If you are a Healthcare Professional and you would like to log in to access this content, please click "Login".
You are now leaving the Lilly Medical Web site
The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Eli Lilly and Company does not control, influence, or endorse this site, and the opinions, claims or comments expressed on this site should not be attributed to Eli Lilly and Company. Eli Lilly and Company is not responsible for the privacy policy of any third party web sites. We encourage you to read the privacy policy of every web site you visit.
Menu closed
Please use a minimum of three unique search wordsOur search is configured to only display links relevant to answer your question. For the best results please use specific and relevant keywords that accurately reflect the information you are seeking.Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at UK: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
Trulicity ® (dulaglutide)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information:
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.
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
Was this answer helpful to you?
Contact Lilly
Call or Email us
If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com