Abstract: FR-OR146
Comparison of Lanthanum Carbonate and Calcium Carbonate in the Cardiovascular Mortality and Morbidity of Hemodialysis Patients
Session Information
- High-Impact Clinical Trials
October 26, 2018 | Location: 20A, San Diego Convention Center
Abstract Time: 11:30 AM - 11:45 AM
Category: Bone and Mineral Metabolism
- No subcategory defined
Authors
- Ogata, Hiroaki, Showa University School of Medicine, Yokohama, Japan
- Fukagawa, Masafumi, Tokai University School of Medicine, Isehara, KANAGAWA, Japan
- Hirakata, Hideki, Fukuoka Renal Clinic, Fukuoka City, Japan
- Kagimura, Tatsuo, Translational Research Center for Medical Innovation, Kobe, Japan
- Akizawa, Tadao, Showa University School of Medicine, Yokohama, Japan
Group or Team Name
- LANDMARK Study Group
Background
The multicenter LANDMARK study (NCT01578200/UMIN000006815) is a randomized, open-label, parallel assignment study comparing the effects of a non-Ca P binder, lanthanum carbonate (LC), with the effects of calcium carbonate (CC) on cardiovascular mortality and morbidity in hemodialysis (HD) patients.
Methods
A total of 2309 hemodialysis patients with at least one risk factor for vascular calcification (VC) (age >65 years, postmenopausal women, type 2 diabetes); intact parathyroid hormone ≤240pg/mL; and life expectancy >1 year were randomly assigned to the LC (n = 1154) or CC (n =1155) group. In the LC group, patients initially received 750 mg/day of LC (or their previous dose) and were titrated up to a maximum of 2250 mg/day to achieve serum P levels of 3.5 to 6.0 mg/dL. In the CC group, patients received 3 g/day of CC (or their previous dose), and were titrated to achieve the same target serum P levels. If these levels were not achieved with the maximum tolerated dose, non-Ca P binders were given to those in the LC group, and P binders other than LC to those in the CC group. The primary endpoint was survival time free of cardiovascular events (CVEs), including cardiovascular death, nonfatal myocardial infarction or stroke, and unstable angina.
Results
A total of 2135 patients (female 40.5%, 68.4 years, diabetes 56.1%) were analyzed in this study. After a median follow-up of 3.16 years, the incident rates of CVEs were 4.80 (/100 patient-years) in the LC group and 4.30 in the CC group, and there was no significant difference in the adjusted hazard ratio (HR) between the two groups (1.11 [95%CI, 0.88–1.41], P = 0.366; log rank test. There is also no significant difference in all-cause death between the LC and CC groups (HR 1.10 [95%CI, 0.88–1.37], P = 0.424).
Conclusion
The non-Ca P binder, LC, did not reduce CVEs as compared with CC among long-term HD patients with high risk of VC.
Funding
- Commercial Support – Bayer Yakuhin, Ltd.