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Trulicity ® (dulaglutide)
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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.
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
There was no significant difference in DBP.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 |
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 |
76.6 |
Difference
vs PBO |
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.
a All data presented as least-square means except baseline values, which are presented as means.
b p< 0.001 for noninferiority test.
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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