Safety Outcomes During Pediatric GH Therapy: Final Results From the Prospective GeNeSIS Observational Program.

ABSTRACT:

Context

Safety concerns have been raised regarding premature mortality, diabetes, neoplasia, and cerebrovascular disease in association with GH therapy.

Objective

To assess incidence of key safety outcomes.

Design

Prospective, multinational, observational study (1999 to 2015).

Setting

A total of 22,311 GH-treated children from 827 investigative sites in 30 countries.

Patients

Children with growth disorders.

Interventions

GH treatment.

Main outcome measures

Standardized mortality ratio (SMR) and standardized incidence ratio (SIR) with 95% CIs for mortality, diabetes, and primary cancer using general population registries.

Results

Predominant short stature diagnoses were GH deficiency (63%), idiopathic short stature (13%), and Turner s

SUBMITTER: Child CJ 

PROVIDER: S-EPMC6300411 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature