Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutid): Användning hos patienter med NAFL/NASH

Behandling med Trulicity (dulaglutid) en gång i veckan förbättrade koncentrationerna av leverenzymer hos patienter med T2DM, samt hos en undergruppsbefolkning med NAFL/ NASH.

Post Hoc Integrated Analysis

A post hoc integrated analysis of 4 AWARD studies, AWARD-1, -5, -8, and -9, was conducted to assess the effect of dulaglutide treatment compared with placebo treatment on the change in hepatic enzyme concentrations from baseline to 6 months in

  • the overall T2DM population, and

  • a subgroup population with NAFL/NASH.1

The NAFL/NASH subgroup population was defined using baseline ALT thresholds of

  • 30 IU/L for males, and

  • 19 IU/L for females.1

Results

A total of 1499 patients were included in the post hoc analysis (Table 1).1

Table 1. Baseline Characteristics of the Overall Population Grouped by Baseline ALT Concentration - Post Hoc Analysis1

Parametera

ALT ≥ULNb
(n=760)

ALT <ULN
(n=739)

Gender, female, n (%)

462 (60.8)

250 (33.8)

Age, y

55.1 (9.6)

58.0 (10.2)

Duration of diabetes, y

7.8 (5.8)

9.9 (6.7)

HbA1c, %

8.2 (1.0)

8.2 (1.1)

FSG, mmol/L [mg/dL]

9.6 (3.0) [172.8 (54.0)]

9.2 (3.0) [165.6 (54.0)]

BMI, kg/m2

32.6 (5.0)

31.5 (5.1)

ALT, IU/L

38.0 (17.5)

18.2 (5.5)

AST, IU/L

27.8 (11.8)

17.1 (5.0)

GGT, IU/L

43.9 (46.7)

26.4 (19.3)

TG, mmol/L [mg/dL]

2.1 (1.3) [186.0 (115.1)]

1.7 (1.2) [150.6 (106.3)]

LDL, mmol/L [mg/dL]

2.6 (0.9) [100.5 (34.8)]

2.5 (0.9) [96.7 (34.8)]

HDL, mmol/L [mg/dL]

1.2 (0.3) [46.4 (11.6)]

1.2 (0.3) [46.4 (11.6)]

Abbreviations: ALT = alanine transaminase; AST = aspartate transaminase; BMI = body mass index; FSG = fasting serum glucose; GGT = gamma-glutamyl transpeptidase; HbA1c = glycated hemoglobin; HDL = high-density lipoprotein; IU = international unit; LDL = low-density lipoprotein; NAFL = nonalcoholic fatty liver; NASH = nonalcoholic steatohepatitis; TG = triglycerides; ULN = upper limit of normal.

a Data presented as mean (SD) unless otherwise indicated.

b ALT ≥ULN refers to the NAFL/NASH subgroup population, defined by baseline ALT thresholds of ≥30 IU/L for males and ≥19 IU/L for females.

With the exception of GGT in patients in the placebo group in the overall T2DM population, an improvement in hepatic enzyme concentrations was observed in the

  • overall T2DM population, and

  • NAFL/NASH subgroup population (Table 2).1

Table 2. Change in Hepatic Enzyme Concentrations From Baseline to 6 Months in the Overall T2DM Population and the NAFL/NASH Subgroup Population - Post Hoc Analysis1

Hepatic Enzyme, IU/La

Overall T2DM Population
DU 1.5 mg
(n=971)

Overall T2DM Population
PBO
(n=528)

Overall T2DM Population
Treatment Difference

NAFL/NASH
Subgroup Population
DU 1.5 mg
(n=490)

NAFL/NASH
Subgroup Population
PBO
(n=270)

NAFL/NASH
Subgroup Population
Treatment Difference

ALT

-4.7b

-3.0b

-1.7
(-2.8, -0.6)c

-8.8b

-6.7b

-2.1
(-3.9, -0.3)c

AST

-1.9b

-0.8

-1.1
(-2.1, -0.1)c

-4.3b

-3.8b

-0.5
(-2.0, 1.1)

GGT

-5.0

1.6

-6.6
(-12.4, -0.8)c

-7.4d

-3.6

-3.8
(-11.8, 4.2)

Abbreviations: ALT = alanine transaminase; AST = aspartate transaminase; DU = dulaglutide; GGT = gamma-glutamyl transpeptidase; ITT = intention-to-treat; IU = international unit; LOCF = last observation carried forward; LSM = least squares mean; NAFL = nonalcoholic fatty liver; NASH = nonalcoholic steatohepatitis; PBO = placebo; T2DM = type 2 diabetes mellitus.

a Data presented as LSM or LSM (95% CI); ITT without postrescue values, parameters analyzed using analysis of covariance (LOCF).

b p<.001 vs baseline.

c p<.05 vs placebo.

d p<.05 vs baseline.

The authors concluded that the improvements in hepatic enzyme concentrations observed with dulaglutide treatment compared with placebo treatment were consistent with those seen with reductions in liver fat.1

Reference

1. Cusi K, Sattar N, García-Pérez LE, et al. Dulaglutide decreases plasma aminotransferases in people with type 2 diabetes in a pattern consistent with liver fat reduction: a post hoc analysis of the AWARD programme. Diabet Med. 2018;35(10):1434-1439. http://dx.doi.org/10.1111/dme.13697

Glossary

ALT = alanine aminotransferase

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

GGT = gamma-glutamyl transpeptidase

IU = international unit

NAFL = nonalcoholic fatty liver

NASH = nonalcoholic steatohepatitis

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2018 M10 19


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