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

BMJ Open

Volumn 4, Issue 12, 2014, Pages

  Gluud, Lise L ^a   Knop, Filip K ^a   Vilsbøll, Tina ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; EXENDIN 4; HEMOGLOBIN A1C; LIRAGLUTIDE; LIXISENATIDE; PLACEBO; SITAGLIPTIN; ANTIDIABETIC AGENT; BIOLOGICAL MARKER; PEPTIDE; ZP10A PEPTIDE;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALCOHOL ABUSE; ALCOHOL LIVER DISEASE; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BODY WEIGHT; DRUG ABUSE; DRUG EFFICACY; HUMAN; HYPERTRANSAMINASEMIA; INFLAMMATORY BOWEL DISEASE; META ANALYSIS; METABOLIC REGULATION; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; OUTCOME ASSESSMENT; PANCREATITIS; PATIENT CODING; RANDOMIZED CONTROLLED TRIAL (TOPIC); STOMACH SURGERY; SYSTEMATIC REVIEW; TREATMENT DURATION; DIABETES MELLITUS, TYPE 2; ENZYMOLOGY; METABOLISM; NON-ALCOHOLIC FATTY LIVER DISEASE; REGRESSION ANALYSIS;

ALANINE TRANSAMINASE; ASPARTATE AMINOTRANSFERASES; BIOMARKERS; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; NON-ALCOHOLIC FATTY LIVER DISEASE; OBESITY; PEPTIDES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGRESSION ANALYSIS;

EID: 84920525855     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2014-005325     Document Type: Article

References (40)

1. Verbeek J, Cassiman D, Lannoo M, et al. Treatment of non-alcoholic fatty liver disease: can we already face the epidemic? Acta Gastroenterol Belg 2013;76:200-9.
2. Parkash O, Hamid S. Are we ready for a new epidemic of under recognized liver disease in South Asia especially in Pakistan? Non alcoholic fatty liver disease. J Pak Med Assoc 2013;63:95-9.
3. Blachier M, Leleu H, Peck-Radosavljevic M, et al. The burden of liver disease in Europe: a review of available epidemiological data. J Hepatol 2013;58:593-608.
4. Szczepaniak LS, Nurenberg P, Leonard D, et al. Magnetic resonance spectroscopy to measure hepatic triglyceride content: prevalence of hepatic steatosis in the general population. Am J Physiol Endocrinol Metab 2005;288:E462-8.
5. Bedogni G, Miglioli L, Masutti F, et al. Prevalence of and risk factors for nonalcoholic fatty liver disease: the Dionysos nutrition and liver study. Hepatology 2005;42:44-52.
6. Targher G, Bertolini L, Padovani R, et al. Prevalence of nonalcoholic fatty liver disease and its association with cardiovascular disease among type 2 diabetic patients. Diabetes Care 2007;30:1212-18.
7. Estep JM, Birerdinc A, Younossi Z. Non-invasive diagnostic tests for non-alcoholic fatty liver disease. Curr Mol Med 2010;10:166-72.
8. Miller MH, Ferguson MA, Dillon JF. Systematic review of performance of non-invasive biomarkers in the evaluation of non-alcoholic fatty liver disease. Liver Int 2011;31:461-73.
9. Barsic N, Lerotic I, Smircic-Duvnjak L, et al. Overview and developments in noninvasive diagnosis of nonalcoholic fatty liver disease. World J Gastroenterol 2012;18:3945-54.
10. Terjung B, Lemnitzer I, Dumoulin FL, et al. Bleeding complications after percutaneous liver biopsy. An analysis of risk factors. Digestion 2003;67:138-45.
11. Copel L, Sosna J, Kruskal JB, et al. Ultrasound-guided percutaneous liver biopsy: indications, risks, and technique. Surg Technol Int 2003;11:154-60.
12. Angelico F, Burattin M, Alessandri C, et al. Drugs improving insulin resistance for non-alcoholic fatty liver disease and/or non-alcoholic steatohepatitis. Cochrane Database Syst Rev 2007;(1):CD005166.
13. Shyangdan D, Clar C, Ghouri N, et al. Insulin sensitisers in the treatment of non-alcoholic fatty liver disease: a systematic review. Health Technol Assess 2011;15:1-110.
14. Dormandy J, Bhattacharya M, van Troostenburg de Bruyn AR. Safety and tolerability of pioglitazone in high-risk patients with type 2 diabetes: an overview of data from PROactive. Drug Saf 2009;32:187-202.
15. Lewis JD, Habel L, Quesenberry C, et al. Proteinuria testing among patients with diabetes mellitus is associated with bladder cancer diagnosis: potential for unmeasured confounding in studies of pioglitazone and bladder cancer. Pharmacoepidemiol Drug Saf 2014;23:636-45.
16. Diaz-Soto G, de Luis DA, Conde-Vicente R, et al. Beneficial effects of liraglutide on adipocytokines, insulin sensitivity parameters and cardiovascular risk biomarkers in patients with type 2 diabetes: a prospective study. Diabetes Res Clin Pract 2014;104:92-6.
17. Gupta NA, Mells J, Dunham RM, et al. Glucagon-like peptide-1 receptor is present on human hepatocytes and has a direct role in decreasing hepatic steatosis in vitro by modulating elements of the insulin signaling pathway. Hepatology 2010;51:1584-92.
18. Vilsboll T, Christensen M, Junker AE, et al. Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. BMJ 2012;344:d7771.
19. Scott LJ. Lixisenatide: a review of its use in patients with type 2 diabetes mellitus. BioDrugs 2013;27:509-23.
20. Christensen M, Knop FK, Vilsboll T, et al. Lixisenatide for type 2 diabetes mellitus. Expert Opin Investig Drugs 2011;20:549-57.
21. Lorenz M, Pfeiffer C, Steinstrasser A, et al. Effects of lixisenatide once daily on gastric emptying in type 2 diabetes - relationship to postprandial glycemia. Regul Pept 2013;185C:1-8.
22. Ratner RE, Rosenstock J, Boka G. Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled trial. Diabet Med 2010;27:1024-32.
23. Riddle MC, Aronson R, Home P, et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care 2013;36:2489-96.
24. Riddle MC, Forst T, Aronson R, et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care 2013;36:2497-503.
25. Seino Y, Min KW, Niemoeller E, et al. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab 2012;14:910-17.
26. Ahren B, Dimas AL, Miossec P, et al. Efficacy and safety of lixisenatide once-daily morning or evening injections in type 2 diabetes inadequately controlled on metformin (GetGoal-M). Diabetes Care 2013;36:2543-50.
27. Fonseca VA, Alvarado-Ruiz R, Raccah D, et al. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care 2012;35:1225-31.
28. Kapitza C, Forst T, Coester HV, et al. Pharmacodynamic characteristics of lixisenatide once daily versus liraglutide once daily in patients with type 2 diabetes insufficiently controlled on metformin. Diabetes Obes Metab 2013;15:642-9.
29. Rosenstock J, Raccah D, Koranyi L, et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). Diabetes Care 2013;36:2945-51.
30. Pinget M, Goldenberg R, Niemoeller E, et al. Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab 2013;15:1000-7.
31. Bolli GB, Munteanu M, Dotsenko S, et al. Efficacy and safety of lixisenatide once daily vs. placebo in people with type 2 diabetes insufficiently controlled on metformin (GetGoal-F1). Diabet Med 2014;31:176-84.
32. Ratner RE, Hanefeld M, Shamanna P, et al. Efficacy and safety of lixisenatide once-daily versus placebo in patients with type 2 diabetes mellitus insufficiently controlled on sulfonylurea ± metformin (GetGoal-S). Diabetologia 2011;54:785.
33. Seino Y, Akane T, Niemoeller E, et al.; on behalf of the GetGoal-Mono Study Group. Long-term Safety of Once-daily (QD) Lixisenatide in Japanese Patients with Type 2 Diabetes Mellitus (T2DM): GetGoal-Mono Japan. 2012. http://www.aa-sd.org/
34. Pan CY, Shang S, Niemoeller E, et al.; on behalf of the GetGoal-M Asia Study Investigators. Lixisenatide in Asian Patients with Type 2 Diabetes (T2DM) Uncontrolled on Metformin±Sulfonylurea (SU): GetGoal-M Asia. 2012. http://www.aa-sd.org/
35. http://handbook.cochrane.org/. Cochrane Handbook for Systematic Reviews of Interventions. Secondary Cochrane Handbook for Systematic Reviews of Interventions.
36. Stewart GB, Altman DG, Askie LM, et al. Statistical analysis of individual participant data meta-analyses: a comparison of methods and recommendations for practice. PLoS ONE 2012;7:e46042.
37. Deeks JJ, Higgins JPT, Altman DG, eds. Chapter 9: Analysing data and undertaking meta-analyses. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. www.cochrane-handbook.org
38. Seino Y, Yabe D. Glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1: incretin actions beyond the pancreas. J Diabetes Investig 2013;4:108-30.
39. Samson SL, Bajaj M. Potential of incretin-based therapies for non-alcoholic fatty liver disease. J Diabetes Complications 2013;27:401-6.
40. Ding X, Saxena NK, Lin S, et al. Exendin-4, a glucagon-like protein-1 (GLP-1) receptor agonist, reverses hepatic steatosis in ob/ob mice. Hepatology 2006;43:173-81.