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Trulicity ® (dulaglutid) injektion
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
The AWARD-5 study was an adaptive, multicenter, randomized, 104-week, double-blind study that compared once-weekly dulaglutide 1.5 mg and dulaglutide 0.75 mg treatments with once-daily sitagliptin 100 mg and placebo in patients with T2DM inadequately controlled with metformin.1
Both dulaglutide 1.5 mg and dulaglutide 0.75 mg treatment doses reported more TEAEs than the sitagliptin treatment group due to greater incidence of GI AEs (Table 1. Adverse Events From Baseline to 104 Weeks in Patients Treated With Dulaglutide 1.5 mg, Dulaglutide 0.75 mg, or Sitagliptin 100 mg in the AWARD-5 Study ).1
A similar incidence of serious AEs was reported across treatment groups (Table 1. Adverse Events From Baseline to 104 Weeks in Patients Treated With Dulaglutide 1.5 mg, Dulaglutide 0.75 mg, or Sitagliptin 100 mg in the AWARD-5 Study ).1
Table 1. Adverse Events From Baseline to 104 Weeks in Patients Treated With Dulaglutide 1.5 mg, Dulaglutide 0.75 mg, or Sitagliptin 100 mg in the AWARD-5 Study 1,2
|
Variablea |
DULA
1.5 mg |
DULA
0.75 mg |
SITA
100 mg |
|
Treatment-emergent adverse events ≥1 |
259 (85) |
255 (84) |
242 (77) |
|
Treatment-emergent GI adverse events |
|||
|
Nausea |
53 (17) |
44 (15) |
21 (7) |
|
Vomiting |
41 (14) |
25 (8) |
11 (4) |
|
Diarrhea |
49 (16) |
36 (12) |
18 (6) |
|
Abdominal pain |
21 (7) |
13 (4) |
11 (4) |
|
Abdominal distention |
13 (4) |
15 (5) |
3 (1) |
|
Dyspepsia |
18 (6) |
19 (6) |
14 (4) |
|
Pancreatic enzymes, median (Q1,Q3) [U/I] |
|||
|
Lipase |
6 (-1,14) |
6 (-1,18) |
3 (-2,9) |
|
Total amylase |
6 (-1,15) |
7 (-1,17) |
3 (-3,12) |
|
p-Amylase |
4 (0,9) |
4 (0,11) |
2 (-1,7) |
|
Pancreatitis |
0 (0) |
0 (0) |
2 (0.6) |
|
Serious adverse events |
36 (12) |
23 (8) |
32 (10) |
|
Infections and infestations |
7 (2) |
3 (1) |
5 (2) |
|
Cardiac disorders |
6 (2) |
2 (1) |
4 (1) |
|
Neoplasms |
5 (2) |
3 (1) |
5 (2) |
|
Gastrointestinal events |
4 (1) |
2 (1) |
4 (1) |
|
Renal/urinary disorders |
5 (2) |
2 (1) |
0 (0) |
|
Death |
1 (<1) |
0 (0) |
2 (1) |
|
Injection site reactions |
4 (1.3) |
3 (1.0) |
3 (1.0) |
|
Hypoglycemiab, mean (SD) |
|||
|
Total |
0.0 (0.2) |
0.0 (0.5) |
0.0 (0.3) |
|
Documented symptomatic |
0.0 (0.1) |
0.0 (0.5) |
0.0 (0.3) |
|
Discontinuation resulting from adverse events |
63 (21) |
64 (21) |
65 (21) |
|
Vital signs, LSM (SE) |
|||
|
Systolic blood pressure, mmHg |
-0.1 (0.8) |
1.3 (0.8) |
<0.1 (0.8) |
|
Diastolic blood pressure, mmHg |
0.4 (0.5) |
1.4 (0.5) |
-0.4 (0.5) |
|
Pulse rate, beats/min |
2.3 (0.5) |
2.8 (0.5) |
-0.8 (0.5) |
Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; DULA = dulagultide; GI = Gastrointestinal; LSM = least squares mean; Q1 = first quartile; Q3 = third quartile; SITA = Sitagliptin; U/l = units per liter.
a Data presented as n (%) unless otherwise indicated.
b <54 mg/dL cutoff, 1-year adjusted rate.
1. Weinstock RS, Guerci B, Umpierrez G, et al. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015;17(9):849-858. http://dx.doi.org/10.1111/dom.12479
2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
AE = adverse event
AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes
GI = gastrointestinal
T2DM = type 2 diabetes mellitus
TEAE = treatment-emergent adverse event
Datum fӧr senaste ӧversyn 2018 M04 25