Skip to main content
Top
Published in: Clinical Drug Investigation 7/2014

01-07-2014 | Short Communication

Observational Study on Dipeptidyl Peptidase-4 Inhibitors: A Real-Life Analysis on 360 Patients from the ASL VCO Territory in Italy

Authors: Giuseppe Saglietti, Giuseppe Placentino, Antonella Schellino

Published in: Clinical Drug Investigation | Issue 7/2014

Login to get access

Abstract

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.

Methods

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).

Results

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.

Conclusions

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.
Literature
3.
go back to reference 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 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
4.
go back to reference 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
5.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
7.
go back to reference Nauck M, Stockmann F, Ebert R, et al. Reduced incretin effect in type 2 (non-insulin-dependent) diabetes. Diabetologia. 1986;29:46–52.PubMedCrossRef Nauck M, Stockmann F, Ebert R, et al. Reduced incretin effect in type 2 (non-insulin-dependent) diabetes. Diabetologia. 1986;29:46–52.PubMedCrossRef
8.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
9.
go back to reference Krentz AJ, Patel MB, Bailey CJ. New drugs for type 2 diabetes mellitus: what is their place in therapy? Drugs. 2008;68:2131–62.PubMedCrossRef Krentz AJ, Patel MB, Bailey CJ. New drugs for type 2 diabetes mellitus: what is their place in therapy? Drugs. 2008;68:2131–62.PubMedCrossRef
10.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
11.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
12.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
13.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
14.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
15.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
16.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
17.
go back to reference Scheen AJ, Radermecker RP. Addition of incretin therapy to metformin in type 2 diabetes. Lancet. 2010;375:1410–2.PubMedCrossRef Scheen AJ, Radermecker RP. Addition of incretin therapy to metformin in type 2 diabetes. Lancet. 2010;375:1410–2.PubMedCrossRef
18.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
19.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
20.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
21.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
22.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
23.
go back to reference 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
24.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
25.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
26.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
27.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
28.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
29.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
30.
go back to reference Monami M, Lamanna C, Desideri CM, et al. DPP-4 inhibitors and lipids: systematic review and meta-analysis. Adv Ther. 2012;29:14–25.PubMedCrossRef Monami M, Lamanna C, Desideri CM, et al. DPP-4 inhibitors and lipids: systematic review and meta-analysis. Adv Ther. 2012;29:14–25.PubMedCrossRef
31.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
32.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
33.
go back to reference Mikhail N. Safety of dipeptidyl peptidase 4 inhibitors for treatment of type 2 diabetes. Curr Drug Saf. 2011;6:304–9.PubMedCrossRef Mikhail N. Safety of dipeptidyl peptidase 4 inhibitors for treatment of type 2 diabetes. Curr Drug Saf. 2011;6:304–9.PubMedCrossRef
Metadata
Title
Observational Study on Dipeptidyl Peptidase-4 Inhibitors: A Real-Life Analysis on 360 Patients from the ASL VCO Territory in Italy
Authors
Giuseppe Saglietti
Giuseppe Placentino
Antonella Schellino
Publication date
01-07-2014
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 7/2014
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.1007/s40261-014-0196-z

Other articles of this Issue 7/2014

Clinical Drug Investigation 7/2014 Go to the issue