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Somatropin (Genotropin) for Subcutaneous Injection: Long-term Treatment of Children who have Growth Failure Due to an Inadequate Secretion of Endogenous Growth Hormone [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan.

APPENDIX 5FINDINGS FROM SYSTEMATIC REVIEWS OF SOMATROPIN IN THE TREATMENT OF GHD IN CHILDREN

Aim

To summarize the findings from systematic reviews of the efficacy and safety of somatropin in children with GHD.

Findings

A health technology assessment by Takeda et al. (Table 12) assessed the clinical effectiveness and cost-effectiveness of somatropin compared with treatment strategies without somatropin for children with GHD, Turner syndrome, and other conditions resulting in growth failure.18 One unblinded randomized controlled trial (RCT) was identified for the treatment of pediatric GHD. It was not specified which somatropin product was used in this trial. The study reported significantly increased growth velocity and higher serum insulin-like growth factor-1 levels in somatropin-treated patients compared with no somatropin therapy. This report was not industry sponsored.

Table 12. Evidence from Systematic Reviews on Long-Term Efficacy and Safety of Somatropin Therapy for Children with GHD.

Table 12

Evidence from Systematic Reviews on Long-Term Efficacy and Safety of Somatropin Therapy for Children with GHD.

One systematic review conducted by Loftus et al. evaluated the clinical efficacy and effectiveness of Genotropin in children with short stature, including those with GHD (Table 12).29 Three RCTs in children with GHD were included in this review. One of them (Romer et al. 200714,15) was included in the current CDR review. The other two RCTs compared different doses of Genotropin, or different Genotropin devices. The Loftus review was sponsored by Pfizer Ltd., the manufacturer of Genotropin.

Conclusion

Systematic reviews of clinical effectiveness and safety of somatropin therapy in children with GHD reported favourable results for somatropin, when compared with no treatment, or equivalent efficacy and safety between Genotropin and another somatropin – Omnitrope. However, long-term data are lacking, particular for clinically meaningful outcomes such as final height and health-related quality of life.

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Cover of Somatropin (Genotropin) for Subcutaneous Injection
Somatropin (Genotropin) for Subcutaneous Injection: Long-term Treatment of Children who have Growth Failure Due to an Inadequate Secretion of Endogenous Growth Hormone [Internet].

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