Renin Angiotensin System Blocker Fetopathy: A Midwest Pediatric Nephrology Consortium Report

Nadeem, Shahid; Hashmat, Shireen; DeFreitas, Marissa; Westreich, Katherine D.; Shatat, Ibrahim F.; Selewski, David T.; Onder, Ali Mirza; Chiang, Myra; Weaver, Donald J.; Steinke, Julia; Barcia, John; Hernandez, Joel D.; Hidalgo, Guillermo; Ingraham, Susan E.; Abitbol, Carolyn; Pan, Cynthia G.; Greenbaum, Larry A.

doi:10.1016/j.jpeds.2015.05.045

Cited by 39 publications

(44 citation statements)

References 23 publications

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“…It can be difficult to accrue sufficient numbers of exposed infants to evaluate such conditions in case reports. In particular, it is worth noting that none of the children in the case series by Nadeem et al 6 had any of the types of congenital heart defects previously reported as possibly associated with intrauterine exposure to RAS blockers (eg, pulmonary valve stenosis, Ebstein anomaly, coarctation of the aorta). 3,10,12-14 The extent to which a lack of such cases in the study by Nadeem et al 6 could be due to the limited sample size, selection bias, or lack of a real effect is unclear.…”

Section: Methodological Issues In Studies Of Adverse Effects In Offspmentioning

confidence: 93%

“…This can result from evaluation of a select sample of pregnancies exposed to a medication of concern. If the criteria for inclusion in a study are exposure to the medication of interest and the presence of a certain disease or clinical findings, such as evidence of renal disease in the report by Nadeem et al, 6 exposed children who have no evidence of renal disease at birth will not be captured. The reported case series may either overestimate the frequency and severity of effects of the drug, or will not detect other unanticipated complications that arise at some point after birth.…”

Section: Methodological Issues In Studies Of Adverse Effects In Offspmentioning

confidence: 99%

“…To assess whether the finding of extra-renal complications might be due to intrauterine exposure to the RAS blockers in the case series by Nadeem et al, 6 it is necessary to compare the occurrence of observed events in the exposed infants with the occurrence of such events in unexposed infants or in the general population. Ideally, this would involve assessing a cohort of offspring from unexposed pregnancies with comparable methods and length of follow-up.…”

Section: Methodological Issues In Studies Of Adverse Effects In Offspmentioning

confidence: 99%

“…In this issue of The Journal , Nadeem et al 6 describe a series of 24 children with acute kidney injury, chronic kidney disease, or tubular dysfunction, and a history of intrauterine exposure to renin-angiotensin system (RAS) blockers including ACEIs or ARBs. These cases of RAS fetopathy presented over a 10-year period to 14 pediatric nephrology centers belonging to the Midwestern Pediatric Nephrology Consortium.…”

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confidence: 99%

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Renin-Angiotensin System Blocker Fetopathy

Cragan

Young

Correa

2015

The Journal of Pediatrics

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Section: Methodological Issues In Studies Of Adverse Effects In Offspmentioning

confidence: 93%

Section: Methodological Issues In Studies Of Adverse Effects In Offspmentioning

confidence: 99%

Section: Methodological Issues In Studies Of Adverse Effects In Offspmentioning

confidence: 99%

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confidence: 99%

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Renin-Angiotensin System Blocker Fetopathy

Cragan

Young

Correa

2015

The Journal of Pediatrics

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“…In the kidney angiotensin acts primarily as a vasoconstrictor at the efferent arteriole (post-glomerulus) to maintain glomerular filtration. The implications of blockade of the renin-angiotensin system on the developing fetus are well known and include a spectrum of disorders ranging from papillary atrophy to pulmonary hypoplasia and renal failure [45,46*]. These outcomes were worse with exposure to angiotensin receptor blockers and when the exposure occurred in the second and third trimesters.…”

Section: Nephrotoxic Medicationsmentioning

confidence: 99%

Drug-induced acute kidney injury in neonates

Hanna

Askenazi

Selewski

2016

Current Opinion in Pediatrics

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Purpose of review Acute kidney injury (AKI) is an independent risk factor for morbidity and mortality in critically ill neonates. Nephrotoxic medication exposure is common in neonates. Nephrotoxicity represents the most potentially avoidable cause of AKI in this population. Recent findings Recent studies in critically ill children revealed the importance of recognizing AKI and potentially modifiable risk factors for the development of AKI such as nephrotoxic medication exposures. Data from critically ill children who have AKI suggests that survivors are at risk for development of chronic kidney disease. Premature infants are born with incomplete nephrogenesis and are at risk for chronic kidney disease (CKD). The use of nephrotoxic medications in the neonatal intensive care unit (NICU) is very common; yet the effects of medication nephrotoxicity on the short and long-term outcomes remains highly understudied. Summary The neonatal kidney is predisposed to nephrotoxic AKI. Our ability to improve outcomes for this vulnerable group depends on heightened awareness of this issue. It is important for clinicians to develop methods to minimize and prevent nephrotoxic AKI in neonates through a multi-disciplinary approach aiming at earlier recognition and close monitoring of nephrotoxin induced AKI.

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Use of real‐world evidence from healthcare utilization data to evaluate drug safety during pregnancy

Huybrechts

Bateman

Hernández–Dı́az

2019

Pharmacoepidemiology and Drug

103

121

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Purpose Because preapproval clinical trials typically exclude pregnant women, the evidence on drug safety during pregnancy required to inform drug labeling must come from postapproval controlled observational studies. Common designs have included pregnancy registries and case‐control studies. Recently, pregnancy cohorts nested within healthcare utilization databases are increasingly being used. Despite clear advantages, these databases share some important limitations that may threaten the validity of studies emerging from them. Methods This paper describes the distinctive methodological aspects of conducting drug safety studies in healthcare utilization databases with special emphasis on design and analytic approaches to minimize biases. Results We describe considerations for study design, cohort definition, and follow‐up. We then address issues related to exposure ascertainment based on prescription fills, including the importance of the etiologically relevant window and of properly accounting for preterm births. This is followed by a discussion of advantages and challenges when ascertaining maternal and infant outcomes based on secondary data. We then explore useful approaches to address confounding within the context of pregnancy research and of the potential for selection bias when restricting the cohort to live births. Finally, we consider issues related to external validity and statistical significance. The examples are mainly drawn from a pregnancy cohort nested in the Medicaid Analytic Extract. Conclusions The approaches presented provide guidance regarding the important methodological considerations that need to be attended to in order to generate valid, minimally biased risk when using large healthcare utilization databases for drug safety surveillance in pregnancy.

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Renin Angiotensin System Blocker Fetopathy: A Midwest Pediatric Nephrology Consortium Report

Cited by 39 publications

References 23 publications

Renin-Angiotensin System Blocker Fetopathy

Renin-Angiotensin System Blocker Fetopathy

Drug-induced acute kidney injury in neonates

Use of real‐world evidence from healthcare utilization data to evaluate drug safety during pregnancy

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