Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutid): REWIND Video - Egenskaper vid Baslinjen

I REWIND-studien randomiserades totalt 9901 patienter i 24 länder. Genomsnittsåldern var 66,2 år och den genomsnittliga HbA1c var 7,3 %. Ungefär 1/3 hade tidigare kardiovskulär sjukdom.

SE_cFAQ_GLP101_REWIND_BASELINE_CHARACTERISTICS_VIDEO
SE_cFAQ_GLP101_REWIND_BASELINE_CHARACTERISTICS_VIDEO
en-GB

Detailed Information

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

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

Baseline Characteristics of Patients Randomized in the REWIND Study2

Clinical Characteristics

Dulaglutide
n=4949

Placebo
n=4952

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.

aUACR ≥30 mg/g

bMyocardial infarction, ischemic stroke,unstable angina with electrocardiogram changes, myocardial ischemia on imaging or stress test, or coronary, carotid,or peripheral revascularization.

References

1Gerstein 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

2Gerstein HC, Colhoun HM, Dagenais GR, et al; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. 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

Datum fӧr senaste ӧversyn March 02, 2020


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