Endocrine Abstracts (2011) 26 P263

Octreotide pharmacokinetics and biochemical control of acromegaly using a subcutaneous octreotide hydrogel implant

C Chieffo1,3, M Ryan1,3, S Bai1,3, X Hu1,3, S Decker1,3, H Quandt1,3, L Frohman2,3 & M Gadelha1,3

1Endo Pharmaceuticals, Inc., Chadds Ford, Pennsylvania, USA; 2University of Illinois at Chicago, Chicago, Illinois, USA; 3Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.

Two randomized open-label, phase II studies evaluated an octreotide hydrogel implant to suppress serum GH and IGF1 levels in adult acromegaly patients. Implants were inserted subcutaneously in the upper arm for 6 months. Patients in study 1 received 1 (n=5) or 2 (n=6) 52-mg octreotide (60 mg octreotide acetate) hydrated implants; patients in study 2 received a hydrated (H) or nonhydrated (NH) 84-mg octreotide acetate implant (n=34, 1 excluded from efficacy and pharmacokinetic population). Efficacy data are shown (table).

Table 1
52 mg (n=11)84 mg (n=33)
1 implant2 implants1 implant (NH or H)
Mean±S.D. Cmax (pg/ml)1705±5894182±22881291±628 (NH)
2399±883 (H)
Mean±S.D. AUC0–t, pg·mo/ml6702±194414 427±61894182±1239 (NH)
5922±1708 (H)
% reduction in mean IGF1 at mo 1/mo 6 (versus baseline)45/4459/5229/18
% reduction in mean GH at mo 1 / mo 6 (versus baseline)91/8666/7474/63
Normalized IGF1, n (%)1 (20)2 (33)17 (52)
Mean GH <5 ng/ml, n (%)5 (100)5 (83)23 (70)
Mean GH <2.5 ng/ml, n (%)4 (80)4 (67)13 (39)
Mean GH <1 ng/ml, n (%)1 (20)2 (33)2 (6)

The most frequent treatment-related adverse event was diarrhea (64%, study 1; 18%, study 2). The octreotide hydrogel implants provided consistent and sustained octreotide release, resulting in IGF1 and GH suppression over 6 months; the 84-mg NH octreotide hydrogel implant is currently being tested in phase III studies.

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