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Exploring and comparing renal adverse effects between PARP inhibitors based on a real-world analysis of
Qiuyu Xu1, Lin Jiang2, Gang Chen1
1Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
Objective:
Poly (ADP-ribose) polymerase inhibitors (PARPis) are emerging targeted therapeutic agents in oncology, primarily indicated for ovarian and metastatic breast cancer. Acute kidney injury (AKI) has been observed in patients undergoing PARPi treatment, while there is still a lack of comprehensive comparisons of AKI associated with different PARPis. Our study aimed to extensively characterize the renal adverse effects (RAEs) of PARPi using real-world data.
Methods:
Disproportionality analysis and Bayesian analysis were employed for data mining to identify suspected RAE cases after different PARPis use within the Food and Drug Administration's Adverse Event Reporting System from January 2004 to September 2023. The time to onset, fatality, and hospitalization rates of PARPi-related RAEs were also investigated.
Results:
We identified 1,696 PARPi-related RAEs, predominantly affecting patients over 85 (56.31%). Veliparib exhibited a more pronounced association with RAEs compared to others, as indicated by the highest reporting odds ratio (ROR = 29.20, 95% CI = 8.79-96.97), proportional reporting ratio (PRR = 19.80, χ2 = 72.62), and empirical Bayes geometric mean (EBGM = 19.80, the lower 90% one-sided CI = 7.25). The median time to RAEs onset was 15 (interquartile range: 6-55.75) days following the initiation of PARPi therapy. PARPi-related RAEs generally led to a 28.15% hospitalization rate and a 4.34% fatality rate.
Conclusion:
Although the majority present with reversible creatinine elevation, PARPi-related RAEs merits broader attention, given its potential for clinical consequences. We should strive to early identify those individuals who may have irreversible kidney damage. The focus should be directed toward monitoring renal function in individuals receiving PARPi, especially in senile people and those with a predisposition to AKI.
Insights
Poly (ADP-ribose) polymerase inhibitors (PARPis) can cause kidney damage, particularly in older adults. Veliparib showed a higher risk, necessitating careful renal function monitoring during PARPi therapy.
Area of Science:
- Oncology
- Nephrology
- Pharmacovigilance
Background:
- Poly (ADP-ribose) polymerase inhibitors (PARPis) are crucial targeted therapies for ovarian and breast cancers.
- Acute kidney injury (AKI) is a known risk with PARPi treatment, but comparative analyses are lacking.
- Real-world data is needed to characterize renal adverse effects (RAEs) of different PARPis.
Purpose of the Study:
- To comprehensively assess and compare the renal adverse effects (RAEs) associated with various poly (ADP-ribose) polymerase inhibitors (PARPis) using real-world data.
- To investigate the incidence, time to onset, and clinical outcomes (hospitalization, fatality) of PARPi-related RAEs.
- To identify specific PARPis with a higher risk profile for RAEs.
Main Methods:
- Utilized disproportionality and Bayesian analyses on the FDA Adverse Event Reporting System (FAERS) database (January 2004 - September 2023).
- Identified suspected RAE cases linked to different PARPis.
- Analyzed time to onset, hospitalization rates, and fatality rates for identified RAEs.
Main Results:
- Identified 1,696 PARPi-related RAEs, with 56.31% occurring in patients over 85.
- Veliparib demonstrated a significantly higher association with RAEs (ROR=29.20, PRR=19.80, EBGM=19.80).
- Median RAE onset was 15 days; hospitalization and fatality rates were 28.15% and 4.34%, respectively.
Conclusions:
- PARPi-related RAEs, though often reversible, require significant clinical attention due to potential severity.
- Early identification of individuals at risk for irreversible kidney damage is crucial.
- Close renal function monitoring is recommended for patients on PARPi, especially the elderly and those with pre-existing kidney conditions.
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