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

Abstract

Maith&eacute; Tauber,1 Delphine Jaquet,2 Monique Jesuran-Perelroizen,3 Marc Petrus,4 Anne Marie Bertrand,5 Regis Coutant6NordiFlex&reg; French Study Group1H&ocirc;pital des Enfants, Toulouse, 2Novo Nordisk, La D&eacute;fense C&eacute;dex, 3Cabinet d&rsquo;Endocrinologie P&eacute;diatrique, Toulouse, 4Centre Hospitalier de Bigorre, Tarbes, 5Centre Hospitalier Universitaire de Besan&ccedil;on, Besan&ccedil;on, 6Centre Hospitalier Universitaire Angers, Angers, FranceBackground/aim: 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&reg; (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: growth hormone therapy, adherence, injection devices, preference, ease of us