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Beraprost Sodium Protects Against Diabetic Nephropathy in Patients with Arteriosclerosis Obliterans: A Prospective,
Ayaka Shima1, Masaaki Miyamoto, Yoshiaki Kubota
1Department of Cardiovascular Medicine, Nippon Medical School.
Background:
Inhibition of the renin-angiotensin system (RAS) has been used to treat diabetic nephropathy. However, RAS inhibition increases the risk of renal complications. In this study, we evaluated the effect of combining RAS inhibitor treatment with beraprost sodium (BPS), a prostaglandin I2 analog, in diabetic nephropathy with arteriosclerosis obliterans.
Methods:
This study was a prospective, randomized, open-label study. Twenty-six Japanese patients (age >30 years) with diabetic nephropathy and arteriosclerosis obliterans were randomly assigned to the BPS group (n=13), which received the combination of an RAS inhibitor and BPS (120 μg/day) therapy, or the control group (n=13), which received only an RAS inhibitor. Patients were followed up for 1 year. The primary endpoint was the effect of BPS on renal function.
Results:
In the control group, serum creatinine (1.64±0.87 to 2.34±1.53 mg/dL, p<0.001), 1/creatinine (0.82±0.47 to 0.65±0.47, p=0.003) cystatin C (1.77±0.61 to 2.18±0.86 mg/L, p<0.001), and the estimated glomerular filtration rate (43.9±26.1 to 34.0±24.6 mL/min/1.73 m(2), p=0.004) were significantly worsened 48 weeks after the start of treatment. Conversely, in the BPS group, serum creatinine (1.71±0.75 to 1.66±0.81 mg/dL, p=0.850), 1/creatinine (0.66±0.19 to 0.71±0.25, p=0.577), cystatin C (1.79±0.55 to 1.80±0.57 mg/L, p=0.999), and the estimated glomerular filtration rate (35.8±10.8 to 38.7±14.4 mL/min/1.73 m(2), p=0.613) were unchanged.
Conclusions:
Combination treatment with BPS and an RAS inhibitor prevented the progression of diabetic nephropathy. These observations should be confirmed in large-scale studies with long-term follow-up.
Insights
Combining beraprost sodium (BPS) with renin-angiotensin system (RAS) inhibitors prevented worsening kidney function in patients with diabetic nephropathy and arteriosclerosis obliterans.
Area of Science:
- Nephrology
- Endocrinology
- Cardiovascular Medicine
Background:
- Diabetic nephropathy is a common complication of diabetes, often treated with renin-angiotensin system (RAS) inhibitors.
- RAS inhibition can increase the risk of renal complications, necessitating alternative or adjunctive therapies.
- Arteriosclerosis obliterans is a condition that can exacerbate renal issues in diabetic patients.
Purpose of the Study:
- To evaluate the efficacy of combining beraprost sodium (BPS), a prostaglandin I2 analog, with RAS inhibitors in treating diabetic nephropathy.
- To assess the impact of this combination therapy on renal function in patients with arteriosclerosis obliterans.
Main Methods:
- A prospective, randomized, open-label study involving 26 Japanese patients (age >30 years) with diabetic nephropathy and arteriosclerosis obliterans.
- Patients were assigned to either a control group (RAS inhibitor only) or a BPS group (RAS inhibitor + BPS 120 μg/day).
- Renal function was monitored for 1 year, with the primary endpoint being the effect of BPS on kidney function.
Main Results:
- In the control group, significant worsening of renal function was observed, including increased serum creatinine and cystatin C, and decreased estimated glomerular filtration rate (eGFR).
- Conversely, the BPS group showed no significant changes in serum creatinine, cystatin C, or eGFR over the 1-year study period.
- Combination therapy with BPS and an RAS inhibitor effectively stabilized renal function.
Conclusions:
- Combination treatment with beraprost sodium (BPS) and a renin-angiotensin system (RAS) inhibitor is effective in preventing the progression of diabetic nephropathy.
- These findings suggest a potential therapeutic strategy for managing diabetic nephropathy in patients with arteriosclerosis obliterans.
- Larger-scale studies with extended follow-up are recommended to confirm these results.
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