ORAL OCTREOTIDE

NEW YORK (Reuters Health) - Oral octreotide appears to be safe and effective in treating acromegaly in patients switched from parenteral therapy, according to a multinational group of researchers.

"Development of an effective oral octreotide formulation is important as it offers our patients with acromegaly an oral therapeutic option for their management," Dr. Shlomo Melmed, of Cedars-Sinai Medical Center, Los Angeles, told Reuters Health by email.

"Oral octreotide capsules (OOC) are safe," he added, "and effectively maintain biochemical control after use of injectable somatostatin analogs."

In a February 9 online paper in The Journal of Clinical Endocrinology & Metabolism, Dr. Melmed and colleagues note that they came to this conclusion after a study of the agent in complete or partially controlled patients.

All had been receiving an injectable somatostatin receptor ligand (SRL) for at least three months. They were switched to oral octreotide capsules. The dose was escalated to as much 80 mg/day to control insulin growth factor-1 (IGF-1). Fixed doses were then maintained for a seven-month core period, followed by a voluntary six-month extension.

In total, 151 of 155 subjects were evaluable. Twenty-six subjects were considered treatment failures and terminated early, and 23 withdrew because of adverse events. Core treatment was completed by 102, and 86% of this group elected to enroll in the 6-month extension.

The agent was effective in controlling and maintaining IGF-1 and integrated growth hormone (GH) levels for up to 13 months. The primary efficacy endpoint was achieved by 65% of subjects at the end of the core treatment and by 62% at the end of 13 months, compared to 89% on injectable SRLs at baseline.

The effect was durable, with 85% of subjects initially controlled maintaining their response for up to 13 months. GH levels were reduced compared to baseline, and acromegaly-related symptoms improved.

Overall, the team conclude, the oral octreotide formulation "appears to be effective and safe as an acromegaly monotherapy."

"Based on the published results," Dr. Melmed added, "switching to oral therapy when approved, will allow for continued and sustained disease control while also eliminating the need for regular somatostatin analog injections."

SOURCE: http://bit.ly/1Ds1HvE

J Clin Endocrinol Metab 2015.