Effectiveness and tolerability of 3-year lanreotide Autogel treatment in patients with acromegaly.

OBJECTIVE: During short-term treatment, monthly subcutaneous injections of lanreotide Autogel are effective in controlling GH/IGF-1 hypersecretion and are well tolerated in patients with acromegaly. This study reports the effectiveness and the tolerability of lanreotide Autogel for at least 3 years in acromegalic patients. PATIENTS: Fourteen patients (nine females, five males) were treated with titrated doses of lanreotide Autogel.
DESIGN: This clinical study was an extension of a previous trial. After three fixed-dose lanreotide Autogel injections, treatment was adjusted according to mean GH and IGF-I levels. After 3 years of treatment, patients were receiving 120 (n=7), 90 (n=2) and 60 mg (n=4) monthly injections of lanreotide Autogel. MEASUREMENTS: Acromegalic symptoms, GH and IGF-1 concentrations were analysed at the end of lanreotide microparticle treatment, and after 4, 8, 12, 24, 30 and 36 months of lanreotide Autogel therapy. Tolerance and side-effects were monitored throughout the 3-year study. RESULTS Hormonal control (GH <or= 2.5 microg/l and age- and sex-normalized IGF-1) was achieved in six (46%) patients. With the exception of an unrelated death due to pulmonary embolism, no patient withdrew from study. The number of patients reporting digestive adverse events was seven (12 episodes) for the fixed-dose period, and four (eight episodes), two (six episodes) and one (three episodes) at the end of the first, second and third year of treatment, respectively. Persistent induration at the injection sites was reported by two patients, and histological findings were consistent with benign injection-site granulomas. New cholelithiasis or sludge occurred in five (35%) patients during the lanreotide Autogel treatment.
CONCLUSION: This 3-year study shows that lanreotide Autogel is effective in controlling GH/IGF-1 hypersecretion and is well tolerated during long-term treatment of patients with acromegaly.