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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 Blood Pressure
Treatment with dulaglutide was associated with a reduction in systolic BP compared with baseline.
Detailed
information
A
phase 2, multicenter, randomized, double-blind, placebo-controlled
study assessed the effects of once-weekly dulaglutide 1.5 mg and
dulaglutide 0.75 mg on BP in 755 patients who had T2DM with or
without hypertension. The primary endpoint was change from baseline
at 16 weeks in mean 24-hour SBP.1
The
treatment effects of dulaglutide on SBP were evident at 4 weeks.1
In
comparison with placebo, dulaglutide 1.5 mg significantly reduced
24-hour SBP by approximately 3 mmHg at 16 and 26 weeks.1
Dulaglutide
1.5 mg and dulaglutide 0.75 mg both demonstrated noninferiority to
placebo in LSM change from baseline in 24-hour SBP.1
Dulaglutide
1.5 mg also demonstrated superiority to placebo in lowering SBP at
both 16 (p≤ 0.001) and 26 weeks (p=.002).1
The
change in SBP from baseline to 16 weeks with dulaglutide 0.75 mg
achieved the primary objective of noninferiority to placebo (p<
0.001).1
Changes
from baseline in ambulatory SBP and DBP can be seen in Table
1.
Table
1. Changes From Baseline in Ambulatory Blood Pressure in a Phase 2
Study Evaluating Once-Weekly Dulaglutide (1.5 mg and 0.75 mg) in
Patients with T2DM With or Without Hypertension1
Timepointa
DU
1.5 mg (n=251)
DU
0.75 mg (n=254)
PBO
(n=250)
24-hour
SBP (mmHg)
Baseline
130.9
Difference
vs PBO
(95% CI)
132.1
Difference
vs PBO (95% CI)
131.1
Change
at 4 wks
-3.7
-1.9
-0.3
Change
at 16 wks
-3.4
-2.8
(-4.6, -1.0)b†
-1.7
-1.1
(-2.8, 0.7)b
-0.6
Change
at 26 wks
-2.5
-2.7
(-4.5, -0.8)b‡
-1.6
-1.7
(-3.5, 0.1)b
0.2
24-Hour
DBP (mmHg)
Baseline
76.3
Difference
vs PBO
(95% CI)
76.6
Difference
vs PBO
(95% CI)
76.0
Change
at 4 wks
-0.2
0.3
-0.1
Change
at 16 wks
-0.2
0.3
(-0.8, 1.4)b
-0.1
0.4
(-0.7, 1.5)b
-0.6
Change
at 26 wks
0.3
0.5
(-0.7, 1.7)b
-0.1
0.2
(-1.0, 1.3)b
-0.2
Abbreviations:
DBP = diastolic blood pressure; DU = dulaglutide; PBO = placebo; SBP
= systolic blood pressure; T2DM = type 2 diabetes mellitus.
†p≤
0.001 for superiority test.
‡p= 0.002 for superiority
test.
aAll data presented as least-square means except baseline
values, which are presented as means.
bp< 0.001 for noninferiority test.
References
1.
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
BP =
blood pressure
DBP
= diastolic blood pressure
LSM
= least squares mean
SBP
= systolic blood pressure
T2DM
= type 2 diabetes mellitus
Date of Last Review:November 02, 2020
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