Pasireotide for Uncontrolled Acromegaly—New Phase III

Home , Lanreotide, Pasireotide

RESEARCH HIGHLIGHTS Nature Reviews Endocrinology 10, 700 (2014); published online 14 October 2014; doi:10.1038/nrendo.2014.176

PHARMACOTHERAPY Pasireotide for uncontrolled acromegaly —new phase III trial data

Results from a phase III clinical trial show patients ... but the greatest unmet need that pasireotide long-acting release (LAR) is in patients inadequately controlled by is more effective than either octreotide first-generation somatostatin analogues”. or lanreotide for treating patients with The multicentre study enrolled 198 acromegaly, supporting use of pasireotide patients, aged ≥18 years, who had LAR for patients with disease that is previously received either 30 mg octreotide

inadequately controlled by first-generation long-acting repeatable or 120 mg Ugreen/iStock/Thinkstock somatostatin analogues. lanreotide Autogel as monotherapy, but Octreotide and lanreotide are the whose acromegaly remained uncontrolled A greater proportion of patients who current first-line therapies for acromegaly; after 6 months of continuous treatment. received pasireotide LAR achieved however, these treatments are estimated to Inadequate control was defined as five- biochemical control and had >25% leave as many as 30–80% of patients with point, 2 h mean growth hormone levels reductions in tumour volume, as well inadequately controlled levels of circulating of >2.5 μg/l and IGF-1 levels >1.3 times as greater improvements in symptoms growth hormone and insulin-like growth the sex-adjusted and age-adjusted upper than patients in the active control group, factor 1 (IGF-1). normal limit. Participants were randomly although patients in all groups reported Prior to this study, a large randomised assigned to one of three groups for increases in quality of life. double-blind clinical trial demonstrated 24 weeks, receiving either 40 mg or that pasireotide LAR was superior to 60 mg of pasireotide LAR every 28 days Jennifer Sargent octreotide in patients with acromegaly or open label active control with continued who had not previously received treatment with octreotide or lanreotide. Original article Gadelha, M. R. et al. Pasireotide versus pharmacological therapy for their disease. The end points of the study were achieving continued treatment with octreotide or lanreotide in Mônica Gadelha, lead author of the adequate control of growth hormone and patients with inadequately controlled acromegaly (PAOLA): study, says “the new study complements the IGF-1 levels, tumour volume reductions, a randomised, phase 3 trial. Lancet Diabetes Endocrinol. doi:10.1016/S2213-8587(14)70169-X earlier study performed in medically naïve changes in symptoms and quality of life.