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Patient Preference and Adherence Volume 13, 2019 - Issue
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Original Research

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 Lee1 Department of Pediatrics, Inha University Hospital, Inha University Graduate School of Medicine, Incheon, Republic of KoreaORCID Iconhttps://orcid.org/0000-0002-7386-0015
ORCID Icon,
Se Young Kim2 Department of Pediatrics & Adolescent Medicine, Bundang Jeseang General Hospital, Daejin Medical Center, Seongnam, Republic of Korea
,
Jae-Ho Yoo3 Department of Pediatrics, Dong-a University Hospital, Dong-a University College of Medicine, Busan, Republic of Korea
,
Il Tae Hwang4 Department of Pediatrics, Kangdong Sacred Heart Hospital, Hallym University, College of Medicine, Seoul, Republic of Korea
,
Jung Sub Lim5 Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea
,
Kyung Hee Yi6 Department of Pediatrics, Wonkwang University Sanbon Medical Center, Gunpo, Republic of KoreaORCID Iconhttps://orcid.org/0000-0002-8123-1497
ORCID Icon,
Young-Jun Rhie7 Department of Pediatrics, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Republic of KoreaORCID Iconhttps://orcid.org/0000-0002-1250-6469
ORCID Icon,
Gyung Min Lee8 Department of Pediatrics, Konyang University Hospital, Daejeon, Republic of Korea
,
Hyo-Kyoung Nam9 Department of Pediatrics, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of KoreaORCID Iconhttps://orcid.org/0000-0003-1512-2062
ORCID Icon,
Hyun Wook Chae10 Department of Pediatrics, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
,
Eun Young Kim11 Department of Pediatrics, Chosun University Hospital, Chosun University School of Medicine, Gwangju, Republic of KoreaORCID Iconhttps://orcid.org/0000-0002-3073-5222
ORCID Icon,
Chong Kun Cheon12 Department of Pediatrics, Pusan National University Children’s Hospital, Pusan National University School of Medicine, Yangsan, Republic of Korea
,
Jieun Lee13 Department of Pediatrics, Inje University Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of KoreaORCID Iconhttps://orcid.org/0000-0002-9776-4204
ORCID Icon,
Young Suk Shim14 Department of Pediatrics & Adolescent Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of KoreaORCID Iconhttps://orcid.org/0000-0002-0850-5279
ORCID Icon,
YuJin Lee15 Life Sciences, LG Chem, Ltd., Seoul, Republic of Korea
,
Eun Young Kim15 Life Sciences, LG Chem, Ltd., Seoul, Republic of Korea
&
Jin Soon Hwang16 Department of Pediatrics & Adolescent Medicine, Ajou University Hospital, Ajou University School of Medicine, Suwon, Republic of KoreaCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-2666-3801
ORCID Icon show all
Pages 2195-2205 | Published online: 20 Dec 2019

References

  • Takeda A, Cooper K, Bird A, et al. Recombinant human growth hormone for the treatment of growth disorders in children: a systematic review and economic evaluation. Health Technol Assess. 2010;14(42):1–209. doi:10.3310/hta14420
  • Rose SR, Cook DM, Fine MJ. Growth hormone therapy guidelines: clinical and managed care perspectives. Am J Pharm Benefits. 2014;6(5):e134–e146.
  • Tauber M, Jaquet D, Jesuran-Perelroizen M, et al. User assessment of Norditropin NordiFlex®, a new prefilled growth hormone pen: a Phase IV multicenter prospective study. Patient Prefer Adherence. 2013;7:455–462. doi:10.2147/PPA.S4346023737664
  • Smith SL, Hindmarsh PC, Brook CG. Compliance with growth hormone treatment–are they getting it? Arch Dis Child. 1993;68(1):91–93. doi:10.1136/adc.68.1.918435018
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  • Hey-Hadavi J, Pleil A, Deeb LC, et al. Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone: a multicenter, 2-month, single-arm, open-label clinical trial in patient-caregiver dyads. Clin Ther. 2010;32(12):2036–2047. doi:10.1016/j.clinthera.2010.11.00721118739
  • Kappelgaard AM, Mikkelsen S, Knudsen TK, Fuchs GS. Patient preference for a new growth hormone injection device: results of an open-label study in Japanese pediatric patients. J Pediatr Endocrinol Metab. 2011;24(7–8):489–496. doi:10.1515/jpem.2011.25221932587
  • Kapoor RR, Burke SA, Sparrow SE, et al. Monitoring of concordance in growth hormone therapy. Arch Dis Child. 2008;93(2):147–148. doi:10.1136/adc.2006.11424917768149
  • Haverkamp F, Johansson L, Dumas H, et al. Observations of nonadherence to recombinant human growth hormone therapy in clinical practice. Clin Ther. 2008;30(2):307–316. doi:10.1016/j.clinthera.2008.02.01718343269
  • Rosenfeld RG, Bakker B. Compliance and persistence in pediatric and adult patients receiving growth hormone therapy. Endocr Pract. 2008;14(2):143–154. doi:10.4158/EP.14.2.14318308651
  • Pleil AM, Darendeliler F, Dörr HG, Hutchinson K, Wollmann HA. Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults. Med Devices (Auckl). 2014;7:61–71. doi:10.2147/MDER.S5982124748824
  • Adachi M. Assessment of user-friendliness of the Norditropin FlexPro for pediatric patients treated with recombinant human growth hormone: results of an open-label user survey. J Pediatr Endocrinol Metab. 2013;26(11–12):1105–1110. doi:10.1515/jpem-2013-007123843576
  • Rapaport R, Saenger P, Schmidt H, et al. Validation and ease of use of a new pen device for self-administration of recombinant human growth hormone: results from a two-center usability study. Med Devices (Auckl). 2013;6:141–146. doi:10.2147/MDER.S5008824039458

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