An estimation of the long-term clinical and economic benefits of insulin lispro in Type 1 diabetes in the UK

Diabetic Medicine

Volumn 26, Issue 8, 2009, Pages 803-814

  Pratoomsoot, C ^a,b   Smith, H T ^c   Kalsekar, A ^c   Boye, K S ^c   Arellano, J ^c   Valentine, W J ^d  

^a IMS Health ^*  (Switzerland)

^b IQVIA   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d Ossian Health Economics and Communications   (Switzerland)

Author keywords

Cost effectiveness analysis; Insulin lispro; Regular human insulin; Type 1 diabetes; UK

Indexed keywords

GLYCOSYLATED HEMOGLOBIN; HUMAN INSULIN; INSULIN LISPRO; ISOPHANE INSULIN;

ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; COST OF ILLNESS; DRUG COST; HEALTH ECONOMICS; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; LIFE EXPECTANCY; MAJOR CLINICAL STUDY; META ANALYSIS; QUALITY ADJUSTED LIFE YEAR; SYSTEMATIC REVIEW; UNITED KINGDOM;

COST-BENEFIT ANALYSIS; DIABETES MELLITUS, TYPE 1; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; LIFE EXPECTANCY; QUALITY-ADJUSTED LIFE YEARS; STATISTICS AS TOPIC; TIME FACTORS;

EID: 68149145388     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/j.1464-5491.2009.02775.x     Document Type: Article

References (89)

1. Vignati L, Anderson JH Jr., Iversen PW. Efficacy of insulin lispro in combination with NPH human insulin twice per day in patients with insulin-dependent or non-insulin-dependent diabetes mellitus. Multicenter Insulin Lispro Study Group. Clin Ther 1997 19 : 1408 1421.
2. Herbst KL, Hirsch IB. Insulin strategies for primary care providers. Clinical Diabetes 2002 20 : 11 17.
3. Lalli C, Ciofetta M, Del SP, Torlone E, Pampanelli S, Compagnucci P et al. Long-term intensive treatment of type 1 diabetes with the short-acting insulin analogue lispro in variable combination with NPH insulin at mealtime. Diabetes Care 1999 22 : 468 477.
4. Anderson JH Jr., Brunelle RL, Koivisto VA, Pfutzner A, Trautmann ME, Vignati L et al. Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analogue treatment. Multicenter Insulin Lispro Study Group. Diabetes 1997 46 : 265 270.
5. Pfutzner A, Kustner E, Forst T, Schulze-Schleppinghoff B, Trautmann ME, Haslbeck M et al. Intensive insulin therapy with insulin lispro in patients with type 1 diabetes reduces the frequency of hypoglycemic episodes. Exp Clin Endocrinol Diabetes 1996 104 : 25 30.
6. Renner R, Pfutzner A, Trautmann M, Harzer O, Sauter K, Landgraf R. Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. German Humalog-CSII Study Group. Diabetes Care 1999 22 : 784 788.
7. Roach P, Trautmann M, Arora V, Sun B, Anderson JH Jr. Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin lispro-protamine formulations, insulin lispro mix25 and insulin lispro mix50. Mix50 Study Group. Clin Ther 1999 21 : 523 534.
8. Gale EA. A randomized, controlled trial comparing insulin lispro with human soluble insulin in patients with Type 1 diabetes on intensified insulin therapy. The UK Trial Group. Diabet Med 2000 17 : 209 214.
9. Brunelle BL, Llewelyn J, Anderson JH Jr., Gale EA, Koivisto VA. Meta-analysis of the effect of insulin lispro on severe hypoglycemia in patients with type 1 diabetes. Diabetes Care 1998 21 : 1726 1731.
10. Holleman F, Schmitt H, Rottiers R, Rees A, Symanowski S, Anderson JH. Reduced frequency of severe hypoglycemia and coma in well-controlled IDDM patients treated with insulin lispro. The Benelux-UK Insulin Lispro Study Group. Diabetes Care 1997 20 : 1827 1832.
11. Ahmed AB, Home PD. The effect of the insulin analogue lispro on night-time blood glucose control in type 1 diabetic patients. Diabetes Care 1998 21 : 32 37.
12. Brange J, Ribel U, Hansen JF, Dodson G, Hansen MT, Havelund S et al. Monomeric insulins obtained by protein engineering and their medical implications. Nature 1988 333 : 679 682.
13. The Information Centre and Yorkshire and Humber Public Health Observatory. Prescribing for Diabetes in England. An analysis of Volume, Expenditure and Trends November 2007. Available at: http://www.yhpho.org.uk/ resource/item.aspx?RID=45983 Last accessed 16 July 2008.
14. National Institute for Clinical Excellence. NICE Guidance CG15: Diagnosis and Management of Type 1 Diabetes in Children, Young People and Adults. 2004. Available at: http://www.nice.org.uk/guidance/CG15 Last accessed 27 June 2008.
15. Shukal V, Otten N. Insulin Lispro: A Critical Evaluation. Canadian Coordinating Office for Health Technology Assessment (CCOHTA). 1999. Available at: http://cadth.ca/media/pdf/lispro-tr-e.pdf Last accessed 16 July 2008.
16. Banerjee S, Tran K, Li H, Cimon K, Daneman D, Simpson S et al. Short-acting Insulin Analogues for Diabetes Mellitus: Meta-analysis of Clinical Outcomes and Assessment of Cost-effectiveness. Canadian Agency for Drugs and Technologies in Health (CADTH). 2007. Available at: http://www.cadth.ca/index. php/en/publication/706 Last accessed 16 July 2008.
17. Siebenhofer A, Plank J, Berghold A, Jeitler K, Horvath K, Narath M et al. Short-acting insulin analogues versus regular human insulin in patients with diabetes mellitus. Cochrane Database Syst Rev 2006, Issue 1. Art. No.: CD003287. DOI:.
18. Institut für qualität und Wirtschaflichkeit im Gesundheitswesen (IQWiG). Kurzwirksame Insulinanaloga zur Behandlung des Diabetes mellitus Typ 1. 2007. Available at: http://iqwig.de/download/A05-02-Abschlussbericht- Kurzwirksame-Insulinanaloga-bei-Diabetes-mellitus-Typ-1.pdf Last accessed 27 June 2008.
19. Institut für qualität und Wirtschaflichkeit im Gesundheitswesen (IQWiG). Rapid-acting Insulin Analogues in Diabetes Mellitus Type 1: Superiority Not Proven. 2007. Available at: http://www.iqwig.de/index.658.en. html Last accessed 27 June 2008.
20. Palmer AJ, Roze S, Valentine WJ, Minshall ME, Foos V, Lurati FM et al. The CORE Diabetes Model: projecting long-term clinical outcomes, costs and cost-effectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement mecision-making. Curr Med Res Opin 2004 20 : S5 S26.
21. Palmer AJ, Roze S, Valentine W, Minshall M, Foos V, Lurati F et al. Validation of the CORE Diabetes Model against epidemiological and clinical studies. Curr Med Res Opin 2004 20 : S27 S40.
22. Currie CJ, Poole CD, Tetlow T, Holmes P, McEwan P. The outcome of care in people with type 1 and type 2 diabetes following switching to treatment with either insulin glargine or insulin detemir in routine general practice in the UK: a retrospective database analysis. Curr Med Res Opin 2007 23 : S33 S39.
23. Tesfaye S, Chaturvedi N, Eaton SE, Ward JD, Manes C, Ionescu-Tirgoviste C et al. Vascular risk factors and diabetic neuropathy. N Engl J Med 2005 352 : 341 350.
24. Currie CJ, Poole CD, Woehl A, Morgan CL, Cawley S, Rousculp MD et al. The financial costs of healthcare treatment for people with Type 1 or Type 2 diabetes in the UK with particular reference to differing severity of peripheral neuropathy. Diabet Med 2007 24 : 187 194.
25. Sibal L, Law HN, Gebbie J, Dashora UK, Agarwal SC, Home P. Predicting the development of macrovascular disease in people with type 1 diabetes: a 9-year follow-up study. Ann N Y Acad Sci 2006 1084 : 191 207.
26. James P, Tan HH, MacAlpine R, Brennan G, Emslie-Smith A, Morris AD. Treatment gap in the use of lipid-lowering drug therapy in diabetes: a population-based study. Diabet Med 2004 21 : 1108 1112.
27. Primatesta P, Poulter NR. Lipid levels and the use of lipid-lowering agents in England and Scotland. Eur J Cardiovasc Prev Rehabil 2004 11 : 484 488.
28. Collado-Mesa F, Colhoun HM, Stevens LK, Boavida J, Ferriss JB, Karamanos B et al. Prevalence and management of hypertension in Type 1 diabetes mellitus in Europe: the EURODIAB IDDM Complications Study. Diabet Med 1999 16 : 41 48.
29. Duggan AK, Niziol CJ. Real-life treatment of hypertension in UK primary care: prescribing habits, results and adherence to clinical guidelines. Br J Cardiol 2003 10 : S3 S7.
30. Benett IJ, Lambert C, Hinds G, Kirton C. Emerging standards for diabetes care from a city-wide primary care audit. Diabet Med 1994 11 : 489 492.
31. Wilson A, Baker R, Thompson J, Grimshaw G. Coverage in screening for diabetic retinopathy according to screening provision: results from a national survey in England and Wales. Diabet Med 2004 21 : 271 278.
32. Office for national statistics. Ethnicity & Identity. Population of the United Kingdom: by Ethnic Group, April 2001. 2004. Available at: http://www.statistics.gov.uk/cci/nugget.asp?id=455 Last accessed 20 May 2008.
33. Heller SR, Amiel SA, Mansell P. Effect of the fast-acting insulin analogue lispro on the risk of nocturnal hypoglycemia during intensified insulin therapy. UK Lispro Study Group. Diabetes Care 1999 22 : 1607 1611.
34. The DCCT Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993 329 : 977 986.
35. MIMS. Monthly Index of Medical Specialties. London : Haymarket Medical Publications Ltd., 2008.
36. eMIMS. MIMS UK Prices for January 2007 (Regional Drug and Therapeutics Centre). Available at: http://www.mims.co.uk Last accessed 10 February 2007.
37. NHS Purchasing and Supply Agency. 2008. Available at: http://www.pasa.nhs.uk/PASAweb Last accessed 27 May 2008.
38. James M, Turner DA, Broadbent DM, Vora J, Harding SP. Cost-effectiveness analysis of screening for sight-threatening diabetic eye disease. Br Med J 2000 320 : 1627 1631.
39. Clarke P, Gray A, Legood R, Briggs A, Holman R. The impact of diabetes-related complications on healthcare costs: results from the UK Prospective Diabetes Study (UKPDS Study No. 65). Diabet Med 2003 20 : 442 450.
40. Currie CJ, Morgan CL, Peters JR. The epidemiology and cost of inpatient care for peripheral vascular disease, infection, neuropathy, and ulceration in diabetes. Diabetes Care 1998 21 : 42 48.
41. UK Prospective Diabetes Study Group. Cost-effectiveness analysis of improved blood pressure control in hypertensive patients with type 2 diabetes: UKPDS 40. Br Med J 1998 317 : 720 726.
42. Leese GP, Wang J, Broomhall J, Kelly P, Marsden A, Morrison W et al. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care 2003 26 : 1176 1180.
43. Scuffham P, Carr L. The cost-effectiveness of continuous subcutaneous insulin infusion compared with multiple daily injections for the management of diabetes. Diabet Med 2003 20 : 586 593.
44. Ghatnekar O, Persson U, Willis M, Odegaard K. Cost-effectiveness of Becaplermin in the treatment of diabetic foot ulcers in four European countries. Pharmacoeconomics 2001 19 : 767 778.
45. Clarke P, Gray A, Holman R. Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62). Med Decis Making 2002 22 : 340 349.
46. Tengs TO, Wallace A. One thousand health-related quality-of-life estimates. Med Care 2000 38 : 583 637.
47. Australian Institute of Health and Welfare. The Burden of Disease and Injury in Australia. 2003. Available at: http://www.aihw.gov.au/publications/ index.cfm/title/10317 Last accessed 16 July 2008.
48. Brown MM, Brown GC, Sharma S. Value-based medicine and vitreoretinal diseases. Curr Opin Ophthalmol 2004 15 : 167 172.
49. Carrington AL, Mawdsley SK, Morley M, Kincey J, Boulton AJ. Psychological status of diabetic people with or without lower limb disability. Diabetes Res Clin Pract 1996 32 : 19 25.
50. index) in people with type 1 diabetes who experience severe hypoglycemia. Diabetologia 2005 48 : A292 A293.
51. National Institute for Health and Clincial Excellence. Guide to the Methods of Technology Appraisal. 2004. Available at: http://www.nice.org.uk/ niceMedia/pdf/TAP-Methods.pdf Last accessed 16 July 2008.
52. Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ 1997 6 : 327 340.
53. Anderson JH Jr., Brunelle RL, Koivisto VA, Trautmann ME, Vignati L, DiMarchi R. Improved mealtime treatment of diabetes mellitus using an insulin analogue. Multicenter Insulin Lispro Study Group. Clin Ther 1997 19 : 62 72.
54. Skrha J, Smahelova A, Andel M, Vrtovec M, Subic J, Kreze A et al. Insulin lispro improves postprandial glucose control in patients with diabetes mellitus. Sb Lek 2002 103 : 15 21.
55. Annuzzi G, Del PS, Arcari R, Bellomo DA, Benzi L, Bruttomesso D et al. Preprandial combination of lispro and NPH insulin improves overall blood glucose control in type 1 diabetic patients: a multicenter randomized crossover trial. Nutr Metab Cardiovasc Dis 2001 11 : 168 175.
56. Caixas A, Perez A, Payes A, Otal C, Carreras G, Ordonez-Llanos J et al. Effects of a short-acting insulin analogue (insulin lispro) versus regular insulin on lipid metabolism in insulin-dependent diabetes mellitus. Metabolism 1998 47 : 371 376.
57. Chan WB, Chow CC, Yeung VT, Chan JC, So WY, Cockram CS. Effect of insulin lispro on glycaemic control in Chinese diabetic patients receiving twice-daily regimens of insulin. Chin Med J (Engl) 2004 117 : 1404 1407.
58. 1c in type 1 diabetes on physiologic intensive therapy with lispro insulin at mealtime. Diabetes Care 1999 22 : 795 800.
59. Del SP, Ciofetta M, Lalli C, Perriello G, Pampanelli S, Torlone E et al. Use of the short-acting insulin analogue lispro in intensive treatment of Type 1 diabetes mellitus: importance of appropriate replacement of basal insulin and time-interval injection-meal. Diabet Med 1998 15 : 592 600.
60. Ferguson SC, Strachan MW, Janes JM, Frier BM. Severe hypoglycaemia in patients with type 1 diabetes and impaired awareness of hypoglycaemia: a comparative study of insulin lispro and regular human insulin. Diabetes Metab Res Rev 2001 17 : 285 291.
61. Ford-Adams ME, Murphy NP, Moore EJ, Edge JA, Ong KL, Watts AP et al. Insulin lispro: a potential role in preventing nocturnal hypoglycaemia in young children with diabetes mellitus. Diabet Med 2003 20 : 656 660.
62. Hedman CA, Orre-Pettersson AC, Lindstrom T, Arnqvist HJ. Treatment with insulin lispro changes the insulin profile but does not affect the plasma concentrations of IGF-I and IGFBP-1 in type 1 diabetes. Clin Endocrinol (Oxf) 2001 55 : 107 112.
63. Herz M, Arora V, Sun B, Ferguson SC, Bolli GB, Frier BM. Basal-bolus insulin therapy in Type 1 diabetes: comparative study of pre-meal administration of a fixed mixture of insulin lispro (50%) and neutral protamine lispro (50%) with human soluble insulin. Diabet Med 2002 19 : 917 923.
64. Jacobs MA, Keulen ET, Kanc K, Casteleijn S, Scheffer P, Deville W et al. Metabolic efficacy of preprandial administration of Lys(B28), Pro(B29) human insulin analogue in IDDM patients. A comparison with human regular insulin during a three-meal test period. Diabetes Care 1997 20 : 1279 1286.
65. Janssen MM, Snoek FJ, Masurel N, Hoogma RP, Deville WL, Popp-Snijders C et al. Optimized basal-bolus therapy using a fixed mixture of 75% lispro and 25% NPL insulin in type 1 diabetes patients: no favorable effects on glycemic control, physiological responses to hypoglycemia, well-being, or treatment satisfaction. Diabetes Care 2000 23 : 629 633.
66. Jansson PA, Ebeling P, Smith U, Conget I, Coves MJ, Gomis R et al. Improved glycemic control can be better maintained with insulin lispro than with human regular insulin. Diabetes Nutr Metab 1998 11 : 194 199.
67. 1c insuman Infusat and less insulin requirement in IDDM patients using insulin lispro in CSII. The Swedish Multicenter Lispro Insulin Study. Diabetes Metab 2000 26 : 192 196.
68. Kotsanos JG, Vignati L, Huster W, Andrejasich C, Boggs MB, Jacobson AM et al. Health-related quality-of-life results from multinational clinical trials of insulin lispro. Assessing benefits of a new diabetes therapy. Diabetes Care 1997 20 : 948 958.
69. 1c and blood glucose stability in IDDM patients treated with lispro insulin analogue in external pumps. Diabetes Care 1998 21 : 977 982.
70. Provenzano C, Vero R, Oliva A, Leto G, Puccio L, Vecci E et al. Lispro insulin in type 1 diabetic patients on a Mediterranean or normal diet: a randomized, cross-over comparative study with regular insulin. Diabetes Nutr Metab 2001 14 : 133 139.
71. Raskin P, Holcombe JH, Tamborlane WV, Malone JI, Strowig S, Ahern JA et al. A comparison of insulin lispro and buffered regular human insulin administered via continuous subcutaneous insulin infusion pump. J Diabetes Complications 2001 15 : 295 300.
72. Recasens M, Aguilera E, Morinigo R, Casamitjana R, Nicoletti F, Gomis R et al. Insulin lispro is as effective as regular insulin in optimising metabolic control and preserving beta-cell function at onset of type 1 diabetes mellitus. Diabetes Res Clin Pract 2003 60 : 153 159.
73. Schmauss S, Konig A, Landgraf R. Human insulin analogue [LYS(B28), PRO(B29)]: the ideal pump insulin? Diabet Med 1998 15 : 247 249.
74. Valle D, Santoro D, Bates P, Scarpa L. Italian multicentre study of intensive therapy with insulin lispro in 1184 patients with Type 1 diabetes. Diabetes Nutr Metab 2001 14 : 126 132.
75. Zinman B, Tildesley H, Chiasson JL, Tsui E, Strack T. Insulin lispro in CSII: results of a double-blind crossover study. Diabetes 1997 46 : 440 443.
76. Bode BW, Strange P. Efficacy, safety, and pump compatibility of insulin aspart used in continuous subcutaneous insulin infusion therapy in patients with type 1 diabetes. Diabetes Care 2001 24 : 69 72.
77. Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med 2002 19 : 393 399.
78. Bott U, Ebrahim S, Hirschberger S, Skovlund SE. Effect of the rapid-acting insulin analogue insulin aspart on quality of life and treatment satisfaction in patients with Type 1 diabetes. Diabet Med 2003 20 : 626 634.
79. DeVries JH, Lindholm A, Jacobsen JL, Heine RJ, Home PD. A randomized trial of insulin aspart with intensified basal NPH insulin supplementation in people with Type 1 diabetes. Diabet Med 2003 20 : 312 318.
80. Heller SR, Colagiuri S, Vaaler S, Wolffenbuttel BH, Koelendorf K, Friberg HH et al. Hypoglycaemia with insulin aspart: a double-blind, randomized, crossover trial in subjects with Type 1 diabetes. Diabet Med 2004 21 : 769 775.
81. Home PD, Lindholm A, Hylleberg B, Round P. Improved glycemic control with insulin aspart: a multicenter randomized double-blind crossover trial in type 1 diabetic patients. UK Insulin Aspart Study Group. Diabetes Care 1998 21 : 1904 1909.
82. Home PD, Lindholm A, Riis A. Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. Diabet Med 2000 17 : 762 770.
83. Home PD, Hallgren P, Usadel KH, Sane T, Faber J, Grill V et al. Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes. Diabetes Res Clin Pract 2006 71 : 131 139.
84. Iwamoto Y, Akanum Y, Niimi H, Sasaki N, Tajima N, Kawamori R. Comparison between insulin aspart and soluble human insulin in type 1 diabetes (IDDM) patients treated with basal-bolus insulin therapy - Phase III clinical trial in Japan. J Jpn Diabetes Soc 2008 44 : 799 811.
85. Raskin P, Guthrie RA, Leiter L, Riis A, Jovanovic L. Use of insulin aspart, a fast-acting insulin analogue, as the mealtime insulin in the management of patients with type 1 diabetes. Diabetes Care 2000 23 : 583 588.
86. Tamas G, Marre M, Astorga R, Dedov I, Jacobsen J, Lindholm A. Glycaemic control in type 1 diabetic patients using optimised insulin aspart or human insulin in a randomised multinational study. Diabetes Res Clin Pract 2001 54 : 105 114.
87. Bode B, Weinstein R, Bell D, McGill J, Nadeau D, Raskin P et al. Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion: a randomized study in type 1 diabetes. Diabetes Care 2002 25 : 439 444.
88. Garg SK, Rosenstock J, Ways K. Optimized basal-bolus insulin regimens in type 1 diabetes: insulin glulisine versus regular human insulin in combination with Basal insulin glargine. Endocr Pract 2005 11 : 11 17.
89. eMIMS. Monthly Index of Medical Specialities 2004. Available at: http://www.mims.co.uk Last accessed 12 September 2004.