Abstract: SA-PO895
Efficacy and Safety of Urate Lowering Therapy (ULT) in CKD Patients With Gout
Session Information
- CKD: Clinical Trials and Pharmacoepidemiology
November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2202 CKD (Non-Dialysis): Clinical‚ Outcomes‚ and Trials
Authors
- Helget, Lindsay Nicole, VA Nebraska-Western Iowa Health Care System, Omaha, Nebraska, United States
- Davis-Karim, Anne, VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico, United States
- O'Dell, James R., VA Nebraska-Western Iowa Health Care System, Omaha, Nebraska, United States
- Mikuls, Ted R., VA Nebraska-Western Iowa Health Care System, Omaha, Nebraska, United States
- Newcomb, Jeff A., VA Nebraska-Western Iowa Health Care System, Omaha, Nebraska, United States
- Androsenko, Maria, VA Boston Cooperative Studies Program Coordinating Center, Boston, Massachusetts, United States
- Brophy, Mary T., VA Boston Cooperative Studies Program Coordinating Center, Boston, Massachusetts, United States
- England, Bryant, VA Nebraska-Western Iowa Health Care System, Omaha, Nebraska, United States
- Ferguson, Ryan, VA Boston Cooperative Studies Program Coordinating Center, Boston, Massachusetts, United States
- Pillinger, Michael, VA New York Harbor Health Care System, New York, New York, United States
- Neogi, Tuhina, Boston University School of Medicine, Boston, Massachusetts, United States
- Wu, Hongsheng, VA Boston Cooperative Studies Program Coordinating Center, Boston, Massachusetts, United States
- Palevsky, Paul M., VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, United States
Background
Limited data exist on the comparative effectiveness of allopurinol (ALL) and febuxostat (FEB) for the management of gout in patients with CKD. Using data from STOP-Gout, a recently completed multicenter RCT, we examined the efficacy and safety of ALL and FEB in the subgroup of patients with CKD.
Methods
Patients with gout and serum urate (SU) concentration ≥6.8 mg/dL were randomized 1:1 to receive ALL or FEB. ULT was titrated during weeks 0-24 (Phase 1) and maintained during weeks 25-48 (Phase 2), with escalation, to reach goal SU of <6.0 mg/dL. Participants were observed on stable ULT dose during weeks 49-72 (Phase 3). CKD was defined as an eGFR 30-59 mL/min/1.73 m2 at baseline. Primary outcome was presence of ≥ 1 gout flare during Phase 3. Secondary outcomes were achievement of SU <6mg/dL at end of Phase 2, gout flare rates, and serious adverse events (SAEs).
Results
351 of 940 trial participants had CKD;277 were assessed for the primary outcome. Fewer patients randomized to ALL had ≥1 gout flare during phase 3 (32% v 45%; p=0.02) despite similar attainment of SU <6.0 mg/dL by the end of Phase 2 (Table). CKD participants did not require higher doses of either ULT to reach goal SU as compared to non-CKD but had more SAEs. There were no differences in overall SAEs between ALL and FEB.
Conclusion
This prespecified sub-analysis from a large, RCT demonstrates that ALL and FEB are equally efficacious and well-tolerated in the treatment of gout in CKD when used in a treat-to-target regimen.
Primary and secondary end points
| Allopurinol (n=181) | Febuxostat (n=170) | Total | P Value | |
| Primary Endpoint | ||||
| ≥1 Gout flare in Phase 3, % | 31.9 (44/138) | 45.3 (63/139) | 38.6 (107/277) | 0.02 |
| Secondary Endpoints | ||||
| Serum Urate <6.0 mg/dl in Phase 2, % | 78.8 (119/151) | 81.3 (117/144) | 80.0 (236/295) | 0.59 |
| Rate of gout flares (events/patient years) | ||||
| during Phase 3 | 1.34 | 2.36 | 1.85 | <0.001 |
| during Phase 1 and 2 | 1.47 | 2.04 | 1.75 | <0.001 |
| Serious Adverse Event, % | 38.1 (69/181) | 35.9 (61/170) | 37.0 (130/351) | 0.66 |
| Cardiovascular event, % | 13.8 (25/181) | 10.6 (18/170) | 12.3 (43/351) | 0.35 |
Funding
- Veterans Affairs Support