INTRAMUSCULAR INJECTIONS OF SLOW-RELEASE LANREOTIDE (BIM-23014) IN ACROMEGALIC PATIENTS PREVIOUSLY TREATED WITH CONTINUOUS SUBCUTANEOUS INFUSION OF OCTREOTIDE (SMS-201-995)

Nine acromegalic patients (five females and four males), mean age 50+/ -4 years, presented macroadenomas (N = 7), microadenoma (N = 1) or nor mal computed tomography scans (N = 1). Patients were treated with cont inuous subcutaneous infusion of octreotide (range 200-600 mu g/day). F ollowing a washout period of 7 days, the patients were injected im wit h 30 mg slow-release lanreotide every 10 days for the first month and then twice monthly. In case of elevated growth hormone (GH) levels at 3 months, the patients were injected every 10 days for the next three months. Plasma GH and insulin-like growth factor I (IGH-I) decreased i n all patients during octreotide treatment. After 6 months of octreoti de treatment, seven patients were considered as well controlled (mean 8 h GH < 5 mu g/l, IGF-I normal) whereas in two patients the mean 8-h GH and/or IGF-I levels remained increased. Serum GH and IGH-I increase d after octreotide withdrawal. In one patient, serum GH and IGF-I incr eased during slow-release lanreotide administration and injections wer e stopped after 45 days. After 3 months of lanreotide, three patients were well controlled while in five patients GH or IGF-I levels were no t normalized. At 6 months, five patients were injected twice monthly a nd three patients had one injection every 10 days. Six patients were w ell controlled and in two patients the mean 8-h GH level remained incr eased. The pituitary tumor volume decreased by 20-30% in two patients during octreotide, as well as in one other during slow-release lanreot ide therapy. Slow-release lanreotide was well tolerated except for min or digestive problems during the early days of treatment or mild pain at the site of injection. Gallbladder echographies were normal during octreotide and lanreotide therapies, except in one patient in whom gal lstones occurred during octreotide treatment. In conclusion, this clin ical study shows that in acromegalic patients, im injections of slow-r elease lanreotide (two or three per month) are well tolerated and are as effective as continuous subcutaneous infusion of octreotide in the control of GH hypersecretion. Therefore, slow-release lanreotide would appear to be a useful therapeutic tool to improve the quality of life in patients with acromegaly.