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).
| 52 mg (n=11) | 84 mg (n=33) | ||
| 1 implant | 2 implants | 1 implant (NH or H) | |
| Mean±S.D. Cmax (pg/ml) | 1705±589 | 4182±2288 | 1291±628 (NH) |
| 2399±883 (H) | |||
| Mean±S.D. AUC0–t, pg·mo/ml | 6702±1944 | 14 427±6189 | 4182±1239 (NH) |
| 5922±1708 (H) | |||
| % reduction in mean IGF1 at mo 1/mo 6 (versus baseline) | 45/44 | 59/52 | 29/18 |
| % reduction in mean GH at mo 1 / mo 6 (versus baseline) | 91/86 | 66/74 | 74/63 |
| 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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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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