What is the clinical evidence from this study?

Study design: RCT. Population: Type 2 diabetes mellitus (n=54). Intervention: Exenatide vs. Placebo. Primary outcome: Change from baseline in mean 24-hour heart rate (p=0.16).

January 28, 2010Cardiovascular Diabetology135 citationsOpen Access

Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study

AGAnne Gill BHByron J. Hoogwerf JBJude Burger

Key Result

Exenatide demonstrated no clinically meaningful effects on mean 24-hour heart rate compared to placebo over 12 weeks of treatment in subjects with type 2 diabetes mellitus (p=0.16).

Study Design

Type

RCT (n=54)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Yes

PICO

Population

54 overweight adults aged 18-75 with type 2 diabetes mellitus on stable metformin and/or thiazolidinedione therapy, followed for 12 weeks.

Intervention / Comparator

Exenatide vs Placebo (5 μg for 4 weeks followed by 10 μg BID)

Primary Outcome

Change from baseline in mean 24-hour heart rate, p=0.16

Main Result

Absolute Event Rate: 2.1% vs -0.7%

p-value: p=0.16

Limitations

The study population of mostly overweight subjects with blood pressure in the early stage-1 hypertensive range does not represent all patients with type 2 diabetes mellitus.
The sample size may have been insufficient for determining statistical significance in some non-primary results.

Abstract

BACKGROUND: Cardiovascular effects of glucose-lowering agents are of increasing interest. Our aim was to assess the effects of the glucagon-like peptide-1 receptor agonist exenatide on heart rate (HR) and blood pressure (BP) in subjects with type 2 diabetes mellitus (T2DM). METHODS: In this double-blind, placebo-controlled trial, subjects with T2DM on metformin and/or a thiazolidinedione were randomized to receive exenatide (5 microg for 4 weeks followed by 10 microg) or placebo BID for 12 weeks. Heart rate and BP were assessed with 24-hour ambulatory BP monitoring. The primary measure was change from baseline in mean 24-hour HR. RESULTS: Fifty-four subjects (28 exenatide, 26 placebo) were randomized and comprised the intent-to-treat population. Baseline values (exenatide and placebo) were (mean +/- SE) 74.4 +/- 2.1 and 74.5 +/- 1.9 beats/minute for HR, 126.4 +/- 3.2 and 119.9 +/- 2.8 mm Hg for systolic BP (SBP), and 75.2 +/- 2.1 and 70.5 +/- 2.0 mm Hg for diastolic BP (DBP). At 12 weeks, no significant change from baseline in 24-hour HR was observed with exenatide or placebo (LS mean +/- SE, 2.1 +/- 1.4 versus -0.7 +/- 1.4 beats/minute, respectively; between treatments, p = 0.16). Exenatide therapy was associated with trends toward lower 24-hour, daytime, and nighttime SBP; changes in DBP were similar between groups. No changes in daytime or nighttime rate pressure product were observed. With exenatide, body weight decreased from baseline by -1.8 +/- 0.4 kg (p < 0.0001; treatment difference -1.5 +/- 0.6 kg, p < 0.05). The most frequently reported adverse event with exenatide was mild to moderate nausea. CONCLUSIONS: Exenatide demonstrated no clinically meaningful effects on HR over 12 weeks of treatment in subjects with T2DM. The observed trends toward lower SBP with exenatide warrant future investigation. TRIAL REGISTRATION: NCT00516074.

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