Ease of use, preference, and safety of the recombinant human growth hormone disposable pen compared with the reusable device: a multicenter, single-arm, open-label, switch-over, prospective, phase iv trial

Ji Eun Lee, Se Young Kim, Jae Ho Yoo, Il Tae Hwang, Jung Sub Lim, Kyung Hee Yi, Young Jun Rhie, Gyung Min Lee, Hyo Kyoung Nam, Hyun Wook Chae, Eun Young Kim, Chong Kun Cheon, Jieun Lee, Young Suk Shim, Yujin Lee, Eun Young Kim, Jin Soon Hwang

Research output: Contribution to journalArticle

Abstract

Purpose: To assess the usability and safety of the disposable pen compared to those of reusable devices in patients receiving recombinant human growth hormone (rhGH) treatment. Patients and methods: This study was a multicenter, single-arm, open-label, switch-over, prospective, Phase IV trial. After screening, eligible patients who were previously treated with rhGH using a reusable device were enrolled to receive treatment with the disposable pen for 8 weeks. The ease of use, preference, and tolerability of the disposable pen compared to those of the reusable device were assessed by the subjects and/or their caregivers using a questionnaire. Adverse events were evaluated by the investigators. Results: Of 116 subjects enrolled in this study, 115 received treatment with the disposable pen and 109 completed the study. The mean age of the subjects was 9.4 years. Compared to the previous reusable device, the disposable pen was assessed as significantly easier to use (mean value 7.88, 95% confidence interval (CI) [7.45–8.30] on a numerical scale ranging from 0 (far less easy) to 10 (far easier)). Furthermore, the percentage of subjects who preferred the disposable pen to the previously used reusable device was 75.7% (95% CI [67.6%–83.8%]). The percentages of subjects who rated pain and discomfort at the injection site as “not at all” were higher after using the disposable pen compared to the reusable device. No specific safety concerns were identified. Conclusion: The disposable pen is easier to use than the reusable devices and is preferred by approximately 75% of patients receiving rhGH treatment. Moreover, the disposable pen is safe and acceptable. Therefore, it could be a good alternative to reusable devices. The disposable pen is expected to provide benefits to patients receiving rhGH treatment.

Original languageEnglish
Pages (from-to)2195-2205
Number of pages11
JournalPatient Preference and Adherence
Volume13
DOIs
Publication statusPublished - 2019

Keywords

  • Disposable equipment
  • Growth hormone
  • Patient preference
  • Safety
  • Usability

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Social Sciences (miscellaneous)
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Health Policy

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  • Cite this

    Lee, J. E., Kim, S. Y., Yoo, J. H., Hwang, I. T., Lim, J. S., Yi, K. H., Rhie, Y. J., Lee, G. M., Nam, H. K., Chae, H. W., Kim, E. Y., Cheon, C. K., Lee, J., Shim, Y. S., Lee, Y., Kim, E. Y., & Hwang, J. S. (2019). Ease of use, preference, and safety of the recombinant human growth hormone disposable pen compared with the reusable device: a multicenter, single-arm, open-label, switch-over, prospective, phase iv trial. Patient Preference and Adherence, 13, 2195-2205. https://doi.org/10.2147/PPA.S229536