placebo group discontinued the study due to adverse events (AEs), and one subject withdrew for personal reasons. Thirteen subjects discontinued the study due to AEs in the pentoxifylline group; one subject was removed due to an overdose violation, and nine subjects withdrew for personal reasons. In total, 8 patients were excluded because urine data were unavailable and the 122 remaining were evaluated. The baseline demographic and clinical characteristics of the two groups were similar (Tables 1 and 2). No significant differences were observed in BP, renal function, urinary protein and albumin excretion, or metabolic parameters, except HbA1c. The pentoxifylline group had a higher HbA1c level than the placebo group (7.5 ± 0.9 vs. 7.2 ± 0.8 % (59 ± 10 vs. 56 ± 9 mmol/mol), p = 0.043). The urinary TNF-α concentration was below or just at the threshold of detection in all patients at baseline and remained so throughout the study (data not shown).Fig. 1

Bottom Line: The percentage changes in proteinuria from baseline in the pentoxifylline and placebo groups were a decrease of 23 % and 4 %, respectively (p = 0.012).However there was no significant difference in serum tumor necrosis factor (TNF)-α between the groups.NCT01382303.

View Article: PubMed Central - PubMed

Affiliation: Department of Endocrinology and Metabolism, Ajou University School of Medicine, 164, World Cup-ro, Yeongtong-gu, Suwon, 443-380 Korea.

ABSTRACT

Background: Pentoxifylline is a methylxanthine derivative with significant anti-inflammatory, anti-fibrotic, and anti-proliferative properties. Studies have shown that pentoxifylline may have renoprotective effects in patients with diabetic nephropathy. However, most of these studies were limited by small sample sizes. Therefore, we investigated whether pentoxifylline could reduce proteinuria in patients with diabetic nephropathy and residual proteinuria who received an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB). We also studied the effects of pentoxifylline on glycemic control, insulin resistance, and inflammatory parameters.

Methods: This was a prospective, randomized double-blind, placebo-controlled, multi-center study. A total of 174 patients with type 2 diabetes and albuminuria (>30 mg/g of creatinine) who were taking the recommended dosage of ACEI or ARB for > 6 months and receiving conventional therapy for diabetes were randomly assigned to receive pentoxifylline (1200 mg, daily; n = 87) or a placebo (n = 87) for 6 months. The endpoints were the effects of pentoxifylline on proteinuria, renal function, glucose control, and inflammatory parameters.

Results: The percentage changes in proteinuria from baseline in the pentoxifylline and placebo groups were a decrease of 23 % and 4 %, respectively (p = 0.012). In addition, significant reductions in fasting plasma glucose, glycated hemoglobin, and insulin resistance according to the homeostasis model assessment were observed in the pentoxifylline group compared to those in the placebo group. However there was no significant difference in serum tumor necrosis factor (TNF)-α between the groups.

Conclusions: Pentoxifylline therapy reduced proteinuria and improved glucose control and insulin resistance without significant change of serum TNF-α in patients with type 2 diabetic nephropathy. Therefore, pentoxifylline is a potential therapeutic alternative for treating diabetes and diabetic nephropathy.

Trial registration: NCT01382303.

No MeSH data available.


Related in: MedlinePlus