A randomized, controlled, multicentre trial comparing pegvisomant alone with combination therapy of pegvisomant and long-acting octreotide in patients with acromegaly

What Was Tested

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

For patients with acromegaly who are suboptimally controlled on long-acting octreotide (LAR), treatment options are to switch to pegvisomant monotherapy (PM) or add pegvisomant to LAR (P-LAR).

Who Took Part

According to the abstract, 27 patients were involved.

By PubMed's age tags, the people studied were adults and middle-aged adults, both men and women.

This was an open-label, multicentre, randomized, 40-week outpatient study.

The control arm consisted of patients controlled on LAR (n = 28).

How the Study Was Run

The researchers set it up as a randomized, open-label and multicenter study.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

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.

Running at several centres spread the Octreotide study over different clinics and patient groups.

The primary end-point was adverse events (AEs).

The RIA for IGF-I was discontinued by the manufacturer during the study and a chemiluminescent assay was subsequently used.

Previously obtained IGF-I levels were re-analysed.

What Was Measured

PubMed files the paper under topics including Acromegaly, Human Growth Hormone, Insulin-Like Growth Factor I, Liver and Octreotide.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Octreotide in 27 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 7 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2009 (Clinical endocrinology), a journal based in England.

More context: the Octreotide compound page, all human trials.