Long-Term Therapy with Recombinant

Bercu, Barry B.; Murray, Frederick T.; Frasier, S. Douglas; Rudlin, C.R.; O’Dea, Louis; Brentzel, Jim; Hanson, Bernard; Landy, Hal

doi:10.1385/endo:15:1:043

Cited by 10 publications

(7 citation statements)

References 18 publications

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“…Most of the AEs that were reported, including nausea, vomiting, headache and dizziness, can be related to the somatostatin infusion [1,2,12-16]. No serious AEs were reported.…”

Section: Discussionmentioning

confidence: 99%

“…It is also indicated for the treatment of GH deficiency (GHD) in adults. Long-term treatment is effective at promoting growth in GH-deficient children [1-7]. In a retrospective survey of 631 children, r-hGH increased height by a mean of approximately 8 cm per year over 2 years [3].…”

Section: Introductionmentioning

confidence: 99%

“…In a retrospective survey of 631 children, r-hGH increased height by a mean of approximately 8 cm per year over 2 years [3]. Similarly, in an open-label study of 69 children with organic or idiopathic GHD, r-hGH was associated with a median growth of 47.5 ± 8.5 cm over 7 years of treatment, with most subjects reaching their predicted final height [1]. …”

Section: Introductionmentioning

confidence: 99%

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Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation

et al. 2010

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BackgroundSomatropin is recombinant human growth hormone (GH) used for the treatment of growth failure in children and GH deficiency in adults. Two concentrations of a liquid formulation have been developed: 5.83 and 8.0 mg/mL. This trial compared the pharmacokinetics (PK), safety and tolerability of these two liquid concentrations against the freeze-dried (FD) formulation in healthy volunteers.MethodsIn an open-label, single-centre, three-way crossover study, volunteers (aged 18-45 years) were given subcutaneous injections of the reconstituted FD and two liquid formulations in random sequential order, each at 4 mg/dose, with a 1-week wash-out period between doses. To suppress endogenous GH secretion, intravenous somatostatin was infused continuously 1 hour before to 24 hours after each dose, achieving a cumulative dose of 3 mg. Primary PK endpoints were area under the serum concentration-time curve (AUC0-t) and maximum serum concentration (Cmax). For each of the two liquid formulations, bioequivalence with the FD formulation was concluded if the 95% confidence intervals (CIs) for the estimated test/reference ratios of geometric means of AUC0-t and Cmax were within the standard pre-specified acceptance range (0.80-1.25).ResultsFifteen men and 15 women enrolled (safety population, n = 30; PK population, n = 28). Bioequivalence with the FD formulation could be shown for both liquid formulations. The ratios of geometric means (95% CI) were 1.046 (0.980, 1.117) and 0.991 (0.929, 1.058) for AUC0-t and 0.954 (0.875, 1.040) and 0.955 (0.876, 1.041) for Cmax for the 5.83 and 8.0 mg/mL formulations, respectively. No significant differences between the three treatments in half-lives, time to reach Cmax, clearance or volume of distribution were observed. After injection, the most common side-effects were pain or injection-site reactions (all of mild intensity). There were no clinically significant abnormal vital signs, ECG or laboratory findings. There were 56 treatment-related adverse events (AEs): 49 mild, 6 moderate and 1 severe (vomiting). No serious AEs occurred. The pattern of AEs was as expected and all resolved by study end.ConclusionBoth concentrations of a new liquid multi-dose formulation are bioequivalent to the FD reference formulation and all are well tolerated.Trial registration numberNCT01034735.

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“…Most of the AEs that were reported, including nausea, vomiting, headache and dizziness, can be related to the somatostatin infusion [1,2,12-16]. No serious AEs were reported.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation

et al. 2010

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“…The 12-, 24- and 36-month auxological data observed with Norditropin® [15] are also comparable to that of Omnitrope®. After 7 years of treatment with Saizen® [16], a HSDS of –1.6 (n = 22) was reported (corresponding to an increase from baseline of 2.2). This compares very well with the increase from baseline in HSDS observed for Omnitrope® after 84 months of treatment (ΔHSDS = 2.24; n = 46).…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2009

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Aim: This phase III clinical study in growth hormone deficiency (GHD) children with growth retardation was designed to compare efficacy and safety of Omnitrope® with Genotropin® and assess the long-term safety and efficacy of Omnitrope®. The results of 7 years of treatment with Omnitrope® are presented. Patients and Methods: Eighty-nine treatment-naïve, prepubertal children with GHD were randomized (part 1) to Omnitrope® lyophilisate (group A, n = 44) or Genotropin® (group B, n = 45) for 9 months and received a subcutaneous dose of 0.03 mg/kg/day. In part 2, patients receiving Omnitrope® lyophilisate continued the same treatment for a further 6 months, while patients on Genotropin® were switched to Omnitrope® liquid for the subsequent 6 months. In part 3, patients in both groups received Omnitrope®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® was well tolerated and safe over 7 years of treatment. Conclusion: The clinical comparability between Omnitrope® and Genotropin® was demonstrated within 9 months of treatment. Long-term safety and efficacy of 7 years of treatment with Omnitrope® was proven.

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“…A study on the use of recombinant somatotropin (r-hGH) as a long-term therapy (11 years) to treat GHD reported positive catch-up growth response and bone age acceleration in accordance with age versus height age [71]. The median HSDS improved significantly from −3.8 at baseline to −3.3 ( p < 0.001) during the first year of r-hGH therapy and improved further to −1.5 after 7 years of the therapy.…”

Section: Resultsmentioning

confidence: 99%

Challenges in the Diagnosis and Management of Growth Hormone Deficiency in India

John¹,

Koledova

Kumar

et al. 2016

International Journal of Endocrinology

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In clinical practice, every year approximately 150,000 children are referred with short stature (SS) based on a cut-off of fifth percentile. The most important endocrine and treatable cause of SS is growth hormone deficiency (GHD). The lack of reliable data on the prevalence of GHD in India limits estimation of the magnitude of this problem. The diagnosis and treatment of GHD are hurdled with various challenges, restricting the availability of growth hormone (GH) therapy to only a very limited segment of the children in India. This review will firstly summarize the gaps and challenges in diagnosis and treatment of GHD based on literature analysis. Subsequently, it presents suggestions from the members at advisory board meetings to overcome these challenges. The advisory board suggested that early initiation of the therapy could better the chances of achieving final adult height within the normal range for the population. Education and awareness about growth disorders among parents, regular training for physicians, and more emphasis on using the Indian growth charts for growth monitoring would help improve the diagnosis and treatment of children with GHD. Availability of an easy-to-use therapy delivery system could also be beneficial in improving adherence and achieving satisfactory outcomes.

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Long-Term Therapy with Recombinant

Cited by 10 publications

References 18 publications

Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation

Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation

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

Challenges in the Diagnosis and Management of Growth Hormone Deficiency in India

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