Dataset Information

Proton pump inhibitors associated acute kidney injury and chronic kidney disease: data mining of US FDA adverse event reporting system.

ABSTRACT: Proton pump inhibitors (PPIs) were widely used. Observational studies suggested increasing risk of kidney injury in patients with PPIs treatment. We gathered six PPI regimens and adverse reports of acute kidney injury (AKI) and chronic kidney disease (CKD) based on US FDA Adverse Event Reporting System (FAERS) database from 2004 to 2019. We employed reporting odds ratio (ROR) to detect signals. Finally, we identified 3187 PPIs-associated AKI cases and 3457 PPIs-associated CKD cases. We detected significant signals between PPIs and AKI as well as CKD. The signal strength was stronger for CKD (ROR?=?8.80, 95% CI 8.49-9.13) than AKI (ROR?=?3.95, 95% CI 3.81-4.10), while dexlansoprazole performed stronger association for CKD (ROR?=?34.94, 95% CI 30.89-39.53) and AKI (ROR?=?8.18, 95% CI 7.04-9.51) than the other five PPIs. The median time from PPIs use to event occurrence was 23 days for AKI and 177 days for CKD. PPIs-associated AKI resulted larger proportion of death, life-threatening, hospitalization and disability events than PPIs-associated CKD. By mining the FAERS big data, we provided more information between PPIs use and the AKI and CKD events. PPIs rational use should be repeatedly stressed.

SUBMITTER: Wu B

PROVIDER: S-EPMC7878877 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Proton pump inhibitors associated acute kidney injury and chronic kidney disease: data mining of US FDA adverse event reporting system.

Wu Bin B Li Dan D Xu Ting T Luo Min M He Zhiyao Z Li Yuwen Y

Scientific reports 20210211 1

Proton pump inhibitors (PPIs) were widely used. Observational studies suggested increasing risk of kidney injury in patients with PPIs treatment. We gathered six PPI regimens and adverse reports of acute kidney injury (AKI) and chronic kidney disease (CKD) based on US FDA Adverse Event Reporting System (FAERS) database from 2004 to 2019. We employed reporting odds ratio (ROR) to detect signals. Finally, we identified 3187 PPIs-associated AKI cases and 3457 PPIs-associated CKD cases. We detected ...[more]

PMID: 33574396

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Project description:BackgroundTaxanes are an essential class of antineoplastic agents used to treat various cancers and are a fundamental cause of hypersensitivity reactions. In addition, other adverse events, such as bone marrow toxicity and peripheral neuropathy, can lead to chemotherapy discontinuation. This study aimed to evaluate the safety of taxanes in the real world.MethodsTaxane-associated adverse events were identified by the Medical Dictionary for Regulatory Activities Preferred Terms and analyzed and compared by mining the US Food and Drug Administration Adverse Event Reporting System pharmacovigilance database from January 2004 to December 2019. Reported adverse events, such as hypersensitivity reaction, bone marrow toxicity, and peripheral neuropathy, were analyzed with the following signal detection algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), Bayesian confidence propagation neural network (BCPNN), and logistic regression methods. Adverse outcome events and death outcome rates were compared between different taxane groups using Pearson's χ2 test, whereas significance was determined at P < 0.05 with a 95% confidence interval (CI).ResultsA total of 966 reports of hypersensitivity reactions, 1109 reports of bone marrow toxicity, and 1374 reports of peripheral neuropathy were analyzed. Compared with paclitaxel and docetaxel, bone marrow toxicity following the use of nab-paclitaxel had the highest ROR of 6.45 (95% two-sided CI, 6.05-6.88), PRR of 5.66, (χ2 = 4342.98), information component of 2.50 (95% one-sided CI = 2.34), and empirical Bayes geometric mean of 5.64 (95% one-sided CI = 5.34). Peripheral neuropathy following the use of nab-paclitaxel showed a higher ROR of 12.78 (95% two-sided CI, 11.55-14.14), PRR of 12.16 (χ2 = 4060.88), information component of 3.59 (95% one-sided CI = 3.25), and empirical Bayes geometric mean of 12.07 (95% one-sided CI = 11.09).ConclusionsThe results showed that bone marrow toxicity and peripheral neuropathy were the major adverse events induced by taxanes. Nab-paclitaxel exhibited the highest potential for taxane-associated adverse events. Further research in the future is warranted to explain taxane-associated adverse effects in real-world circumstances.

Project description:BackgroundInhibitors of the anaplastic lymphoma kinase (ALK) gene mutation are highly effective treatments for ALK-positive lung cancer. We conducted this pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS).Patients and methodsFAERS files from 2012 to 2020 were used. Reports for crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib were filtered. We used the Medical Dictionary for Regulatory Activities (MedDRA version 22.1). Further, we searched for adverse events on the preferred term (PT) level based on case reports in the literature. After filtering duplicate reports, disproportionality analysis was used to detect safety signals by calculating proportional reporting ratios (PRRs), reporting odds ratios (RORs), empirical Bayesian geometric mean, and information component. Reports were considered statistically significant if the 95% confidence interval did not contain the null value.ResultsWithin the system organ classes, significant safety signals were found, including those for crizotinib [eye disorders (PRR 2.09, ROR 2.12)], ceritinib [gastrointestinal disorders (PRR 2.19, ROR 2.41), hepatobiliary disorders (PRR 4.4, ROR 4.52), respiratory disorders (PRR 1.96, ROR 2.08)], alectinib [hepatobiliary disorders (PRR 2.60, ROR 2.63)], brigatinib [respiratory disorders (PRR 2.15, ROR 2.31)], and lorlatinib [metabolism disorders (PRR 3.34, ROR 3.53)]. For adverse events on the PT level, we found several significant signals, including pneumothorax with crizotinib (PRR 3.29, ROR 3.29), ceritinib (PRR 3.13, ROR 3.13), and alectinib (PRR 4.88, ROR 4.89); myasthenia gravis with lorlatinib (PRR 6.05, ROR 6.05); photosensitivity reactions with crizotinib (PRR 2.20, ROR 2.20), ceritinib (PRR 4.30, ROR 4.31), alectinib (PRR 20.43, ROR 20.51), and brigatinib (PRR 20.97, ROR 21.05); pulmonary arterial hypertension with brigatinib (PRR 2.92, ROR 2.92) and lorlatinib (PRR 9.2, ROR 9.24); and rectal perforation with crizotinib (PRR 7.83, ROR 7.83). All the detected safety signals were confirmed using Bayesian methods.ConclusionALK inhibitors differed in their safety profile reports. We found several significant safety signals that matched previously published case reports, including pulmonary arterial hypertension, rectal perforation, myasthenia gravis, and photosensitivity. These signals require further regulatory investigation to determine their significance and potentially update the product labels to inform patients and clinicians.

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Proton pump inhibitors associated acute kidney injury and chronic kidney disease: data mining of US FDA adverse event reporting system.

Publications

Proton pump inhibitors associated acute kidney injury and chronic kidney disease: data mining of US FDA adverse event reporting system.

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