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Trulicity ® (dulaglutide)
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Trulicity Summary of Product Characteristics (SmPC)
Trulicity® (dulaglutide): Effect on Heart Rate
Treatment with dulaglutide was associated with a small increase in heart rate compared with baseline.
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 |
79.0 |
Difference
vs PBO |
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.
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
Date of Last Review: November 02, 2020
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