Trulicity ® (dulaglutid) injektion

För fullständig produktresumé för Trulicity® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Trulicity® (dulaglutid): Nedsatt leverfunktion

Dulaglutid kräver inte dosjustering hos patienter med nedsatt leverfunktion.

Use of Dulaglutide in Patients With Impaired Hepatic Function

Clinical Pharmacology Study

In a clinical pharmacology study in patients with varying degrees of hepatic impairment, no clinically relevant change in the PK of dulaglutide was observed.1

Compared with subjects with normal hepatic function, dulaglutide systemic exposure decreased by

  • 23% in patients with mild hepatic impairment

  • 33% in patients with moderate hepatic impairment, and

  • 21% in patients with severe hepatic impairment.2

The Cmax was decreased by a similar magnitude.2

Use of Dulaglutide in Patients With NAFL/NASH

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.3

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

  • 30 IU/L for males, and

  • 19 IU/L for females.3

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 1).3

Table 1. Change in Hepatic Enzyme Concentrations From Baseline to 6 Months in the Overall T2DM Population and the NAFL/NASH Subgroup Population - Post Hoc Analysis3

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.

References

1. Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

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

3. 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

Cmax = maximum serum concentration

GGT = gamma-glutamyl transpeptidase

IU = international unit

NAFL = nonalcoholic fatty liver

NASH = nonalcoholic steatohepatitis

PK = pharmacokinetic

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2018 M10 22


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