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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
24-month use of once-weekly GH, LB03002, in prepubertal children with GH deficiency
Journal of Clinical Endocrinology and Metabolism, Volume 99, No. 1, Year 2014
Notification
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Description
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: Weconducted a phase III, 12-month, multinational, randomized, open-label, comparatorcontrolled 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. Theleast 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 candidate for long-term GH replacement in GH-deficient children. (J Clin Endocrinol Metab 99: 126-132, 2014). © Copyright 2014 by The Endocrine Society.
Authors & Co-Authors
Khadilkar, Vaman V.
Unknown Affiliation
Radjuk, Klavdia A.
Unknown Affiliation
Bolshova, Elena
Unknown Affiliation
Khadgawat, Rajesh
Unknown Affiliation
El-Kholy, Mohamed S.
Unknown Affiliation
Desai, Meena
Unknown Affiliation
Peterkova, Valentina A.
Unknown Affiliation
Mericq, Verónica
Unknown Affiliation
Kratzsch, Jürgen
Unknown Affiliation
Siepl, E. Christine
Unknown Affiliation
Martin, Dieter
Unknown Affiliation
Lopez, Prema
Unknown Affiliation
Ji, Hyi Jeong
Unknown Affiliation
Bae, Yoon Ju
Unknown Affiliation
Lee, Jin Hwa
Unknown Affiliation
Saenger, Paul H.
Unknown Affiliation
Statistics
Citations: 42
Authors: 16
Affiliations: 13
Identifiers
Doi:
10.1210/jc.2013-2502
ISSN:
0021972X
e-ISSN:
19457197
Research Areas
Maternal And Child Health
Study Design
Randomised Control Trial