Hormone research · 2009
Long-acting lanreotide in adolescent girls with constitutional tall stature.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Carel Jean-Claude, Blumberg Joëlle, Bougeard-Julien Muriel, Rochiccioli Pierre, Chaussain Jean-Louis, Tauber Maïthé, Lanreotide in Tall Stature Study Group
Аннотация
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.
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.