Lisinopril (L) pharmacokinetics (PK) in hypertensive children and infants

Shaw, Wayne; Hogg, Ron; Delucchi, Angela; Sakihara, Graciela; Wells, Thomas G.; Tenney, Frank; Batisky, Donald L.; Blumer, Jeffrey L.; Vogt, Beth A.; Murphy, Gail; Lo, Mimi; Hand, Elizabeth; Panebianco, Deborah; Rippley, Ronda; Shahinfar, Shahnaz

doi:10.1016/s0895-7061(02)02388-9

Cited by 5 publications

(4 citation statements)

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“…Another study in hypertensive pediatric patients suggested 2.5 mg once daily dose of lisinopril in children of less than 6 year age with body weight less than 25 kg and 5 mg as dose for age greater than 6 years and body weight 25 to 45 kg. For children of age greater than 6 years and weight greater than 45 kg, the suggested dose was 10 mg [53] which was in line with the present findings ( Table 4). The present dose was also supported by another study where lisinopril showed maximum antihypertensive efficacy at dose of 5 mg in children of 6-16 years age [23].…”

Section: Predicted Lisinopril Pediatric Dosesupporting

confidence: 91%

Prediction of lisinopril pediatric dose from the reference adult dose by employing a physiologically based pharmacokinetic model

Rashid

Sarfraz

Arafat

et al. 2020

BMC Pharmacol Toxicol

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Background: This study aimed to assess the pediatric lisinopril doses using an adult physiological based pharmacokinetic (PBPK) model. As the empirical rules of dose calculation cannot calculate gender-specific pediatric doses and ignores the age-related physiological differences. Methods: A PBPK model of lisinopril for the healthy adult population was developed for oral (fed and fasting) and IV administration using PK-Sim MoBI® and was scaled down to a virtual pediatric population for prediction of lisinopril doses in neonates to infants, infants to toddler, children at preschool age, children at school age and the adolescents. The pharmacokinetic parameters were predicted for the above groups at decremental doses of 20 mg, 10 mg, 5 mg, 2.5 mg, and 1.5 mg in order to accomplish doses producing the pharmacokinetic parameters, similar (or comparable) to that of the adult population. The above simulated pediatric doses were compared to the doses computed using the conventional four methods, such as Young's rule, Clark's rule, and weight-based and body surface area-based equations and the dose reported in different studies. Results: Though the doses predicted for all subpopulations of children were comparable to those calculated by Young's rule, yet the conventional methods overestimated the pediatric doses when compared to the respective PBPK-predicted doses. The findings of previous real time pharmacokinetic studies in pediatric patients supported the present simulated dose. Conclusion: Thus, PBPK seems to have predictability potential for pediatric dose since it takes into consideration the physiological changes related to age and gender.

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Section: Predicted Lisinopril Pediatric Dosesupporting

confidence: 91%

Prediction of lisinopril pediatric dose from the reference adult dose by employing a physiologically based pharmacokinetic model

Rashid

Sarfraz

Arafat

et al. 2020

BMC Pharmacol Toxicol

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“…In children aged 1 month to 16 years, the pharmacokinetic parameters of losartan and its active metabolite E-3174 were similar across all age groups after oral administration, and treatment was well tolerated (8). A randomized, double-blind study showed that once-daily losartan reduced BP in a dosedependent manner and was well tolerated in hypertensive children aged 6-16 years (9).…”

Section: Introductionmentioning

confidence: 92%

A Randomized, Open-Label, Dose-Response Study of Losartan in Hypertensive Children

Webb

Wells

Shahinfar

et al. 2014

Clinical Journal of the American Society of Nephrology

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Background and objectives Once-daily losartan reduces BP in a dose-dependent manner and is well tolerated in hypertensive children aged 6-16 years. This study assessed the dose-response relationship, safety, and tolerability of losartan in hypertensive children aged 6 months to 6 years.Design, setting, participants, & measurements This was a 12-week, randomized, open-label, dose-ranging study, with a 2-year extension. Patients were randomized to losartan at the following dosages: 0.1 mg/kg per day (low), 0.3 mg/kg per day (medium), or 0.7 mg/kg per day (high). Losartan was titrated to the next dose level (to a 1.4 mg/kg per day maximum dosage, not exceeding 100 mg/d, which was not one of the three original doses offered at randomization) at weeks 3, 6, and 9 for patients who did not attain their goal BP and were not taking the highest dose. Dose response was evaluated by analyzing the slope of change in sitting systolic BP (SBP; primary end point) and diastolic BP (DBP; secondary end point) after 3 weeks compared with baseline. Adverse events (AEs) were recorded throughout.Results Of the 101 patients randomized, 99 were included in the analysis (low dose, n=32; medium dose, n=34; and high dose, n=33). Mean sitting BP decreased from baseline in the low-, medium-, and high-dose groups by 7.3, 7.6, and 6.7 mmHg, respectively, for SBP and 8.2, 5.1, and 6.7 mmHg, respectively, for DBP after 3 weeks. No dose-response relationship was established by the slope analysis on SBP (P=0.75) or DBP (P=0.64). The BPlowering effect was observed throughout the 2-year extension. The incidence of AEs was low and comparable between groups.Conclusions Hypertensive children aged 6 months to 6 years treated with losartan 0.1-0.7 mg/kg per day had clinically significant decreases from baseline in SBP and DBP, yet no dose-response relationship was evident. Losartan, at a dosage up to 1.4 mg/kg per day, was well tolerated.

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“…The pharmacokinetics and dynamics of lisinopril have recently been evaluated in two multicenter pediatric trials [18,19]. The pharmacokinetic study included 46 children aged 1 month to 16 years, whereas the safety and efficacy study included children aged 6 to 16 years.…”

Section: Lisinoprilmentioning

confidence: 99%

Systemic hypertension: Management in children and adolescents

Belsha

2002

Curr Treat Options Cardio Med

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Recognition of systemic hypertension in children and adolescents requires careful blood pressure measurement using proper technique to compare with appropriate normative data. Selected use of ambulatory blood pressure monitoring can identify children with "white coat" hypertension, thus avoiding unnecessary diagnostic testing and treatment in these children. Nonpharmacologic therapies including dietary sodium restriction, weight loss, and exercise may benefit children and adolescents with borderline hypertension and mild essential hypertension. These therapies may be important adjunctive agents in children requiring antihypertensive therapy as well. Historically, pharmacologic management of hypertension in children has been limited by a lack of controlled studies and age-appropriate formulations. Recent clinical trials have provided new information regarding a number of antihypertensive agents in this age group.

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Lisinopril (L) pharmacokinetics (PK) in hypertensive children and infants

Cited by 5 publications

References 0 publications

Prediction of lisinopril pediatric dose from the reference adult dose by employing a physiologically based pharmacokinetic model

Prediction of lisinopril pediatric dose from the reference adult dose by employing a physiologically based pharmacokinetic model

A Randomized, Open-Label, Dose-Response Study of Losartan in Hypertensive Children

Systemic hypertension: Management in children and adolescents

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