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Abstract: TH-PO855

Early Dapagliflozin Utilization for CKD Treatment in the United States

Session Information

Category: CKD (Non-Dialysis)

  • 2201 CKD (Non-Dialysis): Epidemiology‚ Risk Factors‚ and Prevention

Authors

  • Wittbrodt, Eric T., AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, United States
  • Wright, Jason M., AstraZeneca Pharmaceuticals LP, Wilmington, Delaware, United States
  • Garcia Sanchez, Juan Jose, AstraZeneca UK Ltd, Cambridge, Cambridgeshire, United Kingdom
  • Arnold, Matthew, AstraZeneca UK Ltd, Cambridge, Cambridgeshire, United Kingdom
  • Nan, Cassandra, AstraZeneca AB, Mölndal, Sweden
Background

In 2021, dapagliflozin was approved for the treatment of adults with chronic kidney disease (CKD) in the United States (US). OPTIMISE-CKD is a multinational, observational, secondary data study program describing dapagliflozin treatment for CKD in routine clinical practice, contextualized by contemporary CKD management. This first observational analysis aims to describe early dapagliflozin utilization under the approved CKD indication in the US.

Methods

Adult patients with CKD in administrative claims data linked with electronic medical records in the OPTUM Market Clarity database from 30 March 2020 - 30 June 2021 were included. Criteria for CKD included any of the following: ≥1 UACR ≥30 mg/g, 2 eGFR ≥90 days apart of which the second was ≤75 ml/min/1.73m2, or a CKD diagnosis code. Patients with type 1 diabetes, gestational diabetes or <365 days continuous enrolment were excluded. Patients were dapagliflozin eligible if they met the CKD indication after 30 April 2021 and did not have a previous prescription for dapagliflozin 10 mg. Dapagliflozin CKD initiators had a recorded prescription for dapagliflozin 10 mg within 90 days of dapagliflozin eligibility.

Results

A total of 583 patients met the study criteria and had initiated dapagliflozin during the first 2 months since approval. The median age was 69 years (interquartile range; IQR 59-77) and 46% were female. For the 316 initiators with known CKD stage, the distribution was as follows: 4% stage 1, 16% stage 2, 28% stage 3a, 38% stage 3b, 13% stage 4 and 1% stage 5 (non-dialysis). The most common comorbidities were hypertension (91%), heart failure (44%) and type 2 diabetes (82%). Lipid lowering drugs (61%), diuretics (58%), renin-angiotensin-aldosterone system inhibitors (57%) and angiotensin receptor/neprilysin inhibitor (9%) were commonly prescribed. Similar patterns were found among patients who were not treated with dapagliflozin.

Conclusion

Early use of dapagliflozin in the US was observed in a broad range of patients with CKD with respect to baseline characteristics and was representative of treatment-eligible patients overall. Further analyses across more patients and countries in the OPTIMISE-CKD program will provide additional insight into the real-world experience of novel treatments for CKD and facilitate optimized CKD management.

Funding

  • Commercial Support –