esrd post-hospitalization anemia and esa utilization

1
(Szczech et al. 2008 KI 74:791). In 2011, implementation of CMS ESRD bundled payment and FDA-mandated ESA label changes that target lower hemoglobin (Hb) created further downward pressure on ESA doses. Long- term safety of intravenous (IV) iron is poorly understood. This study evaluated temporal changes in the ratio of IV iron-to-epoetin use across patients (N¼200,170) from a large dialysis organization from 2008 through 2011. Mean IV iron use was normalized to mg/month. Mean epoetin was normalized to U/month. The IV iron-to-epoetin ratio was calculated by taking the mean IV iron value relative to mean epoetin (per 1000U/month) for Q1 2008 – Q4 2011. Although mean epoetin utilization has fallen since start of Q3 2010, mean IV iron utilization has remained fairly stable. From Q1 2008 to Q3 2010, the ratio of IV iron-to-epoetin was constant (2.5 mg/month for every 1000 U per month), but has risen 46% from Q3 2010 to Q4 2011, while hemoglobin levels have fallen 0.9 g/dL (11.5 to 10.6 g/dL). While ESA doses decreased, iron doses remained constant, resulting in a shift toward a higher ratio of iron-to-ESA use from Q3 2010 through Q4 2011. Further analyses are warranted to understand the appropriate balance between iron and ESA use with regards to efficacy and safety http://dx.doi.org/10.1016/j.krcp.2012.04.628 305 ESRD POST-HOSPITALIZATION ANEMIA AND ESA UTILIZATION Alex Yang 1 , Will Harrison 2 , Ali Hariri 3 1 Affymax, Inc., Palo Alto, CA 2 ZS Associates, San Francisco, CA 3 Takeda, Deerfield, IL On average ESRD patients are hospitalized twice yearly for 12 days a year (USRDS 2011 Ann. Report). Hb levels decline immediately post- hospitalization, requiring extended periods for recovery and elevated ESA dosing for 41 year (Solid et al. Hemodial Int. 2007). We evaluated post- hospitalization anemia trends and ESA use in ESRD. Data from an LDO (N ¼273,877 pts; Q1 2008–Q1 2011) were evaluated for post-hosp Hb change (difference, pre- and post-hosp Hb measurement), time to Hb recovery (time from discharge to when Hb levels Z pre-hosp level), time to ESA recovery (time from discharge until 3 consecutive non- zero epoetin doses r pre-hosp dose) and incremental ESA (sum of all differences from last pre-hosp dose until ESA recovery, 6 months if no recovery, or end of follow-up for long-term follow-up population). 62% of all hospitalizations were associated with declining Hb (mean, - 1.29 g/dL; Figure); 54% of these never returned to pre-hosp levels. Among hospitalizations that experienced a Hb drop and eventually recovered Hb (mean recovery time, 42 days), 73% used a mean 56K U of incremental epoetin until recovery; dose was recovered within 68 days on average. For the remaining 27% who never returned to pre-hosp ESA dose, an additional 266K U of epoetin were utilized. The majority of hospitalizations ( 2/3) had considerable post-hosp Hb drops (mean 41 g/dL), with 450% permanently reduced. 1.5 months were needed to recover Hb, with elevated ESA doses for 42 months. ESA dose was permanently elevated in 27% of hospitalizations that recovered Hb. Strategies to address post-hosp anemia may mitigate the protracted recovery time and increased ESA use. http://dx.doi.org/10.1016/j.krcp.2012.04.629 306 ESTIMATION OF PEGINESATIDE UTILIZATION REQUIRES PATIENT-LEVEL DATA Alex Yang 1 , Will Harrison 2 1 Affymax, Inc., Palo Alto, CA 2 ZS Associates, San Francisco, CA Post hoc analysis of two Phase 3 pivotal trials (EMERALD 1,2) of peginesatide vs epoetin for anemia due to chronic kidney disease in hemodialysis patients on stable epoetin showed that for increasing doses of baseline epoetin, relatively less peginesatide was needed to achieve similar Hb levels (Fishbane et al, ASN 2011). Estimation of peginesatide should therefore be dictated by underlying epoetin dose distribution rather than total volume or mean epoetin dose in a population. This analysis compared estimated peginesatide utilization for facilities using comparable levels of epoetin. Eight facilities from a large dialysis organization whose epoetin utilization was within 71% of median utilization across all facilities from Q4 2011 were compared. The label-specified dose conversion table was used to convert weekly epoetin dose (defined using all pt-months with Z1 dose) to monthly peginesatide dose for each facility Comparison of total epoetin use (Q4 2011) from the 8 facilities showed relative differences of o2% (range, 6.4-6.5M U). Facility utilization of post- conversion peginesatide was estimated to range from 668-901 mg, representing relative differences of up to 35% (Figure) In contrast, calculations based on mean epoetin doses resulted in 41- 184% overestimation of peginesatide use. Due to the nonlinear dose relationship between peginesatide and epoetin, facilities with similar epoetin use ( o2% relative difference) had up to 35% difference in estimate of peginesatide use. For accurate estimation of peginesatide utilization, it is important to base conversions on epoetin dose distribution rather than mean epoetin dose. http://dx.doi.org/10.1016/j.krcp.2012.04.630 307 EARLY AND LONG TERM BODY COMPOSITION EVOLUTION POST KIDNEY TRANSPLANTATION INFLUENCED BY THE PRE TRANSPLANT NUTRITIONAL CHARACTERISTICS: RESULTS OF THE CORPOS STUDY Karine Moreau, Aurelie Desseix, Thomas Bachelet, Lionel Couzi, Hel ene Savel, Rodolphe Thiebaut, Philippe Chauveau Renal Transplant Unit and USMR, Pellegrin Hospital, Bordeaux, France Many previous studies of renal transplant recipients have demonstrated that weight gain post kidney transplantation (KT) is frequent and may predispose to co morbidity. The aim of this prospective study was to evaluate changes in body composition (BC) during the first two years post KT and to determine predictors of these changes, with a special focus on pre KT parameters. When listed for a KT, 41 patients (14 women - 27 men) were included between 2007 and 2008 in a longitudinal study of evaluation of BC. Fat Free Kidney Res Clin Pract 31 (2012) A16–A96 A94

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Page 1: ESRD POST-HOSPITALIZATION ANEMIA AND ESA UTILIZATION

Kidney Res Clin Pract 31 (2012) A16–A96A94

(Szczech et al. 2008 KI 74:791). In 2011, implementation of CMS ESRDbundled payment and FDA-mandated ESA label changes that target lowerhemoglobin (Hb) created further downward pressure on ESA doses. Long-term safety of intravenous (IV) iron is poorly understood. This studyevaluated temporal changes in the ratio of IV iron-to-epoetin use acrosspatients (N¼200,170) from a large dialysis organization from 2008through 2011.

Mean IV iron use was normalized to mg/month. Mean epoetin wasnormalized to U/month. The IV iron-to-epoetin ratio was calculated bytaking the mean IV iron value relative to mean epoetin (per 1000U/month)for Q1 2008 – Q4 2011.

Although mean epoetin utilization has fallen since start of Q3 2010,mean IV iron utilization has remained fairly stable. From Q1 2008 to Q32010, the ratio of IV iron-to-epoetin was constant (2.5 mg/month for every1000 U per month), but has risen 46% from Q3 2010 to Q4 2011, whilehemoglobin levels have fallen 0.9 g/dL (11.5 to 10.6 g/dL).

While ESA doses decreased, iron doses remained constant, resulting in ashift toward a higher ratio of iron-to-ESA use from Q3 2010 through Q42011. Further analyses are warranted to understand the appropriatebalance between iron and ESA use with regards to efficacy and safety

http://dx.doi.org/10.1016/j.krcp.2012.04.628

305ESRD POST-HOSPITALIZATION ANEMIA AND ESA UTILIZATIONAlex Yang 1, Will Harrison 2, Ali Hariri 3

1

Affymax, Inc., Palo Alto, CA2

ZS Associates, San Francisco, CA3

Takeda, Deerfield, ILOn average ESRD patients are hospitalized twice yearly for 12 days a year

(USRDS 2011 Ann. Report). Hb levels decline immediately post-hospitalization, requiring extended periods for recovery and elevated ESAdosing for 41 year (Solid et al. Hemodial Int. 2007). We evaluated post-hospitalization anemia trends and ESA use in ESRD.

Data from an LDO (N¼273,877 pts; Q1 2008–Q1 2011) were evaluatedfor post-hosp Hb change (difference, pre- and post-hosp Hb measurement),time to Hb recovery (time from discharge to when Hb levels Z pre-hosplevel), time to ESA recovery (time from discharge until 3 consecutive non-zero epoetin doses r pre-hosp dose) and incremental ESA (sum of alldifferences from last pre-hosp dose until ESA recovery, 6 months if norecovery, or end of follow-up for long-term follow-up population).

62% of all hospitalizations were associated with declining Hb (mean, -1.29 g/dL; Figure); 54% of these never returned to pre-hosp levels. Amonghospitalizations that experienced a Hb drop and eventually recovered Hb(mean recovery time, 42 days), 73% used a mean 56K U of incrementalepoetin until recovery; dose was recovered within 68 days on average. Forthe remaining 27% who never returned to pre-hosp ESA dose, an additional266K U of epoetin were utilized.

The majority of hospitalizations (�2/3) had considerable post-hosp Hbdrops (mean 41 g/dL), with 450% permanently reduced. �1.5 monthswere needed to recover Hb, with elevated ESA doses for 42 months. ESAdose was permanently elevated in 27% of hospitalizations that recoveredHb. Strategies to address post-hosp anemia may mitigate the protracted

recovery time and increased ESA use.

http://dx.doi.org/10.1016/j.krcp.2012.04.629

306ESTIMATION OF PEGINESATIDE UTILIZATION REQUIRESPATIENT-LEVEL DATAAlex Yang 1, Will Harrison 2

1

Affymax, Inc., Palo Alto, CA2

ZS Associates, San Francisco, CAPost hoc analysis of two Phase 3 pivotal trials (EMERALD 1,2) of

peginesatide vs epoetin for anemia due to chronic kidney disease inhemodialysis patients on stable epoetin showed that for increasing doses ofbaseline epoetin, relatively less peginesatide was needed to achieve similarHb levels (Fishbane et al, ASN 2011). Estimation of peginesatide shouldtherefore be dictated by underlying epoetin dose distribution rather thantotal volume or mean epoetin dose in a population. This analysis comparedestimated peginesatide utilization for facilities using comparable levels ofepoetin.

Eight facilities from a large dialysis organization whose epoetinutilization was within 71% of median utilization across all facilities fromQ4 2011 were compared. The label-specified dose conversion table wasused to convert weekly epoetin dose (defined using all pt-months with Z1dose) to monthly peginesatide dose for each facility

Comparison of total epoetin use (Q4 2011) from the 8 facilities showedrelative differences of o2% (range, 6.4-6.5M U). Facility utilization of post-conversion peginesatide was estimated to range from 668-901 mg,representing relative differences of up to 35% (Figure)

In contrast, calculations based on mean epoetin doses resulted in 41-184% overestimation of peginesatide use.

Due to the nonlinear dose relationship between peginesatide andepoetin, facilities with similar epoetin use (o2% relative difference) had upto 35% difference in estimate of peginesatide use. For accurate estimationof peginesatide utilization, it is important to base conversions on epoetindose distribution rather than mean epoetin dose.

http://dx.doi.org/10.1016/j.krcp.2012.04.630

307EARLY AND LONG TERM BODY COMPOSITION EVOLUTION POST KIDNEYTRANSPLANTATION INFLUENCED BY THE PRE TRANSPLANTNUTRITIONAL CHARACTERISTICS: RESULTS OF THE CORPOS STUDYKarine Moreau, Aurelie Desseix, Thomas Bachelet, Lionel Couzi,Hel�ene Savel, Rodolphe Thiebaut, Philippe ChauveauRenal Transplant Unit and USMR, Pellegrin Hospital, Bordeaux, France

Many previous studies of renal transplant recipients have demonstratedthat weight gain post kidney transplantation (KT) is frequent and maypredispose to co morbidity. The aim of this prospective study was toevaluate changes in body composition (BC) during the first two years postKT and to determine predictors of these changes, with a special focus onpre KT parameters.

When listed for a KT, 41 patients (14 women - 27 men) were includedbetween 2007 and 2008 in a longitudinal study of evaluation of BC. Fat Free