Comparison of lixisenatide in combination with basal insulin vs other insulin regimens for the treatment of patients with type 2 diabetes inadequately controlled by basal insulin: Systematic review, network meta-analysis and cost-effectiveness analysis.
antidiabetic drug
cost-effectiveness
glucagon-like peptide-1 analogue
insulin therapy
network meta-analysis
systematic review
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
13
03
2019
revised:
08
08
2019
accepted:
28
08
2019
pubmed:
31
8
2019
medline:
21
5
2021
entrez:
31
8
2019
Statut:
ppublish
Résumé
To evaluate the comparative efficacy and safety of lixisenatide combined with basal insulin (BI) vs intensive premix insulin (premix), BI plus prandial insulin with the main meal (basal-plus) or progressively covering all meals (basal-bolus) in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by BI, and the long-term cost-effectiveness of lixisenatide from a Chinese healthcare system perspective. Randomized controlled trials (RCTs) published between 1998 and 2018 were systematically searched. The clinical efficacy and safety of each treatment were compared by network meta-analysis (NMA). The IQVIA CORE Diabetes Model was used to estimate the lifetime quality-adjusted life-years (QALYs) and direct medical costs of patients treated with different strategies. Eight RCTs were finally included. Lixisenatide plus BI showed a similar reduction in HbA1c from baseline compared with premix, basal-plus and basal-bolus. There were significant differences in the change of body weight in favour of lixisenatide plus BI compared with the three insulin regimens. The risk of symptomatic hypoglycaemia of lixisenatide plus BI was significantly lower compared with premix and basal-bolus. Lixisenatide plus BI was cost-effective compared with premix, basal-plus and basal-bolus with incremental cost-effectiveness ratios of Chinese yuan (CNY) 87 219, 48 173 and 48 670 per QALY gained, respectively, under the threshold of three times the gross domestic product (GDP) per capita in China. Lixisenatide plus BI shows a similar HbA1c reduction compared with insulin regimens, accompanied by lower risk of hypoglycaemia and greater body weight reduction. It is a cost-effective treatment alternative for patients with T2DM inadequately controlled by BI in China.
Substances chimiques
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin
0
Peptides
0
lixisenatide
74O62BB01U
Types de publication
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
107-115Subventions
Organisme : Sanofi China
Pays : International
Informations de copyright
© 2019 John Wiley & Sons Ltd.
Références
International Diabetes Federation. IDF Diabetes Atlas. 8th ed. Brussels, Belgium: International Diabetes Federation; 2017.
Downie M, Kilov G, Wong J. Initiation and intensification strategies in type 2 diabetes management: a comparison of basal plus and premix regimens. Diabetes Ther. 2016;7:641-657.
Davies MJ, DʼAlessio DA, Fradkin J, et al. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018;61:2461-2498.
Chinese Diabetes Society. Guidelines for the prevention and treatment of type 2 diabetes in China (2017 edition). Chin J Diabetes. 2018;10:4-67.
McCarty D, Coleman M, Boland CL. Lixisenatide: a new daily GLP-1 agonist for type 2 diabetes management. Ann Pharmacother. 2017;51:401-409.
Meier JJ. GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2012;8:728-742.
Trujillo JM, Goldman J. Lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist for the treatment of adults with type 2 diabetes. Pharmacotherapy. 2017;37:927-943.
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;36:2489-2496.
Seino Y, Min K, Niemoeller E, Takami A, Investigators EGLAS. 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;14:910-917.
Yang W, Min K, Zhou Z, et al. Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: the GetGoal-L-C randomized trial. Diabetes Obes Metab. 2018;20:335-343.
Werner U, Haschke G, Herling AW, Kramer W. Pharmacological profile of lixisenatide: a new GLP-1 receptor agonist for the treatment of type 2 diabetes. Regul Pept. 2010;164:58-64.
Lixisenatide. Summary of Product Characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002445/WC500140401.pdf. Accessed August 22, 2018.
Rosenstock J, Guerci B, Hanefeld M, et al. Prandial options to advance basal insulin glargine therapy: testing lixisenatide plus basal insulin versus insulin glulisine either as basal-plus or basal-bolus in type 2 diabetes: the GetGoal Duo-2 trial. Diabetes Care. 2016;39:1318-1328.
Maiorino MI, Chiodini P, Bellastella G, Capuano A, Esposito K, Giugliano D. Insulin and glucagon-like peptide 1 receptor agonist combination therapy in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Care. 2017;40:614-624.
Maiorino MI, Chiodini P, Bellastella G, et al. Free and fixed-ratio combinations of basal insulin and GLP-1 receptor agonists versus basal insulin intensification in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2018;20:2309-2313.
Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR task force on indirect treatment comparisons good research practices: part 1. Value Health. 2011;14:417-428.
Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151:264-269.
Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane Collaborationʼs tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
Salanti G, Higgins JP, Ades A, Ioannidis JP. Evaluation of networks of randomized trials. Stat Methods Med Res. 2008;17:279-301.
Dias S, Welton NJ, Sutton AJ, Ades A. NICE DSU Technical Support Document 2: A Generalised Linear Modelling Framework for Pairwise and Network Meta-Analysis of Randomised Controlled Trials. London: National Institute for Health and Care Excellence (NICE); 2011.
Bodnar O, Link A, Arendacká B, Possolo A, Elster C. Bayesian estimation in random effects meta-analysis using a non-informative prior. Stat Med. 2017;36:378-399.
Gilks WR, Richardson S, Spiegelhalter D. Markov Chain Monte Carlo in Practice. New York: Chapman and Hall/CRC; 1995.
Higgins J, Jackson D, Barrett J, Lu G, Ades A, White I. Consistency and inconsistency in network meta-analysis: concepts and models for multi-arm studies. Res Synth Methods. 2012;3:98-110.
Dias S, Sutton AJ, Ades A, Welton NJ. Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making. 2013;33:607-617.
Puhan MA, Schünemann HJ, Murad MH, et al. A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta-analysis. BMJ. 2014;349:g5630.
Palmer AJ, Roze S, Valentine WJ, et al. The CORE diabetes model: projecting long-term clinical outcomes, costs and costeffectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making. Curr Med Res Opin. 2004;20:S5-S26.
Palmera AJ, Rozea S, Valentinea WJ, et al. Validation of the CORE diabetes model against epidemiological and clinical studies. Curr Med Res Opin. 2004;20:S27-S40.
Nan Y, Xi Z, Yang Y, et al. The 2015 China Adult Tobacco Survey: exposure to second-hand smoke among adults aged 15 and above and their support to policy on banning smoking in public places. Chin J Epidemiol. 2016;37:810-815.
World Health Organization. Global Status Report on Alcohol and Health 2014. https://www.who.int/substance_abuse/publications/alcohol_2014/en. Accessed August 1, 2019.
Wang L, Gao P, Zhang M, et al. Prevalence and ethnic pattern of diabetes and prediabetes in China in 2013. JAMA. 2017;317:2515-2523.
Foos V, Moor RD, Xiong T, et al. Economic implications of improving type 2 diabetes Management in China. Shanghai: QuintilesIMS Institute; 2017.
Jones LE, Doebbeling CC. Depression screening disparities among veterans with diabetes as compared to the general veteran population. Diabetes Care. 2007;30:2216-2221.
Ji L-N, Lu J-M, Guo X-H, et al. Glycemic control among patients in China with type 2 diabetes mellitus receiving oral drugs or injectables. BMC Public Health. 2013;13:602.
Duan X, Li Y, Liu Q, Liu L, Li C. Epidemiological characteristics, medical costs and healthcare resource utilization of diabetes-related complications among Chinese patients with type 2 diabetes mellitus. Expert Rev Pharmacoecon Outcomes Res. 2019;3:1-9.
Chen X, Wei Y, Li W, Yang W, Guan H. Cost-effectiveness analysis of switch from premix human insulin to biphasic insulin aspart 30 in Chinese patients with type 2 diabetes mellitus. Chin J Diab. 2015;7:741-747.
Wu J, He X, Liu Y. The cost-effectiveness analysis of insulin aspart 30 and insulin glargine in patients with type 2 diabetes mellitus in China. Chin J Pharm. 2016;3:242-247.
Yang L, Christensen T, Sun F, Chang J. Cost-effectiveness of switching patients with type 2 diabetes from insulin glargine to insulin detemir in Chinese setting: a health economic model based on the PREDICTIVE study. Value Health. 2012;15:S56-S59.
Adler AI, Stratton IM, Neil HAW, et al. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000;321:412-419.
Clarke P, Gray A, Briggs A, et al. A model to estimate the lifetime health outcomes of patients with type 2 diabetes: the United Kingdom Prospective Diabetes Study (UKPDS) outcomes model (UKPDS no. 68). Diabetologia. 2004;47:1747-1759.
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:837-853.
Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study Group. Lancet. 1998;352:854-865.
Kothari V, Stevens RJ, Adler AI, et al. UKPDS 60: risk of stroke in type 2 diabetes estimated by the UKProspective Diabetes Study risk engine. Stroke. 2002;33:1776-1781.
Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999;281:2005-2012.
Bagust A, Beale S. Modelling EuroQol health-related utility values for diabetic complications from CODE-2 data. Health Econ. 2005;14:217-230.
Husereau D, Drummond M, Petrou S, et al. Consolidated health economic evaluation reporting standards (CHEERS)-explanation and elaboration: a report of the ISPOR health economic evaluation publication guidelines good reporting practices task force. Value Health. 2013;16:231-250.
Weinstein MC, Torrance G, McGuire A. QALYs: the basics. Value Health. 2009;12:S5-S9.
National Health and Family Planning Commission. China Health Statistics Yearbook. Beijing: Peking Union Medical College Press; 2018.
Ligthelm R, Gylvin T, DeLuzio T, Raskin P. A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study. Endocr Pract. 2010;17:41-50.
Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008;31:20-25.
Tinahones F, Gross J, Onaca A, Cleall S, Rodriguez A. Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial. Diabetes Obes Metab. 2014;16:963-970.
Vora J, Cohen N, Evans M, Hockey A, Speight J, Whately-Smith C. Intensifying insulin regimen after basal insulin optimization in adults with type 2 diabetes: a 24-week, randomized, open-label trial comparing insulin glargine plus insulin glulisine with biphasic insulin aspart (LanScape). Diabetes Obes Metab. 2015;17:1133-1141.
Russell-Jones D, Khan R. Insulin-associated weight gain in diabetes-causes, effects and coping strategies. Diabetes Obes Metab. 2007;9:799-812.
Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-339.
Markovic TP, Campbell LV, Balasubramanian S, et al. Beneficial effect on average lipid levels from energy restriction and fat loss in obese individuals with or without type 2 diabetes. Diabetes Care. 1998;21:695-700.
Williamson DF, Thompson TJ, Thun M, Flanders D, Pamuk E, Byers T. Intentional weight loss and mortality among overweight individuals with diabetes. Diabetes Care. 2000;23:1499-1504.
Cryer PE. Hypoglycemia is the limiting factor in the management of diabetes. Diabetes Metab Res Rev. 1999;15:42-46.
Barendse S, Singh H, Frier B, Speight J. The impact of hypoglycaemia on quality of life and related patient-reported outcomes in Type 2 diabetes: a narrative review. Diabet Med. 2012;29:293-302.
Zhao Y, Campbell CR, Fonseca V, Shi L. Impact of hypoglycemia associated with antihyperglycemic medications on vascular risks in veterans with type 2 diabetes. Diabetes Care. 2012;35:1126-1132.
Polonsky W, Thompson S, Wei W, et al. Greater fear of hypoglycaemia with premixed insulin than with basal-bolus insulin glargine and glulisine: patient-reported outcomes from a 60-week randomised study. Diabetes Obes Metab. 2014;16:1121-1127.