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Trulicity Summary of Product Characteristics (SmPC)
Treatment with dulaglutide was associated with a small increase in heart rate compared with baseline.
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.
aAll data presented as least-square means except baseline
values, which are presented as means.
bp≤.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
Date of Last Review:November 02, 2020
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