Oral therapy shows promise as injection alternative for acro
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Adults with acromegaly assigned an investigational oral form of the somatostatin analogue octreotide maintained a biochemical response at 36 weeks achieved with previous injection therapy with no serious adverse events, according to findings from the OPTIMAL study accepted for presentation at the Endocrine Society Annual Meeting.

Many adults with acromegaly prescribed long-acting somatostatin receptor ligand injections as first-line therapy report limitations, such as disease symptoms that worsen near the end of the injection cycle, as well as injection site pain. “Oral octreotide capsules (Mycapssa, Chiasma) will provide us with a new option for appropriate patients with acromegaly, which we have not had before,” Samson told Healio. “It provides a novel treatment using the same principles of somatostatin analogues, which we already understand with respect to their efficacy as well as their side effects.”

In a randomized controlled trial, Samson and colleagues analyzed data from 56 adult patients with active acromegaly, defined as an insulin-like growth factor I level of at least 1.3 times the upper limit of normal at least 3 months after last pituitary surgery, and an average IGF-I level below one times the upper limit of normal while prescribed a stable dose somatostatin receptor ligand injections.

Researchers randomly assigned participants to octreotide (n = 28) or placebo (n = 28) for 36 weeks, followed by an optional, open-label oral octreotide extension phase. Primary endpoint was the proportion of participants maintaining a biochemical response, defined as IGF-I level below one times the upper limit of normal (a two-value average at weeks 34 and 36); secondary endpoints were need for rescue with somatostatin receptor ligand injections, growth hormone level response and time to loss of IGF-I response.

At 36 weeks, 58% of participants assigned octreotide and 19% of participants assigned placebo maintained an IGF-I response (P = .008). Mean IGF-I levels were within the reference range at 36 weeks for participants in the octreotide group (mean, 0.97 times the upper limit of normal) vs. those assigned placebo (mean, 1.69 times the upper limit of normal).

Source: https://www.healio.com/endocrinology/neuroendocrinology/news/online/{d3e8933f-e270-4439-8048-7703e6050aed}/oral-therapy-shows-promise-as-injection-alternative-for-acromegaly?page=2
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