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Results of the largest Phase III study of acromegaly patients to date show the novel therapy pasireotide (SOM230) long-acting release (LAR), was significantly more effective at inducing full biochemical control compared with the current standard medical therapy, Sandostatin® LAR® (octreotide/IM injection).
These data were presented at the 2012 joint 15th International Congress of Endocrinology and 14th European Congress of Endocrinology meeting (ICE/ECE) in Florence, Italy.
Acromegaly is a rare endocrine disorder characterised by enlargement of the hands, feet and internal organs, as well as changes in facial structure. The majority of acromegaly cases are caused by a non-cancerous tumour in the pituitary gland that secretes excess growth hormone (GH), leading to elevated levels of insulin like growth factor (IGF)-1.
The study met its primary endpoint, with significantly more patients treated with pasireotide LAR (31.3%) experiencing full control of their disease (defined as the combination of both GH <2.5µg/L and age- and sex-matched normalised IGF-1 levels) than those taking octreotide LAR (19.2%) (p=0.007).
Patients treated with pasireotide LAR were 63% more likely to achieve control of their disease than those on octreotide LAR. The safety profile of pasireotide LAR was similar to that of octreotide LAR with the exception of a higher degree of hyperglycaemia.
Growth hormone and IGF-1 levels are typically used to determine control of the disease with the most commonly used standard medical therapy, somatostatin analogs.
Currently, only 20-25% of acromegaly patients naïve to previous somatostatin analog treatment achieve full control over their disease when treated with current somatostatin analogs, as measured by these two levels.
“While Sandostatin LAR is an effective treatment, inadequate control of GH and IGF-1 remains an issue for many patients with acromegaly and new therapeutic approaches are needed for these patients to better control their disease,” said Annamaria Colao, MD, lead study investigator and Professor of Endocrinology, Chief of the Neuroendocrine Unit at the Department of Molecular and Clinical Endocrinology and Oncology, Federico II University of Naples.
“We are very encouraged by the findings of this study, the largest ever in this population, which found that pasireotide LAR provided full control in nearly a third of study participants.”