New Oral Octreotide Approved to Treat Acromegaly скачать в хорошем качестве

New Oral Octreotide Approved to Treat Acromegaly

Susan Samson, MD, PhD, of Baylor College of Medicine talks about the recently approved Mycapssa (octreotide) capsules as long-term maintenance therapy for people with acromegaly. Mycapssa is the only oral form of octreotide, a somatostatin analog, approved by the US Food and Drug Administration (FDA) to treat acromegaly. Acromegaly is a rare endocrine disorder usually caused by a benign pituitary tumor and is characterized by excess production of growth hormone and insulin-like growth factor-1 hormone. As Dr. Samson explains in this interview, the approval was largely based on the pivotal phase 3 CHIASMA OPTIMAL clinical trial showing Mycapssa to be superior to placebo in the randomized, double-blind, placebo-controlled, nine-month study. The most common adverse events observed with Mycapssa were: cholelithiasis and complications of cholelithiasis; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; and decreased vitamin B12 levels and abnormal Schilling’s tests.