Glucagon-like peptide analogues for type 2 diabetes mellitus: systematic review and meta-analysis
Tóm tắt
Từ khóa
Tài liệu tham khảo
Turner R, Cull C, Holman R: United Kingdom prospective diabetes study 17: A 9-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus. Annals of Internal Medicine. 1996, 124: 136-145.
Stratton IM, Adler AI, Neil HAW, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR, UK Prospective Diabetes Study Grp: Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. British Medical Journal. 2000, 321: 405-412. 10.1136/bmj.321.7258.405.
Type 2 diabetes: the management of type 2 diabetes. NICE clinical guideline 87. [ http://www.nice.org.uk/cg87 ]
UKPDS16: U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995, 44: 1249-1258. 10.2337/diabetes.44.11.1249.
Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B: Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009, 32: 193-203. 10.2337/dc08-9025.
Hayward RA, Manning WG, Kaplan SH, Wagner EH, Greenfield S: Starting insulin therapy in patients with type 2 diabetes - Effectiveness, complications, and resource utilization. Jama-Journal of the American Medical Association. 1997, 278: 1663-1669. 10.1001/jama.278.20.1663.
Baggio LL, Huang QL, Brown TJ, Drucker DJ: A recombinant human glucagon-like peptide (GLP)-1-albumin protein (Albugon) mimics peptidergic activation of GLP-1 receptor-dependent pathways coupled with satiety, gastrointestinal motility, and glucose homeostasis. Diabetes. 2004, 53: 2492-2500. 10.2337/diabetes.53.9.2492.
Nauck MA, Kleine N, Orskov C, Holst JJ, Willms B, Creutzfeldt W: Normalization of Fasting Hyperglycemia by Exogenous Glucagon-Like Peptide-1 (7-36 Amide) in Type-2 (Non-Insulin-Dependent) Diabetic-Patients. Diabetologia. 1993, 36: 741-744. 10.1007/BF00401145.
Amori RE, Lau J, Pittas AG: Efficacy and safety of incretin therapy in type 2 diabetes - Systematic review and meta-analysis. Jama-Journal of the American Medical Association. 2007, 298: 194-206. 10.1001/jama.298.2.194.
Barnett AH: New treatments in type 2 diabetes: a focus on the incretin-based therapies. Clinical Endocrinology. 2009, 70: 343-353. 10.1111/j.1365-2265.2008.03396.x.
Monami M, Marchionni N, Mannucci E: Glucagon-like peptide-1 receptor agonists in type 2 diabetes: a meta-analysis of randomized clinical trials. European Journal of Endocrinology. 2009, 160: 909-917. 10.1530/EJE-09-0101.
Norris SL, Lee N, Thakurta S, Chan BKS: Exenatide efficacy and safety: a systematic review. Diabetic Medicine. 2009, 26: 837-846. 10.1111/j.1464-5491.2009.02790.x.
Xu G, Stoffers DA, Habener JF, Bonner-Weir S: Exendin-4 stimulates both beta-cell replication and neogenesis, resulting in increased beta-cell mass and improved glucose tolerance in diabetic rats. Diabetes. 1999, 48: 2270-2276. 10.2337/diabetes.48.12.2270.
Farilla L, Bulotta A, Hirshberg B, Calzi SL, Khoury N, Noushmehr H, Bertolotto C, Di Mario U, Harlan DM, Perfetti R: Glucagon-like peptide 1 inhibits cell apoptosis and improves glucose responsiveness of freshly isolated human islets. Endocrinology. 2003, 144: 5149-5158. 10.1210/en.2003-0323.
Li YZ, Hansotia T, Yusta B, Ris F, Halban PA, Drucker DJ: Glucagon-like peptide-1 receptor signaling modulates beta cell apoptosis. Journal of Biological Chemistry. 2003, 278: 471-478. 10.1074/jbc.M209423200.
Kobayashi M, Yamazaki K, Hirao K, Oishi M, Kanatsuka A, Yamauchi M, Takagi H, Kawai K: The status of diabetes control and antidiabetic drug therapy in Japan--a cross-sectional survey of 17,000 patients with diabetes mellitus (JDDM 1). Diabetes Res Clin Pract. 2006, 73: 198-204. 10.1016/j.diabres.2006.01.013.
Neville SE, Boye KS, Montgomery WS, Iwamoto K, Okamura M, Hayes RP: Diabetes in Japan: a review of disease burden and approaches to treatment. Diabetes Metab Res Rev. 2009, 25: 705-716. 10.1002/dmrr.1012.
Kaku K, Rasmussen MF, Clauson P, Seino Y: Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2010, 12: 341-347. 10.1111/j.1463-1326.2009.01194.x.
Higgins J, Altman DG: Assessing Risk of Bias in Included Studies. Cochrane Handbook for Systematic Reviews of Interventions. 2008, 187-241. full_text.
Kadowaki T, Namba M, Yamamura A, Sowa H, Wolka AM, Brodows RG: Exenatide Exhibits Dose-Dependent Effects on Glycemic Control over 12 Weeks in Japanese Patients with Suboptimally Controlled Type 2 Diabetes. Endocrine Journal. 2009, 56: 415-424. 10.1507/endocrj.K08E-296.
Kendall DM, Riddle MC, Rosenstock J, Zhuang DL, Kim DD, Fineman MS, Baron AD: Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005, 28: 1083-1091. 10.2337/diacare.28.5.1083.
DeFronzo RA, Triplitt C, Qu Y, Lewis MS, Maggs D, Glass LC: Effects Of Exenatide Plus Rosiglitazone On Beta Cell Function And Insulin Sensitivity In Subjects With Type 2 Diabetes On Metformin. Diabetes Care. 2010
Rosenstock J, Reusch J, Bush M, Yang F, Stewart M: Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care. 2009, 32: 1880-1886. 10.2337/dc09-0366.
Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R: Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care. 2009, 32: 1237-1243. 10.2337/dc08-1961.
Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R: Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med. 2010, 27: 556-562. 10.1111/j.1464-5491.2010.02990.x.
Gill A, Hoogwerf BJ, Burger J, Bruce S, MacConell L, Yan P, Braun D, Giaconia J, Malone J: Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study. Cardiovasc Diabetol. 2010, 9: 6-10.1186/1475-2840-9-6.
Derosa G, Maffioli P, Salvadeo SA, Ferrari I, Ragonesi PD, Querci F, Franzetti IG, Gadaleta G, Ciccarelli L, Piccinni MN: Exenatide versus glibenclamide in patients with diabetes. Diabetes Technol Ther. 2010, 12: 233-240. 10.1089/dia.2009.0141.
Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V, NovoLog Mix-vs-Exenatide Study Grp: Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. Current Medical Research and Opinion. 2009, 25: 65-75. 10.1185/03007990802597951.
Bunck MC, Diamant M, Corner A, Eliasson B, Malloy JL, Shaginian RM, Deng W, Kendall DM, Taskinen MR, Smith U: One-year Treatment With Exenatide Improves beta-Cell Function, Compared With Insulin Glargine, in Metformin-Treated Type 2 Diabetic Patients A randomized, controlled trial. Diabetes Care. 2009, 32: 762-768. 10.2337/dc08-1797.
Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A: Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obesity & Metabolism. 2009, 11: 1153-1162.
Davis SN, Johns D, Maggs D, Xu H, Northrup JH, Brodows RG: Exploring the substitution of exenatide for insulin in patients with type 2 diabetes treated with insulin in combination with oral antidiabetes agents. Diabetes Care. 2007, 30: 2767-2772. 10.2337/dc06-2532.
Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG, Gwaa SG: Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes - A randomized trial. Annals of Internal Medicine. 2005, 143: 559-569.
Nauck MA, Duran S, Kim D, Johns D, Northrup J, Festa A, Brodows R, Trautmann M: A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study. Diabetologia. 2007, 50: 259-267. 10.1007/s00125-006-0510-2.
Diamant M, Van GL, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M: Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010, 375: 2234-2243. 10.1016/S0140-6736(10)60406-0.
Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simo R, Liraglutide Effect AD: 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: 2046-2055. 10.1007/s00125-009-1472-y.
Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR, Study G: 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. 10.2337/dc08-1355.
Bergenstal RM, Wysham C, MacConell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE: Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010
Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, Sondergaard RE, Davies M: 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: 1447-1456. 10.1016/S0140-6736(10)60307-8.
Marre M, Shaw J, Brandle M, Bebakar WMW, Kamaruddin NA, Strand J, Zdravkovic M, Le Thi TD, Colagiuri S, Su SG: 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). Diabetic Medicine. 2009, 26: 268-278. 10.1111/j.1464-5491.2009.02666.x.
Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L, Study G: 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. 10.1016/S0140-6736(09)60659-0.
Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang DL, Porter L, Study G: Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008, 372: 1240-1250. 10.1016/S0140-6736(08)61206-4.
DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD: Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005, 28: 1092-1100. 10.2337/diacare.28.5.1092.
Apovian CM, Bergenstal RM, Cuddihy RM, Qu Y, Lenox S, Lewis MS, Glass LC: Effects of exenatide combined with lifestyle modification in patients with type 2 diabetes. Am J Med. 2010, 123: 468-17. 10.1016/j.amjmed.2009.11.019.
Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, Hale PM, Zdravkovic M, Blonde L, Study I: 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: 1224-1230. 10.2337/dc08-2124.
Gao Y, Yoon KH, Chuang LM, Mohan V, Ning G, Shah S, Jang HC, Wu TJ, Johns D, Northrup J: Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea. Diabetes Research and Clinical Practice. 2009, 83: 69-76. 10.1016/j.diabres.2008.09.037.
Kendall D, Nielsen L, Han J, Brodows R, Bhole D: Metabolic improvement associated with temporal pattern of weight loss in exenatide-treated patients with type 2 diabetes. Diabetologia. 2008, 51: 886-
Loh J, Clement SC: Efficacy of exenatide therapy over two years in a "Real World" setting. Diabetes. 2008, 57: A32-
Guideline for managment of postmeal glucose. [ http://www.idf.org/webdata/docs/Guideline_PMG_final.pdf ]
Guide to the methods of technology appraisal. [ http://www.nice.org.uk/aboutnice/howwework/devnicetech/technologyappraisalprocessguides/guidetothemethodsoftechnologyappraisal.jsp ]
Waugh N, Cummins E, Royle P, Clar C, Marien M, Richter B, Philip S: Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation. Health Technology Assessment. 2010,
Sheffield CA, Kane MP, Busch RS, Bakst G, Abelseth JM, Hamilton RA: Safety and efficacy of exenatide in combination with insulin in patients with type 2 diabetes mellitus. Endocr Pract. 2008, 14: 285-292.
Information for Healthcare Professionals: Exenatide (marketed as Byetta). [ http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124713.htm ]
Byetta Safety Update for Healthcare Professionals. [ http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190406.htm ]
Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta). [ http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm188656.htm ]
Assessment report for Victoza (liraglutide). [ http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001026/human_med_001137.jsp%26murl=menus/medicines/medicines.jsp%26mid=WC0b01ac058001d125# ]
Butler PC, Matveyenko AV, Dry S, Bhushan A, Elashoff R: Glucagon-like peptide-1 therapy and the exocrine pancreas: innocent bystander or friendly fire?. Diabetologia. 2010, 53: 1-6. 10.1007/s00125-009-1591-5.
Schernthaner G, Barnett AH, Betteridge DJ, Carmena R, Ceriello A, Charbonnel B, Hanefeld M, Lehmann R, Malecki MT, Nesto R: Is the ADA/EASD algorithm for the management of type 2 diabetes (January 2009) based on evidence or opinion? A critical analysis. Diabetologia. 2010, 53: 1258-1269. 10.1007/s00125-010-1702-3.
Fewtrell MS, Kennedy K, Singhal A, Martin RM, Ness A, Hadders-Algra M, Koletzko B, Lucas A: How much loss to follow-up is acceptable in long-term randomised trials and prospective studies?. Arch Dis Child. 2008, 93: 458-461. 10.1136/adc.2007.127316.
Schulz KF, Grimes DA: Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet. 2002, 359: 781-785. 10.1016/S0140-6736(02)07882-0.
Fonseca V, Rosenstock J, Patwardhan R, Salzman A: Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. JAMA. 2000, 283: 1695-1702. 10.1001/jama.283.13.1695.
Bunck MC, Corner A, Eliasson B, Heine RJ, Shaginian RM, Taskinen MR, Smith U, Yki-Jarvinen H, Diamant M: Three-Year Exenatide Therapy, Followed by a 4-Week Off-Drug Period, Had a Sustainable Effect on ß-Cell Disposition Index in Metformin Treated Patients with Type 2 Diabetes. 70th Scientific Session of the American Diabetes Association, June 25 - 29, Orlando, Florida. 2010
Vilsboll T: The effects of glucagon-like peptide-1 on the beta cell. Diabetes, Obesity & Metabolism. 2009, 11 (Suppl-8):
Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, Paul SK: Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009, 361: 1736-1747. 10.1056/NEJMoa0905479.
Diabetes - liraglutide: appraisal consultation 2 document. [ http://www.nice.org.uk/guidance/index.jsp?action=article%26o=49173 ]
Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Wintle ME, Maggs DG: Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008, 24: 275-286.
Yki-Jarvinen H, Ryysy L, Nikkila K, Tulokas T, Vanamo R, Heikkila M: Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial. Ann Intern Med. 1999, 130: 389-396.