Long-acting lanreotide in adolescent girls with constitutional tall stature.

Abstract

Background/aims: The aim of the study was to evaluate the efficacy and safety of lanreotide prolonged release (PR) 30 mg (long-acting lanreotide) in girls with constitutional tall stature (CTS).

Methods: This open label prospective study included 35 girls (mean age 12.6 years) with CTS and a predicted adult height of >180 cm. Intramuscular injections of lanreotide PR 30 mg were given every 14 days, for a minimum of 12 months and up to 36 months. Adult height was compared with pretreatment predicted height.

Results: The mean predicted adult height was reduced by 3.8 cm (95% CI 3.7-4.9 cm) in the restricted intent-to-treat population. Mean growth velocity decreased from 7.9 +/- 1.5 cm/year at preinclusion to 1.7 +/- 2.3 cm/year at the last visit on treatment (n = 35). Gastrointestinal adverse events and cholelithiasis were reported in 35/37 patients and 5/37 patients, respectively. There was 1 withdrawal due to gastrointestinal disorders.

Conclusions: Biweekly intramuscular lanreotide PR 30 mg given to girls with CTS after the onset of pubertal development reduced adult height as compared with predicted height. Treatment-associated adverse events were consistent with the overall safety profile of lanreotide 30 mg PR and did not deter most patients from long-term treatment.