Comparison of octreotide acetate LAR and lanreotide SR in patients with acromegaly.
OBJECTIVE
The most effective option for the medical treatment of patients with acromegaly is the use of somatostatin analogues. Long-acting depot formulations for intramuscular injection of two somatostatin analogues have recently become available: octreotide acetate LAR (Sandostatin LAR, Novartis Pharma AG) and lanreotide SR (Somatuline, Ipsen Biotech). We wished to compare efficacy of octreotide LAR and lanreotide SR in acromegalic patients.


METHODS
A group of 125 patients with acromegaly (67 females; mean age, 47 years; 59 patients had previous pituitary irradiation) from 26 medical centres in France, Spain and Germany were studied. Before the study, all patients had been treated with intramuscular injections of lanreotide SR (mean duration, 26 months) at a dose of 30 mg which was injected every 10 days in 64 and every 14 days in 61 patients, respectively. All patients were switched from lanreotide SR to intramuscular injections of 20 mg of octreotide LAR once monthly for three months. In order to obtain efficacy and safety data of lanreotide SR under study conditions, it was decided to randomly assign at day 1, in a 3 : 1 ratio, the time point of the treatment switch; 27 of the patients were randomly assigned to continue the lanreotide SR treatment for the first 3 months of the study (group A); they were on octreotide LAR 20 mg from month 4-6. The other 98 patients were assigned to be switched to treatment with octreotide LAR 20 mg at day 1 (group B). In group B patients, octreotide LAR treatment was continued until month 6, with an adjustment of the dose based on GH levels obtained at month 3.


RESULTS
The mean GH concentration decreased from 9.6 +/- 1.3 mU/l at the last evaluation on lanreotide SR to 6.8 +/- 1.0 mU/l after three injections of octreotide LAR (P < 0.001). The percentages of patients with mean GH values < or = 6.5 mU/l (2.5 microg/l) and < or = 2.6 mU/l (1.0 microg/l) at the last evaluation on lanreotide SR were 54% and 14%, and these values increased after 3 months treatment with octreotide LAR to 68% and 35% (P < 0.001), respectively. IGF-I levels were normal in 48% at the last evaluation on lanreotide SR and in 65% after 3 months on octreotide LAR (P < 0.001). Patients with pre-study pituitary irradiation had lower mean GH and IGF-I concentrations. But the effects of the treatment change did not differ between the irradiated and the nonirradiated patients. In general both drugs were well tolerated.


CONCLUSIONS
Octreotide LAR 20 mg administered once monthly was more effective than lanreotide SR 30 mg administered 2 or 3 times monthly in reducing GH and IGF-I in patients with acromegaly.
Chanson
P
P
Novartis Pharma AG, Clinical Research and Development, Basel, Switzerland.
Boerlin
V
V
Ajzenberg
C
C
Bachelot
Y
Y
Benito
P
P
Bringer
J
J
Caron
P
P
Charbonnel
B
B
Cortet
C
C
Delemer
B
B
Escobar-Jiménez
F
F
Foubert
L
L
Gaztambide
S
S
Jockenhoevel
F
F
Kuhn
J M
JM
Leclere
J
J
Lorcy
Y
Y
Perlemuter
L
L
Prestele
H
H
Roger
P
P
Rohmer
V
V
Santen
R
R
Sassolas
G
G
Scherbaum
W A
WA
Schopohl
J
J
Torres
E
E
Varela
C
C
Villamil
F
F
Webb
S M
SM
D000172:Acromegaly / Q000097:blood / Q000188:drug therapy* / Q000532:radiotherapy; D000293:Adolescent; D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006728:Hormones / Q000627:therapeutic use*; D019382:Human Growth Hormone / Q000097:blood; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use*; D010456:Peptides, Cyclic / Q000627:therapeutic use*; D010910:Pituitary Irradiation; D011897:Random Allocation; D013004:Somatostatin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D006728:Hormones; D010456:Peptides, Cyclic; C060347:lanreotide; D019382:Human Growth Hormone; D013004:Somatostatin; D007334:Insulin-Like Growth Factor I; D015282:Octreotide