Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial

What Was Tested

The paper reports a study of Octreotide and Somatostatin, published as a randomized controlled trial.

Pasireotide (SOM230) is a novel multireceptor ligand somatostatin analog with affinity for somatostatin receptor subtypes sst(1-3) and sst(5).

Who Took Part

The age groups tagged for this paper are teenagers, young adults, adults, middle-aged adults, older adults and people over 80, both men and women.

Sixty patients with acromegaly, defined by a 2-h five-point mean GH level higher than 5 microg/liter, lack of suppression of GH to less than 1 microg/liter after oral glucose tolerance test, and elevated IGF-I for age- and sex-matched controls.

Patients could have had previous surgery, radiotherapy, and/or medical therapy or no previous treatment.

How the Study Was Run

In design terms this was a randomized, double-blind, open-label, crossover and multicenter study.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Each person switched between Octreotide and the comparison at some point, usually with a gap in between.

The researchers conducted a phase II, randomized, multicenter, open-label, three-way, crossover study.

After treatment with octreotide 100 microg s.c. three times daily for 28 d, each patient received pasireotide 200, 400, and 600 microg s.c. twice daily in random order for 28 d.

What Was Measured

Topics PubMed links to this paper include Acromegaly, Blood Glucose, Endpoint Determination, Human Growth Hormone, Insulin-Like Growth Factor I, Magnetic Resonance Imaging and Octreotide.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Octreotide and Somatostatin.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2010 (The Journal of clinical endocrinology and metabolism), a journal based in United States.

More context: the Octreotide compound page and the Somatostatin compound page.