Somatuline(R) Autogel(R), a new formulation of lanreotide for the treatment of acromegalic patients

Lanreotide Autogel((R)) is a new long-acting aqueous preparation of lanreotide for the treatment of acromegaly, and is administered by deep sc injection from small-volume pre-filled syringes. The aim of this study was to evaluate the efficacy and safety of this new long-acting formulation in a large population of acromegalic patients previously responsive to im lanreotide 30mg (sustained release microparticle formulation). Lanreotide Autogel((R)) was administered by deep sc injection every 28 days to 107 patients (54 males, 53 females; mean age 54+/-1.2 years). All patients had been treated with lanreotide 30mg for at least 3 months before study entry, and had a mean GH level<10 ng/mL after at least four subsequent im injections every 14 days (48%), 10 days (32%) or 7 days (20%). Treatment was switched from lanreotide 30mg injected every 14, 10 or 7 days to lanreotide Autogel((R)) 60, 90 or 120mg, respectively, every 28 days. After three fixed-dose injections of lanreotide Autogel((R)), mean lanreotide levels were similar to those obtained at steady state with lanreotide 30mg. During lanreotide Autogel((R)) treatment, the control of acromegalic symptoms was comparable with that previously achieved during lanreotide 30mg treatment. After three injections of lanreotide Autogel((R)), mean values for GH (2.87+/-0.22ng/mL) and IGF-1 (317+/-15ng/mL) were comparable with those recorded at the end of lanreotide 30mg treatment (GH: 2.82 +/- 0.19ng/mL; IGF-1: 323+/-16ng/mL). GH<2.5ng/mL and age-sex-normalised IGF-1 was achieved in 33% and 39% of patients during lanreotide 30mg and lanreotide Autogel((R)) treatment, respectively. Diarrhoea, abdominal pain and nausea were reported by 38, 22 and 18% of patients during lanreotide 30mg treatment, and by 29, 17 and 9% of patients, respectively, during lanreotide Autogel((R)) treatment. In conclusion, this clinical study shows that lanreotide Autogel((R)) is at least as efficacious and well tolerated as lanreotide 30mg. This new long-acting lanreotide formulation, lanreotide Autogel((R)), which is administered from small-volume pre-filled syringes by deep sc injection, is therefore likely to improve the acceptability of medical treatment for patients requiring long-term somatostatin analogue therapy.