Searchable abstracts of presentations at key conferences in endocrinology

ea0026p263 | Pituitary | ECE2011

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

Chieffo C , Ryan M , Bai S , Hu X , Decker S , Quandt H , Frohman L , Gadelha M

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...

ea0041ep901 | Pituitary - Clinical | ECE2016

High burden of illness at baseline in patients with uncontrolled acromegaly participating in the PAOLA study

Shimon Ilan , Raverot Gerald , Coculescu Mihail , Bolanowski Marek , Colao Annamaria , Kandra Albert , Resendiz Karina Hermosillo , Pedroncelli Alberto M , Gadelha Monica

Background: The Phase III PAOLA study assessed the efficacy and safety of pasireotide LAR versus continued treatment with octreotide LAR or lanreotide Autogel in patients with uncontrolled acromegaly. The current analysis investigated overall baseline characteristics and response rates to pasireotide according to co-morbidities.Methods: Patients were classified into five groups of co-morbidities related to acromegaly: glucose- (n=104), endocrine...

ea0029p1355 | Pituitary Basic | ICEECE2012

Lycopene and β-carotene induce growth-inhibitory and proapoptotic effects on pituitary tumor cells: the mechanism could involve Connexin 43

Haddad N. , Teodoro A. , Soares N. , Oliveira F. , Mattos R. , Gomes F. , Gadelha M. , Nasciutti L. , Miranda-Alves L.

Pituitary adenomas account for ~10–15% of intracranial tumors and result in morbidity due to both altered hormonal patterns as well as side effects of therapy. Currently, great attention has been given to natural coumpouds from functional foods. Among these substances, we highlight that the consumption of carotenoids is associated with reduced risk of chronic diseases including cancer and vascular diseases. In this study we evaluate the influence of β-carotene and ly...

ea0029oc1.1 | Pituitary Clinical I | ICEECE2012

Pasireotide LAR is significantly more effective than octreotide LAR at inducing biochemical control in patients with acromegaly: results of a 12-month randomized, double-blind, multicenter, Phase III study

Colao A. , Bronstein M. , Freda P. , Gu F. , Shen C. , Gadelha M. , Fleseriu M. , Hermosillo Resendiz K. , Ruffin M. , Chen Y. , Sheppard M.

Introduction: Using the criterion of GH<2.5 μg/l and normalized IGF1, response rates to currently available somatostatin analogues in medically-naïve patients with acromegaly are 20–25% after 12 m. The broader somatostatin receptor binding profile of pasireotide may potentially improve response rates. This randomized, double-blind 12-m study compared pasireotide LAR with octreotide LAR.Methods: Patients with acromegaly (GH>5 μ...

ea0029p1404 | Pituitary Clinical | ICEECE2012

Pasireotide LAR vs octreotide LAR in patients with acromegaly: double-blind, crossover, extension period to a randomized, double-blind, multicenter, phase III study

Fleseriu M , Sheppard M , Bronstein M , Freda P , Gu F , Shen C , Gadelha M , Hermosillo Resendiz K , Ruffin M , Chen Y , Colao A

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: Medicall...

ea0029p1408 | Pituitary Clinical | ICEECE2012

Pasireotide treatment is associated with clinically meaningful improvements in health-related quality of life in Cushing’s disease: results from a large, randomized, double-blind phase III trial

Webb S , Badia X , Zgliczynski W , Portocarrero-Ortiz L , Maldonado M , Trovato A , Forsythe A , Nelson L , McLeod L , De Block C , Gadelha M

Introduction: Patients with Cushing’s disease have significantly impaired health-related quality of life (HRQoL). Effective treatment is needed to treat Cushing’s disease and improve HRQoL; however, there are currently no approved medical treatments for Cushing’s disease. The effect of pasireotide on HRQoL in patients with Cushing’s disease was evaluated as part of a randomized, phase III study.Methods: Patients with persistent/recurr...

ea0011p433 | Endocrine disruptors | ECE2006

A randomized, open-label, multicenter study to evaluate octreotide LAR with surgical therapy as primary therapy patients with acromegaly

Colao A , Bouterfa H , Cappabianca P , Caron P , De Menis E , Farrall A , Gadelha M , Reed A , Reincke M , Safari M , T’Sjoen G , Cuneo R

This is the first prospective study to compare the efficacy and safety of medical therapy and surgery as primary therapy in acromegaly.A total of 104 patients with untreated acromegaly were enrolled. Eighty-one patients randomized to receive either octreotide LAR 20 mg (n=40) or surgery (n=41) completed the 48 weeks treatment period, and constituted the population used for this analysis, regardless of response to treatment.<p class="abs...

ea0037ep810 | Pituitary: clinical | ECE2015

Pasireotide long-acting release maintains biochemical control in patients with acromegaly: results from the extension of randomised, Phase III, PAOLA study

Colao Anna Maria , Bronstein Marcello D , Brue Thierry , Coculescu Mihail , Marinis Laura De , Fleseriu Maria , Guitelman Mirtha A , Pronin Vyacheslav , Raverot Gerald , Shimon Ilan , Fleck Juergen , Kandra Albert , Pedroncelli Alberto M , Gadelha Monica R

Introduction: The PAOLA study in patients with inadequately-controlled acromegaly (n=198) demonstrated superior efficacy of pasireotide long-acting release (LAR; 40 mg/60 mg) in biochemical control (GH <2.5 μg/l and normalized IGF-1) vs continued treatment with octreotide LAR 30 mg/lanreotide Autogel 120 mg (15.4% and 20.0% vs 0%). Here we report preliminary data from the extension phase of PAOLA at wk28.Methods: Pasireotide-LAR (40 mg/...