Conclusions There is no evidence to support differences in the effects of long-acting GH compared with those of daily GH .
Purpose Long-acting growth hormone ( GH ) has been developed to address the noncompliance and decreased efficacy associated with daily GH injections .
We aim ed to evaluate the efficacy and safety of long-acting GH replacement therapy in children with short stature .
24-month use of once-weekly GH, LB03002, in prepubertal children with GH deficiency.
BACKGROUND Sustained-release GH formulations may provide a strategy for improving treatment compliance and persistence in GH-deficient patients . OBJECTIVE The aim of the study was to examine efficacy and safety of LB03002 , a sustained-release GH formulation for once-weekly administration . DESIGN We conducted a phase III , 12-month , multinational , r and omized , open-label , comparator-controlled trial with a 12-month uncontrolled extension . PATIENTS Prepubertal GH treatment-naive GH-deficient children ( mean age , 7.8 y ) participated in the study . INTERVENTION We administered once-weekly LB03002 ( n=91 ) or daily GH ( n=87 ) for 1 year , followed by once-weekly LB03002 for all patients for another year ( LB03002 throughout , n=87 ; switched to LB03002 , n=80 ) . OUTCOME MEASURES Height , height velocity ( HV ) , IGF-1 , GH antibodies , and adverse events were determined throughout . Primary analysis was noninferiority of LB03002 vs daily GH at 1 year by analysis of covariance . RESULTS Mean±SD HV during year 1 was 11.63±2.60 cm/y with LB03002 , and 11.97±3.09 cm/y with daily GH , with increases from baseline of 8.94±2.91 and 9.04±3.19 cm/y , respectively . The least square mean HV difference for LB03002 - daily GH was -0.43 cm/y ( 99 % confidence interval , -1.45 to 0.60 cm/y ) . Mean HV also remained above baseline in year 2 ( 8.33±1.92 cm/y in the LB03002 throughout group , and 7.28±2.34 cm/y in the switched to LB03002 group ) . Injection site reactions occurred more frequently in LB03002-treated patients but were considered mild to moderate in > 90 % of cases . CONCLUSIONS Growth response with once-weekly LB03002 in GH-deficient children is comparable to that with daily GH , achieving expected growth rates for 24 months . Once-weekly LB03002 is a strong c and i date for long-term GH replacement in GH-deficient children
Conclusions There is no evidence to support differences in the effects of long-acting GH compared with those of daily GH .
Purpose Long-acting growth hormone ( GH ) has been developed to address the noncompliance and decreased efficacy associated with daily GH injections .
We aim ed to evaluate the efficacy and safety of long-acting GH replacement therapy in children with short stature .