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IntroductionInformation on the economic burden of focal segmental glomerulosclerosis (FSGS) is sparse. This study characterized health care resource utilization (HCRU) and costs in patients with FSGS, and evaluated the impact of nephrotic range proteinuria on these outcomes.MethodsThis retrospective, observational cohort study used administrative claims data from the Optum Clinformatics Data Mart Database from October 2015 to December 2019. Patients with FSGS (n = 844; first claim = index event) between April 2016 and December 2018 were matched on index date, age, sex, and race to non-FSGS controls (n = 1688). FSGS nephrotic range (urine protein/creatinine ratio >3000 mg/g or albumin/creatinine ratio >2000 mg/g) and non-nephrotic subpopulations were identified. Baseline comorbidities, 12-month post-index all-cause HCRU and costs (per patient per year [PPPY]), and immunosuppressant prescriptions were compared between matched cohorts and between FSGS subpopulations.ResultsComorbidity burden was higher in FSGS. Of 308 patients with available urine protein/creatinine ratio/albumin/creatinine ratio results, 36.4% were in nephrotic range. All-cause HCRU was higher in FSGS across resource categories (all P < 0.0001); 50.6% of FSGS and 23.3% of controls were prescribed glucocorticoids (P < 0.0001). Mean total medical costs were higher in FSGS ($59,753 vs. $8431 PPPY; P < 0.0001), driven by outpatient costs. Nephrotic range proteinuria was associated with higher all-cause inpatient, outpatient, and prescription costs versus nonnephrotic patients (all P < 0.0001), resulting in higher total costs ($70,481 vs. $36,099 PPPY; P < 0.0001).ConclusionsFSGS is associated with significant clinical and economic burdens; the presence of nephrotic range proteinuria increased the economic burden. New treatment modalities are needed to reduce proteinuria, help improve patient outcomes, and reduce HCRU and associated costs.

Abstract Background and Aims The burden of disease associated with FSGS has not been well characterized, especially with regard to health care resource utilization (HCRU) and related costs. The aim of this study was to evaluate all-cause HCRU and estimate associated costs in patients with FSGS compared with a matched non-FSGS cohort; a secondary aim was to evaluate the impact of nephrotic range proteinuria on these outcomes. Method Data were from the Optum Clinformatics® Data Mart Database. Patients with ≥ 1 claim (1st claim = index event) for FSGS between April 2016 and December 2018 were identified based on ICD-10-CM codes and matched 1:2 (FSGS:controls) on index date, age, sex, and race to non-FSGS controls; continuous enrollment 6 months pre- and 12 months post-index was required. FSGS nephrotic range (either UPCR >3000 mg/g or ACR >2000 mg/g) and non-nephrotic subpopulations were also identified. Quan-Charlson Comorbidity Index (CCI) and individual comorbidities at baseline, and 12-month post-index all-cause HCRU and associated costs (per patient per year [PPPY]) as well as medication prescriptions related to FSGS treatment were compared between the matched cohorts and between the FSGS subpopulations; t-tests were used for continuous variables and chi-square tests for categorical variables. Results 844 patients with FSGS were matched with 1688 non-FSGS controls; 57.4% male, 56.9% white, mean (SD) age 54.7 (18.4) years. Mean (SD) CCI was higher in the FSGS cohort relative to matched controls (2.72 [2.12] vs 0.55 [1.29]; P < .0001), with prevalence of most individual comorbidities higher in the FSGS cohort. Only 308 FSGS patients (36.5%) had UPCR or ACR tests with available results during the review period; 112 (36.4%) were in the nephrotic range and 196 were non- nephrotic (63.6%). The FSGS cohort was characterized by higher rates of all-cause HCRU across resource categories (all P < .0001) (Table 1); outpatient visits was the most frequently used category (99.1% vs 69.0%), followed by prescription medications. Among patients who used these resources, units of use were significantly higher in FSGS vs matched controls except for length of stay (Table 1). Readmission rates following 1st post-index hospitalization were higher in the FSGS cohort vs matched controls at 30 days (16.1% vs 6.0%; P < .05) and 365 days (39.1% vs 22.9%; P < .05). Glucocorticoids were the most frequently prescribed FSGS-related medication in both cohorts, with a higher rate in FSGS vs matched controls (50.6% vs 23.3%; P < .0001); other FSGS-related medications were infrequently prescribed (< 14%). Inpatient, outpatient, and prescription costs were higher in the FSGS cohort vs matched controls (all P < .0001) resulting in mean total annual medical costs of $59,753 vs $8,431 PPPY (P < .0001) that were driven by outpatient costs (Fig. 1A). Nephrotic range proteinuria was associated with higher all-cause inpatient, outpatient, and prescription costs vs non-nephrotic patients (all P < .0001; Fig. 1B), resulting in higher total costs ($70,481 vs $36,099 PPPY; P < .0001). A higher proportion of nephrotic range patients were prescribed FSGS-modifying medications (73.2% vs 54.1%; P = 0.001), with glucocorticoids the most frequent medication. However, 26.8% of nephrotic range patients were not prescribed any FSGS-related medications. Conclusion FSGS is associated with significant clinical and economic burdens with total annual medical costs > 7-fold higher than matched controls that were driven by outpatient costs. The presence of nephrotic range proteinuria substantially and significantly increased the economic burden. New treatment modalities leading to lower rates of proteinuria may help improve patient outcomes while reducing HCRU and their associated costs.

Abstract Background This short-term study assessed the efficacy and safety of lanthanum carbonate in the treatment of hyperphosphatemia in dialysis patients; here, we report a prespecified subgroup analysis of patients undergoing peritoneal dialysis. Methods Men and women (n = 39) who had received continuous ambulatory peritoneal dialysis for chronic kidney disease for 6 months or more were enrolled in eight renal medicine departments in the United Kingdom. A 2-week washout period was followed by a 4-week dose-titration phase during which patients received lanthanum carbonate titrated up to 2250 mg/day. This was followed by a 4-week, randomized, placebo-controlled, parallel-group phase during which patients continued to receive either lanthanum carbonate at the titrated dose, or a matched dose of placebo. The main outcome measure was control of serum phosphate levels (1.3-1.8 mmol/l) at the end of the parallel-group phase. Results Serum phosphate was controlled in 3/39 (8%) patients at the beginning of the dose-titration phase (after washout) and in 18/31 (58%) patients treated with lanthanum carbonate at its end. After the parallel-group phase, 60% of lanthanum carbonate-treated patients and 10% of those receiving placebo had controlled serum phosphate. There was no difference in mean (95% confidence interval) serum phosphate levels between groups at randomization: lanthanum carbonate, 1.57 (1.34-1.81) mmol/l; placebo, 1.58 (1.40-1.76) mmol/l (p = 0.96). However, a difference was seen at the end of the parallel-group phase: lanthanum carbonate, 1.56 (1.33-1.79) mmol/l; placebo, 2.25 (1.81-2.68) mmol/l (p = 0.0015). There were no clinically important changes in nutritional parameters and no serious treatment-related adverse events were recorded. Conclusions At doses up to 2250 mg/day, lanthanum carbonate is well tolerated and controls hyperphosphatemia effectively. Treatment with higher doses of lanthanum carbonate may allow patients undergoing peritoneal dialysis the potential to increase their dietary protein intake without compromising their phosphate control.

The purpose of this study was to conduct a retrospective analysis of serum phosphate level variability in patients new to hemodialysis (HD) and to identify patient characteristics associated with this variability. The medical records of 47,742 incident HD patients attending US outpatient dialysis centers between January 1, 2006 and March 31, 2009 were analyzed. Monthly mean serum phosphate levels determined over a 6-month evaluation period (months 4-9 after HD initiation) were assigned to one of three strata: low (>1.13 mmol/L [<3.5 mg/dL]); target (1.13-1.78 mmol/L [3.5-5.5 mg/dL]); or high (>1.78 mmol/L [>5.5 mg/dL]). Patients were classified into one of six serum phosphate variability groups based on variability among monthly mean phosphate levels over the 6-month evaluation period: consistently target; consistently high; high-to-target; high-to-low; target-to-low; or consistently low. Only 15% of patients (consistently target group) maintained monthly mean serum phosphate levels within the target range throughout the 6-month evaluation period. Age, Charlson comorbidity index, serum phosphate, and intact parathyroid hormone levels prior to HD initiation were strongly associated (P<0.001) with serum phosphate levels after HD initiation. Overall patient-reported phosphate binder usage increased from 35% at baseline to 52% at end of study. The low proportion of patients achieving target phosphate levels and low rates of phosphate binder usage observed during the study suggest that alternative strategies could be developed to control serum phosphate levels. Possible strategies that might be incorporated to help improve the management of hyperphosphatemia in incident HD patients include dietary modification, dialysis optimization, and earlier and sustained use of phosphate binders. [ABSTRACT FROM AUTHOR]

Background: Calcium-based and non-calcium-based phosphate binders have similar efficacy in the treatment of hyperphosphatemia; however, calcium-based binders may be associated with hypercalcemia, vascular calcification, and adynamic bone disease., Scope: A post hoc analysis was carried out of data from a 16-week, Phase IV study of patients with end-stage renal disease (ESRD) who switched to lanthanum carbonate monotherapy from baseline calcium acetate/calcium carbonate monotherapy. Of the intent-to-treat population (N=2520), 752 patients with recorded dose data for calcium acetate (n=551)/calcium carbonate (n=201) at baseline and lanthanum carbonate at week 16 were studied. Elemental calcium intake, serum phosphate, corrected serum calcium, and serum intact parathyroid hormone levels were analyzed., Findings: Of the 551 patients with calcium acetate dose data, 271 (49.2%) had an elemental calcium intake of at least 1.5 g/day at baseline, and 142 (25.8%) had an intake of at least 2.0 g/day. Mean (95% confidence interval [CI]) serum phosphate levels were 6.1 (5.89, 6.21) mg/dL at baseline and 6.2 (6.04, 6.38) mg/dL at 16 weeks; mean (95% CI) corrected serum calcium levels were 9.3 (9.16, 9.44) mg/dL and 9.2 (9.06, 9.34) mg/dL, respectively. Of the 201 patients with calcium carbonate dose data, 117 (58.2%) had an elemental calcium intake of at least 1.5 g/day, and 76 (37.8%) had an intake of at least 2.0 g/day. Mean (95% CI) serum phosphate levels were 5.8 (5.52, 6.06) mg/dL at baseline and 5.8 (5.53, 6.05) mg/dL at week 16; mean (95% CI) corrected serum calcium levels were 9.7 (9.15, 10.25) mg/dL and 9.2 (9.06, 9.34) mg/dL, respectively., Conclusion: Calcium acetate/calcium carbonate phosphate binders, taken to control serum phosphate levels, may result in high levels of elemental calcium intake. This may lead to complications related to calcium balance., Competing Interests: and potential conflicts of interest: J Brian Copley is an employee of Shire. Rosamund J Wilson is a consultant to Shire. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests forms for the authors are available for download at: http://www.drugsincontext.com/wp-content/uploads/2017/01/dic.212302-COI.pdf.