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Outcomes in End-Stage Renal Disease Patients on Hemodialysis Taking Patiromer for Hyperkalemia TH-PO779 Dinesh K

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Outcomes in End-Stage Renal Disease Patients on Hemodialysis Taking Patiromer for Hyperkalemia TH-PO779 Dinesh K Outcomes in End-Stage Renal Disease Patients on Hemodialysis Taking Patiromer for Hyperkalemia TH-PO779 Dinesh K. Chatoth, MD1, Peter M. Wahl, ScD2, Viatcheslav Rakov, MD3, Carly R. Van Zandt, MS4, Kathryn P. Anastassopoulos, MS2, Sam Colman, MSc2, Tyler Knight, MS2, Nina Oestreicher, PhD5, Ann Mooney, MSN4, David M. Spiegel, MD5, Matthew R. Weir, MD6 1Fresenius Medical Care North America, Waltham, MA, 2Covance Market Access Inc., Gaithersburg, MD, 3Vifor Pharma, Glattbrugg, Switzerland, 4Frenova Renal Research, Waltham, MA, 5Relypsa Inc., Redwood City, CA, 6University of Maryland Medical Center, Baltimore, MD INTRODUCTION AND AIMS METHODS (CONT’D) RESULTS (CONT’D) • Hyperkalemia (HK) is a life-threatening condition that is common in patients with • Patiromer treatment patterns were examined during the post-index period: Demographics and pre-index clinical characteristics (Table 1) Serum potassium pre- and post-index (Figure 3) end-stage renal disease (ESRD) and is associated with adverse clinical consequences. – Prescribed initiation dose – Dose titrations up and down • Mean age was 57.5 years. • Average sK was 5.8 mEq/L in the pre-index period. • Currently, there are a limited number of pharmaceutical products to treat and control HK. – Prescribed daily dose – Prescribed length of therapy • Over half were male (55.2%). • Overall, sK decreased 0.3 mEq/L by week 1 and remained decreased by • Sodium polystyrene sulfonate (SPS) was the only available potassium binder in the • Post-index sK were the last recorded values in the post-index time periods: • Majority (77.2%) of patients were white. 0.5 mEq/L at month 6. 2 United States (US) until the US Food and Drug Administration approved patiromer in – Week 1: 1-7 days (day 1 is index date) – Month 3: 60-90 days • Average body mass index was 27.4 kg/m . • Within the subgroups, sK decreased most among those with higher October 2015 for the treatment of HK.1 – Week 2: 8-14 days – Month 4: 91-121 days • Average time on dialysis was 4.9 years. pre-index sK: • The current version of the US Prescribing Information (November 2016)2 for patiromer – Week 3: 15-21 days Month 5: 122-152 days • The two most common causes of ESRD were type 2 diabetes (41.4%) and – – 5.5 mEq/L subgroup: no decrease reflects the most up-to-date pharmacovigilance information and supports the known – Week 4: 22-28 days – Month 6: 153-182 days hypertension (23.5%). – >5.5 mEq/L subgroup: 0.6 mEq/L by week 1 safety profile of patiromer. – Month 2: 29-59 days • Use of SPS in daily practice is limited due to poor tolerability and reported serious • Analyses were conducted for all patients and the following pre-index sK subgroups: Table 1. Demographics and Pre-index Clinical Characteristics – >6.5 mEq/L subgroup: 1.3 mEq/L by week 1 gastrointestinal events.3-7 – sK 5.5 mEq/L Demographic/Clinical Characteristic N=268 Figure 3. Mean Serum Potassium (mEq/L) Before and After Patiromer 8,9 • Clinical trials have demonstrated the efficacy of patiromer, but little has been reported – sK >5.5 mEq/L Age (years), mean (SD) 57.5 (13.1) Initiation about patiromer in the dialysis setting in clinical practice since it became commercially – sK >6.5 mEq/L (subset of >5.5 mEq/L) Male, n (%) 148 (55.2) available in the US. 7.5 Race, n (%) • Previously, we reported data describing the real-world patient characteristics and White 207 (77.2) Overall ≤5.5 mEq/L >5.5 mEq/L >6.5 mEq/L management of patiromer for the treatment of HK in patients undergoing hemodialysis RESULTS 7.0 (HD) for ESRD in a large US ESRD provider network.10 Results showed that compared Patient population Black 36 (13.4) with a 3-month pre-index period, the occurrence and frequency of potassium baths (1K) Other 25 (9.4) • Among 317 patiromer initiators at FKC centers, 268 (84.5%) met the selection criteria 6.5 decreased in the 3 months after initiating patiromer for hyperkalemia treatment. (Figure 1). Body mass index (kg/m2), mean (SD) 27.4 (6.4) • The aim of the current analysis study is to describe serum K+ outcomes over 6 months Time on dialysis (years), mean (SD) 4.9 (3.6) after patiromer initiation in the same population. Figure 1. Selection of Patient Population ESRD cause, n (%), top 5 6.0 Type 2 diabetes mellitus 111 (41.4) METHODS Hypertension 63 (23.5) 5.5 Initiated patiromer (first recorded prescription) Nephritis 18 (6.7) between October 1, 2015 and July 31, 2016 Study design Type 1 diabetes mellitus 17 (6.3) (n=317) • Retrospective, descriptive cohort study of patients undergoing dialysis at Fresenius Polycystic kidney disease 16 (6.0) 5.0 Kidney Care (FKC) centers using data from July 1, 2015, through October 31, 2016. ESRD, end-stage renal disease; SD, standard deviation. • Patients were included in the study who met the following criteria: 4.5 – Initiated patiromer (first recorded prescription) between October 2015 and July 2016. Prescribed permanent, in-center HD at FKC prior to patiromer initiation Patiromer treatment patterns (Figure 2) Pre- 1 2 3 4 Month 2 Month 3 Month 4 Month 5 Month 6 (n=279) • The majority (69.4%) of patients initiated patiromer therapy on 8.4 g/day. – Prescribed permanent, in-center HD at FKC prior to patiromer initiation. index – Prescribed HD 3 times per week. • Another 23.5% of patients initiated patiromer therapy on <8.4 g/day, resulting in a Week Month – 18 years of age. prescribed initiation average daily dose of 7.7 g/day. Prescribed HD 3 times per week • Few patients were titrated up (10.4%) or down (4.1%). – 1 serum potassium (sK) lab value recorded in the 91 days prior to patiromer (n=275) initiation. • Average daily dose during the post-index period was 8.0 g/day. LIMITATIONS – No report of never filling patiromer prescription. • 156 patients (58.2%) had at least 182 days of continuous patiromer therapy. • This is a retrospective observational study that was designed to be purely descriptive. Age 18 • Analyses did not adjust for pre-index patient or clinical characteristics. Definitions (n=274) Figure 2. Patiromer Prescribed Initiation Dose • Index event: First recorded patiromer prescription at an FKC dialysis center. • Index date: The start date on the first recorded patiromer prescription. 8.4 g once a day 69.4% CONCLUSIONS • Pre-index period: Up to the 91 days prior to the index date. 1 sK lab value recorded in the 91 days prior to patiromer initiation 8.4 g four times a week 13.4% • These results from observational data on patiromer in FKC dialysis centers in the US • Post-index period: The period of continuous patiromer therapy including and following (n=272) 8.4 g three times a week 5.2% suggest that hyperkalemia management with patiromer lowers serum potassium in the index date, where continuous therapy ends at the earliest of the following: stop date ESRD patients undergoing hemodialysis. of last patiromer prescription, death date, FKC discharge date, or 182 days after index 8.4 g two times a week 2.6% date. If there is a gap between a patiromer prescription stop date and a following No report of never filling patiromer prescription • The predominant use of the recommended starting dose of 8.4 g/day as maintenance patiromer prescription start date, continuous therapy will end with the prior patiromer (n=268) 16.8 g once a day 2.6% in this population supports the further study of this dose for long-term serum potassium prescription stop date. 8.4 g every other day 0.7% control. Analysis 8.4 g missing frequency 2.2% References Pre-index sK 5.5 mEq/L Pre-index sK >5.5 mEq/L 1. US Department of Health and Human Services. US Food and Drug Administration. • Patient demographics and clinical characteristics were examined during the (n=89) (n=179) 8.4 g once a week 1.1% http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468546.htm. Updated October 22, 2015. pre-index period. Accessed October 13, 2017. 2. Relypsa Inc. (2016). Retrieved from 16.8 g four times a week • sK was examined during the pre-index and post-index periods. 0.7% https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf. Accessed October 13, 2017. 3. Palmer BF. N Engl J Med. 2004;351(6):585-592. 4. Harel Z, et al. Am J Med. 2013;126(3):264.e9-264.e24. 4.2 g once a day 0.4% • Pre-index sK was defined as the measurement taken on the date during the pre-index FKC, Fresenius Kidney Care; HD, hemodialysis; Pre-index sK >6.5 mEq/L 5. Nguyen T, et al. JAAPA. 2015;28(3):41-45. 6. Hagan AE, et al. Clin Nephrol. 2016;85(1):38-43. 7. Montaperto AG, et period nearest to and before the date of patiromer initiation, which may not have been (n=39) al. Curr Med Res Opin. 2016;32(1):155-164. 8. Bakris GL, et al; AMETHYST-DN Investigators. JAMA. 2015;314(2):151- sK, serum potassium. 8.4 g twice a day 0.4% the sK measurement that triggered the prescription for patiromer. 161. 9. Weir MR, et al; OPAL-HK Investigators. N Engl J Med. 2015;372(3):211-221. 10. Chatoth DK et al, presented at the 54th ERA–EDTA Congress, 3–6 June, 2017, Madrid, Spain. Presented at the American Society of Nephrology, Kidney Week 2017, November 2-5, 2017, New Orleans, LA. Supported by Relypsa, Inc., a Vifor Pharma Group Company.
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