RESUMO
BACKGROUND: SurePal™ is a reusable self-injection system that has been developed to support daily administration of Omnitrope(®) (Sandoz, Kundl, Austria). A questionnaire-based cross-sectional survey was conducted to evaluate acceptability of, and preference for, SurePal™ in pediatric patients who were prescribed treatment with Omnitrope(®) within routine clinical care. METHODS: This multicenter, observational study was incorporated into the ongoing non-interventional PATRO (PAtients TReated with Omnitrope(®)) Children study. Patients (or caregivers) were provided with a questionnaire that included five main topics; attractiveness of the device, training received, using SurePal™, the low drug wastage system, and experience versus other devices used previously (where applicable). Questions were scored on a 5-point scale, with -2 being the worst possible outcome (eg, very hard/very poor) and 2 being the best possible outcome (eg, very easy/excellent). RESULTS: A total of 186 patients were included in this study (Germany, n=154; UK, n=32). The attractiveness of SurePal™ was rated as excellent/good by 87.1% of patients. Overall, 86.5% of patients found that using their SurePal™ was very easy/easy. Almost all patients (96.2%) found that preparing their SurePal™ for injection was very easy/easy, and 89.2% found that injecting with SurePal™ was very easy/easy. 85.5% of patients recorded that the dose memory function was helpful, and 87.6% that taking their SurePal™ apart after an injection was very easy/easy. Of the 88 patients who recorded that they had used the low drug waste feature, 89.8% found the feature to be helpful. Among pre-treated patients (n=42), 81% recorded that SurePal™ was much better/better than their previously used device. CONCLUSION: This questionnaire-based cross-sectional survey in pediatric patients confirms the ease of use and patient preference for SurePal™, a reusable self-injection system that has been developed to support daily administration of Omnitrope(®).
RESUMO
OBJECTIVE: Hypoglycaemia may be a frequent occurrence in young GH deficient patients and so we studied the response to fasting in children and adolescents with GH and/or cortisol deficiency. METHODS: A total of 20 patients (2-18 years) fasted for 14 h (22.00-12.00 h) on two occasions as part of a randomized cross-over study. Fourteen had pituitary hormone deficiency (PHD) including GH deficiency (GHD). Of the 14 patients, seven were ACTH sufficient (PHDC+) and seven ACTH deficient (PHDC-). Six had primary adrenal failure (PAF). Subjects administered or omitted their normal dose of evening GH and/or morning hydrocortisone. Glucose, insulin, GH, cortisol, ketones and catecholamines were measured at 04.00 h and regularly from 07.00 to 12.00 h. Insulin sensitivity was assessed by HOMA and hypoglycaemia defined as a blood glucose (BG)
