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The Prevention of Contrast Induced Nephropathy by Sarpogrelate: a Prospective Randomized Controlled Clinical Trial
You Jeong Ki1,2, Sun A Kwon1, Hack Lyoung Kim1,2
1Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
Insights
Sarpogrelate did not demonstrate a renoprotective effect against contrast induced nephropathy (CIN) in patients with chronic kidney disease. The study found no significant difference in CIN incidence between the sarpogrelate and control groups.
Area of Science:
- Nephrology
- Cardiology
- Pharmacology
Background:
- Strategies for preventing contrast-induced nephropathy (CIN) lack established efficacy.
- Sarpogrelate exhibits potential vasospasm relief and anti-inflammatory properties.
- This research investigates sarpogrelate's potential to prevent CIN and subsequent renal impairment post-coronary angiography.
Purpose of the Study:
- To evaluate the efficacy of sarpogrelate in reducing the incidence of contrast-induced nephropathy (CIN).
- To assess the impact of sarpogrelate on renal function up to four weeks after coronary angiography.
- To compare the outcomes of sarpogrelate administration versus a control group in patients with chronic renal failure.
Main Methods:
- A randomized controlled trial involving 74 participants with chronic renal failure.
- Participants were assigned to either the sarpogrelate or control group.
- Sarpogrelate was administered orally from 24 hours before contrast exposure to one month post-exposure. The primary outcome was CIN incidence within 48 hours.
Main Results:
- The study analyzed 31 control subjects and 35 sarpogrelate subjects.
- CIN incidence was numerically higher at 48 hours in the sarpogrelate group (11.4% vs. 6.5%) and lower at one month (11.4% vs. 16.1%), neither reaching statistical significance.
- Estimated glomerular filtration rate (eGFR) was lower in the sarpogrelate group at 12 and 48 hours (P=0.023 and P=0.020, respectively), but normalized by one month as eGFR worsened in the control group.
Conclusions:
- Sarpogrelate did not show a statistically significant renoprotective effect against contrast-induced acute kidney injury.
- The study failed to demonstrate the efficacy of sarpogrelate in preventing CIN in patients with chronic renal failure undergoing coronary angiography.
- Further research may be needed to explore alternative strategies for CIN prophylaxis.
Background:
Although some strategies are used for prophylaxis of contrast induced nephropathy, their efficacy is not fully established. Sarpogrelate can relieve vasospasm and have anti-inflammatory action. This study examined whether sarpogrelate reduces the incidence of contrast induced nephropathy (CIN) or subsequent renal impairment during four weeks after coronary angiography compared with a control group.
Methods:
Seventy-four participants with chronic renal failure were randomly assigned to the sarpogrelate or control group. Patients assigned to the sarpogrelate group received oral saporogelate from 24 hours before contrast exposure up to one month after contrast exposure. The primary outcome of this study was the incidence of CIN within 48 hours after exposure to the contrast agent.
Results:
Thirty-one subjects in the control group and 35 subjects in the sarpogrelate group were used for the analysis. Cumulative CIN occurred numerically more at 48 hours in the sarpogrelate group and less at one month without statistical significance (11.4% vs. 6.5% at 48 hours and 11.4% vs. 16.1% at one month, respectively). Baseline renal function was similar in both groups, but the estimated glomerular filtration rate (eGFR) was lower in the sarpogrelate group at 12 and 48 hours compared with the control group (45.6 vs. 54.7 mL/min/1.73m²; P = 0.023 and 39.9 vs. 50.6 mL/min/1.73m²; P = 0.020, respectively). At one month, the eGFR became comparable between the two groups because the eGFR was aggravated in the control group and maintained in the sarpogrelate group.
Conclusion:
This study failed to demonstrate that sarpogrelate has a renoprotective effect against contrast induced acute kidney injury.
Trial Registration:
ClinicalTrials.gov Identifier: NCT01165567.
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