Observational Study on Dipeptidyl Peptidase-4 Inhibitors: A Real-Life Analysis on 360 Patients from the ASL VCO Territory in Italy
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
Background and Objectives
Diabetes mellitus is a complex, progressive disease that can lead to complications if it is not strictly controlled. The literature suggests that only 50 % of Italian patients with type 2 diabetes mellitus (T2DM) achieve guideline-recommended levels of glycaemic control, suggesting that treatment regimens need to be improved. The present study aimed to evaluate the effectiveness of dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of glycaemic control, body weight and lipid profile in a series of patients with T2DM attending a diabetes outpatient facility.
This was an observational retrospective study performed on a series of patients with T2DM attending our three outpatient clinics. The study included 360 patients with T2DM of both sexes, aged between 30 and 85 years, with a body mass index (BMI) of 22–45 kg/m2 who were uncontrolled [glycated haemoglobin (HbA1c) 7.1–10 %] despite dietary restrictions or treatment with pharmacological therapy. Patients included in the analysis received therapy with a DPP-4 inhibitor (sitagliptin, n = 244; vildagliptin, n = 97; saxagliptin, n = 19).
Vildagliptin reduced HbA1c by 1.2 % compared with sitagliptin and saxagliptin (−0.9 %) from a baseline of 8 % (similar in all groups). The greatest decrease in fasting plasma glucose was seen with vildagliptin (−37 mg/dL) compared with sitagliptin and saxagliptin (−20 and −29 mg/dL, respectively). A greater reduction in total cholesterol was achieved with vildagliptin (−24 mg/dL) than with sitagliptin (−11 mg/dL) and saxagliptin (−3.6 mg/dL). Effectiveness was maintained in all age groups, provided disease duration was short (~5 to 6 years). Adverse effects were mild and transient and did not require treatment discontinuation.
DPP-4 inhibitors are a viable option in patients with T2DM not adequately controlled by existing therapy. They demonstrate comparable efficacy to other antidiabetic medicines with regard to HbA1c reduction. The positive changes in the lipid profile make DPP-4 inhibitors a particularly interesting class of drugs; however, further studies are needed to confirm their true impact on cardiovascular risk in a real-world setting.
- International Diabetes Federation. Diabetes Atlas. 2013. http://www.idf.org/diabetesatlas/. Accessed 14 Mar 2014.
- Centers for Disease Control and Prevention. National diabetes fact sheet, 2011. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed 14 Mar 2014.
- UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837–53. CrossRef
- Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364–79. CrossRef
- Sinclair AJ, Paolisso G, Castro M, et al. European Diabetes Working Party for Older People 2011 clinical guidelines for type 2 diabetes mellitus. Executive summary. Diabetes Metab. 2011;37(Suppl 3):S27–38. CrossRef
- Annali AMD 2012 - Analisi prospettica degli indicatori di qualità dell'assistenza del diabete in Italia (2004-2011). http://www.infodiabetes.it/files/ANNALI-AMD/2012. Accessed 27 Sep 2013.
- Nauck M, Stockmann F, Ebert R, et al. Reduced incretin effect in type 2 (non-insulin-dependent) diabetes. Diabetologia. 1986;29:46–52. CrossRef
- Tourrel C, Bailbe D, Meile MJ, et al. Glucagon-like peptide-1 and exendin-4 stimulate beta-cell neogenesis in streptozotocin-treated newborn rats resulting in persistently improved glucose homeostasis at adult age. Diabetes. 2001;50:1562–70. CrossRef
- Krentz AJ, Patel MB, Bailey CJ. New drugs for type 2 diabetes mellitus: what is their place in therapy? Drugs. 2008;68:2131–62. CrossRef
- Phung OJ, Scholle JM, Talwar M, et al. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010;303:1410–8. CrossRef
- Scheen AJ. DPP-4 inhibitors in the management of type 2 diabetes: a critical review of head-to-head trials. Diabetes Metab. 2012;38:89–101. CrossRef
- Bosi E, Camisasca RP, Collober C, et al. Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care. 2007;30:890–5. CrossRef
- Goldstein BJ, Feinglos MN, Lunceford JK, et al. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007;30:1979–87. CrossRef
- Pfutzner A, Paz-Pacheco E, Allen E, et al. Initial combination therapy with saxagliptin and metformin provides sustained glycaemic control and is well tolerated for up to 76 weeks. Diabetes Obes Metab. 2011;13:567–76. CrossRef
- Rosenstock J, Kim SW, Baron MA, et al. Efficacy and tolerability of initial combination therapy with vildagliptin and pioglitazone compared with component monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2007;9:175–85. CrossRef
- Ahren B. Clinical results of treating type 2 diabetic patients with sitagliptin, vildagliptin or saxagliptin—diabetes control and potential adverse events. Best Pract Res Clin Endocrinol Metab. 2009;23:487–98. CrossRef
- Scheen AJ, Radermecker RP. Addition of incretin therapy to metformin in type 2 diabetes. Lancet. 2010;375:1410–2. CrossRef
- Ahren B, Pacini G, Foley JE, et al. Improved meal-related beta-cell function and insulin sensitivity by the dipeptidyl peptidase-IV inhibitor vildagliptin in metformin-treated patients with type 2 diabetes over 1 year. Diabetes Care. 2005;28:1936–40. CrossRef
- Balas B, Baig MR, Watson C, et al. The dipeptidyl peptidase IV inhibitor vildagliptin suppresses endogenous glucose production and enhances islet function after single-dose administration in type 2 diabetic patients. J Clin Endocrinol Metab. 2007;92:1249–55. CrossRef
- Mari A, Scherbaum WA, Nilsson PM, et al. Characterization of the influence of vildagliptin on model-assessed -cell function in patients with type 2 diabetes and mild hyperglycemia. J Clin Endocrinol Metab. 2008;93:103–9. CrossRef
- Lukashevich V, Schweizer A, Shao Q, et al. Safety and efficacy of vildagliptin versus placebo in patients with type 2 diabetes and moderate or severe renal impairment: a prospective 24-week randomized placebo-controlled trial. Diabetes Obes Metab. 2011;13:947–54. CrossRef
- Kothny W, Shao Q, Groop PH, et al. One-year safety, tolerability and efficacy of vildagliptin in patients with type 2 diabetes and moderate or severe renal impairment. Diabetes Obes Metab. 2012;14:1032–9. CrossRef
- Schweizer A, Dejager S. Experience with vildagliptin in patients ≥75 years with type 2 diabetes and moderate or severe renal impairment. Diabetes Ther. 2013;4:257–67. CrossRef
- Irons BK, Weis JM, Stapleton MR, et al. An update in incretin-based therapy: a focus on dipeptidyl peptidase-4 inhibitors. Curr Diabetes Rev. 2012;8:169–82. CrossRef
- Ahren B, Schweizer A, Dejager S, et al. Mechanisms of action of the dipeptidyl peptidase-4 inhibitor vildagliptin in humans. Diabetes Obes Metab. 2011;13:775–83. CrossRef
- Barzilai N, Guo H, Mahoney EM, et al. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011;27:1049–58. CrossRef
- Doucet J, Chacra A, Maheux P, et al. Efficacy and safety of saxagliptin in older patients with type 2 diabetes mellitus. Curr Med Res Opin. 2011;27:863–9. CrossRef
- Schweizer A, Dejager S, Foley JE, et al. Clinical experience with vildagliptin in the management of type 2 diabetes in a patient population ≥75 years: a pooled analysis from a database of clinical trials. Diabetes Obes Metab. 2011;13:55–64. CrossRef
- Strain WD, Lukashevich V, Kothny W, et al. Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study. Lancet. 2013;382:409–16. CrossRef
- Monami M, Lamanna C, Desideri CM, et al. DPP-4 inhibitors and lipids: systematic review and meta-analysis. Adv Ther. 2012;29:14–25. CrossRef
- White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369:1327–35. CrossRef
- Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369:1317–26. CrossRef
- Mikhail N. Safety of dipeptidyl peptidase 4 inhibitors for treatment of type 2 diabetes. Curr Drug Saf. 2011;6:304–9. CrossRef
- Observational Study on Dipeptidyl Peptidase-4 Inhibitors: A Real-Life Analysis on 360 Patients from the ASL VCO Territory in Italy
Clinical Drug Investigation
Volume 34, Issue 7 , pp 513-519
- Cover Date
- Print ISSN
- Online ISSN
- Springer International Publishing
- Additional Links
- Industry Sectors