Swiss drug maker Novartis on Monday presented the final-stage trial of Signifor long-acting release (LAR) therapy and expressed confidence that it can do wonders in treating patients with the endocrine disorder acromegaly than existing therapies.
The clinical trial was presented at the 16th European Congress of Endocrinology3.
The study, conducted by Novartis, showed that patients who took pasireotide LAR achieved greater disease control when it was compared with continued treatment with the standard somatostatin analogue therapies, octreotide LAR or lanreotide Autogel.
Acromegaly is a bad health condition which is caused by a benign (non-cancerous)tumor in the pituitary gland. This leads to secretion of excess growth hormone and can even cause enlargement of body parts including hands, feet and facial features.
This can also cause serious morbidities such as cardiovascular, metabolic and respiratory diseases.
Study author Dr. Monica Gadelha, who is a professor at Federal University of Rio de Janeiro, said, “Historically, we have evaluated somatostatin analogues for the treatment of acromegaly by the decrease in either growth hormone or insulin-like growth factor levels. With more sensitive assays and more stringent evaluation criteria, a recent meta-analysis indicates that up to 45 percent of patients can have either GH or IGF-I still elevated.”
“As the health risks associated with acromegaly may persist until both GH and IGF-1 levels are normalized, this study further supports the importance of monitoring for and achieving full biochemical control,” he further said.
Novartis study evaluated pasireotide LAR 40 mg and 60 mg against continued therapy with octreotide LAR or lanreotide Autogel. Only those patients were included in the study who did not achieve GH and IGF-1 biochemical control despite receiving the maximum approved doses of these currently available somatostatin analogues (SSAs).
During the trial period, researchers found that patients in significant number achieved biochemical control with each dose of pasireotide LAR compared to the octreotide LAR and lanreotide Autogel control arm.