scholarly journals POS1121 DEMOGRAPHICS, COMORBIDITIES, AND RENAL FUNCTION OF UNCONTROLLED GOUT PATIENTS WHO RECEIVED PEGLOTICASE: FINDING FROM A LARGE US CLAIMS DATABASE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 839.2-840
Author(s):  
C. Vesel ◽  
A. Morton ◽  
M. Francis-Sedlak ◽  
B. Lamoreaux
Keyword(s):  
Kidney Function ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Small Subset ◽  
Phase 3 ◽  
Claims Database ◽  
Medical Diagnoses ◽  
Ckd Stage ◽  
Before And After ◽  
The Impact

Background:NHANES data indicate that approximately 9.2 million Americans have gout,1 with a small subset having uncontrolled disease.2 Pegloticase is a PEGylated recombinant uricase enzyme indicated for treating uncontrolled gout that markedly reduces serum uric acid levels (sUA)3 and resolves tophi in treatment responders.4 Despite pegloticase availability in the US for many years, real world demographics of pegloticase users in the treatment of uncontrolled gout have not been previously reported in a population-based cohort.Objectives:This study utilized a large US claims database to examine demographics and co-morbidities of uncontrolled gout patients treated with pegloticase. Kidney function before and after pegloticase treatment and concomitant therapy with immunomodulators were also examined.Methods:The TriNetX Diamond database includes de-identified data from 4.3 million US patients with gout (as of September 2019), including demographics, medical diagnoses, laboratory values, procedures (e.g. infusions, surgeries), and pharmacy data. Patients who had received ≥1 pegloticase infusion were included in these analyses. The number of infusions was evaluated for a subgroup of patients who were in the database ≥3 months before and ≥2 years after the first pegloticase infusion (i.e. first infusion prior to September 2017) to ensure only complete courses of therapy were captured. In this subpopulation, kidney function before and after pegloticase therapy was examined, along with the presence of immunomodulation prescriptions (methotrexate, mycophenolate mofetil, azathioprine, leflunomide) within 60 days prior to and 14 days after the first pegloticase infusion.Results:1494 patients treated with pegloticase were identified. Patients were 63.1 ± 14.0 years of age (range: 23–91), mostly male (82%), and white (76%). Mean sUA prior to pegloticase was 8.7 ± 2.4 mg/dL (n=50), indicating uncontrolled gout in the identified population. The most commonly reported comorbidities were chronic kidney disease (CKD, 48%), essential hypertension (71%), type 2 diabetes (39%), and cardiovascular disease (38%), similar to pegloticase pivotal Phase 3 trial populations. In patients with pre-therapy kidney function measures (n=134), pre-treatment eGFR averaged 61.2 ± 25.7 ml/min/1.73 m2, with 44% having Stage 3-5 CKD. In patients with complete therapy course capture and pre- and post-therapy eGFR measures (n=48), kidney function remained stable (change in eGFR: -2.9 ± 18.2 ml/min/1.73 m2) and CKD stage remained the same or improved in 81% of patients. In 791 patients with complete treatment course capture, patients had received 8.7 ± 13.8 infusions (median: 3, IQR: 2-10). Of these, 189 (24%) patients received only 1 pegloticase infusion and 173 (22%) received ≥12 infusions. As the data cut-off for this analysis pre-dated emerging data on the use of immunomodulation as co-therapy, only 19 of 791 (2%) patients received immunomodulation co-therapy with pegloticase.Conclusion:This relatively large group of patients with uncontrolled gout treated with pegloticase had similar patient characteristics of those studied in the phase 3 randomized clinical trials. Patients with uncontrolled gout are significantly burdened with systemic co-morbid diseases. The majority of patients had stable or improved kidney function following pegloticase treatment. As these results reflect patients initiating treatment prior to 2018, before co-treatment with immunomodulation was introduced, this cohort only included a small percentage of patients who were co-treated with an immunomodulator. Future studies using more current datasets are needed to evaluate real world outcomes in patients treated with pegloticase/immunomodulator co-therapy and to evaluate the impact of systemic co-morbid diseases.References:[1]Chen-Xu M, et al. Arthritis Rheumatol 2019 71:991-999.[2]Fels E, Sundy JS. Curr Opin Rheumatol 2008;20:198-202.[3]Sundy J, et al. JAMA 2011;306:711-720.[4]Mandell BF, et al. Arthritis Res Ther 2018;20:286.Disclosure of Interests:Claudia Vesel Shareholder of: Horizon Therapeutics plc, Employee of: Horizon Therapeutics plc, Allan Morton Speakers bureau: Sanofi, Amgen, and Horizon, Megan Francis-Sedlak Shareholder of: Horizon Therapeutics plc, Employee of: Horizon Therapeutics plc, Brian LaMoreaux Shareholder of: Horizon Therapeutics plc, Employee of: Horizon Therapeutics plc.

scholarly journals Postnatal persistence of sex-dependent renal developmentally programmed structural and molecular changes in nonhuman primates

2020 ◽  
Author(s):  
Andrew C. Bishop ◽  
Kimberly D. Spradling-Reeves ◽  
Robert E. Shade ◽  
Kenneth J. Lange ◽  
Shifra Birnbaum ◽  
...  
Keyword(s):  
Gene Expression ◽  
Renal Disease ◽  
Kidney Function ◽  
Nonhuman Primates ◽  
Disease Risk ◽  
Postnatal Life ◽  
Urine Metabolites ◽  
Baboon Model ◽  
Before And After ◽  
The Impact

AbstractBackgroundPoor nutrition during development programs kidney function. No studies on postnatal consequences of decreased perinatal nutrition exist in nonhuman primates (NHP) for translation to human renal disease. Our baboon model of moderate maternal nutrient restriction (MNR) produces intrauterine growth restricted (IUGR) and programs renal fetal phenotype. We hypothesized that the IUGR phenotype persists postnatally, influencing responses to a high-fat, high-carbohydrate, high-salt (HFCS) diet.MethodsPregnant baboons ate chow (Control; CON) or 70% of control intake (MNR) from 0.16 gestation through lactation. MNR offspring were IUGR at birth. At weaning, all offspring (CON and IUGR females and males, n=3/group) ate chow. At ~4.5 years of age, blood, urine, and kidney biopsies were collected before and after a 7-week HFCS diet challenge. Kidney function, unbiased kidney gene expression, and untargeted urine metabolomics were evaluated.ResultsIUGR female and male kidney transcriptome and urine metabolome differed from CON at 3.5 years, prior to HFCS. After the challenge, we observed sex-specific and fetal exposure-specific responses in urine creatinine, urine metabolites, and renal signaling pathways.ConclusionsWe previously showed mTOR signaling dysregulation in IUGR fetal kidneys. Before HFCS, gene expression analysis indicated that dysregulation persists postnatally in IUGR females. IUGR male offspring response to HFCS showed uncoordinated signaling pathway responses suggestive of proximal tubule injury. To our knowledge, this is the first study comparing CON and IUGR postnatal juvenile NHP and the impact of fetal and postnatal life caloric mismatch. Perinatal history needs to be taken into account when assessing renal disease risk.

Tracking the Impact of a Toll Increase on Managed Lane Travel Behavior

2019 ◽  
Vol 2673 (2) ◽  
pp. 779-788 ◽  
Author(s):  
Mark W. Burris ◽  
Sruthi Ashraf
Keyword(s):  
Real World ◽  
Travel Behavior ◽  
General Purpose ◽  
Managed Lanes ◽  
Before And After ◽  
The Impact

Tolled managed lanes (ML) are an innovative way to increase capacity and regulate demand on roadways. They are still relatively new and a lot remains unknown about how travelers choose to use MLs or not. This paper uses disaggregate real-world travel data of travelers who choose between paying a toll to use ML or travel toll free on the adjacent general purpose lanes (GPL). The travel behavior before and after a toll increase is evaluated. The change in toll rates did not affect the overall ML use as anticipated. Overall, ML use increased after the toll increase. In addition, frequent ML users (more than 10 ML trips in a month) and infrequent ML users (1–3 ML trips in a month) behaved differently following the increase in the toll.

SO092REDUCED QUALITY OF LIFE IN ADPKD PATIENTS WITH CKD STAGE 1-3: THE CYSTIC I QUALITY OF LIFE STUDY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Jean Winterbottom ◽  
Roslyn Simms ◽  
Albert Ong
Keyword(s):  
Quality Of Life ◽  
Kidney Disease ◽  
Kidney Function ◽  
Well Being ◽  
Flank Pain ◽  
Kidney Volume ◽  
Ckd Stage ◽  
Stage 1 ◽  
The Impact

Abstract Background and Aims ADPKD is the most common inherited kidney disease in man, a major cause of end-stage renal disease and is a significant medical and economic burden across Europe. However the impact of this major disease on the quality of life of patients with preserved kidney function has not been systematically explored. Method The CYSTic 1 study was an academic prospective study designed to study the natural history of ADPKD, the impact of the disease on individual patients and the health economic costs on care systems across Europe in adult patients with preserved kidney function (eGFR ≥30 mls/min). Around 400 patients were recruited from 6 expert centres across Europe (Belgium, France, Italy, Netherlands, Spain, UK) with baseline clinical data recorded including HR-QOL (Health-Related Quality of Life) incorporating a Kidney Disease QOL short form (KDQOL-SF v1.3 questionnaire), renal MRI for TKV (Total Kidney Volume) and DNA for genotyping. Here we report initial results based on baseline HR-QOL data in the UK patients. Results Detailed analysis was conducted on 76 patients recruited from a single centre (UK) whose mean age was 43 years, 53.9% were female with a mean eGFR-EPI of 69ml/min/1.73m2 and mean height-adjusted TKV (Ht-TKV) of 664ml/m. The cohort was subdivided by groups based on eGFR stage (I, II, III), Ht-TKV (<>750ml/m) and genotype (PKD1 v PKD2/NMD) and correlated with HR-QOL scores. As expected, age, hypertension and Ht-TKV were significantly associated with eGFR stage. Of interest, flank pain was more frequently reported in patients with smaller kidneys (Ht-TKV<750) and patients with PKD1 more likely to be hypertensive. All QOL scores (SF36) were significantly lower in patients with progressively lower eGFR except for emotional well-being whereas Symptom/problem (p=0.043) and Sleep (p=0.021) (KDQOL-SF1.3) were significantly worse in patients with lower kidney function. SF36 scores for Physical functioning (p=0.001), General health (p=0.026) and physical component summary (PCS) (P=0.019) decreased in patients with more advanced disease defined by larger kidneys (ht-TKV>750). Conclusion In ADPKD patients with stage 1-3 chronic kidney disease (CKD), stepwise lower QOL scores were consistently found and significantly associated with decreasing eGFR. A notable reported item was disturbed sleep. Unexpectedly, patients with smaller kidneys reported significantly more flank pain. PKD1 patients and those with large kidneys were more likely to be hypertensive. Our results suggest that the impact of ADPKD on patients with stage 1-3 CKD is underestimated. Future work will investigate possible national differences and the relationship of HR-QOL with markers of disease within the entire cohort.

scholarly journals Impact of chronic kidney disease and anemia on health-related quality of life and work productivity: Analysis of multinational real-world data

2019 ◽  
Author(s):  
Heleen van Haalen ◽  
James Jackson ◽  
Bruce Spinowitz ◽  
Gary Milligan ◽  
Rebecca Moon
Keyword(s):  
Quality Of Life ◽  
Kidney Disease ◽  
Real World ◽  
Work Productivity ◽  
Regression Analyses ◽  
Activity Impairment ◽  
Ckd Stage ◽  
Related Quality ◽  
The Impact

Abstract Background. Reductions in health-related quality of life (HRQoL) in patients with chronic kidney disease (CKD) are thought to be exacerbated by the low hemoglobin (Hb) levels that define anemia, a common complication of CKD. The current analysis evaluated the impact of anemia on HRQoL and work productivity in patients with non-dialysis dependent and dialysis dependent CKD using real‑world data.Methods. Data were collected in France, Germany, Italy, Spain, the UK, the USA and China in 2012–2018 in the Adelphi Real World Disease Specific Programme™ (DSP) for CKD, a large, cross-sectional, survey of physicians and their patients. Patients completed three patient-reported outcomes (PRO) instruments: the EuroQol 5-Dimension 3-level (EQ-5D-3L), the Kidney Disease Quality of Life (KDQOL-36) instrument and the Work Productivity and Activity Impairment (WPAI) questionnaire. PROs were assessed by CKD stage and Hb levels, and regression analyses were performed with CKD stage and Hb level as independent variables and PROs as outcome variables, while adjusting for age, sex, CKD stage, comorbidities and CV risk.Results. Overall, 5276 patients participated in the survey, including 28% stage 4 and 36% dialysis patients. Patients with lower Hb levels more often reported problems/issues on all EQ-5D-3L domains (p<0.0001). Regression analyses showed significant associations between lower Hb levels and the probability of low (<0.8) EQ-5D-3L utility scores (p<0.0001) and low visual analog scale (VAS) scores (p<0.05), indicating poorer health status. Associations were seen even when adjusting for CKD stage and other potential confounding factors. Significant associations were observed between Hb level and the 12-Item Short-Form Health Survey (SF‑12) Physical Component Summary (PCS), SF-12 Mental Component Summary (MCS) and the three KDQOL-36 subscales (all p<0.0001), and were confirmed using linear regression analyses adjusting for CKD stage and other potential confounders. Numerically greater work productivity losses and greater activity impairment were observed with lower Hb levels.Conclusions. Lower Hb levels worsen the impact of CKD on HRQoL, and are associated with lower work productivity in patients with CKD. Assessment and treatment of anemia should be recognized as a key component of integral CKD management throughout all stages of the disease.

scholarly journals MO470PATIROMER PHARMACOUTILIZATION IN REAL-WORLD GERMAN CKD PATIENTS WITH MODERATELY TO SEVERELY REDUCED EGFR

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Roberto Pecoits-Filho ◽  
Daniel Muenz ◽  
K P McCullough ◽  
Johannes Duttlinger ◽  
Viviane Calice-Siva ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Real World ◽  
Regression Models ◽  
High Serum ◽  
High Morbidity ◽  
Logistic Regression Models ◽  
Ckd Stage ◽  
Before And After ◽  
Lower Egfr

Abstract Background and Aims Hyperkalemia (HK) (serum K&gt;5.0 mEq/L) is a chronic condition in patients with chronic kidney disease (CKD) associated with high morbidity and mortality, and it is a frequent reasons for renin angiotensin aldosterone inhibition (RAASi) discontinuation. Patiromer is a non-absorbed, sodium-free, K+ binder that has been shown to reduce serum K+ in patients with HK, and thereby enable RAASi therapy, which is supported by randomized trial evidence. The description of patiromer utilization in patients with moderate to advanced CKD in the real-world setting in Europe is lacking. The objective of this analysis was to describe predictors of patiromer initiation and time to discontinuation among CKD patients using contemporary (April 2018-October 2020) data from German participants in CKD Outcomes and Practice Patterns Study (CKDopps). Method We identified 136 patiromer users (116 with matching K measurement) during the observation period. Patients with eGFR &lt;60ml/min/1.73m2 and a serum potassium ≥4mEq/L who never initiated patiromer during the follow up were used as a comparison. We used the most recent lab and drug use information available within the 6-month period prior to baseline, which was defined as either first use of patiromer, April 1, 2018, or entry into the PDOPPS study. The median time between the most recent K+ measurement and baseline was 45 days for non-patiromer users and 4 days for patiromer users. Logistic regression models were used to test associations between patient factors and whether the patient was in the patiromer initiation group or the comparison group. Time on patiromer was estimated using a Kaplan-Meier curve, censoring for death, dialysis, transplantation, or loss of follow-up. Results Patiromer was prescribed to ≥2 patients in 11 clinics, one patient in 19 clinics, and zero patients in 57 clinics. Patients prescribed patiromer had lower eGFR (23.2 [15.8, 28.6] vs 36.9 [27.7, 46.3]ml/min) and higher serum K levels (5.6 [5.4, 6.1] vs 4.6 [4.3, 5.0]ml/min). There were no major differences according to patiromer use in other demographic, clinical, and biochemical characteristics. Despite the differences in serum K, use of RAAS inhibitors was similar in patiromer users (83%) versus non-users (80%). Thirty three percent of patiromer users were prescribed polystyrene sulfonate (SPS) before patiromer initiation. In a multiple logistic regression models (including serum K, CKD stage, gender, age, prescription of RAASi, diabetes, coronary artery disease, heart failure), patiromer use was strongly associated more advanced CKD stage (independently of high serum K), with odds ratios of initiation &gt;3 for CKD stage 4 or 5 versus CKD stage 3. Among new users, 90% of patients had active prescription at 30 days and about one-half had active prescription at one year (Figure). Conclusion The main predictors of Patiromer initiation were advanced CKD stage and hyperkalemia. Treatment decisions did not appear to be based on other patient or clinical characteristics. Patiromer was often prescribed to patients already receiving alternative HK treatment (SPS), suggesting use for chronic hyperkalemia rather than response to acute event. Further analysis with a larger population and measurements of K+ before and after patiromer initiation may improve the understanding of its pharmacoutilization in moderate to advanced CKD.

scholarly journals Analysis of US Claims Real World Data of Hemophilia a & B Patients: Units Dispensed & Expenditures Associated with Utilization of and Switching from Standard to Extended Half-Life Factor Products

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3508-3508
Author(s):  
Bartholomew J. Tortella ◽  
Amit Chhabra ◽  
José Alvir ◽  
Emily R. Rubinstein ◽  
Lisa J. Young ◽  
...  
Keyword(s):  
Real World ◽  
Half Life ◽  
Hemophilia A ◽  
Real World Data ◽  
World Data ◽  
Treatment Scheme ◽  
Before And After ◽  
Male Patients ◽  
The Impact ◽  
Life Factor

Abstract Background: Both standard half-life (SHL) and extended half-life (EHL) factor replacement products are used to treat patients with hemophilia A (hem-A) and B (hem-B). A comparison of international unit (IU) utilization and expenditures ($USD) was made between patients on SHL and EHL factor replacement products to compare utilization and to determine the impact of switching from an SHL to an EHL product. Methods: De-identified claims data from both the Truven Health MarketScan® Research (Truven) and Optum® Clinformatics® (Optum) US claims databases included male patients with hem-A (Truven from Aug 2014-Apr 2018 and Optum from Aug 2014-Dec 2017) and hem-B (Truven from Jun 2014-Apr 2018 and Optum from Jul 2014-Dec 2017) who had data for at least 3 months of product dispensation. The SHL and EHL groups were compared. A separate "switch" analysis using the Truven database examined expenditures and IUs before and after switching from nonacog-α (SHL) to FIX-Fc (EHL). Descriptive statistics were used and medians reported for expenditures and IUs to accommodate for the skewness of data distribution. Results: Hem-A: The analysis included 896 SHL and 202 EHL patients, including those who switched from an SHL to an EHL product. Quarterly expenditures and IUs dispensed were analyzed. Both the Optum and Truven databases (see Table) demonstrated higher IU dispensation (Optum: 35%, Truven: 50% higher) and expenditures (Optum: 87%, Truven: 117%) associated with EHL products versus SHL products. In the switch analysis, 35 patients switched from nonacog-α to FIX-Fc; median IUs rose from 61,228 to 75,914 [24%] and median expenditures rose from $78,945 to $155,203 [97%]. Hem-B: The analysis included 50 FIX-Fc, 13 FIX-Alb, and 132 nonacog-α patients. Both databases (see Table) demonstrated higher median expenditures for the EHL products compared with nonacog-α (Optum: 179% for FIX-Fc, 189% for FIX-Alb; Truven: 234% for FIX-Fc, 245% for FIX-Alb). The IU results varied in Optum: FIX-Fc was 23% higher than nonacog-α, but FIX-Alb was 9 % lower than nonacog-α. Similarly, in Truven, the IU results varied: IUs were mixed for the SHL product compared with the EHL products: 62% higher for FIX-Fc than nonacog-α, and approximately the same for FIX-Alb and nonacog-α. In the switch analysis, 16 patients switched from nonacog-α to FIX-Fc; median IUs rose from 62,857 (nonacog-α) to 69,816 (FIX-Fc) [11%], while expenditures rose from $75,064 (nonacog-a) to $210,482 (FIX-Fc) [180%]. Conclusions: This analysis in more than 1000 patients, unadjusted for severity of disease or treatment scheme, demonstrated in hem-A that higher IU utilization and expenditures were associated with EHL use compared with SHL use, and in hem-B, that higher expenditures were seen with EHL products, while IU dispensation in some cases decreased, remained the same, or increased. In patients switching from the SHL to an EHL product, higher IU dispensation and expenditures were seen. These real-world data may challenge assumptions regarding typical factor usage and expenditures associated with EHL products in patients with hem-A and hem-B. Additional analyses with adjustment for treatment scheme and disease severity are needed. Table. Table. Disclosures Tortella: Pfizer Inc.: Employment. Chhabra:Pfizer Inc.: Employment. Alvir:Pfizer Inc.: Employment. Rubinstein:Pfizer Inc.: Employment. Young:Pfizer Ltd.: Employment. Fogarty:Pfizer Inc.: Employment.

scholarly journals Impact of chronic kidney disease and anemia on health-related quality of life and work productivity: Analysis of multinational real-world data

2020 ◽  
Author(s):  
Heleen van Haalen ◽  
James Jackson ◽  
Bruce Spinowitz ◽  
Gary Milligan ◽  
Rebecca Moon
Keyword(s):  
Quality Of Life ◽  
Kidney Disease ◽  
Real World ◽  
Work Productivity ◽  
Regression Analyses ◽  
Real World Data ◽  
Activity Impairment ◽  
Ckd Stage ◽  
The Impact

Abstract Background Reductions in health-related quality of life (HRQoL) in patients with chronic kidney disease (CKD) are thought to be exacerbated by the low hemoglobin (Hb) levels that define anemia, a common complication of CKD. The current analysis evaluated the impact of anemia on HRQoL and work productivity in patients with non-dialysis dependent and dialysis-dependent CKD using real-world data. Methods Data were collected in France, Germany, Italy, Spain, the UK, the USA and China in 2012–2018 in the Adelphi Real World Disease Specific Programme™ for CKD, a large, cross-sectional, survey of physicians and their patients. Patients completed three patient-reported outcomes (PRO) instruments: the EuroQol 5-Dimension 3-level (EQ-5D-3L), the Kidney Disease Quality of Life (KDQOL-36) instrument and the Work Productivity and Activity Impairment questionnaire. PROs were assessed by CKD stage and Hb levels, and regression analyses were performed with CKD stage and Hb level as independent variables and PROs as outcome variables, while adjusting for age, sex, CKD stage, comorbidities and cardiovascular risk. Results Overall, 5276 patients participated in the survey, including 28% stage 4 and 36% dialysis patients. Patients with lower Hb levels more often reported problems/issues on all EQ-5D-3L domains (p<0.0001). Regression analyses showed significant associations between lower Hb levels and the probability of low (<0.8) EQ-5D-3L utility scores (p<0.0001) and low visual analog scale scores (p<0.05), indicating poorer health status. Associations were seen even when adjusting for CKD stage and other potential confounding factors. Significant associations were observed between Hb level and the 12-Item Short-Form Health Survey (SF-12) Physical Component Summary, SF-12 Mental Component Summary and the three KDQOL-36 subscales (all p<0.0001), and were confirmed using linear regression analyses adjusting for CKD stage and other potential confounders. Numerically greater work productivity losses and greater activity impairment were observed with lower Hb levels. Conclusions Lower Hb levels worsen the impact of CKD on HRQoL, and are associated with lower work productivity in patients with CKD. Assessment and treatment of anemia should be recognized as a key component of integral CKD management throughout all stages of the disease.

scholarly journals Impact of chronic kidney disease and anemia on health-related quality of life and work productivity: Analysis of multinational real-world data

2020 ◽  
Author(s):  
Heleen van Haalen ◽  
James Jackson ◽  
Bruce Spinowitz ◽  
Gary Milligan ◽  
Rebecca Moon
Keyword(s):  
Quality Of Life ◽  
Kidney Disease ◽  
Real World ◽  
Work Productivity ◽  
Regression Analyses ◽  
Real World Data ◽  
Activity Impairment ◽  
Ckd Stage ◽  
The Impact

Abstract Background Reductions in health-related quality of life (HRQoL) in patients with chronic kidney disease (CKD) are thought to be exacerbated by the low hemoglobin (Hb) levels that define anemia, a common complication of CKD. The current analysis evaluated the impact of anemia on HRQoL and work productivity in patients with non-dialysis dependent and dialysis-dependent CKD using real-world data. Methods Data were collected in France, Germany, Italy, Spain, the UK, the USA and China in 2012–2018 in the Adelphi Real World Disease Specific Programme™ for CKD, a large, cross-sectional, survey of physicians and their patients. Patients completed three patient-reported outcomes (PRO) instruments: the EuroQol 5-Dimension 3-level (EQ-5D-3L), the Kidney Disease Quality of Life (KDQOL-36) instrument and the Work Productivity and Activity Impairment questionnaire. PROs were assessed by CKD stage and Hb levels, and regression analyses were performed with CKD stage and Hb level as independent variables and PROs as outcome variables, while adjusting for age, sex, CKD stage, comorbidities and cardiovascular risk. Results Overall, 5276 patients participated in the survey, including 28% stage 4 and 36% dialysis patients. Patients with lower Hb levels more often reported problems/issues on all EQ-5D-3L domains (p<0.0001). Regression analyses showed significant associations between lower Hb levels and the probability of low (<0.8) EQ-5D-3L utility scores (p<0.0001) and low visual analog scale scores (p<0.05), indicating poorer health status. Associations were seen even when adjusting for CKD stage and other potential confounding factors. Significant associations were observed between Hb level and the 12-Item Short-Form Health Survey (SF-12) Physical Component Summary, SF-12 Mental Component Summary and the three KDQOL-36 subscales (all p<0.0001), and were confirmed using linear regression analyses adjusting for CKD stage and other potential confounders. Numerically greater work productivity losses and greater activity impairment were observed with lower Hb levels. Conclusions Lower Hb levels worsen the impact of CKD on HRQoL, and are associated with lower work productivity in patients with CKD. Assessment and treatment of anemia should be recognized as a key component of integral CKD management throughout all stages of the disease.

Real-world treatment profile for patients with tuberous sclerosis complex related angiomyolipoma: A U.S. Healthcare Claims Database study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15096-e15096
Author(s):  
Peter Sun ◽  
Zhimei Liu ◽  
Michael Kohrman ◽  
John Bissler
Keyword(s):  
Tuberous Sclerosis ◽  
Surgical Procedures ◽  
Tuberous Sclerosis Complex ◽  
Real World ◽  
Repeated Measures ◽  
Claims Database ◽  
Real World Setting ◽  
Management Procedures ◽  
The Impact ◽  
Treatment Profile

e15096 Background: Angiomyolipoma (AML) is a common benign neoplasm associated with tuberous sclerosis complex (TSC). The objective of this study is to examine the treatment profile for patients with TSC related AML in a real world setting. Methods: A retrospective cohort study was performed using a large US commercial healthcare claims database. Patients with a TSC claim (ICD-9CM: 759.5X) and an AML claim (ICD-9CM: 223.0X) between 2000 and 2009 and with continuous 12-month health plan enrollment after their first AML claim were included into the study. The utilization rates of thirty two medication groups, eight procedure categories, five service places and fifteen provider types were assessed and ranked respectively for the year before first AML claim and the year after the first AML claim. Repeated measures analysis was used to compare these utilization rates between the last pre-AML year and the first post-AML year. Results: The study included 180 patients with a mean age of 28.2 years on their first AML claims, and 67.8% were females. During the first post-AML year, the top five medication groups were central nervous system medications (59.4%), anti-infective agents (50.6%), hormones & synthetic substance (22.8%), cardiovascular agents (18.9%), and autonomic drugs (17.8%); the most commonly used outpatient procedures were evaluation & management procedures (99.4%), anesthesia procedures (99.4%), surgical procedures (72.8%), radiology procedures (96.1%), and medicine procedures (100.0%). More patients consume the following care in the first post-AML year than in the last pre-AML year: anti-infective agents (50.6% vs. 35.0%, p<0.05), surgical procedures (72.8% vs. 60.6%, p<0.05), emergency rooms care (31.1% vs. 18.3%, p<0.05), urologists’ care (38.9% vs. 16.1%, p<0.05), nephrologists’ care (22.3% vs. 11.7%, p<0.05). Conclusions: In a real world setting and among TSC patients with AML, treatment profile changed after the first observed AML diagnosis. Further research is needed to examine the impact of these changes on economic and clinical outcomes of healthcare for patients with TSC related AML.

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