Adverse effects of proton pump inhibitors (PPIs) on the renal system using data mining algorithms (DMAs)
We have examined the adverse effects of proton pump inhibitors (PPIs) on the renal system using data from FDA Adverse Event Reporting System of the USA between 1 January 2004 and 30 September 2021. After doing the subgroup as well as sensitivity analysis, we have identified a positive signal of susp...
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| Vydané v: | Expert opinion on drug safety Ročník ahead-of-print; číslo ahead-of-print; s. 1 - 12 |
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| Jazyk: | English |
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Taylor & Francis
03.08.2023
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| Abstract | We have examined the adverse effects of proton pump inhibitors (PPIs) on the renal system using data from FDA Adverse Event Reporting System of the USA between 1 January 2004 and 30 September 2021. After doing the subgroup as well as sensitivity analysis, we have identified a positive signal of suspected chronic kidney disease, acute kidney injury, renal failure, renal injury, and end-stage renal disease with selected PPIs. Therefore, the adverse effects of selected PPIs on the renal system should be considered and further causality assessment should be performed to confirm the association.
Various adverse drug reactions (ADRs) are associated with proton pump inhibitors (PPIs). However, the effects of PPIs on the renal system are unclear so far. Thus, the main objective of the current study was to identify the possible signals of PPIs in the renal system.
Data mining algorithms such as proportional reporting ratio i.e. PRR (≥2) with associated chi-squared value (>4), reporting odds ratio i.e. ROR (≥2) with 95% confidence interval and case count (≥3) were calculated to identify a possible signal.
The calculated PRR and ROR have indicated a positive signal of PPIs with suspected chronic kidney disease, acute kidney injury, renal failure, renal injury, and end-stage renal disease. The subgroup analysis results have shown a greater number of cases in the age group (18-64 years) as compared to other age groups whereas the number of cases in the female was found to be more as compared to males. The sensitivity analysis results have also shown no significant impact of concomitantly administered drugs on the outcome.
PPIs may be associated with various ADRs on the renal system. |
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| AbstractList | Various adverse drug reactions (ADRs) are associated with proton pump inhibitors (PPIs). However, the effects of PPIs on the renal system are unclear so far. Thus, the main objective of the current study was to identify the possible signals of PPIs in the renal system.
Data mining algorithms such as proportional reporting ratio i.e. PRR (≥2) with associated chi-squared value (>4), reporting odds ratio i.e. ROR (≥2) with 95% confidence interval and case count (≥3) were calculated to identify a possible signal.
The calculated PRR and ROR have indicated a positive signal of PPIs with suspected chronic kidney disease, acute kidney injury, renal failure, renal injury, and end-stage renal disease. The subgroup analysis results have shown a greater number of cases in the age group (18-64 years) as compared to other age groups whereas the number of cases in the female was found to be more as compared to males. The sensitivity analysis results have also shown no significant impact of concomitantly administered drugs on the outcome.
PPIs may be associated with various ADRs on the renal system. Various adverse drug reactions (ADRs) are associated with proton pump inhibitors (PPIs). However, the effects of PPIs on the renal system are unclear so far. Thus, the main objective of the current study was to identify the possible signals of PPIs in the renal system.BACKGROUNDVarious adverse drug reactions (ADRs) are associated with proton pump inhibitors (PPIs). However, the effects of PPIs on the renal system are unclear so far. Thus, the main objective of the current study was to identify the possible signals of PPIs in the renal system.Data mining algorithms such as proportional reporting ratio i.e. PRR (≥2) with associated chi-squared value (>4), reporting odds ratio i.e. ROR (≥2) with 95% confidence interval and case count (≥3) were calculated to identify a possible signal.MATERIALS AND METHODSData mining algorithms such as proportional reporting ratio i.e. PRR (≥2) with associated chi-squared value (>4), reporting odds ratio i.e. ROR (≥2) with 95% confidence interval and case count (≥3) were calculated to identify a possible signal.The calculated PRR and ROR have indicated a positive signal of PPIs with suspected chronic kidney disease, acute kidney injury, renal failure, renal injury, and end-stage renal disease. The subgroup analysis results have shown a greater number of cases in the age group (18-64 years) as compared to other age groups whereas the number of cases in the female was found to be more as compared to males. The sensitivity analysis results have also shown no significant impact of concomitantly administered drugs on the outcome.RESULTSThe calculated PRR and ROR have indicated a positive signal of PPIs with suspected chronic kidney disease, acute kidney injury, renal failure, renal injury, and end-stage renal disease. The subgroup analysis results have shown a greater number of cases in the age group (18-64 years) as compared to other age groups whereas the number of cases in the female was found to be more as compared to males. The sensitivity analysis results have also shown no significant impact of concomitantly administered drugs on the outcome.PPIs may be associated with various ADRs on the renal system.CONCLUSIONPPIs may be associated with various ADRs on the renal system. We have examined the adverse effects of proton pump inhibitors (PPIs) on the renal system using data from FDA Adverse Event Reporting System of the USA between 1 January 2004 and 30 September 2021. After doing the subgroup as well as sensitivity analysis, we have identified a positive signal of suspected chronic kidney disease, acute kidney injury, renal failure, renal injury, and end-stage renal disease with selected PPIs. Therefore, the adverse effects of selected PPIs on the renal system should be considered and further causality assessment should be performed to confirm the association. Various adverse drug reactions (ADRs) are associated with proton pump inhibitors (PPIs). However, the effects of PPIs on the renal system are unclear so far. Thus, the main objective of the current study was to identify the possible signals of PPIs in the renal system. Data mining algorithms such as proportional reporting ratio i.e. PRR (≥2) with associated chi-squared value (>4), reporting odds ratio i.e. ROR (≥2) with 95% confidence interval and case count (≥3) were calculated to identify a possible signal. The calculated PRR and ROR have indicated a positive signal of PPIs with suspected chronic kidney disease, acute kidney injury, renal failure, renal injury, and end-stage renal disease. The subgroup analysis results have shown a greater number of cases in the age group (18-64 years) as compared to other age groups whereas the number of cases in the female was found to be more as compared to males. The sensitivity analysis results have also shown no significant impact of concomitantly administered drugs on the outcome. PPIs may be associated with various ADRs on the renal system. |
| Author | Kumar, Anoop Sharma, Gazal Jain, Devanshi |
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| Title | Adverse effects of proton pump inhibitors (PPIs) on the renal system using data mining algorithms (DMAs) |
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