Long-term safety of long-acting octreotide in patients with diabetic retinopathy: results of pooled data from 2 randomized, double-blind, placebo-controlled phase 3 studies

What Was Tested

This randomized controlled trial paper looks at Octreotide in the context of diabetic retinopathy and glaucoma.

Octreotide (OCT) has been successfully used for treatment of acromegaly and neuroendocrine tumors for more than 30 years.

However, long-term safety of OCT has not been documented in placebo-controlled setting.

Who Took Part

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

Two studies (NCT00131144, NCT001308450) were conducted in patients with diabetic retinopathy (OCT20 = 191, OCT30 = 348, placebo = 347).

In this analysis, patients were stratified based on baseline glomerular filtration rate.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

A placebo (an inactive look-alike) gave the Octreotide group a baseline to be compared against.

Hepatic, cardiac, and renal adverse events (AEs) were identified by standardized MedDRA queries.

What Was Measured

The subject headings attached to it are Cholelithiasis, Diabetic Retinopathy, Diarrhea, Hypertension, Hypoglycemia and Octreotide.

The authors tagged it with the keywords Cardiac function, Hepatic function, Long-term safety and Renal function.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Octreotide in people with diabetic retinopathy and glaucoma.

The abstract goes on to report its results in about 9 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2018 (Endocrine), a journal based in United States.

More context: the Octreotide compound page, Diabetic retinopathy and glaucoma research.