Predictors of Potentially Inappropriate Stimulant Prescribing Among Adults

Pharmacoepidemiology and Drug Safety January 2025

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Thakkar PV, Boutzoukas AE, Compton SN, Sivashankar O, Zimmerman KO, Benjamin DK Jr, Brookhart MA

Increases in adult stimulant prescribing pose a potential risk due to the higher prevalence of contraindicated conditions among this population. This study sought to identify patient, provider, and visit characteristics predictive of potentially inappropriate adult stimulant prescriptions. The proportion of potentially inappropriate adult stimulant prescriptions increased over time and with patient age. Visits to primary care providers were predictive of potentially inappropriate prescribing, and a history of substance abuse was predictive of new stimulant prescriptions; therefore, quality improvement interventions regarding safe stimulant prescribing practices may be warranted.

Pharmacoepidemiology of combination pulmonary vasodilator therapy in critically ill infants

Cardiology in the Young January 2025

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Kumar KR, Ciociola EC, Skinner KR, Dixit GM, Alvarez S, Benjamin EK, Faulkner JC, Greenberg RG, Clark RH, Benjamin Jr DK, Hornik CP and Jan Hau Lee

New drugs to target different pathways in pulmonary hypertension have resulted in increased combination therapy, but details of this use in infants are not well described. This large multicenter database study describes the pharmacoepidemiology of combination pulmonary vasodilator therapy in critically ill infants. The study revealed an increased use of combination pulmonary vasodilator therapy, favouring inhaled nitric oxide and sildenafil, yet with considerable practice variation. Further research is needed to determine the optimal combination, sequence, dosing, and disease-specific indications for combination therapy.

Thumbnail screenshot of lorazepam results-at-a-glance summary

Lorazepam Results-at-a-Glance

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Status epilepticus (SE) is a serious condition that affects the brain. SE can be caused by medical conditions, illnesses, or injuries. A preferred treatment for SE is lorazepam. However, lorazepam is not approved by the FDA for children under 18 years old. This summary is for a study performed by the Pediatric Trials Network (PTN). The study was needed to find out how children with SE process lorazepam.

Trends in Gabapentin Use in Neonatal Intensive Care Units from 2005 to 2020

American Journal of Perinatology November 2024

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Roberts AG, Kilpatrick R, Diaz LD, Benjamin S, Espinoza Santiago AJ, Jallow B, Monteith MF, Rumsey S, Clark RH, Zimmerman K, Benjamin DK Jr, Greenberg RG

This study aimed to analyze trends in gabapentin use in neonatal intensive care units (NICUs) and examine demographic characteristics, diagnoses, and concomitant medications associated with its use. Gabapentin use was rare but increased over time despite limited research on its safety and efficacy in infants, illuminating the need for further studies.

Thumbnail screenshot of Oxcarbazepine results-at-a-glance summary

Oxcarbazepine Results-at-a-Glance

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Oxcarbazepine is a medicine that is approved by the U.S. Food and Drug Administration (FDA) for treating seizures in adults and children older than two years. However, guidance for children who have obesity was lacking. This study was needed to learn how a child’s obesity status affects the way they process oxcarbazepine.

Pharmacokinetics of Dexamethasone in Children and Adolescents with Obesity

The Journal of Clinical Pharmacology August 2024

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Wen J, McCann S, Balevic S, Muller WJ, Hornik C, Autmizguine J, Anderson SG, Payne EH, Turdalieva S, Gonzalez D., Best Pharmaceuticals for Children Act – Pediatric Trials Network

Dexamethasone is a synthetic glucocorticoid approved for treating disorders of various organ systems in both adult and pediatric populations. Currently, approved pediatric dosing recommendations are weight-based, but it is unknown whether differences in dexamethasone drug disposition and exposure exist for children with obesity. This study aimed to develop a population pharmacokinetic (PopPK) model for dexamethasone with data collected from children with obesity.

Physiologically-based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population

CPT: Pharmacometrics & Systems Pharmacology August 2024

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Thompson EJ, Jeong A, Helfer VE, Shakhnovich V, Edginton A, Balevic SJ, James LP, Collier DN, Anand R, Gonzalez D., Best Pharmaceuticals for Children Act – Pediatric Trials Network

Pantoprazole is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease, a condition that disproportionately affects children with obesity. Appropriately dosing pantoprazole in children with obesity requires understanding the body size metric that best guides dosing, but pharmacokinetic (PK) trials using traditional techniques are limited by the need for larger sample sizes and frequent blood sampling. This study explored the effect of obesity on pantoprazole PK and evaluated label-suggested dosing in this population.

Using Real-World Data to Externally Evaluate Population Pharmacokinetic Models of Dexmedetomidine in Children and Infants

The Journal of Clinical Pharmacology August 2024

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McCann S, Helfer VE, Balevic SJ, Hornik CH, Goldstein SL, Autmizguine J, Meyer M, Al-Uzri A, Anderson SG, Payne EH, Turdalieva S, Gonzalez D., Best Pharmaceuticals for Children Act – Pediatric Trials Network

Dexmedetomidine is a sedative used in both adults and off-label in children with considerable reported pharmacokinetic (PK) interindividual variability affecting drug exposure across populations. Several published models describe the population PKs of dexmedetomidine in neonates, infants, children, and adolescents, though very few have been externally evaluated. A prospective PK dataset of dexmedetomidine plasma concentrations in children and young adults aged 0.01-19.9 years was collected as part of a multicenter opportunistic PK study.