Related Experiment Video
Updated: Jun 16, 2025
A Large Animal Model for Acute Kidney Injury by Temporary Bilateral Renal Artery Occlusion
Published on: February 2, 2021
Association between PCSK9 inhibitors and acute kidney injury: a pharmacovigilance study
1Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, China.
Background:
PCSK9 inhibitors are a novel class of lipid-lowering medications, and numerous clinical studies have confirmed their significant role in improving the progression of chronic kidney disease. However, recent case reports have indicated new evidence regarding their association with acute kidney injury (AKI), with some patients experiencing acute tubular injury after PCSK9 inhibitors use.
Objectives:
To clarify the relationship between PCSK9 inhibitors and AKI, we conducted a pharmacovigilance study.
Methods:
Using the Food and Drug Administration Adverse Event Reporting System (FAERS) database from the third quarter of 2015 to the fourth quarter of 2022, a disproportionality analysis was employed to identify adverse events suggestive of AKI after PCSK9 inhibitors use. The drugs of interest included evolocumab and alirocumab.
Results:
A total of 144,341 adverse event reports related to PCSK9 inhibitors were analyzed, among which 444 cases were suspected of AKI for evolocumab, and 172 cases for alirocumab. Evolocumab had a greater impact on AKI in males (ROR 1.4, 95% CI 1.54-1.69). The ROR and 95% CI for evolocumab and Alirocumab were 0.13 (0.12-0.14) and 0.26 (0.23-0.30) respectively. Further analysis of AKI associated with the concomitant use of PCSK9 inhibitors with cephalosporins, furosemide, torsemide, pantoprazole, omeprazole, and esomeprazole revealed ROR and 95% CI of 0.38 (0.23-0.62), 0.38 (0.31-0.48), 0.18 (0.08-0.38), 0.23 (0.17-0.29), 0.20 (0.16-0.26), and 0.14 (0.10-0.20) respectively.
Conclusion:
Through the FAERS database, we analyzed the clinical characteristics of AKI associated with PCSK9 inhibitors, exploring its risks. Our findings suggest that PCSK9 inhibitors might have a potential protective effect against AKI and exhibit similar effects when co-administered with other nephrotoxic drugs.
Insights
PCSK9 inhibitors, used for lowering lipids, may offer a protective effect against acute kidney injury (AKI). This pharmacovigilance study analyzed FAERS data, suggesting a potential benefit even with co-administration of other drugs.
Area of Science:
- Pharmacology
- Nephrology
- Cardiovascular Medicine
Background:
- PCSK9 inhibitors are novel lipid-lowering drugs with established benefits in chronic kidney disease.
- Recent case reports suggest a potential association between PCSK9 inhibitors and acute kidney injury (AKI).
Purpose of the Study:
- To investigate the relationship between PCSK9 inhibitors (evolocumab, alirocumab) and AKI.
- To clarify the safety profile of PCSK9 inhibitors concerning kidney function.
Main Methods:
- A pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database (Q3 2015–Q4 2022).
- Disproportionality analysis was employed to identify AKI events associated with PCSK9 inhibitors.
Main Results:
- Analysis of 144,341 adverse event reports identified 444 suspected AKI cases for evolocumab and 172 for alirocumab.
- Evolocumab showed a higher impact on AKI in males (ROR 1.4).
- Concomitant use with certain drugs like furosemide and pantoprazole showed specific RORs, suggesting potential interactions or protective effects.
Conclusions:
- PCSK9 inhibitors may possess a potential protective effect against AKI.
- This protective effect appears consistent even when co-administered with other potentially nephrotoxic medications.
More Related Videos
Related Concept Videos
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:11Renal Failure: Dose Adjustments
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
01:17Factors Affecting Renal Clearance: Renal Impairment
One condition associated with renal failure is uremia. Uremia is characterized by impaired glomerular filtration and fluid accumulation in the body. This condition hinders the renal clearance of drugs, resulting in drug accumulation and potential...
01:31Factors Affecting Renal Clearance: Drug's Physicochemical Properties and Plasma Levels
One important factor is the drug's molecular size. The kidneys readily excrete smaller molecules below 300 Daltons (Da). On the other hand, molecules weighing between 300 and 500 Da are excreted through both urine and bile. Larger molecules above 500 Da tend to be excreted...
01:25Antihypertensive Drugs: Direct Renin Inhibitors
00:59Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis
One important characteristic of noncompartmental analyses is that drug exposure increases proportionally with increasing doses. This...