Reducing Pill Burden for Patients on Dialysis
Reducing Pill Burden for Patients on Dialysis
Floege J, Covic AC, Ketteler M, et al
Kidney Int. 2014;86:638-647
One of the greatest obstacles faced by patients on dialysis is the number of pills they must take every day. One study suggests that the median daily pill burden is 19, with a maximum of more than 30 tablets per day. Among these pills are phosphate binders, which can account for up to 49% of the total daily pill burden. Indeed, the large number of phosphate binder pills that must be ingested daily contributes to patient noncompliance, which can result in hyperphosphatemia, worsened secondary hyperparathyroidism, and severe bone abnormalities. Thus, any intervention that would allow patients to achieve better phosphate control and a lower pill burden would be of great interest to these patients and their physicians. Enter PA21.
PA21 is an iron-based, calcium-free phosphate binder. It contains 500 mg of iron and has a high phosphate-binding capacity throughout a wide range of intraintestinal pH levels.
In the PA21 study, investigators compared the phosphate-controlling effects of PA21 with sevelamer carbonate, a commonly used calcium-free phosphate binder. A total of 1055 patients on hemodialysis were randomly assigned to receive PA21 or sevelamer carbonate. PA21 was found to be as effective as sevelamer; phosphorous levels were reduced by 0.71 mmol/L with PA21, compared with a 0.79-mmol/L decrease with sevelamer.
The most impressive findings, however, were the number of tablets required to achieve parity with sevelamer and overall adherence to the regimens. Over the 24-week period, patients taking PA21 required a mean of 3.1 pills/day compared with 8.1 pills/day of sevelamer. This resulted in an adherence rate of 82.6% with PA21 vs 77.2% with sevelamer during the 24-week study.
Of note, although each PA21 tablet contains 500 mg of iron, PA21 caused more diarrhea than sevelamer (20.1% vs 7.5%), with 65% of the diarrhea occurring in the first 3 weeks of PA21 use. The diarrhea did not seem to impair the overall adherence to PA21; however, diarrhea was the most common reason why patients chose to discontinue PA21 therapy.
Pill burden is a serious challenge that patients on dialysis must overcome. Too high a pill burden results in nonadherence and, thus, untreated hyperphosphatemia. It is refreshing to see that, when compared head-to-head against a commonly used phosphate binder, PA21 was able to achieve a comparable serum phosphate reduction at a much lower pill burden.
The 24-week study period for this trial was short; a longer study using PA21 will be needed to determine whether the high rate of diarrhea would discourage more patients from adhering to the regimen over the long term. Nevertheless, this study showcases both the efficacy and efficiency of PA21 in managing hyperphosphatemia at a lower pill burden.
Abstract
A Phase III Study of the Efficacy and Safety of a Novel Iron-Based Phosphate Binder in Dialysis Patients
Floege J, Covic AC, Ketteler M, et al
Kidney Int. 2014;86:638-647
Background
One of the greatest obstacles faced by patients on dialysis is the number of pills they must take every day. One study suggests that the median daily pill burden is 19, with a maximum of more than 30 tablets per day. Among these pills are phosphate binders, which can account for up to 49% of the total daily pill burden. Indeed, the large number of phosphate binder pills that must be ingested daily contributes to patient noncompliance, which can result in hyperphosphatemia, worsened secondary hyperparathyroidism, and severe bone abnormalities. Thus, any intervention that would allow patients to achieve better phosphate control and a lower pill burden would be of great interest to these patients and their physicians. Enter PA21.
PA21 is an iron-based, calcium-free phosphate binder. It contains 500 mg of iron and has a high phosphate-binding capacity throughout a wide range of intraintestinal pH levels.
The Study
In the PA21 study, investigators compared the phosphate-controlling effects of PA21 with sevelamer carbonate, a commonly used calcium-free phosphate binder. A total of 1055 patients on hemodialysis were randomly assigned to receive PA21 or sevelamer carbonate. PA21 was found to be as effective as sevelamer; phosphorous levels were reduced by 0.71 mmol/L with PA21, compared with a 0.79-mmol/L decrease with sevelamer.
The most impressive findings, however, were the number of tablets required to achieve parity with sevelamer and overall adherence to the regimens. Over the 24-week period, patients taking PA21 required a mean of 3.1 pills/day compared with 8.1 pills/day of sevelamer. This resulted in an adherence rate of 82.6% with PA21 vs 77.2% with sevelamer during the 24-week study.
Of note, although each PA21 tablet contains 500 mg of iron, PA21 caused more diarrhea than sevelamer (20.1% vs 7.5%), with 65% of the diarrhea occurring in the first 3 weeks of PA21 use. The diarrhea did not seem to impair the overall adherence to PA21; however, diarrhea was the most common reason why patients chose to discontinue PA21 therapy.
Commentary
Pill burden is a serious challenge that patients on dialysis must overcome. Too high a pill burden results in nonadherence and, thus, untreated hyperphosphatemia. It is refreshing to see that, when compared head-to-head against a commonly used phosphate binder, PA21 was able to achieve a comparable serum phosphate reduction at a much lower pill burden.
The 24-week study period for this trial was short; a longer study using PA21 will be needed to determine whether the high rate of diarrhea would discourage more patients from adhering to the regimen over the long term. Nevertheless, this study showcases both the efficacy and efficiency of PA21 in managing hyperphosphatemia at a lower pill burden.
Abstract