Diabetes Ther. 2016 Jun;7(2):241-58. doi: 10.1007/s13300-016-0166-y. Epub 2016 Apr 05.
Clinical Effectiveness and Safety of Analog Glargine in Type 1 Diabetes: A Systematic Review and Meta-Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders
Lays P Marra, Vania E Araújo, Thales B C Silva, Leonardo M Diniz, Augusto A Guerra Junior, Francisco A Acurcio, Brian Godman, Juliana Álvares
Affiliations
Affiliations
- School of Pharmacy, Graduate Program in Medicines and Pharmaceutical Assistance, Federal University of Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil. [email protected].
- School of Pharmacy, Graduate Program in Medicines and Pharmaceutical Assistance, Federal University of Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.
- School of Medicine, Federal University of Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.
- Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.
- Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.
- Liverpool Health Economics Centre, University of Liverpool Management School, Liverpool, UK.
PMID: 27048292
PMCID: PMC4900976 DOI: 10.1007/s13300-016-0166-y
Abstract
INTRODUCTION: The use of insulin analogs for the treatment of type 1 diabetes mellitus (T1DM) is widespread; however, the therapeutic benefits still require further evaluation given their higher costs. The objective of this study was to evaluate the effectiveness and safety of analog insulin glargine compared to recombinant DNA (rDNA) insulin in patients with T1DM in observational studies, building on previous reviews of randomized controlled trials comparing neutral protamine Hagedorn insulin and insulin glargine.
METHODS: A systematic review with a meta-analysis was performed. The review included cohort studies and registries available on PubMed, LILACS, and the Cochrane Central Register of Controlled Trials (CENTRAL), as well as manual and gray literature searches. The meta-analysis was conducted in Review Manager 5.3 software. The primary outcomes were glycated hemoglobin (Hb1Ac), weight gain, and hypoglycemia. Methodological quality was assessed using the Newcastle-Ottawa scale.
RESULTS: Out of 796 publications, 11 studies were finally included. The meta-analysis favored insulin glargine in HbA1c outcomes (adult patients) and hypoglycemic episodes (P < 0.05), but without reaching glycemic control (Hb1Ac to approximately 7%). The methodological quality of the studies was moderate, noting that 45% of studies were funded by pharmaceutical companies.
CONCLUSION: Given the high heterogeneity of the studies, the discrete value presented by the estimated effect on effectiveness and safety, potential conflicts of interest of the studies, and the appreciable higher cost of insulin glargine, there is still no support for recommending first-line therapy with analogs. The role of analogs in the treatment of T1DM could be better determined by further observational studies of good methodological quality to assess their long-term effectiveness and safety, as well as their cost-effectiveness.
Keywords: Comparative effectiveness research; Glargine; Insulin; Meta-analysis; Systematic review; Type 1 diabetes mellitus
References
- Diabetes Res Clin Pract. 2005 Oct;70(1):1-7 - PubMed
- Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41 - PubMed
- N Engl J Med. 1993 Aug 19;329(8):573-6 - PubMed
- Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006297 - PubMed
- JAMA. 2003 Jan 22-29;289(4):454-65 - PubMed
- Diabetes Care. 2000 May;23(5):644-9 - PubMed
- Curr Med Res Opin. 2007 Dec;23(12):3131-6 - PubMed
- Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003287 - PubMed
- Health Policy. 2012 Aug;106(3):225-32 - PubMed
- Am J Psychiatry. 2006 Feb;163(2):185-94 - PubMed
- Diabetes Technol Ther. 2004 Oct;6(5):589-95 - PubMed
- Pharmacoepidemiol Drug Saf. 2013 Dec;22(12):1326-35 - PubMed
- BMJ. 2013 Feb 06;346:f755 - PubMed
- Diabetes. 2000 Dec;49(12):2142-8 - PubMed
- Appl Health Econ Health Policy. 2014 Feb;12(1):19-32 - PubMed
- Intern Med. 2007;46(13):937-43 - PubMed
- JAMA. 2000 Apr 19;283(15):2008-12 - PubMed
- Pediatr Diabetes. 2005 Sep;6(3):150-4 - PubMed
- Vasc Health Risk Manag. 2009;5(1):121-8 - PubMed
- Diabetes Care. 2002 Feb;25(2):275-8 - PubMed
- J Pediatr Endocrinol Metab. 2007 Apr;20(4):517-25 - PubMed
- BMJ. 2012 Jan 03;344:d7292 - PubMed
- Diabetes Technol Ther. 2003;5(5):801-6 - PubMed
- Front Pharmacol. 2013 May 14;4:39 - PubMed
- Clin Ther. 2003 Jun;25(6):1541-77, discussion 1539-40 - PubMed
- Clin Chem. 2003 Aug;49(8):1245-7 - PubMed
- Health Technol Assess. 2004 Nov;8(45):iii, 1-57 - PubMed
- Pediatr Diabetes. 2008 Jun;9(3 Pt 2):83-90 - PubMed
- Pol Arch Med Wewn. 2011 Jul-Aug;121(7-8):237-46 - PubMed
- Pediatr Diabetes. 2011 Aug;12(5):501-5 - PubMed
Publication Types