LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial

What Was Tested

Researchers studied Liraglutide in the context of low blood pressure and orthostatic hypotension in this randomized controlled trial publication.

As glucagon-like peptide-1 receptor agonists lower blood pressure (BP) in type 2 diabetes mellitus (T2DM), the researchers examined BP control in relation to targets set by international bodies prior to randomization in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial.

Who Took Part

According to the abstract, 9340 people were involved.

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

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

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

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

The researchers analyzed baseline data from LEADER (NCT01179048), an ongoing phase 3B, randomized, double-blind, placebo-controlled cardiovascular outcomes trial examining the cardiovascular safety of the glucagon-like peptide-1 receptor agonist liraglutide in 9340 people with T2DM from 32 countries [age (all mean ± SD) 64 ± 7.2 years, BMI 32.5 ± 6.3 kg/m, duration of diabetes 12.7 ± 8.0 years], all of whom were at high risk for cardiovascular disease (CVD).

What Was Measured

PubMed files the paper under topics including Antihypertensive Agents, Blood Pressure, Diabetes Mellitus, Type 2, Glucagon-Like Peptide-1 Receptor, Hypertension, Hypoglycemic Agents and Liraglutide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Liraglutide in 9340 people in people with low blood pressure and orthostatic hypotension.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2016 (Journal of hypertension), a journal based in Netherlands.

More context: the Liraglutide compound page, Low blood pressure and orthostatic hypotension research.