Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study.
OBJECTIVE
Lanreotide Autogel 120 mg (ATG120; Ipsen S.p.A, Milan, Italy) is a high-dose, sustained-release aqueous gel formulation, supplied in a prefilled syringe and given by deep subcutaneous injection. The aim of this study was to compare efficacy and tolerability of ATG120 given every 4-8 weeks with those of octreotide LAR (o-LAR) given every 4 weeks. DESIGN PATIENTS AND INTERVENTION: A phase III multicentre Italian open clinical study of 23 acromegalic patients (15 female, 8 male). All patients had received o-LAR for 6-18 months and, after 3 months wash out, ATG120 was given every 6 weeks for a total of four injections (Period 1). Then the interval between ATG120 injections was adjusted according to three different schemes: every 4, 6 or 8 weeks depending on GH levels (GH > 2.5 microg/l; 1 < GH <or= 2.5 microg/l; GH <or= 1 microg/l, respectively). ATG120 was given for a further two to three doses, with a final assessment (Period 2) at Week 34, 36 or 42.


METHODS
Hormonal (GH and IGF-I) and clinical efficacy and tolerability.


RESULTS
ATG120 induced a significant GH decrease from 9.9 +/- 11.3 at baseline (Visit 1) to 3.5 +/- 5.7 at the end of Period 1 (P < 0.01) and to 3.8 +/- 5.7 microg/l at the final visit (P < 0.01). IGF-I also decreased from 544 +/- 312 at baseline (Visit 1) to 318 +/- 181 at Period 1 and to 356 +/- 187 microg/l at the final visit (both P < 0.05 vs. baseline). The frequency of ATG120 administrations was adjusted to every 4 weeks in 12 patients, every 6 weeks in 4 patients and every 8 weeks in 6 patients; 1 patient withdrew before the dose adjustment. Serum GH and IGF-I achieved at the end of Period 1 and Period 2 were similar to those reached with o-LAR. The number of patients who achieved GH < 2.5 microg/l was comparable between o-LAR (43%) and ATG120 at Period 1 (48%) and at Period 2 (62%). Normal IGF-I levels were recorded in 8 patients during o-LAR (35%), 11 during ATG Period 1 (48%) and 10 at the final visit (43%). Last, 4 patients showed a better response to ATG120 and 2 to o-LAR.


CONCLUSIONS
Lanreotide Autogel 120 mg is an effective and well-tolerated therapy for acromegaly. In approximately half of patients ATG120 may be administered every 6-8 weeks, instead of every 4 weeks, without lost of efficacy.
Ronchi
C L
CL
Department of Medical Sciences, University of Milan, Unit of Endocrinology and Metabolism, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy. cristina.ronchi@unimi.it
Boschetti
M
M
Degli Uberti
E C
EC
Mariotti
S
S
Grottoli
S
S
Loli
P
P
Lombardi
G
G
Tamburrano
G
G
Arvigo
M
M
Angeletti
G
G
Boscani
P F
PF
Beck-Peccoz
P
P
Arosio
M
M
D000172:Acromegaly / Q000097:blood / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D002352:Carrier Proteins / Q000097:blood; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006023:Glycoproteins / Q000097:blood; D013006:Growth Hormone / Q000037:antagonists & inhibitors* / Q000097:blood; D006801:Humans; D007273:Injections, Intramuscular; D007333:Insulin Resistance; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use; D010456:Peptides, Cyclic / Q000627:therapeutic use*; D011388:Prolactin / Q000097:blood; D013004:Somatostatin / Q000031:analogs & derivatives* / Q000627:therapeutic use
D002352:Carrier Proteins; D003692:Delayed-Action Preparations; D006023:Glycoproteins; D010456:Peptides, Cyclic; C075944:insulin-like growth factor binding protein, acid labile subunit; C060347:lanreotide; D013004:Somatostatin; D007334:Insulin-Like Growth Factor I; D011388:Prolactin; D013006:Growth Hormone; D015282:Octreotide