User assessment of Norditropin NordiFlex(®), a new prefilled growth hormone pen: a Phase IV multicenter prospective study

Maithé Tauber, Delphine Jaquet, Monique Jesuran-Perelroizen, Marc Petrus, Anne Marie Bertrand, Regis Coutant, NordiFlex® French Study Group, Maithé Tauber, Delphine Jaquet, Monique Jesuran-Perelroizen, Marc Petrus, Anne Marie Bertrand, Regis Coutant, NordiFlex® French Study Group

Abstract

BACKGROUNDAIM: In growth disorders, ensuring long-term growth hormone therapy (GHT) remains a challenge that might compromise the clinical outcome. Consequently, strategies aiming at alleviating the burden of daily injection might improve the treatment benefit. The study reported here was performed to assess the ease of use of Norditropin NordiFlex(®) (Novo Nordisk, Princeton, NJ, USA) compared with that of the devices previously used in children treated with GHT with recombinant somatropin.

Methods: This Phase IV prospective, multicenter, open-label study was conducted in France. All patients received Norditropin NordiFlex for 6 weeks. Oral questionnaires were administered by the physician to the patients and/or the parents at inclusion and at the final visit.

Results: This study included 103 patients aged between 6 and 17 years. The patients assessed Norditropin NordiFlex as significantly easier to use than their previous device (median value = 7.5, P < 0.001). Almost three-quarters of patients (64.4%) preferred Norditropin NordiFlex to their previous device. Among physicians and nurses, 73% assessed Norditropin NordiFlex training as "very easy" and 26% as "easy." Norditropin NordiFlex improved patient autonomy, with 41% of patients able to self-inject the treatment.

Conclusion: This study has shown that Norditropin NordiFlex is reliable, safe, and easy to use and most study patients preferred it to their previous device. These characteristics may improve the adherence to GHT.

Keywords: adherence; ease of use; growth hormone therapy; injection devices; preference.

Figures

Figure 1
Figure 1
Parents’/patients’ ratings of the ease of injection steps with Norditropin NordiFlex® (Novo Nordisk, Princeton, NJ, USA) at the 6-week visit.
Figure 2
Figure 2
Norditropin NordiFlex® (Novo Nordisk, Princeton, NJ, USA) ease of training assessed by the health care professionals (physician or nurse) in charge of giving device instructions to patients/parents.
Figure 3
Figure 3
Patients’ preference for Norditropin NordiFlex® (Novo Nordisk, Princeton, NJ, USA) at the 6-week visit.

References

    1. Haute Autorité de Santé (HAS) Dispositifs médicaux pour autosurveillance et autotraitement : révision des descriptions génériques de la liste des produits et prestations remboursables. [Medical devices for self-monitoring and self-care: review of generic descriptions of the list of reimbursable products and services]. Paris: HAS; 2007. [Accessed April 3, 2013]. (Fre). Available from: . French.
    1. Rogol AD. Clinical and humanistic aspects of growth hormone deficiency and growth-related disorders. Am J Manag Care. 2011;17(Suppl 18):eS4–eS10.
    1. Müller J, Skakkebaek NE, Jacobsen BB, et al. Norditropin SimpleXx: a liquid human growth hormone formulation, a pen system and an auto-insertion device. Horm Res. 1999;51(Suppl 3):109–112.
    1. Hindmarsh PC, Brook CG. Compliance with growth hormone treatment – is it a problem? Horm Res. 1999;51(Suppl 3):104–108.
    1. Oyarzabal M, Aliaga M, Chueca M, Echarte G, Ulied A. Multicentre survey on compliance with growth hormone therapy: what can be improved? Acta Paediatr. 1998;87(4):387–391.
    1. Kapoor RR, Burke SA, Sparrow SE, et al. Monitoring of concordance in growth hormone therapy. Arch Dis Child. 2008;93(2):147–148.
    1. Hunter I, deVries C, Morris A, Greene S. Human growth hormone therapy: poor adherence equals poor growth. Proceedings of the 4th Spring Meeting of Royal College of Paediatrics and Child Health; 2000 April 10–13; London, UK.
    1. Desrosiers P, O’Brien F, Blethen S. Patient outcomes in the GHMonitor: the effect of delivery device on compliance and growth. Pediatr Endocrinol Rev. 2005;2(Suppl 3):327–331.
    1. Hokken-Koelega A, Keller A, Rakov V, Kipper S, Dahlgren J. Patient Acceptance, Ease of Use, and Preference for Norditropin NordiFlex with NordiFlex PenMate: Results from an Open-Label, User Survey of Everyday Use. ISRN Endocrinol. 2011;2011:803948.
    1. Norgren S. Adherence remains a challenge for patients receiving growth hormone therapy. Pediatr Endocrinol Rev. 2009;6(Suppl 4):545–548.
    1. Osterberg L, Blaschke T. Adherence to medication. New Engl J Med. 2005;353(5):487–497.
    1. [homepage on the Internet] [Accessed on April 15, 2013]. .
    1. Dumas H, Panayiotopoulos P, Parker D, Pongpairochana V. Understanding and meeting the needs of those using growth hormone injection devices. BMC Endocr Disord. 2006;6:5.
    1. Bozzola M, Colle M, Halldin-Stenlid M, Larroque S, Zignani M easypod™ survey study group. Treatment adherence with the easypod™ growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents. BMC Endocr Disord. 2011;11:4.
    1. Smith SL, Hindmarsh PC, Brook CG. Compliance with growth hormone treatment – are they getting it? Arch Dis Child. 1993;68(1):91–93.
    1. Ida S, Yoshimura N, Nakacho M, et al. Evaluation of the use of PenNeedle(R) 32G Taper in children being treated with growth hormone. Clin Pediatr Endocrinol. 2008;17(1):1–7.
    1. Laursen T, Hansen B, Fisker S. Pain perception after subcutaneous injections of media containing different buffers. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.

Source: PubMed

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