Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly.
OBJECTIVE
To evaluate efficacy and safety of lanreotide autogel (ATG) 120 mg injections every 4-8 weeks in somatostatin analogue-naïve patients with acromegaly.


METHODS
Open, non-comparative, phase III, multicenter clinical study.


METHODS
Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied. ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if <or=2.5 microg/l every 8 weeks (group A, 17 patients); if 2.5-5 microg/l every 6 weeks (group B, 15 patients); and if >5 microg/l every 4 weeks (group C, 19 patients). Treatment duration was 48-52 weeks. The primary objective was to control GH and IGF-I levels (GH<or=2.5 microg/l and IGF-I normalized for age/gender). Secondary objectives were to assess GH, IGF-I, and acid-labile subunit (ALS) decrease, improvement of clinical symptoms and quality of life (QoL).


RESULTS
GH levels normalized in 32 patients (63%), similarly in de novo and post-op patients (72% vs 50%, p=0.48); in 100% of group A, in 73% of group B and in 21% of group C (p<0.0001). IGF-I levels normalized in 19 patients (37%), similarly in the de novo and post-op patients (33% vs 50%, p=0.48): in 65% of group A, 33% of group B, and in 16% of group C. Circulating GH levels decreased by 80+/-17%, IGF-I levels by 44+/-27%, and ALS by 30+/-17%. Symptoms (hyperhidrosis (68.6%), swelling (68.6%), asthenia (58.8%), spine arthralgia (54.9%), and paresthesias (52.9%) and QoL (from 9.1+/-7.9 to 6.1+/-6.6) significantly improved (p<0.001). No patient withdrew from the study because of adverse events (AE). The most frequent AE was diarrhea (76.2% of patients): at study end 16 mild and 1 moderate diarrhea were recorded. Gallstones developed in 12% of patients.


CONCLUSIONS
ATG 120 mg in somatostatin-naïve patients with acromegaly controls GH secretion in 63% and IGF-I secretion in 37% during a 48-52 week period without any difference between de novo and post-op patients. The treatment was associated with improvement in clinical symptoms and QoL and with a good, safe profile.
Lombardi
G
G
Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples, Naples, Italy. gaelomba@unina.it
Minuto
F
F
Tamburrano
G
G
Ambrosio
M R
MR
Arnaldi
G
G
Arosio
M
M
Chiarini
V
V
Cozzi
R
R
Grottoli
S
S
Mantero
F
F
Bogazzi
F
F
Terzolo
M
M
Tita
P
P
Boscani
P F
PF
Colao
A
A
D000172:Acromegaly / Q000188:drug therapy* / Q000209:etiology; D000236:Adenoma / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000465:Algorithms; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005782:Gels / Q000008:administration & dosage / Q000009:adverse effects; D049912:Growth Hormone-Secreting Pituitary Adenoma / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000008:administration & dosage* / Q000009:adverse effects; D013004:Somatostatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D055815:Young Adult
D000970:Antineoplastic Agents; D003692:Delayed-Action Preparations; D005782:Gels; D010456:Peptides, Cyclic; C060347:lanreotide; D013004:Somatostatin