The Indian Practitioner

Abstract

Objective: To evaluate effectiveness and safety of WEPOX® Pen, a pre-calibrated pen device loaded with 30,000 IU cartridge of recombinant human EPO (rHuEPO), in management of anemia in CKD patients, in the real-world clinical settings.

Material and Methods: In this prospective, multi-center, open-label, post marketing surveillance study, ambulatory pediatric and adult patients of either gender, diagnosed with CKD and anemia were enrolled to access the effectiveness and safety of WEPOX® Pen. Patients were divided in two groups based on baseline Hb (g/dL) levels; Hb<10g/dL (Group 1) and Hb≥10g/dL (Group 2). Results were recorded in the follow up visits scheduled at weeks 5, and 12. Investigator had the choice to discontinue the patient from the study as per his/ her discretion based on significant adverse drug reaction or lack of expected effectiveness.

Results: A total of 409 patients were enrolled in the study; out of which 377 (92.2%) patients were enrolled in Group 1 and 32 (7.8%) patients in Group 2. Proportion of patients in Group 1 achieving ≥1 g/dL rise in Hb value from baseline were 70.3% and 86.5% at week 5 and 12, respectively. Similarly, proportion of patients in group 2 maintaining Hb levels of ≥10 g/dL were 68.7% and 96.8% at week 5 and 12 respectively. Overall compared to baseline, Hb (g/dL) levels increased in 366 (97.1%) and 30 (93.8%) patients, in group 1 and 2 respectively, at 12-weeks. No adverse events were reported during the study duration.

Conclusion: Treatment with WEPOX® Pen (rHuEPO Injection) in CKD patients with anemia was well tolerated and produced a clinically relevant improvement in Hb levels.

Keywords

Full Text

References