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Trulicity ® (dulaglutide)
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Trulicity Summary of Product Characteristics (SmPC)
Trulicity® (dulaglutide): REWIND Baseline Characteristics Video
In the REWIND study a total of 9901 patients in 24 countries were randomized. The average age was 66.2 years and the average HbA1c was 7.3 %. Around 1/3 had prior CVD, so most of the participants did not have previous CV disease or a previous CV event.
The REWIND study was an event-driven, randomized, double-blind, phase 3 CV outcomes study of dulaglutide.1
The study evaluated the effect on MACE-3 and other serious outcomes with once-weekly dulaglutide 1.5 mg treatment compared with placebo when added to standard of care in participants 50 years of age and older with T2DM and established CV disease and/or risk factors.1
Eligible patients had
newly diagnosed or established T2DM
an HbA1c value of 9.5% or lower, and
vascular diseases or CV risk factors depending on their age (Table 1).1,2
Table 1. Age-Specific Inclusion Criteria for REWIND Trial1
|
If the participant's age was... |
Then they had to have... |
|
50-54 y |
established CVD. |
|
55-59 y |
established CVD or evidence of other subclinical CVD. |
|
60 y or older |
established CVD, evidence of other subclinical CVD, or at least 2 other CV risk factors. |
Abbreviations: CV = cardiovascular; CVD = cardiovascular disease; REWIND = Researching cardiovascular Events with a Weekly INcretin in Diabetes.
Patients were excluded if they had
liver disease
a history of pancreatitis
gastric emptying abnormalities
an eGFR of less than 15 mL/min/1.73m2 or on dialysis
a coronary or cerebrovascular event in the last 2 months or plans to revascularize, or
history of medullary C-cell hyperplasia or medullary thyroid cancer.1,2
A total of 9901 patients in 24 countries were randomized.2
More detailed information on baseline characteristics is found in
Table 2. Baseline Characteristics of Patients Randomized in the REWIND Study2
|
Clinical Characteristics |
Dulaglutide |
Placebo |
|
Age, y, mean (SD) |
66.2 (6.5) |
66.2 (6.5) |
|
Females, n (%) |
2306 (46.6) |
2283 (46.1) |
|
DM duration, y, mean (SD) |
10.5 (7.3) |
10.6 (7.2) |
|
HbA1c, %, mean (SD) |
7.3 (1.1) |
7.4 (1.1) |
|
BMI, kg/m2, mean (SD) |
32.3 (5.7) |
32.3 (5.8) |
|
BP, mmHg, mean (SD) |
137.1 (16.6)/78.4 (9.8) |
137.3 (17.0)/78.5 (9.9) |
|
Pulse, beats/min, mean (SD) |
71.4 (10.7) |
71.6 (11.0) |
|
Cholesterol, mmol/L [mg/dL], Mean (SD) |
4.52 (1.16) [174.79 (44.86)] |
4.52 (1.16) [174.79 (44.86)] |
|
LDL cholesterol, mmol/L [mg/dL], Mean (SD) |
2.56 (0.98) [98.99 (37.90)] |
2.56 (0.98) [98.99 (37.90)] |
|
HDL cholesterol, mmol/L [mg/dL], Mean (SD) |
1.18 (0.33) [45.63 (12.76)] |
1.18 (0.36) [45.63 (13.92)] |
|
Median triglycerides (IQR), mmol/L [mg/dL], Mean (SD) |
1.60 (1.15-2.2) [141.72 (101.86-194.86)] |
1.60 (1.20-2.25) [141.72 (106.29-199.30)] |
|
eGFR<60 mL/min/1.73 m2, n (%) |
1081 (21.8) |
1118 (22.6) |
|
Albuminuria, n (%)a |
1707 (34.5) |
1760 (35.5) |
|
Prior CV disease b, n (%) |
1560 (31.5) |
1554 (31.4) |
|
Prior hypertension, n (%) |
4605 (93.0) |
4619 (93.3) |
|
Prior heart failure, n (%) |
421 (8.5) |
432 (8.7) |
|
Prior diabetic retinopathy, n (%) |
448 (9.1) |
443 (8.9) |
|
Current tobacco use, n (%) |
694 (14.0) |
713 (14.4) |
Abbreviations: BMI = body mass index; BP = blood pressure; CV = cardiovascular; DM = diabetes mellitus; eGFR = estimated glomerular filtration rate; HbA1c = glycated hemoglobin; HDL = high-density lipoprotein; IQR = interquartile range; LDL = low-density lipoprotein; REWIND = Researching cardiovascular Events with a Weekly INcretin in Diabetes.
a UACR ≥30 mg/g
b Myocardial infarction, ischemic stroke,unstable angina with electrocardiogram changes, myocardial ischemia on imaging or stress test, or coronary, carotid,or peripheral revascularization.
1. Gerstein HC, Colhoun HM, Dagenais GR, et al. REWIND Trial Investigators. Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. Diabetes Obes Metab. 2018;20(1):42-49. https://doi.org/10.1111/dom.13028
2. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet. 2019;394(10193):121-130. https://doi.org/10.1016/S0140-6736(19)31149-3
Glossary
CV = cardiovascular
CVD = cardiovascular disease
eGFR = estimated glomerular filtration rate
HbA1c = glycated hemoglobin
MACE-3 = major adverse cardiovascular events (death due to cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke)
REWIND = Researching cardiovascular Events with a Weekly INcretin in Diabetes
T2DM = type 2 diabetes mellitus
Date of Last Review: March 02, 2020
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