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Published on: June 2, 2022
Valvular calcification in hemodialysis patients randomized to calcium-based phosphorus binders or sevelamer
Paolo Raggi1, Juergen Bommer, Glenn M Chertow
1Division of Cardiology, Tulane University School of Medicine, New Orleans, LA 70112, USA. praggi@tulane.edu
Insights
Sevelamer, a phosphorus binder, significantly reduced valvular and vascular calcification progression in hemodialysis patients. This treatment arrested or regressed calcification in nearly 50% of subjects, offering a potential therapeutic strategy.
Area of Science:
- Nephrology
- Cardiology
- Pharmacology
Background:
- Valvular calcification is prevalent in end-stage renal disease (ESRD) patients, correlating with poor outcomes.
- Non-calcium-based phosphorus binders are being investigated to manage calcification in ESRD.
Purpose of the Study:
- To evaluate the efficacy of sevelamer in attenuating valvular calcification progression in hemodialysis patients.
- To compare sevelamer with calcium-based phosphorus binders regarding calcification changes.
Main Methods:
- A randomized trial involving 200 hemodialysis patients, comparing sevelamer to calcium-based binders.
- Electron beam tomography (EBT) used at baseline and 52 weeks to assess coronary, aortic, mitral, and aortic valve calcification.
- Changes in valvular and combined valvular/vascular calcification were monitored.
Main Results:
- Sevelamer treatment significantly lowered the combined change in valvular and vascular calcification compared to calcium binders.
- A significantly greater proportion of sevelamer-treated patients experienced arrest (45%) or regression (26%) of total calcification.
- Sevelamer's effect was independent of various clinical factors and calcium preparation used.
Conclusions:
- Sevelamer demonstrated a significant ability to arrest valvular and vascular calcification progression in nearly half of hemodialysis patients.
- Combined with intensive mineral control, sevelamer may be a key therapeutic agent for managing cardiac valvular calcification in ESRD.
Background And Aim Of The Study:
Valvular calcification is common in patients with end-stage renal disease, and is associated with an unfavorable prognosis. It was hypothesized that sevelamer, a non-calcium-based phosphorus binder, might attenuate the progression of valvular calcification.
Methods:
Two hundred subjects on maintenance hemodialysis received either sevelamer or calcium-based phosphorus binders. To assess the extent of calcification, 186 subjects underwent baseline electron beam tomography (EBT) of the coronary arteries, aorta and mitral and aortic valves, and 132 had follow up EBT scans at week 52. Changes in valvular calcification and combined valvular/vascular calcification were monitored and compared.
Results:
At baseline, mitral valve calcification was seen in 46% of subjects, aortic valve calcification in 33%. Most subjects with zero values at baseline failed to progress over one year. Aortic valve calcification was significantly increased in calcium-treated subjects. Changes in mitral valve calcification, and combined mitral + aortic valve calcification were less in sevelamer-treated than in calcium-treated subjects, but not significantly so. When combining valvular and vascular calcification, the median (10%, 90%) change in sevelamer-treated subjects was significantly lower than in calcium-treated subjects (6, -5084 to 1180 versus 81, -1150 to 2944, p = 0.04). The effect of sevelamer remained significant after adjustment for baseline calcification and the time-averaged calcium-phosphorus product, and was independent of the calcium preparation (acetate versus carbonate), geographic region (US versus Europe), LDL- or HDL-cholesterol, C-reactive protein and statin use. Significantly more sevelamer-treated subjects experienced an arrest (45 versus 28%, p = 0.047) or regression (26 versus 10%, p = 0.02) in total valvular and vascular calcification.
Conclusion:
Sevelamer arrested the progression of valvular and vascular calcification in almost 50% of hemodialysis subjects. Sevelamer treatment, plus intensive control of calcium and phosphorus levels, may attenuate progression of, or achieve regression in, cardiac valvular calcification.
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