ESPE Abstracts (2023) 97 P1-354

ESPE2023 Poster Category 1 Pituitary, Neuroendocrinology and Puberty (73 abstracts)

The effect of leuprolide acetate 11.25mg 3-month formulation in children with central precocious puberty: A systematic review and meta-analysis

Wei Wu , Ke Huang , Guanping Dong & Junfen Fu

Department of Endocrinology, The Children’s Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China

Background: Central precocious puberty (CPP) results from the premature pubertal activation of the hypothalamic-pituitary-gonadal axis before eight years for girls or nine years for boys. A systematic review and meta-analysis was conducted to evaluate the long-term efficacy and safety of leuprolide acetate (LA) 11.25mg 3-month formulation in children with CPP.

Methods: A systematic search in PubMed and Embase was conducted for eligible studies. Primary end points include mean stimulated or peak LH, FSH (≤4 IU/L), oestradiol (<20 pg/ml) and testosterone (≤30 ng/dL) level after treatment; proportion of children with a supressed LH, FSH, oestradiol, testosterone levels; Secondary endpoints include height, weight, BMI, bone age, bone age to chronological age (BA-CA) and growth velocity before and after treatment; proportion of children with clinical suppression of breast or genitals.

Results: A total of 11 articles were included in this study and consisted of 582 patients with CPP. After treatment, the mean stimulated LH levels decreased to 1.03 IU/L (95% CI: 0.56 ̶ 1.49) at 6 months and remained low at 12 months (1.78 IU/L [95% CI: 1.19 ̶ 2.37]). The proportion of children with a suppressed LH at 6 months was 89.0% (95% CI: 82–94). The mean stimulated FSH levels were decreased to 1.65 IU/L (95% CI: 0.62 ̶ 2.68) by 6 months. The mean basal estradiol and testosterone levels were suppressed in 97% (95% CI: 81–100) and 91% (95% CI: 79–97). Compared to baseline, the mean change in BA-CA ratio decreased at 6, 12 months and 3 years to -0.04 (95% CI: -0.08 ̶ -0.00), -0.30 (95% CI: -0.46 ̶ -0.14) and -0.65 (95% CI: -1.50 ̶ 0.20) respectively. The mean growth velocity was 6.07 cm/year (95% CI: 2.27 ̶ 9.87) at 6 months and decreased to 4.45 cm/year (95% CI: 3.05 ̶ 5.85) at 12 months. LA 3-month formulation was well tolerated and most observed adverse events (AEs) were moderate.

Conclusion: LA 11.25 mg 3-month formulation is efficacious in suppressing LH, FSH peak, other gonadal hormones and in slowing the bone age and growth velocity in children with CPP.

Volume 97

61st Annual ESPE (ESPE 2023)

The Hague, Netherlands
21 Sep 2023 - 23 Sep 2023

European Society for Paediatric Endocrinology 

Browse other volumes

Article tools

My recent searches

No recent searches.