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A Real-World Disproportionality Analysis of Olaparib: Data Mining of the Public Version of FDA Adverse Event
Yamin Shu1, Xucheng He2, Yanxin Liu3
1Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.
Background:
Olaparib, the world's first poly ADP-ribose polymerase (PARP) inhibitor (PARPi), has been approved for treatment of ovarian cancer, breast cancer, pancreatic cancer and prostate cancer by FDA. The current study was to assess olaparib-related adverse events (AEs) of real-world through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).
Methods:
Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms were employed to quantify the signals of olaparib-associated AEs.
Results:
Out of 8,450,009 reports collected from the FAERS database, 6402 reports of olaparib-associated AEs were identified. A total of 118 significant disproportionality preferred terms (PTs) conforming to the four algorithms simultaneously were retained. The most common AEs included anemia, thrombocytopenia, nausea, decreased appetite, blood creatinine increased and dermatomyositis, which were corresponding to those reported in the specification and clinical trials. Unexpected significant AEs as interstitial lung disease, Pneumocystis jirovecii pneumonia, folate deficiency, renal impairment and intestinal obstruction might also occur. The median onset time of olaparib-related AEs was 61 days (interquartile range [IQR] 14-182 days), and most of the cases occurred within the first 1 month after olaparib initiation.
Conclusion:
Results of our study were consistent with clinical observations, and we also found potential new and unexpected AEs signals for olaparib, suggesting prospective clinical studies were needed to confirm these results and illustrate their relationship. Our results could provide valuable evidence for further safety studies of olaparib.
Insights
This study analyzed real-world data on olaparib adverse events (AEs). While common AEs like anemia were confirmed, unexpected events such as interstitial lung disease were also identified.
Area of Science:
- Oncology
- Pharmacovigilance
- Data Mining
Background:
- Olaparib is a PARP inhibitor approved for ovarian, breast, pancreatic, and prostate cancers.
- Real-world adverse event (AE) data provides crucial insights beyond clinical trials.
- The US Food and Drug Administration Adverse Event Reporting System (FAERS) is a key resource for pharmacovigilance.
Purpose of the Study:
- To assess olaparib-related adverse events (AEs) using real-world data from the FAERS database.
- To identify both known and potentially novel safety signals associated with olaparib treatment.
- To provide evidence for future olaparib safety studies and clinical monitoring.
Main Methods:
- Utilized disproportionality analyses, including ROR, PRR, BCPNN, and MGPS algorithms.
- Analyzed 8,450,009 reports from the FAERS database to identify olaparib-associated AEs.
- Quantified AE signals to determine statistical significance and clinical relevance.
Main Results:
- Identified 6402 reports of olaparib-associated AEs, with 118 significant disproportionality preferred terms (PTs).
- Common AEs included anemia, thrombocytopenia, nausea, and decreased appetite, consistent with known side effects.
- Detected unexpected significant AEs such as interstitial lung disease, folate deficiency, and intestinal obstruction.
Conclusions:
- Real-world data analysis confirmed known olaparib AEs and identified potential new safety signals.
- The median onset time for AEs was 61 days, with most occurring within the first month.
- Further clinical studies are recommended to validate these unexpected findings and inform olaparib safety.
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