A comparative study of 2 new phosphate binders (sevelamer and lanthanum carbonate) in routine clinical practice.

INTRODUCTION: Lack of adherence may influence the efficiency of phosphate binders. Our clinical hypothesis was that if lanthanum carbonate (LC) might offer some advantage over sevelamer (S), that that would be in those patients in whom serum phosphate (P) levels were not controlled by S or in those requiring high doses of it, presuming that therapeutic compliance with S could be inadequate. The aim of this study was to compare the cost-consequences of changing from S to LC. METHODS: This was a prospective comparative before-after interventional study. Fifty-one hemodialysis patients prescribed a large number of tablets of S (≥ 9 tablets/day) and/or had serum phosphorus (P) levels >5.5 mg/dL were changed from S to LC; 68 patients who did not meet those criteria served as controls. RESULTS: Mean daily number of total phosphate binder tablets was reduced after the introduction of LC (13.9 ± 5.5 at time 0 vs. 7.7 ± 4.6 at 12 months; p<0.001). LC was suspended in 14 patients (31.1%), due to a wish to return to the previous medication (S). Percentage compliance with the objectives recommended by the NFK-KDOQI guidelines improved after the change (patients with P <5.5 mg/dL: 46.9% at month 0 and 72.5% at month 12; p<0.01). The incremental cost of changing from S (month 0) to LC (month 12) was -107.8 monthly, considering only the costs of phosphate binders. LC reached the P objective at a lower cost (euro 582.2 vs. euro 1,038.5; -44%; p<0.01). CONCLUSIONS: A complete change from S to LC in these particular kinds of patients significantly decreased the cost of treatment while also improving the achievement of NFK-KDOQI guideline objectives for mineral metabolism.

Challenge of phosphorus control in hemodialysis patients: a problem of adherence?

OBJECTIVE: Few studies have investigated nonadherence to phosphate binders. The aim of this study was to evaluate the degree of adherence of our hemodialysis (HD) patients to phosphate binders and to determine which variables were related to nonadherence to treatment. METHODS: In 165 HD patients, the degree of adherence to the drugs prescribed was studied using the Simplified Medication Adherence Questionnaire. RESULTS: Of patients, 40% were nonadherent. Specific nonadherence to phosphate binder and hypotensive medication was admitted by 21% and 13% of patients, respectively. Nonadherent patients had significantly higher mean serum phosphorus (P) (4.7 ± 0.9 mg/dL vs. 4.4 ± 0.7 mg/dL; p=0.007) and potassium levels (6.3 ± 4.4 mEq/L vs. 5.3 ± 1.4 mEq/L; p=0.04). There was a statistically significant association between mean P levels >5.5 mg/dL in the last 6 months and nonadherence to treatment (X2=4.8; 95% confidence interval [95% CI], 1.0-6.6; p=0.02). No relationship was found between patients with blood pressure levels >140/90 mm Hg and nonadherence to hypotensive medication (X2=0.02; 95% CI, 0.2-4.1; p=0.88). Patients specifically nonadherent to phosphate binders were more likely to have P levels >5.5 mg/dL (X2=4.7; 95% CI, 1.07-6.5; p=0.03). No statistically significant association was found between patients noncompliant with hypotensive agents and those noncompliant with phosphate binders (X2=0.39; 95% CI, 0.4-4.7; p=0.53). There were no significant differences between adherent and nonadherent patients in terms of age, time on hemodialysis, Charlson Comorbidity Index, number of drugs prescribed and number of tablets per day (p>0.05). CONCLUSION: Nonadherence to pharmacological treatment in dialysis patients is high. Nonadherence to phosphate binders was greater than for hypotensive agents, did not coexist in the same patients and had a greater impact on target achievement.

Consequences of the implementation of K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease in a population of patients on chronic hemodialysis.

BACKGROUND: After application of K/DOQI recommendations, a large proportion of our patients failed to reach the proposed targets. This study examined the causes of these findings. METHODS: Patients (n=163) were compared in 2 periods (8 months before and after application of K/DOQI guidelines). Serum calcium (Ca), phosphorus (P), parathyroid hormone (PTH) and calcium x phosphate product (Ca x P); mean dialysate Ca content; mean doses of vitamin D; and average prescription of Ca-based phosphate binders and sevelamer in both periods were analyzed. RESULTS: Prescription of Ca salts as phosphate-binding agents decreased and prescription of sevelamer increased in an attempt to maintain serum Ca levels between 8.4 and 9.5 mg/dL post-K/DOQI. Increased serum PTH levels were associated with decreased serum Ca levels (relative risk [RR] = 41.1, p<0.001) and increased serum P levels (RR=6.81, p<0.01). Use of dialysis fluids with Ca content of 2.5 mEq/L was associated with an increased risk of having PTH levels >300 pg/mL (RR=11.4, p<0.003). Vitamin D metabolites had to be discontinued in 26 patients (37.1% of those receiving them from study start) due to hyperphosphoremia or hypercalcemia post-K/DOQI; and serum PTH significantly increased (445.8 +/- 238.2 pg/mL vs. 715.2 +/- 549.5 pg/mL; p<0.001). Ninety-three patients (57%) did not receive vitamin D at study start; in 20 of those (21.5%), vitamin D had to be started post-K/DOQI. CONCLUSIONS: Clinical guidelines do not appear to be sufficient to overcome all difficulties arising in daily management of these patients.

Emotional distress and health-related quality of life in patients on hemodialysis: the clinical value of COOP-WONCA charts.

BACKGROUND: A significant percentage of patients on hemodialysis (HD) present with affective disorders such as anxiety and/or depression. The purpose of this study was to explore adaptive mixed affective disorders of patients on HD and to analyze the clinical value of a brief health-related quality-of-life (HRQoL) instrument, the COOP-WONCA charts, in our population of HD patient. METHODS: Seventy-five patients (mean age 49.2 years; range 20.1-64.9), who had been on HD for a mean 110 months (range 6.1-364.5 months) were studied. The Beck Depression Inventory (BDI), Hamilton Scale of Depression (HDRS) and Hamilton Scale of Anxiety (HARS) were used. To evaluate patient HRQoL, we used the validated Spanish version of the COOP-WONCA charts. RESULTS: Of the 75 patients studied, 44.0% (BDI) and 53.4% (HDRS) had some depressive symptoms which were moderate-severe in 14.7% (BDI) and in 22.7% (HDRS). Anxiety symptoms were observed in 46.6% of the patients (13.3% were of moderate-severe degree). There was a high level of association between both depression scales (BDI and HDRS) (r=0.70; p<0.001), as well as between both scales and the HARS (HDRS, r=0.82; p<0.001; BDI, r=0.53; p<0.001). The most affected dimensions of the COOP-WONCA charts were "Physical fitness" and "Overall health," whereas the least affected were "Social activities" and "Daily activities." The global score of the COOP-WONCA charts was associated with the presence of depressive (BDI, r=0.64, and HDRS, r=0.75; p<0.001) and anxiety symptoms (HARS, r=0.52; p<0.001). A score of >or= 3 corresponding to the dimension "Feelings" on the COOP-WONCA charts allowed the detection of 81.8% of the patients with clinically significant depressive symptoms (BDI >18), with a sensitivity of 96.8% and a specificity of 75% for this cutoff point. CONCLUSIONS: A high percentage of patients on HD present with mixed emotional disorders (anxiety and/or depression); a good correlation is observed between HRQoL and the levels of anxiety and depression in these patients; and measuring HRQoL with the COOP-WONCA charts may help diagnose such problems.

Implementation of 'K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease' after the introduction of cinacalcet in a population of patients on chronic haemodialysis.

BACKGROUND: The purpose of the present study was to evaluate the impact of cinacalcet administration on the attainment of Kidney Disease Outcomes Quality Initiative of the National Kidney Foundation (NFK-K/DOQI) targets, in a group of dialysis patients with secondary hyperparathyroidism that were not controlled with vitamin D metabolites due to inadequate elevations in serum calcium and/or phosphorus. METHODS: Twenty-eight patients undergoing haemodialysis that presented secondary hyperparathyroidism (PTH > 300 pg/ml) with difficulty to use vitamin D either because of hypercalcaemia (>10.2 mg/dl) and/or hyperphosphoraemia (>5.5 mg/dl) were included in this study. The follow-up period was 9 months before and after the introduction of cinacalcet. We started by adding 30 mg of cinacalcet orally once daily to their previous vitamin D metabolite treatment. The following variables were calculated and recorded: the mean of all measurements of serum Ca, P and parathyroid hormones (PTH), and Ca x P in each patient; calcium in dialysate (mEq/l); doses of vitamin D administered; doses of cinacalcet used, and the average prescription of calcium-based phosphate binders, sevelamer hydrochloride and aluminum binders, corresponding to two periods according to the introduction of cinacalcet. The proportions of patients with different serum Ca levels as well as serum P levels; serum PTH levels and CaxP at the beginning and at the end of the nine month period of treatment with cinacalcet were calculated. RESULTS: Serum PTH (826.9 +/- 325 vs 248.1 +/- 77.3, P < 0.001), serum calcium (9.9 +/- 0.6 vs 8.6 +/- 0.4, P < 0.001) and the Ca x P product (94.7 +/- 7.3 vs 43.6 +/- 8.5; P < 0.001) diminished significantly whereas serum phosphorus remained unchanged (4.8 +/- 1.5 vs 4.3 +/- 1.1; P = NS). Before cinacalcet, 23 patients had severe hyperparathyroidism (serum PTH > 500) and 15 patients hypercalcaemia (serum calcium >10.2 mg/dl). After 9 months of treatment, all 28 patients showed serum PTH < 500 pg/ml and serum calcium <10.2 mg/dl; 64.7% of the patients achieved Ca, P, Ca x P and PTH objectives simultaneously. While the mean dose of cinacalcet increased along the 9 months of treatment (P < 0.001), there were no significant changes in vitamin D metabolites (P = 0.5), neither in the mean doses of calcium-containing agents, nor in the mean prescribed doses of sevelamer (P < 0.01), and aluminium-containing agents diminished significantly (P < 0.05). CONCLUSIONS: In summary, the combination of cinacalcet and low doses of vitamin D improved significantly the control of PTH and Ca x P in patients with severe secondary hyperparathyroidism on chronic haemodialysis, without adverse effects and with lower doses of phosphate binders.