Norditropin (R) SimpleXx (TM): A liquid human growth hormone formulation, a pen system and an auto-insertion device

Patient compliance is of vital importance for the outcome of any medical th erapy. Compliance is especially a problem in long-term treatment of non-lif e threatening diseases, such as growth retardation in children. Until recen tly, all human growth hormone (hGH) products required a reconstitution proc ess. Norditropin(R) SimpleXx(TM) is a liquid formulation of the biosyntheti c hGH product Norditropin(R), and, together with an improved NovoPen(R) 1.5 , NordiPen(TM), and an auto-insertion device, PenMate(TM)/NordiPenMate(TM), it has been developed in order to ease the injection process for patients. A randomized, open, multicentre, crossover trial compared Norditropin(R) S impleXx(TM)/improved NovoPen(R) 1.5 with freeze-dried Norditropin(R) PenSet (R)/Nordiject(R). A total of 67 children with GH deficiency, aged 5-18 year s, were treated with either Norditropin(R) SimpleXx(TM) for 6 weeks followe d by Norditropin(R) for 6 weeks or the opposite (sequences I and II, respec tively). Acceptability/convenience and pain perception were evaluated by qu estionnaire after each period. The function and handling of the PenMate(TM) were evaluated in a Dutch trial by 27 OH-treated children with intrauterin e growth retardation, aged 4-16 years, and their parents. All children were accustomed to using the Nordiject(R) pen. The evaluation of the PenMate(TM ) was based on a questionnaire. A similar trial was conducted in England, i n which the NordiPen(TM) and the NordiPenMate(TM) were evaluated by 25 OH-t reated children and their parents. Norditropin(R) SimpleXx(TM) was found to be easier to inject by 64% of the children, and 98% of the children found the system easier to use overall. There was no difference in pain perceptio n between the two administration systems, as judged by questionnaires and v isual analogue scale score. Three out of four patients preferred to continu e treatment with Norditropin(R) SimpleXx(TM). The safety profiles of the tw o systems were similar. In the Dutch trial, the PenMate(TM) was found to be easy and safe to handle, even for very young children (aged 4-5 years). Of patients who took a long time to get used to the injections, 73% found tha t the new pen would help. A total of 88% of the children would prefer to us e the PenMate(TM) in the future. Positive results of the handling tests wer e also reported in the British trial. The use of Norditropin(R) SimpleXx(TM ) and the auto-insertion device may improve patient compliance. Copyright ( C) 1999 S. Karger AG, Basel.