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Liraglutide for the treatment of type 2 diabetes : a single technology appraisal

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Shyangdan, Deepson S., Cummins, E. (Ewen), Royle, Pamela and Waugh, Norman. (2011) Liraglutide for the treatment of type 2 diabetes : a single technology appraisal. Health Technology Assessment, Vol.15 (Supp.1). ISSN 1366-5278

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Official URL: http://www.hta.ac.uk/project/2157.asp

Abstract

This paper presents a summary of the Evidence Review Group (ERG) report into the clinical effectiveness and cost-effectiveness of liraglutide in the treatment of type 2 diabetes mellitus, based upon the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The manufacturer proposed the use of liraglutide as a second or third drug in patients with type 2 diabetes whose glycaemic control was unsatisfactory with metformin, with or without a second oral glucoselowering drug. The submission included six manufacturer-sponsored trials that compared the efficacy of liraglutide against other glucose-lowering agents. Not all of the trials were relevant to the decision problem. The most relevant were Liraglutide Effects and Actions in Diabetes 5 (LEAD-5) (liraglutide used as part of triple therapy and compared against insulin glargine) and LEAD-6 [liraglutide in triple therapy compared against another glucagon like peptide-1 (GLP-1) agonist, exenatide]. Five of the six trials were published in full and one was then unpublished. Two doses of liraglutide, 1.2 and 1.8 mg, were used in some trials but in the two comparisons in triple therapy, against glargine and exenatide, only the 1.8-mg dose was used. Liraglutide in both doses was found to be clinically effective in lowering blood glucose concentration [glycated haemoglobin (HbA1c)], reducing weight (unlike other glucose-lowering agents, such as sulphonylureas, glitazones and insulins, which cause weight gain) and also reducing systolic blood pressure (SBP). Hypoglycaemia was uncommon. The ERG carried out meta-analyses comparing the 1.2- and 1.8-mg doses of liraglutide, which suggested that there was no difference in control of diabetes, and only a slight difference in weight loss, insufficient to justify the extra cost.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences
Library of Congress Subject Headings (LCSH): Non-insulin-dependent diabetes -- Treatment
Journal or Publication Title: Health Technology Assessment
Publisher: NIHR Health Technology Assessment programme
ISSN: 1366-5278
Date: 2011
Volume: Vol.15
Number: Supp.1
Status: Peer Reviewed
Publication Status: Published
Funder: NIHR Health Technology Assessment Programme (Great Britain)
Grant number: 08/230/01 (HTA)
References: 1. National Insitute for Health and Clinical Excellence (NICE). Guide to the single technology appraisal (STA) process. www.nice.org.uk/aboutnice/howwework/devnicetech/ developing_nice_single_technology_appraisals.jsp?domedia=1&mid=912F667C-19B9- E0B5-D43AD56E114A62D9 24/09/2010 (accessed 4 October 2010). 2. Yorkshire and Humber Public Health Observatory. Diabetes in England. www.yhpho.org.uk/ resource/item.aspx?RID=10113 14/11/2008 (accessed 4 October 2010). 3. National Institute for Health and Clinical Excellence (NICE). Type 2 Diabetes: newer agents (partial update of CG66).Clinical Guideline: CG87. http://guidance.nice.org.uk/CG87 01/05/2009 (accessed 1 May 2010). 4. Vilsboll T. The effects of glucagon-like peptide-1 on the beta cell. Diabetes Obes Metab 2009;11:11–18. 5. Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet 2009;374:39–47. 6. Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet 2010;375:1447–56. 7. Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 Met+SU): a randomised controlled trial. Diabetologia 2009;52:2046–55. 8. Marre M, Shaw J, Brandle M, Bebakar WMW, Kamaruddin NA, Strand J, et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet Med 2009;26:268–78. 9. Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, et al. efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes. The LEAD (Liraglutide Effect and Action in Diabetes)–2 study. Diabetes Care 2009;32:84–90. 10. Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, et al. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care 2009;32:1224–30. 11. Aas AM, Bergstad I, Thorsby PM, Johannesen O, Solberg M, Birkeland KI. An intensified lifestyle intervention programme may be superior to insulin treatment in poorly controlled Type 2 diabetic patients on oral hypoglycaemic agents: results of a feasibility study. Diabet Med 2005;22:316–22. 12. Blickle JF, Hancu N, Piletic M, Profozic V, Shestakova M, Dain MP, et al. Insulin glargine provides greater improvements in glycaemic control vs. intensifying lifestyle management for people with type 2 diabetes treated with OADs and 7–8% A1c levels. The TULIP study. Diabetes Obes Metab 2009;11:379–86. 13. Yorkshire and Humber Public Health Observatory. Prescribing for Diabetes in England. An analysis of volume, expenditure and trends. June 2009. www.yhpho.org.uk/resource/item. aspx?RID=9711 11/06/2009 (accessed 4 October 2010). 14. Waugh N, Cummins E, Royle P, Clar C, Marien M, Richter B, et al. Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation. Health Technol Assess 2010;14(36).
URI: http://wrap.warwick.ac.uk/id/eprint/52128

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