By Ric Susman
ORLANDO, Fla -- May 21, 2008 -- The investigative drug pasireotide effectively suppressed growth-hormone production in acromegaly patients, including in patients unresponsive to octreotide, without causing clinically relevant changes in glucose tolerance, according to research presented here at the 17th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE).
"This study indicates that pasireotide is an effective and well-tolerated treatment for patients with de novo or persistent/recurrent acromegaly," said Joan E. Glusman, MD, Senior Medical Researcher, Novartis Pharmaceuticals, East Hanover, New Jersey, speaking at a poster presentation here May 17.
Dr. Glusman and colleagues recruited 12 individuals with acromegaly and treated them 3 times daily with subcutaneous octreotide 100 mcg for 28 days, to assess patient response to standard treatment. Following this treatment period, patients received twice-daily subcutaneous pasireotide in 200-mcg doses, 400-mcg doses, or 600-mcg doses for 28 days. The doses were administered in a random fashion.
The majority of patients (n = 8) experienced statistically significantly stronger growth-hormone suppression with pasireotide treatment (reduction of 75.1%) than with octreotide (reduction of 22.8%) (P < .01), Dr. Glusman noted.
The other 4 patients in the study achieved a similar growth-hormone nadir following both treatment with pasireotide (reduction of 71%) and octreotide (reduction of 72.3%). The difference, however, was not clinically significant.
"We found that pasireotide is effective at suppressing growth hormone in patients with acromegaly, including those unresponsive to octreotide, without inducing clinically relevant changes in glucose tolerance in the majority of patients during the study period," Dr. Glusman reported.
Long-term studies are necessary to confirm the efficacy and safety of pasireotide, the team concluded.
Acromegaly is a rare condition characterised by chronic hypersecretion of growth hormones that is caused by a pituitary adenoma in more than 90% of patients. It is associated with significant morbidity and mortality if not treated successfully.
[Presentation title: Results From a Phase II Study of Pasireotide (som230) in Patients With Acromegaly: Effects on Glucose Metabolism and Growth Hormone Nadir During the Oral Glucose Tolerance Test. Abstract 808]
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