Treatment of type 2 diabetes in chronic kidney disease: a case for linagliptin in the treatment of diabetes in severe renal impairment

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Abstract

Diabetes is the leading cause of chronic kidney disease, and the prevalence of both diseases is rising worldwide. Treatment of type 2 diabetes is difficult in patients with chronic kidney disease because most oral antidiabetic agents are affected by renal function and their use may be contraindicated in this patient population. Antidiabetic agents that can be used in patients with type 2 diabetes and declining renal function are needed. Incretin-based therapies, such as dipeptidyl peptidase-4 inhibitors, are a recent therapeutic class of glucose-lowering agents that may offer an effective treatment option in patients with chronic kidney disease. Within the dipeptidyl peptidase-4 class, linagliptin has a unique profile with a primarily nonrenal route of elimination, requiring no dose adjustment in patients with chronic kidney disease. This communication summarizes the findings of a 1-year, randomized, double-blind, placebo-controlled study demonstrating the favorable safety and efficacy profile of linagliptin in patients with type 2 diabetes and severe renal impairment.

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Most cited references 8

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Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association.

R Sherwin, Richard Bergenstal, Robert Bonow … (2009)

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Long-Term Efficacy and Safety of Linagliptin in Patients With Type 2 Diabetes and Severe Renal Impairment

Janet McGill, Lance Sloan, Jennifer Newman … (2013)

OBJECTIVE This placebo-controlled study assessed long-term efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in patients with type 2 diabetes and severe renal impairment (RI). RESEARCH DESIGN AND METHODS In this 1-year, double-blind study, 133 patients with type 2 diabetes (HbA1c 7.0–10.0%) and severe RI (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) at screening were randomized to linagliptin 5 mg (n = 68) or placebo (n = 65) once daily, added to existing background therapy. The primary efficacy end point was HbA1c change from baseline to week 12. Efficacy and safety end points were assessed after 1 year. RESULTS At week 12, adjusted mean HbA1c decreased by −0.76% with linagliptin and −0.15% with placebo (treatment difference, −0.60%; 95% CI −0.89 to −0.31; P < 0.0001). HbA1c improvements were sustained with linagliptin (−0.71%) over placebo (0.01%) at 1 year (treatment difference −0.72%, −1.03 to −0.41; P < 0.0001). Mean insulin doses decreased by −6.2 units with linagliptin and −0.3 units with placebo. Overall adverse event incidence was similar over 1 year (94.1 vs. 92.3%). Incidence of severe hypoglycemia with linagliptin and placebo was comparably low (three patients per group). Linagliptin and placebo had little effect on renal function (median change in eGFR, −0.8 vs. −2.2 mL/min/1.73 m2), and no drug-related renal failure occurred. CONCLUSIONS In patients with type 2 diabetes and severe RI, linagliptin provided clinically meaningful improvements in glycemic control with very low risk of severe hypoglycemia, stable body weight, and no cases of drug-related renal failure. The potential for linagliptin to spare insulin and provide long-term renal safety warrants further investigations.

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How can we achieve global equity in provision of renal replacement therapy?

Terra White, Alan Cass, Stephen Jan … (2008)

There is a significant emerging burden of chronic and end-stage kidney disease in low- and middle-income countries, driven by population ageing and the global epidemic of type 2 diabetes. Sufferers of end-stage kidney disease require ongoing dialysis or kidney transplantation to survive; however, in many low- and middle-income countries, treatment options are strictly limited or unaffordable. Low numbers of maintenance dialysis patients and transplant recipients reflect profound economic and service provision challenges for health-care systems in low- and middle-income countries in sustaining renal replacement therapy programmes. Underdeveloped organ donor and transplant programmes, health system and financing issues, ethical regulation of transplantation and the cost of pharmaceuticals commonly pose additional barriers to the delivery of efficient and cost-effective renal replacement therapy. Development of locally appropriate transplant programmes, effective use of nongovernmental sources of funding, service planning and cost containment, use of generic drugs and local manufacture of dialysis consumables have the potential to make life-saving renal replacement therapy available to many more in need. Select low- and middle-income countries demonstrate more equitable provision of renal replacement therapy is possible outside high-income countries. For other low- and middle-income countries, education, the development of good public policy and a supportive international environment are critical. Prevention of end-stage kidney disease, ideally as part of an integrated approach to chronic vascular diseases, must also be a key objective.

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Author and article information

Journal

Journal ID (nlm-ta): Diabetes Metab Syndr Obes

Journal ID (iso-abbrev): Diabetes Metab Syndr Obes

Title: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy

Publisher: Dove Medical Press

ISSN (Electronic): 1178-7007

Publication date Collection: 2013

Publication date (Electronic): 02 October 2013

Volume: 6

Pages: 359-363

Affiliations

Clinical Research Development Associates, Rosedale, NY, USA

Author notes

Correspondence: David Scott, Clinical Research Development Associates, 1 Cross Island Plaza, LL4, Rosedale, NY 11413, USA, Tel +1 718 276 4750, Fax +1 718 276 4571, Email dscott@ 123456clinicalresearchdevelopment.org

Article

Publisher ID: dmso-6-359

DOI: 10.2147/DMSO.S51795

PMC ID: 3795009

PubMed ID: 24124385

SO-VID: be857bf2-c7d9-4c58-9b79-3859ecab10b5

License:

The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.