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Pharmacokinetics of drugs for pediatric pulmonary hypertension.

Author information

Affiliations

  • 1. Department of Pediatrics, Asahikawa Medical University, Asahikawa, Japan.
      Authors
    • Nakau K 1
    • Sugimoto M 1
    • Oka H 1
    • Kajihama A 1
    • Azuma H 1
    (5 authors)
  • 2. Department of Pediatrics, Keio University School of Medicine, Tokyo, Japan.
      Authors
    • Maeda J 2
    • Yamagishi H 2
    (2 authors)
  • 3. Asahikawa Medical University Hospital Pharmacy, Asahikawa, Japan.
      Authors
    • Kamiyama N 3
    • Tasaki Y 3
    (2 authors)
  • 4. Department of Pediatrics, Abashiri-Kosei General Hospital, Abashiri, Japan.
      Authors
    • Kajino H 4
    (1 author)

ORCIDs linked to this article

Pediatrics International : Official Journal of the Japan Pediatric Society, 14 Jul 2016, 58(11):1112-1117
https://doi.org/10.1111/ped.12997 PMID: 27038140 

Abstract 

Background

Over the past few years, several drugs, each with a different mechanism, have been developed for the treatment of pulmonary hypertension (PH) and are now prescribed in the clinical setting. While the optimal doses of these drugs in adults have been determined, the optimal dose in children, however, is unclear. The aim of this study was therefore, to measure blood drug levels and analyze the pharmacokinetics of two such drugs in children.

Methods

From April 2010 to May 2015, we prospectively enrolled 23 children with PH for treatment with bosentan and/or tadalafil. Twenty children were treated with bosentan and 19 received tadalafil. Sixteen children were given both drugs. Blood samples were collected after 2 weeks of treatment, and blood drug levels measured using high-performance liquid chromatography.

Results

For both drugs, the peak plasma concentration was lower and the half-life was shorter than the known values in adults. The blood trough level of bosentan significantly correlated with its dose, but no such correlation was seen for tadalafil. For both drugs, no correlation was observed between age and blood drug levels.

Conclusions

Oral dosing with bosentan and tadalafil in children may not achieve therapeutic blood concentration. Thus, the optimal dosing must be established individually while monitoring blood drug level.

Full text links 

Read article at publisher's site: https://doi.org/10.1111/ped.12997

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Funding 

Funders who supported this work.

Japan Research Foundation for Clinical Pharmacology

    Takeda Science Foundation