Trulicity® (dulaglutide): Effect on Heart Rate

Detailed Information

An integrated analysis showed that treatment with dulaglutide 1.5 mg and dulaglutide 0.75 mg resulted in a mean increase in HR of 2 to 4 bpm.¹

Clinical trial data, based on the evaluation of the full duration of phase 2 and phase 3 clinical studies, identified sinus tachycardia as being commonly reported by patients who were treated with dualglutide, ≤1/100.¹

In the phase 2 study of patients with T2DM with or without hypertension, both dulaglutide doses increased HR at 4,16, and 26 weeks.²

Dulaglutide 0.75 mg demonstrated noninferiority to placebo in LSM changes from baseline in HR at 4,16, and 26 weeks (p≤.02 for both) but dulaglutide 1.5 mg did not show noninferiority (Table 1).²

Table 1. Changes from Baseline in Heart Rate in a Phase 2 Study Evaluating Once-Weekly Dulaglutide (1.5 mg and 0.75 mg) in Patients with T2DM With or Without Hypertension²

Timepointa	DU 1.5 mg (n=251)		DU 0.75 mg (n=254)			PBO (n=250)
24-Hour HR (bpm)
Baseline	79.9	Difference vs PBO   (95% CI)		79.0	Difference vs PBO   (95% CI)		79.9
Change at 4 wks	4.6			2.7			0.3
Change at 16 wks	3.7	2.8 (1.5, 4.2)		2.5	1.6 (0.3, 2.9)b		0.9
Change at 26 wks	4.2	3.5 (2.1, 4.9)		1.9	1.3 (-0.1, 2.6)b		0.7

Abbreviations: bpm = beats per minute; DU = dulaglutide; HR = heart rate; PBO = placebo; T2DM = type 2 diabetes mellitus.

^a All data presented as least-square means except baseline values, which are presented as means.

^b p≤.02 for noninferiority test.

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Ferdinand KC, White WB, Calhoun DA, et al. Effects of the once-weekly glucagon-like peptide-1 receptor agonist dulaglutide on ambulatory blood pressure and heart rate in patients with type 2 diabetes mellitus. Hypertension. 2014;64(4):731-737. http://dx.doi.org/10.1161/HYPERTENSIONAHA.114.03062

Glossary 

bpm = beats per minute

LSM = least squares mean

T2DM = type 2 diabetes mellitus