Trulicity ® (dulaglutide)

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Were there cardiovascular adverse events (AEs) in the AWARD-11 study on Trulicity® (dulaglutide)?

The overall incidence of positively adjudicated major cardiovascular (CV) events through the end of the study was low (0.1%-0.3%) in each CV event category.

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UK_cFAQ_GLP093_CV_AEs_AWARD-11
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Study Details AWARD-11

The AWARD-11 trial was a phase 3, randomized, double-blind, active-controlled, parallel-arm study that assessed the efficacy and safety of dulaglutide 3.0 mg and dulaglutide 4.5 mg compared with dulaglutide 1.5 mg in patients with inadequately controlled type 2 diabetes (T2D) on concomitant metformin therapy.1

 

In the AWARD-11 trial, 1842 patients were randomized 1:1:1 to receive treatment with

  • dulaglutide 1.5 mg once weekly (n = 612)
  • dulaglutide 3.0 mg once weekly (n = 616), or
  • dulaglutide 4.5 mg once weekly (n = 614).

All 3 treatment groups were also concomitantly treated with metformin.1,2

The study included a 12-week dose-escalation phase in which all patients were initiated on the 0.75 mg dulaglutide dose for 4 weeks. The dose was increased to the next dose level, 1.5 mg, 3.0 mg, or 4.5 mg, every 4 weeks until the final randomized dose was reached.1

Cardiovascular Adverse Events in AWARD-11

Death and nonfatal CV AEs in the AWARD-11 study were adjudicated by a committee of physicians external to Lilly with cardiology expertise.2

The adjudicated nonfatal CV AEs included

  • Myocardial infarction
  • hospitalization for unstable angina
  • hospitalization for heart failure
  • coronary interventions such as a coronary artery bypass graft or percutaneous coronary intervention (PCI), and
  • cerebrovascular events including cerebrovascular accidents such as strokes and transient ischemic attacks (TIAs).2

Because of the dose-escalation design of the study, CV events could have had an onset date prior to when the patient had escalated to his/her final assigned dose of dulaglutide. The number of adjudication-confirmed CV events through the end of the safety follow-up period was summarized by treatment group and by dulaglutide dose at the time of event in Summary of Patients With CEC-Confirmed Cardiovascular Events Through Safety Follow-up Period and Summary of CEC-Confirmed CV Events by Treatment Group and Dulaglutide Dose at the Time of the Event.2

Summary of Patients With CEC-Confirmed Cardiovascular Events Through Safety Follow-up Period2

Event

DULA 1.5 mg
(n = 612)
n (%)

DULA 3.0 mg
(n = 616)
n (%)

DULA 4.5 mg
(n = 614)
n (%)

Total
(n = 1842)
n (%)

Patients with ≥1 CEC-confirmed CV eventsa

2 (0.3)

8 (1.3)

5 (0.8)

15 (0.8)

Cardiovascular death

1 (0.2)

2 (0.3)

1 (0.2)

4 (0.2)

Sudden cardiac death

0 (0)

1 (0.2)

1 (0.2)

2 (0.1)

Acute myocardial infarction

1 (0.2)

0 (0)

0 (0)

1 (0.1)

Stroke

0 (0)

1 (0.2)

0 (0)

1 (0.1)

Acute coronary syndrome events

1 (0.2)

3 (0.5)

1 (0.2)

5 (0.3)

MI

1 (0.2)

2 (0.3)

1 (0.2)

4 (0.2)

Hospitalized unstable angina

0 (0)

1 (0.2)

0 (0)

1 (0.1)

Coronary revascularizationb

1 (0.2)

4 (0.6)

1 (0.2)

6 (0.3)

Hospitalization for heart failure

0 (0)

0 (0)

1 (0.2)

1 (0.1)

Cerebrovascular events

0 (0)

3 (0.5)

2 (0.3)

5 (0.3)

Ischemic stroke

0 (0)

2 (0.3)

2 (0.3)

4 (0.2)

Transient ischemic stroke

0 (0)

1 (0.2)

0 (0)

1 (0.1)

Abbreviations: CEC = Clinical Endpoint Committee; CV = cardiovascular; DULA = dulaglutide; MI = myocardial infarction; N = number of patients randomized and treated; n = number of patients with event.

aPatients may appear in more than 1 category.

bAll but 1 patient (in the 3.0 mg group) with CEC-confirmed coronary revascularization are also included among those with CEC-confirmed acute coronary syndrome events. 

Summary of CEC-Confirmed CV Events by Treatment Group and Dulaglutide Dose at the Time of the Event2

Abbreviations: CEC = Clinical Endpoint Committee; CV = cardiovascular; Dula = dulaglutide; N = number of patients randomized and treated. 

The overall incidence of positively adjudicated major CV events through the end of the study was low (0.1%-0.3%) in each CV event category that included

  • CV death
  • acute coronary syndrome
  • cerebrovascular events
  • hospitalization for heart failure events, and
  • coronary revascularization.2

Although the 5 patients with adjudication-confirmed cerebrovascular events were assigned to either the 3.0-mg or 4.5-mg group, 2 of these events occurred while the patient was taking a lower dose such that there was no dose relationship between the occurrence of adjudication-confirmed cerebrovascular events and the actual dose taken at the time of the event.2  

Additionally, 3 of the 5 patients with an adjudication-confirmed cerebrovascular event had pre-existing conditions that put them at high risk for experiencing an event, including pre-existing carotid artery stenosis and established peripheral or coronary atherosclerotic CV disease.2

For most individual event categories, few events were confirmed in each dose group with no evidence of an increase in incidence of events by dose.2

References

1Frias JP, Nevárez Ruiz L, Li YG, et al. Efficacy and safety of higher dulaglutide doses (3.0 mg and 4.5 mg) when added to metformin in patients with type 2 diabetes: a phase 3, randomized, double-blind, parallel arm study (AWARD-11). J Endocr Soc. 2020;4(suppl 1):A1036. Endocrine Society abstract OR26-08. https://doi.org/10.1210/jendso/bvaa046.2057

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: 05 November 2020


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