RESUMEN
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(®).
RESUMEN
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) = 3.3 mmol/l. RESULTS: BG was related to age and body mass index on treatment but no subject became hypoglycaemic on or off therapy prior to 07.00 h. Five children (aged 3, 4, 7, 8 and 11 years) were hypoglycaemic between 07.00 and 12.00 h off treatment. There was a positive relationship between GH AUC and minimum BG in patients with PHD on treatment (r(2) = 0.45, P = 0.012) with increased insulin sensitivity off treatment. Increased cortisol levels were seen in PHDC+ patients off GH (P < 0.001). A negative relationship was observed between minimum BG and adrenaline (r(2) = 0.37, P = 0.01), ketone bodies (r(2) = -0.20, P = 0.05) and NEFA (r(2) = -0.35, P = 0.02). Noradrenaline levels were reduced in patients with PHDC-. Low BMI (on treatment) and young age (off treatment) were determinants of low BG levels in a multiple regression model. CONCLUSIONS: Unrecognized overnight hypoglycaemia in children and adolescents on pituitary hormone replacement is uncommon but BG levels quickly become abnormal when treatment and meals are omitted. The insulin antagonistic actions of GH are important in preventing hypoglycaemia. Patients with PHD have altered sympathetic nerve activity.