Abstract: TH-PO153
Comparative Effectiveness of Alternative Treatment Approaches to Secondary Hyperparathyroidism (SHPT) in Patients on Maintenance Hemodialysis (HD)
Session Information
- CKD-MBD: Targets and Outcomes
November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Authors
- Platt, Alyssa C., Duke University, Durham, North Carolina, United States
- Wilson, Jonathan A., Duke University, Durham, North Carolina, United States
- Hall, Rasheeda K., Duke University, Durham, North Carolina, United States
- Ephraim, Patti, Northwell Health, New Hyde Park, New York, United States
- Morton, Sarah N., Duke University, Durham, North Carolina, United States
- Shafi, Tariq, The University of Mississippi Medical Center, Jackson, Mississippi, United States
- Weiner, Daniel E., Tufts Medical Center, Boston, Massachusetts, United States
- Boulware, L. Ebony, Duke University, Durham, North Carolina, United States
- Pendergast, Jane F., Duke University, Durham, North Carolina, United States
- Scialla, Julia J., University of Virginia, Charlottesville, Virginia, United States
Background
Optimal approaches to treat SHPT in patients on HD are not established in randomized controlled trials (RCTs). Using observational data, we emulate RCTs of different parathyroid hormone (PTH) targets (Trial 1) and different primary agents (Trial 2) for treatment of HD-related SHPT.
Methods
Adults with kidney failure on HD at centers affiliated with a moderate-sized, not-for-profit, national dialysis provider were eligible for Trial 1 if they had new onset SHPT between 2009-2014. They were eligible for Trial 2 if they had SHPT and were using low to moderate dose vitamin D sterol, but were cinacalcet naïve. In both trials, patients had ≥180 days of Medicare primary payer before eligibility, and did not have contraindications to either arm or health status likely to limit follow-up. After eligibility, patients were observed for 30 days to define the treatment arm and then for 24 months for outcomes. In Trial 1, upward titration of either vitamin D sterols or cinacalcet in the 30 day period after new SHPT defined a proactive approach targeting lower PTH. Lack of upward titration defined a reactive approach. In Trial 2, the first upward titration defined a vitamin D-favoring (vitamin D first), cinacalcet-favoring (cinacalcet first), or undefined approach (no upward titration; excluded). The primary outcome was all-cause death; secondary outcomes include cardiovascular (CV) hospitalization or the composite of CV hospitalization or death.
Results
1,152 patients were included in Trial 1 (635 proactive, 517 reactive). 3,001 patients were included in Trial 2 including multiple trials if eligible (6,268 vitamin D-favoring, 459 cinacalcet-favoring). The proactive approach associated with lower adjusted hazard of death (HR 0.71; 95% CI 0.52, 0.93), CV hospitalization (HR 0.78; 95% CI 0.63, 0.98), and their composite (HR 0.74; 95% CI 0.61, 0.89). Cinacalcet vs. vitamin D-favoring approach demonstrated modestly lower adjusted risk of death (HR 0.79; 95% CI 0.62, 0.99), but not CV hospitalization or the composite.
Conclusion
Proactive SHPT care is associated with better outcomes. A RCT of lower vs. higher PTH targets to prevent death and cardiovascular disease in patients with secondary hyperparathyroidism is justified.
Funding
- NIDDK Support