ICEECE2012 Poster Presentations Pituitary Clinical (183 abstracts)
Pasireotide LAR vs octreotide LAR in patients with acromegaly: double-blind, crossover, extension period to a randomized, double-blind, multicenter, phase III study
M Fleseriu 1 , M Sheppard 2 , M Bronstein 3 , P Freda 4 , F Gu 5 , C Shen 6 , M Gadelha 7 , K Hermosillo Reséndiz 8 , M Ruffin 9 , Y Chen 8 & A Colao 10
1Oregon Health and Science University, Portland, Oregon; 2University of Birmingham, Edgbaston, Birmingham, UK; 3University of São Paulo Medical School, São Paulo, Brazil; 4Columbia University, College of Physicians and Surgeons, New York, USA; 5Ministry of Health, Peking Union Medical College Hospital, Beijing, China; 6National Yang-Ming University, Taipei, Taiwan; 7Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; 8Novartis Pharmaceuticals Corporation, Florham Park, New jersey, USA; 9Novartis Pharma AG, Basel, Switzerland; 10University of Naples ’Federico II’, Naples, Italy.
Introduction: In a large, randomized, double-blind, phase III trial in patients with acromegaly, pasireotide LAR was significantly more effective than octreotide LAR at inducing GH<2.5 μg/l and normal IGF1 after 12 months of therapy (core study). The crossover phase of this trial allowed patients without full biochemical control at month 12 to switch treatments. This abstract reports the results of patients who switched therapy.
Methods: Medically-naïve patients with active acromegaly (GH>5 μg/l or GH nadir≥1 μg/l post-OGTT, and IGF1>ULN) who were de novo with a visible adenoma on MRI or post-surgical, and who completed 12 months’ therapy with pasireotide LAR 40–60 mg/28day or octreotide LAR 20–30 mg/28day, could enter a double-blind extension phase. Patients with GH<2.5 μg/l and normal IGF1 at month 12 could continue on their randomized therapy, whereas patients with GH≥2.5 μg/l and/or IGF1>ULN (age and sex related) could switch treatment at month 13 to either pasireotide LAR 40 mg/28day or octreotide LAR 20 mg/28day, with dose titration allowed at 3-month intervals. Significance testing was not planned or performed during the extension phase.
Results: 80.1% (141/176) and 85.7% (156/182) of pasireotide LAR and octreotide LAR recipients completed the 12-month core study. 81 patients switched to pasireotide LAR; 38 patients switched to octreotide LAR. GH<2.5 μg/l and normal IGF1 was achieved by 21.0% (17/81) and 2.6% (1/38) of patients 6 months after switching to pasireotide LAR and octreotide LAR, respectively; GH<2.5 μg/l was recorded in 43.2% (35/81) and 31.6% (12/38); normal IGF1 was recorded in 30.9% (25/81) and 7.9% (3/38). The most common AEs (pasireotide LAR and octreotide LAR) were hyperglycemia (25.9 and 7.9%), diarrhea (21.0 and 15.8%), nasopharyngitis (16.0 and 18.4%) and headache (18.5 and 10.5%).
Conclusions: In patients with uncontrolled acromegaly after 12 months’ therapy with octreotide LAR, switching to pasireotide LAR improved biochemical control. The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of hyperglycemia. Pasireotide LAR may provide a pituitary-targeted alternative treatment option for patients inadequately controlled with currently available somatostatin analogues.
Declaration of interest: I fully declare a conflict of interest. Details below:
Funding: This work was supported, however funding details unavailable.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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