LEADER-4: Treating Diabetes Controls Blood Pressure

Patients with type 2 diabetes mellitus (T2DM) are at risk of developing high blood pressure, which can cause renal and cardiovascular complications. Thus, a T2DM treatment plan must include blood pressure treatment.

The healthcare community has watched the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular outcome Results (LEADER) study with great interest.

LEADER — a continuing 3B cardiovascular outcome trial – studies treatment of T2DM individuals treated with the glucagon-like peptide-1 analogue liraglutide who are at a high risk of developing cardiovascular disease.

The study, published in the Journal of Hypertension, examined this treatment through the lens of cardiovascular safety and treatment benefits.

Participants were treated with a placebo or liraglutide for 3.5 to five years and the two groups’ cardiovascular events were compared. LEADER defines cardiovascular events as nonfatal stroke in adult participants, primary endpoint of cardiovascular death, and nonfatal myocardial infarction.

The authors analyzed data from 9,340 LEADER participants in 32 countries.

The average participant was 64 years old, overweight (BMI 32.5) and had had diabetes for approximately 13 years. All participants were at high risk for cardiovascular disease (CVD).

Approximately 81% of participants had prior CVD, and 90% had a prior history of hypertension. The latter is the highest prevalence of hypertension reported in any previous study of glucose-lowering therapy.

At baseline, all participants were taking multiple antihypertensive agents, but only half had achieved a target blood pressure reading of less than 140/85 mmHg. Additionally, only 26% met the recommended baseline target of less than 130/80 mmHg.

The team also found that only 50—54% of trial participants achieved acceptable blood pressure control. Blood pressure was better controlled in secondary prevention participants (81% of the total) than in those in the primary prevention category. Secondary prevention tends to be more intense than primary prevention, and relies more on drug therapy.

The authors concluded the data they analyzed showed that blood pressure in a large percentage of T2DM patients — especially those living outside North America – is uncontrolled.