Concordance with prescribing information dosage recommendations for dipeptidyl-peptidase-4 inhibitors among type 2 diabetes mellitus patients with moderate to severe chronic kidney disease

Abstract

Objective: To estimate the proportion of patients with moderate to severe chronic kidney disease (CKD) whose initial dipeptidyl-peptidase-4 inhibitor (DPP4-i) dosage was concordant with prescribing information (label) recommendations in the United States.

Methods: Adult patients with type 2 diabetes mellitus (T2DM) who initiated a DPP4-i (linagliptin, sitagliptin, saxagliptin) between 1 January 2011 and 30 June 2014 were identified using electronic medical records and administrative claims, with index date being the date of first observed DPP4-i treatment. Patients were required to have chronic kidney disease (CKD) stage 3b, 4 or 5 (estimated Glomerular Filtration Rate [eGFR] value <45 ml/min/1.73 m²) during the 12 month pre-index period. Patients were classified as concordant or not concordant based on whether the first prescribed dose was consistent with label recommendations. Demographics, clinical characteristics, resource use and costs during pre-index were evaluated by DPP4-i concordance status.

Results: Of the 492 patients (323 sitagliptin, 57 saxagliptin, 112 linagliptin), 36.2% were prescribed doses that were not concordant with label recommendations (44.9% for sitagliptin, 57.9% for saxagliptin and 0% for linagliptin [which does not require dosage adjustment]). Concordant patients were slightly older (mean age 71 years vs. 68, p = .01) but had similar gender distribution (55% vs. 60% female, p = .31) compared to those who were not concordant. They had lower general health status (Charlson Comorbidity Score 2.6 vs. 2.2, p = .03), and had similar pre-index all-cause total costs ($25,245 vs. $21,972, p = .68) and lower pre-index T2DM-related costs ($1618 vs. $1922, p = .05).

Conclusions: More than a third of DPP4-i patients with CKD stage 3b or higher were prescribed doses not concordant with DPP4-i label dosage recommendations.

Keywords:

• Concordance
• dosage
• dipeptidyl-peptidase-4 inhibitors
• chronic kidney disease

Transparency

Declaration of funding

This study was funded by Boehringer Ingelheim Pharmaceuticals Inc.

Author contributions: All of the authors contributed to the study design, data interpretation, and discussion of the study results. All authors approved this manuscript and actively participated throughout the entire study. H.H., S.S. and K.L. researched and discussed data, and wrote and reviewed the manuscript. E.B. conducted data and statistical analyses and reviewed the manuscript.

Declaration of financial/other relationships

S.S. has disclosed that she/he is an employee of Boehringer Ingelheim Pharmaceuticals. H.H., E.B. and K.L. have disclosed that they are employees of IQVIA (formerly QuintilesIMS) and were contracted to conduct this study by Boehringer Ingelheim Pharmaceuticals Inc.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentation: This work was previously presented as a poster titled “Non-concordance with prescribing information (PI) for dipeptidyl-peptidase-4 inhibitors (DPP4-i) among type 2 diabetes mellitus (T2DM) patients with moderate to severe chronic kidney disease (CKD)” at the 76th Scientific Sessions of American Diabetes Association, New Orleans, LA, USA, 10–14 June 2016.

Acknowledgements

No assistance in the preparation of this article is to be declared.