Suki W, Zabaneh R, Cangiano J, Reed J, Fischer D, Garrett L, Ling B et al. Effects of sevelamer and calcium-based phosphate binders on mortality in hemodialysis patients. Kidney Int; 29 August 2007; doi:10.1038/sj.ki.5002466
Effects of sevelamer and calcium on coronary artery calcification in patients new to hemodialysis
Background
Coronary artery calcification is prevalent in hemodialysis patients, however examining the development and progression in new hemodialysis patients is unknown.
Trial Design
This was an open-label, intention-to-treat, randomized controlled trial.
Population
The study included one-hundred twenty-nine patients new to hemodialysis. They were randomized within 90 days of starting hemodialysis.
**The study demographics are shown in a chart below.
Intervention/Comparator
Sevelamer hydrochloride was compared with calcium containing phosphate binders. Subjects remained on their assigned phosphate binder during the original trial's study period (i.e. 18 months). After which, subjects could be given phosphate binders at the discretion of their primary nephrologist. Participants underwent electron beam computed tomography scanning at entry into the study and at 6, 12 and 18 months.
Primary and Secondary Outcomes
The primary endpoint was the change in coronary artery calcification at 18 months of hemodialysis patients.
Results
Participants who had no coronary artery calcification at baseline did not have significant progression in coronary artery calcium scores (CACS) over 18 months. Participants with a CACS > 30 at baseline showed progressive increases in CACS in both treatment arms (P < 0.05). More rapid and severe increased in CACS occurred in the subjects treated with calcium containing phosphate binders compared to those receiving sevelamer hydrochloride (P = 0.056 at 12 months, P = 0.01 at 18 months)
Limitations
The study had very small numbers and was open label. It also did not control for lipid levels (no lipid protocol) or control for vitamin D.
Bottom Line
Patients new to hemodialysis show little evidence of coronary artery disease over 18 months, if they do not have any evidence of coronary artery calcification at baseline. If a patient has mild coronary artery calcification at baseline, they will likely have significant progression over a period of 18 months. Calcium-containing phosphate binders may contribute to a more rapid progression of coronary calcification than sevelamer hydrochloride.
Effects of sevelamer and calcium on coronary artery calcification in patients new to hemodialysis
Background
Coronary artery calcification is prevalent in hemodialysis patients, however examining the development and progression in new hemodialysis patients is unknown.
Trial Design
This was an open-label, intention-to-treat, randomized controlled trial.
Population
The study included one-hundred twenty-nine patients new to hemodialysis. They were randomized within 90 days of starting hemodialysis.
**The study demographics are shown in a chart below.
Intervention/Comparator
Sevelamer hydrochloride was compared with calcium containing phosphate binders. Subjects remained on their assigned phosphate binder during the original trial's study period (i.e. 18 months). After which, subjects could be given phosphate binders at the discretion of their primary nephrologist. Participants underwent electron beam computed tomography scanning at entry into the study and at 6, 12 and 18 months.
Primary and Secondary Outcomes
The primary endpoint was the change in coronary artery calcification at 18 months of hemodialysis patients.
Results
Participants who had no coronary artery calcification at baseline did not have significant progression in coronary artery calcium scores (CACS) over 18 months. Participants with a CACS > 30 at baseline showed progressive increases in CACS in both treatment arms (P < 0.05). More rapid and severe increased in CACS occurred in the subjects treated with calcium containing phosphate binders compared to those receiving sevelamer hydrochloride (P = 0.056 at 12 months, P = 0.01 at 18 months)
Limitations
The study had very small numbers and was open label. It also did not control for lipid levels (no lipid protocol) or control for vitamin D.
Bottom Line
Patients new to hemodialysis show little evidence of coronary artery disease over 18 months, if they do not have any evidence of coronary artery calcification at baseline. If a patient has mild coronary artery calcification at baseline, they will likely have significant progression over a period of 18 months. Calcium-containing phosphate binders may contribute to a more rapid progression of coronary calcification than sevelamer hydrochloride.