Does all the evidence say that insulin analogues are more effective than human insulins?

Authors

  • M.V. Neborachko MyDiabetesSolutions, Kyiv, Ukraine
  • O.G. Phakadze MyDiabetesSolutions, Kyiv, Ukraine

DOI:

https://doi.org/10.22141/2224-0721.17.7.2021.244975

Keywords:

diabetes mellitus, insulin therapy, insulin analogues, recombinant human insulin, efficacy

Abstract

Currently, a large amount of data has been accumulated to compare recombinant human insulin with insulin analogues, including meta-analyzes of comparative efficacy and safety, as well as cost-effectiveness data and data on the possible carcinogenicity of new products. Insulin treatment is a necessity for some people with diabetes mellitus (DM) due to the need to maintain optimal blood glucose levels. The authors emphasize the need to keep in mind that new insulin drugs are much more expensive, which may limit their use. Factors such as the effectiveness of treatment, its safety, and patient satisfaction should be taken into account when deciding on the choice of therapy, but the cost of treatment cannot be ignored, given that it is usually reimbursable from the budget. In this regard, insulin therapy should be individually selected taking into account the needs of patients, treatment goals, safety, and cost. The authors propose an analysis of these data on the feasibility of using insulin analogues in comparison with recombinant human insulin for patients with type 1 diabetes and patients with type 2 diabetes and their effectiveness in both types of diabetes. A reasonable policy for the use of insulin therapy should be developed based on available clinical data based on comparative studies in different groups of diabetics and comprehensive analysis of economic data. The feasibility of a new drug should be evaluated and regularly reviewed in light of the practical results of its use in clinical practice. It is also necessary to regularly conduct a retrospective economic analysis to assess the pharmacoeconomic benefits. All of these steps should assist decision-makers and regulators in implementing effective national programs to develop new effective insulin procurement systems.

Downloads

Download data is not yet available.

References

World Health Organization (WHO). The selection and use of essential medicines: Report of the 21st WHO Expert Committee. 2017, March 27-31; Geneva, Switzerland. Geneva: WHO-press; 2017. 15 p.

Sibal L, Home PD. Management of type 2 diabetes: NICE guidelines. Clin Med (Lond). 2009 Aug;9(4):353-357. doi:10.7861/clinmedicine.9-4-353.

Nathan DM, Buse JB, Davidson MB, et al. 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 Jan;32(1):193-203. doi:10.2337/dc08-9025.

Horvath K, Jeitler K, Berghold A, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD005613. doi:10.1002/14651858.CD005613.pub3.

Raskin P, Allen E, Hollander P, et al. Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005 Feb;28(2):260-265. doi:10.2337/diacare.28.2.260.

Dailey G, Rosenstock J, Moses RG, Ways K. Insulin glulisine provides improved glycemic control in patients with type 2 diabetes. Diabetes Care. 2004 Oct;27(10):2363-2368. doi:10.2337/diacare.27.10.2363.

American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S13-S27. doi:10.2337/dc18-S002.

American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S14-S31. doi:10.2337/dc20-S002.

Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020 Jan 7;41(2):255-323. doi:10.1093/eurheartj/ehz486.

American Diabetes Association. Economic costs of diabetes in the US in 2012. Diabetes Care. 2013 Apr;36(4):1033-1046. doi:10.2337/dc12-2625.

National Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management: NICE guideline [NG28]. Available from: www.nice.org.uk/guidance/NG28. Accessed: December 16, 2020.

Holden SE, Poole CD, Morgan CL, Currie CJ. Evaluation of the incremental cost to the National Health Service of prescribing analogue insulin. BMJ Open. 2011 Jan 1;1(2):e000258. doi:10.1136/bmjopen-2011-000258.

World Health Organization (WHO). Review of the evidence comparing insulin (human or animal) with analogue insulins. 18t Expert Committee on the Selection and Use of Essential Medicines. 2011, March 21-25; Accra, Ghana. Geneva: WHO-press; 2011. 15 p.

Cameron CG, Bennett HA. Cost-effectiveness of insulin analogues for diabetes mellitus. CMAJ. 2009 Feb 17;180(4):400-407. doi:10.1503/cmaj.081180.

Siebenhofer A, Plank J, Berghold A, et al. Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003287. doi:10.1002/14651858.CD003287.pub4.

Qayyum R, Bolen S, Maruthur N, et al. Systematic review: comparative effectiveness and safety of premixed insulin analogues in type 2 diabetes. Ann Intern Med. 2008 Oct 21;149(8):549-559. doi:10.7326/0003-4819-149-8-200810210-00242.

Nabrdalik K, Kwiendacz H, Sawczyn T, et al. Efficacy, Safety, and Quality of Treatment Satisfaction of Premixed Human and Analogue Insulin Regimens in a Large Cohort of Type 2 Diabetic Patients: Progens Benefit Observational Study. Int J Endocrinol. 2018 Mar 5;2018:6536178. doi:10.1155/2018/6536178.

Grzeszczak W, Bijoś P, Borkowski M, Manikowski A. Comparison of the efficacy and safety of pre-mixed human insulin (Gensulin M30) versus pre-mixed insulin aspart 30/70 (NovoMix 30) in patients with type 2 diabetes mellitus. Diabetologia Doświadczalna i Kliniczna. 2010;10(1):53-58.

Singh SR, Ahmad F, Lal A, Yu C, Bai Z, Bennett H. Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis. CMAJ. 2009 Feb 17;180(4):385-397. doi:10.1503/cmaj.081041.

Pathak RD, Schroeder EB, Seaquist ER, et al. Severe Hypoglycemia Requiring Medical Intervention in a Large Cohort of Adults With Diabetes Receiving Care in US Integrated Health Care Delivery Systems: 2005-2011. Diabetes Care. 2016 Mar;39(3):363-370. doi:10.2337/dc15-0858.

Mühlhauser I, Overmann H, Bender R, Bott U, Berger M. Risk factors of severe hypoglycaemia in adult patients with Type I diabetes--a prospective population based study. Diabetologia. 1998 Nov;41(11):1274-1282. doi:10.1007/s001250051065.

Gough SC. A review of human and analogue insulin trials. Diabetes Res Clin Pract. 2007 Jul;77(1):1-15. doi:10.1016/j.diabres.2006.10.015.

Taylor JR, Campbell KM. Insulin analogs for the management of type 2 diabetes. Am J Health Syst Pharm. 2013 Feb 15;70(4):320-334. doi:10.2146/ajhp110381.

Müller N, Frank T, Kloos C, Lehmann T, Wolf G, Müller UA. Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin. Diabetes Care. 2013 Jul;36(7):1865-1869. doi:10.2337/dc12-1694.

Rys P, Pankiewicz O, Łach K, Kwaskowski A, Skrzekowska-Baran I, Malecki MT. Efficacy and safety comparison of rapid-acting insulin aspart and regular human insulin in the treatment of type 1 and type 2 diabetes mellitus: a systematic review. Diabetes Metab. 2011 Jun;37(3):190-200. doi:10.1016/j.diabet.2010.12.003.

Institute for Quality and Efficiency in Health Care (IQWiG). Long-acting insulin analogues in the treatment of diabetes mellitus type 2: Executive summary of final report A05-03, Version 1.1. Cologne, Germany: IQWiG; 2005. Available from: https://www.ncbi.nlm.nih.gov/books/NBK84172/. Accessed: February 26, 2009.

Werner H, Weinstein D, Yehezkel E, Laron Z. Controversies in the use of insulin analogues. Expert Opin Biol Ther. 2011 Feb;11(2):199-209. doi:10.1517/14712598.2011.540233.

Holden SE, Poole CD, Morgan CL, Currie CJ. Evaluation of the incremental cost to the National Health Service of prescribing analogue insulin. BMJ Open. 2011 Jan 1;1(2):e000258. doi:10.1136/bmjopen-2011-000258.

Institute for Quality and Efficiency in Health Care (IQWiG). Long-acting insulin analogues in the treatment of diabetes mellitus type 2: Executive summary of final report A05-03, Version 1.1. Cologne, Germany: IQWiG; 2005. 429 p. (in German).

Neugebauer R, Schroeder EB, Reynolds K, et al. Comparison of Mortality and Major Cardiovascular Events Among Adults With Type 2 Diabetes Using Human vs Analogue Insulins. JAMA Netw Open. 2020 Jan 3;3(1):e1918554. doi:10.1001/jamanetworkopen.2019.18554.

Published

2021-11-25

How to Cite

Neborachko, M., & Phakadze, O. (2021). Does all the evidence say that insulin analogues are more effective than human insulins?. INTERNATIONAL JOURNAL OF ENDOCRINOLOGY (Ukraine), 17(7), 581–588. https://doi.org/10.22141/2224-0721.17.7.2021.244975

Issue

Section

Рoint of view