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Effect of renal function on antihypertensive drug safety and efficacy in children
Kevin M Watt1,2, Debbie Avant3, Jennifer Sherwin4
1Department of Pediatrics, Duke University, Durham, NC, USA. kevin.watt@duke.edu.
Insights
Antihypertensive treatments are safe and effective for children with chronic kidney disease (CKD). Children with decreased renal function experienced similar adverse events and showed greater blood pressure reduction with high-dose medication.
Area of Science:
- Pediatric Nephrology
- Cardiovascular Research
- Clinical Pharmacology
Background:
- Hypertension is common in children with chronic kidney disease (CKD).
- Treating hypertension in pediatric CKD patients is crucial for preventing cardiovascular disease.
- Limited safety and efficacy data exist for antihypertensive drugs in children with CKD due to trial exclusions.
Purpose of the Study:
- To evaluate the safety and efficacy of antihypertensive medications in pediatric patients with varying degrees of renal function.
- To determine the incidence of adverse events in children with and without decreased renal function during antihypertensive drug trials.
Main Methods:
- Analysis of adverse event data from 10 pediatric antihypertensive trials (1998-2005) submitted to the FDA.
- Comparison of adverse events between children with normal renal function and those with decreased renal function (eGFR <90 mL/min/1.73 m²).
- Assessment of serious adverse events and drug-related adverse reactions in relation to renal function.
Main Results:
- Out of 1,703 children, 315 had decreased renal function; no significant difference in adverse events or drug reactions was observed between groups.
- Only 5 participants (all with decreased renal function) had serious adverse events, none deemed study drug-related.
- Children with decreased renal function receiving high-dose medication showed a significantly greater reduction in diastolic blood pressure.
Conclusions:
- Antihypertensive therapy is safe and effective in children with renal dysfunction.
- Children with CKD should be considered for inclusion in select antihypertensive drug development programs.
- Further research is warranted to optimize antihypertensive strategies in pediatric CKD populations.
Background:
Hypertension and chronic kidney disease (CKD) are common comorbidities. Guidelines recommend treating hypertension in children with CKD because it is a modifiable risk factor for subsequent cardiovascular disease. Children with CKD are frequently excluded from antihypertensive drug trials. Consequently, safety and efficacy data for antihypertensive drugs are lacking in children with CKD.
Methods:
We determined the incidence of adverse events in 10 pediatric antihypertensive trials to determine the effect of renal function on antihypertensive safety and efficacy in children. These trials were submitted to the US Food and Drug Administration from 1998 to 2005. We determined the number and type of adverse events reported during the trials and compared these numbers in participants with normal renal function and those with decreased function (defined as an estimated glomerular filtration rate [eGFR] <90 mL/min/1.73 m2 calculated using the original Schwartz equation).
Results:
Among the 1,703 children in the 10 studies, 315 had decreased renal function. We observed no difference between the two cohorts in the incidence of adverse events or adverse drug reactions related to study drug. Only 5 participants, all with decreased renal function, experienced a serious adverse event; none was recorded by investigators to be study drug-related. Among treated participants, children with decreased renal function who received a high dose of study drug had a significantly larger drop in diastolic blood pressure compared with children with normal renal function.
Conclusions:
These data show that antihypertensive treatment in children with renal dysfunction can be safe and efficacious, and consideration should be given to their inclusion in selected drug development programs.
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