Long-term safety and efficacy of the recombinant human growth hormone Omnitrope® in the treatment of Spanish growth hormone deficient children: results of a phase III study.

INTRODUCTION: This phase III study in growth hormone (GH) deficient (GHD) children with growth retardation was designed to demonstrate the safety and efficacy of longterm treatment with the recombinant human GH Omnitrope® (Sandoz BioPharmaceuticals, Holzkirchen, Germany). METHODS: Treatment-naïve, prepubertal Spanish children (n=70) with isolated GHD were treated with Omnitrope 0.03 mg/kg/day subcutaneously. Changes in height, height standard deviation score (HSDS), height velocity (HV), HV standard deviation score (HVSDS), serum insulin-like growth factor (IGF)-1, and insulin-like growth factor binding protein (IGFBP)-3 levels were recorded. RESULTS: Omnitrope treatment provided a good growth response after 4 years, shown by a significant increase in mean body height (31.1 cm [95% CI: 29.6-32.6]), HSDS (Tanner) (1.42 [1.13-1.70]), HV (2.4 cm [1.7-3.1]), and HVSDS values (3.5 [2.7-4.3]). Mean IGF-1 and IGFBP-3 serum levels also increased significantly. CONCLUSION: At a dose of 0.03 mg/kg/day, Omnitrope was safe, effective, and well tolerated during long-term treatment of children with GHD.

Seven years of safety and efficacy of the recombinant human growth hormone Omnitrope in the treatment of growth hormone deficient children: results of a phase III study.

AIM: This phase III clinical study in growth hormone deficiency (GHD) children with growth retardation was designed to compare efficacy and safety of Omnitrope((R)) with Genotropin((R)) and assess the long-term safety and efficacy of Omnitrope((R)). The results of 7 years of treatment with Omnitrope((R)) are presented. PATIENTS AND METHODS: Eighty-nine treatment-naïve, prepubertal children with GHD were randomized (part 1) to Omnitrope((R)) lyophilisate (group A, n = 44) or Genotropin((R)) (group B, n = 45) for 9 months and received a subcutaneous dose of 0.03 mg/kg/day. In part 2, patients receiving Omnitrope((R))lyophilisate continued the same treatment for a further 6 months, while patients on Genotropin((R)) were switched to Omnitrope((R)) liquid for the subsequent 6 months. In part 3, patients in both groups received Omnitrope((R))liquid for a period up to 69 months. RESULTS: The development of the 4 auxological parameters (height, height SD score, height velocity and height velocity SD score) and IGF-1 and IGFBP-3 levels were comparable between both groups of patients and confirmed the well-known growth response of GHD children to recombinant human GH treatment. Omnitrope((R)) was well tolerated and safe over 7 years of treatment. CONCLUSION: The clinical comparability between Omnitrope((R)) and Genotropin((R)) was demonstrated within 9 months of treatment. Long-term safety and efficacy of 7 years of treatment with Omnitrope((R)) was proven.

Measuring the efficacy of psychopharmacological treatment of psychomotoric restlessness in dementia: clinical evaluation of tiapride.

A major problem in psychogeriatrics is the treatment of demented patients suffering from severe restlessness and aggressive behavior. There have been few controlled studies of the efficacy of antipsychotic drugs in the treatment of this condition. Therefore, a multi-centre, double-blind, randomized study, measuring the efficacy and safety of tiapride vs. melperone in hospitalized dementia patients suffering from psychomotoric agitation, was conducted in 24 psychiatric hospitals in Germany. A total of 176 patients were enrolled: 175 of them were included in the safety analysis and 156 were evaluated for efficacy. Both treatment groups were comparable regarding the severity of disease and demographic data as well as with regard to the neuropsychological baseline assessment. The CGI (item, 2) was the primary efficacy parameter. Both groups yielded an identical response rate of 74.36%. The secondary efficacy parameters (NOSIE, AIMS, RAPSU, BePU, VAS) showed correspondingly a marked improvement for both groups. No significant changes of the safety parameters (blood pressure, pulse rate, ECG, clinical examination) occurred in the study. The overall number of adverse events was slightly higher in the tiapride group, serious events occurring less frequently. This study demonstrates that tiapride is as effective and as safe as melperone. These results are consistent with international experience on tiapride.