Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial

What Was Tested

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

Cushing's disease is a rare debilitating endocrine disorder for which few prospective interventional studies have been done.

The researchers report results of the first phase 3 trial assessing long-acting intramuscular pasireotide in patients with Cushing's disease.

Who Took Part

The age groups tagged for this paper are adults, both men and women.

Exclusion criteria included previous pasireotide treatment, mitotane therapy within 6 months, and pituitary irradiation within 10 years.

The primary endpoint was the proportion of patients in each group with an mUFC concentration of less than or equal to the ULN at month 7.

How the Study Was Run

The researchers set it up as a randomized study.

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

The timeline in the abstract includes 6 months.

The researchers stratified randomisation by screening mUFC concentration (1·5 to <2·0 × ULN and 2·0-5·0 × ULN).

This trial is registered with ClinicalTrials.gov, number NCT01374906.

What Was Measured

The researchers report results of the first phase 3 trial assessing long-acting intramuscular pasireotide in patients with Cushing's disease.

PubMed files the paper under topics including Cushing Syndrome, Hormones, Safety and Somatostatin.

What This Means in Plain Language

The paper is a randomized study of Somatostatin and Pasireotide over 6 months.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2018 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Somatostatin compound page and the Pasireotide compound page, all human trials.