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Oral Octreotide in Patients With Acromegaly

Maria Fleseriu, MD, Director of the Pituitary Center at Oregon Health and Science University, discusses a post hoc analysis of three phase 3 studies analyzing the use of oral octreotide in patients with acromegaly. Acromegaly is a hormonal disorder that results from the pituitary gland producing too much growth hormone (GH). It is most often diagnosed in middle-aged adults, although symptoms can appear at any age. Common signs and symptoms include: Abnormal growth Swelling of the hands and feet Bone changes that alter various facial features Arthritis Carpal tunnel syndrome Enlargement of body organs The condition is usually caused by benign tumors on the pituitary called adenomas. Rarely, it is caused by tumors of the pancreas, lungs, and other parts of the brain stimulating the pituitary gland to produce GH. Acromegaly may also be part of other genetic syndromes. Current management involves surgery to remove or reduce the tumor. However, about half of acromegaly patients require further, lifelong medical therapies following surgery. Oral octreotide is a somatostatin analog that suppresses GH secretion from the pituitary gland and from GH-secreting adenomas, decreases Gh binding to hepatocytes, inhibits hepatic Insulin-like Growth Factor 1 (IGF-1) production, and controls tumor growth. A post hoc analysis of three phase 3 trials was conducted. All patients enrolled in the three studies had been on injectable somatostatin receptor ligands at the beginning of the study and were then switched to oral octreotide. Biochemical control was maintained by the majority of patients throughout the study, with 72% achieving the target of IGF-1 levels of less than 1 and 40% achieving levels of less than 1.3. Improvement of symptoms were observed in moderate to severe symptoms over the first six months. Specifically, symptoms such as joint pain and swelling were improved. The most common adverse events with oral octreotide are gastrointestinal issues. These symptoms typically occur in the first few weeks of therapy with a median duration of 14 days. Overall, tolerability and safety were observed. Chapters: Acromegaly Overview 00:00 Octreotide Clinical Trials 1:20