Efficacy of the New Long-Acting Formulation of Lanreotide (Lanreotide Autogel) in the Management of Acromegaly

Abstract

Lanreotide Autogel is a new long-acting aqueous preparation of lanreotide for the treatment of acromegaly and is administered by deep sc injection from a small volume, prefilled syringe. 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 lanreotide 30 mg, im (sustained release microparticle formulation). Lanreotide Autogel was administered by deep sc injection every 28 d to 107 patients (54 males and 53 females; mean age, 54 +/- 1.2 yr). All patients had been treated with lanreotide (30 mg) for at least 3 months before study entry and had a mean GH level less than 10 ng/ml after at least 4 subsequent im injections every 14 d (48%), 10 d (32%), or 7 d (20%). Treatment was switched from lanreotide 30 mg injected every 14, 10, or 7 d to 60, 90, or 120 mg lanreotide Autogel, respectively, every 28 d. After three fixed dose injections of lanreotide Autogel, mean lanreotide levels were similar to those obtained at steady state with lanreotide 30 mg. During lanreotide Autogel treatment, the control of acromegalic symptoms was comparable with that previously achieved during lanreotide 30 mg treatment. After 3 injections of lanreotide Autogel, mean GH (2.87 +/- 0.22 ng/ml) and IGF-I (317 +/- 15 ng/ml) values were comparable with those recorded at the end of lanreotide 30 mg treatment (GH, 2.82 +/- 0.19 ng/ml; IGF-I, 323 +/- 16 ng/ml). GH levels below 2.5 ng/ml and age-/sex-normalized IGF-I were achieved in 33% and 39% of patients during lanreotide 30 mg and lanreotide Autogel treatment, respectively. Diarrhea, abdominal pain, and nausea were reported by 38%, 22%, and 18% of patients during lanreotide 30 mg treatment and by 29%, 17%, and 9% of patients, respectively, during lanreotide Autogel treatment. In conclusion, this clinical study shows that lanreotide Autogel is at least as efficacious and well tolerated as lanreotide 30 mg. This new long-acting lanreotide formulation, lanreotide Autogel, which is administered from a small volume, prefilled syringe by deep sc injection, is therefore likely to improve the acceptability of medical treatment for patients requiring long-term somatostatin analog therapy.

Factors predicting pasireotide responsiveness in somatotroph pituitary adenomas resistant to first-generation somatostatin analogues: an immunohistochemical study

“…While earlier studies reported a high success rate for firstgeneration SSAs, octreotide and lanreotide (3,4), more recent studies show that control of growth hormone (GH) and insulin-like growth factor 1 (IGF1) levels using stricter criteria is achieved in !40% of patients (5,6). Pasireotide is a multireceptor-targeted SSA that binds SSTR1, SSTR2, SSTR3 and SSTR5, with the highest affinity for SSTR5 (7).…”

The Use of a Long-Acting Somatostatin Analogue (Lanreotide) in Three Children with Focal Forms of Congenital Hyperinsulinaemic Hypoglycaemia

“…Three long-acting formulations, namely octreotide LAR, lanreotide acetate, and an aqueous slow-release depot preparation (autogel) have been developed in an effort to increase the dosing interval and provide a more sustained clinical effect [16-18]. Previous studies [19-23] concluded that lanreotide acetate may be a safe and effective alternative therapy in patients with diffuse forms of CHI, offering an improved quality of life, since it is well tolerated and contributes to a clear simplification of the medical care.…”

Management of acromegaly: Is there a role for primary medical therapy?

“…Lanreotide Autogel (also referred to as lanreotide LAR or Somatuline) has been shown to have near identical efficacy to lanreotide SR in a few studies, including a fouryear follow-up study reported by Gutt et al [47,55,56]. Lanreotide Autogel has also been compared with octreotide LAR in two small cross-over studies, with no clear evidence of superiority for either drug [57,58].…”