Effects of lixisenatide on elevated liver transaminases: systematic review with individual patient data meta-analysis of randomised controlled trials on patients with type 2 diabetes
Publikation: Bidrag til tidsskrift › Review › Forskning › fagfællebedømt
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Effects of lixisenatide on elevated liver transaminases : systematic review with individual patient data meta-analysis of randomised controlled trials on patients with type 2 diabetes. / Gluud, Lise L; Knop, Filip K; Vilsbøll, Tina.
I: B M J Open, Bind 4, Nr. 12, e005325, 2014, s. 1-10.Publikation: Bidrag til tidsskrift › Review › Forskning › fagfællebedømt
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TY - JOUR
T1 - Effects of lixisenatide on elevated liver transaminases
T2 - systematic review with individual patient data meta-analysis of randomised controlled trials on patients with type 2 diabetes
AU - Gluud, Lise L
AU - Knop, Filip K
AU - Vilsbøll, Tina
N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
PY - 2014
Y1 - 2014
N2 - OBJECTIVE: To evaluate the effects of the glucagon-like peptide-1 receptor agonist lixisenatide on elevated liver blood tests in patients with type 2 diabetes.DESIGN: Systematic review.DATA SOURCES: Electronic and manual searches were combined.STUDY SELECTION: Randomised controlled trials (RCTs) on lixisenatide versus placebo or active comparators for type 2 diabetes were included.PARTICIPANTS: Individual patient data were retrieved to calculate outcomes for patients with elevated liver blood tests.MAIN OUTCOME MEASURES: Normalisation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).DATA SYNTHESIS: The results of included trials were combined in meta-analyses. Sequential, subgroup and regression analyses were performed to evaluate heterogeneity and bias.RESULTS: We included 12 RCTs on lixisenatide versus placebo and 3 RCTs with the active comparators liraglutide, exenatide or sitagliptin. The mean treatment duration was 29 weeks. Lixisenatide increased the proportion of patients with normalisation of ALT (risk difference: 0.07; 95% CI 0.01 to 0.14; number needed to treat: 14 patients, p=0.042). The effect was not confirmed in sequential analysis. No effects of lixisenatide were identified on AST, alkaline phosphatase or bilirubin. No evidence of bias was identified. Mixed effect multilevel meta-regression analyses suggest that the benefit of lixisenatide on ALT was limited to patients who were overweight or obese.CONCLUSIONS: This review suggests that lixisenatide increases the proportion of obese or overweight patients with type 2 diabetes who achieve normalisation of ALT. Additional research is needed to determine if the findings translate to clinical outcome measures.TRIAL REGISTRATION NUMBER: PROSPERO; CRD42013005779.
AB - OBJECTIVE: To evaluate the effects of the glucagon-like peptide-1 receptor agonist lixisenatide on elevated liver blood tests in patients with type 2 diabetes.DESIGN: Systematic review.DATA SOURCES: Electronic and manual searches were combined.STUDY SELECTION: Randomised controlled trials (RCTs) on lixisenatide versus placebo or active comparators for type 2 diabetes were included.PARTICIPANTS: Individual patient data were retrieved to calculate outcomes for patients with elevated liver blood tests.MAIN OUTCOME MEASURES: Normalisation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).DATA SYNTHESIS: The results of included trials were combined in meta-analyses. Sequential, subgroup and regression analyses were performed to evaluate heterogeneity and bias.RESULTS: We included 12 RCTs on lixisenatide versus placebo and 3 RCTs with the active comparators liraglutide, exenatide or sitagliptin. The mean treatment duration was 29 weeks. Lixisenatide increased the proportion of patients with normalisation of ALT (risk difference: 0.07; 95% CI 0.01 to 0.14; number needed to treat: 14 patients, p=0.042). The effect was not confirmed in sequential analysis. No effects of lixisenatide were identified on AST, alkaline phosphatase or bilirubin. No evidence of bias was identified. Mixed effect multilevel meta-regression analyses suggest that the benefit of lixisenatide on ALT was limited to patients who were overweight or obese.CONCLUSIONS: This review suggests that lixisenatide increases the proportion of obese or overweight patients with type 2 diabetes who achieve normalisation of ALT. Additional research is needed to determine if the findings translate to clinical outcome measures.TRIAL REGISTRATION NUMBER: PROSPERO; CRD42013005779.
U2 - 10.1136/bmjopen-2014-005325
DO - 10.1136/bmjopen-2014-005325
M3 - Review
C2 - 25526792
VL - 4
SP - 1
EP - 10
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 12
M1 - e005325
ER -
ID: 137409664