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Table 2 Predictors of discontinuation and reinitiation

From: Dynamics of cinacalcet use and biochemical control in hemodialysis patients: a retrospective New-user cohort design

Characteristica

Discontinuation (HR, 95 % CI)

Reinitiation (HR, 95 % CI)

Number of time intervals for analysis, N (%)

100,706 (90.7 %)

78,789 (96.0 %)

Demographics

 Age, years, reference 46-55

  

  ≤45

0.92 (0.85, 1.00)

0.95 (0.90, 1.02)

  56-65

1.05 (0.97, 1.13)

0.98 (0.92, 1.04)

  66-75

1.05 (0.97, 1.15)

0.90 (0.85, 0.97)

  ≥75

0.98 (0.88, 1.09)

0.95 (0.87, 1.04)

 Time on dialysis, years, reference <1

  

  1-3

1.15 (1.01, 1.30)

1.00 (0.91, 1.11)

  ≥4

1.14 (1.00, 1.30)

1.03 (0.92, 1.14)

 Female

1.07 (1.01, 1.13)

1.00 (0.96, 1.05)

 African American

1.04 (0.98, 1.10)

1.08 (1.03, 1.13)

 Cause of ESRD, reference diabetes mellitus

  

  Hypertension

1.02 (0.94, 1.10)

1.04 (0.98, 1.11)

  Glomerulonephritis

1.01 (0.90, 1.12)

1.08 (0.99, 1.17)

  Other

0.96 (0.87, 1.06)

1.03 (0.95, 1.12)

 Body mass index, kg/m2, reference normal

  

  Underweight

1.07 (0.93, 1.23)

0.98 (0.87, 1.10)

  Overweight

1.03 (0.96, 1.10)

1.03 (0.98, 1.09)

  Obese

0.98 (0.91, 1.04)

1.11 (1.05, 1.17)

Financial considerations

 Medicaid

1.03 (0.96, 1.11)

0.96 (0.91, 1.02)

 Low-income subsidy

0.76 (0.68, 0.85)

1.32 (1.22, 1.43)

 Concomitant medications in baseline periodb

0.98 (0.97, 0.99)

1.00 (0.99, 1.01)

 Concomitant medications in follow-up periodb

0.96 (0.95, 0.97)

0.98 (0.97, 0.99)

 Copay in follow-up periodc

1.04 (1.01, 1.06)

1.04 (1.02, 1.06)

 Last benefit phase in follow-up, reference: coveredd

  

  Entering the gap period

1.19 (1.00, 1.41)

1.01 (0.85, 1.21)

  Exiting or going through gap period

0.98 (0.77, 1.23)

1.03 (0.81, 1.32)

  In the gap period

1.10 (1.04, 1.16)

1.01 (0.96, 1.06)

Biochemical values

 Albumin in baseline period, reference: <3.3 g/dL

  

  3.3-3.9 g/dL

1.11 (0.97, 1.28)

1.13 (1.00, 1.27)

  >3.9 g/dL

1.05 (0.91, 1.21)

1.09 (0.96, 1.23)

 Albumin in follow-up period, reference: <3.3 g/dL

  

  3.3-3.9 g/dL

0.85 (0.76, 0.95)

1.13 (1.02, 1.25)

  >3.9 g/dL

0.78 (0.69, 0.88)

1.23 (1.10, 1.36)

 Phosphorus in baseline period, mg/dL

1.02 (1.00, 1.04)

0.98 (0.96, 0.99)

 Phosphorus in follow-up period, mg/dL

1.02 (1.00, 1.04)

0.99 (0.98, 1.01)

 Parathyroid hormone in baseline period, pg/mLe

1.00 (0.99, 1.01)

1.00 (0.99, 1.00)

 Parathyroid hormone in follow-up period, reference: >600 pg/mL

  

  <150 pg/mL

1.24 (1.12, 1.37)

0.70 (0.64, 0.76)

  150-300 pg/mL

0.91 (0.83, 0.99)

0.71 (0.66, 0.75)

  301-600 pg/mL

0.89 (0.82, 0.97)

0.85 (0.80, 0.90)

 Parathyroid hormone in follow-up period, change in quintiles, reference: no changef

  

  Increase

1.15 (1.07, 1.23)

1.08 (1.03, 1.14)

  Decrease

0.90 (0.84, 0.97)

1.12 (1.06, 1.19)

 Calcium in baseline period, mg/dL

0.95 (0.91, 0.99)

1.16 (1.12, 1.20)

 Calcium in follow-up period, reference: >8.7 mg/dLg

  

  <7.5 mg/dL

1.07 (0.89, 1.29)

1.12 (0.91, 1.39)

  7.5-8.7 mg/dL

0.85 (0.80, 0.91)

1.26 (1.19, 1.33)

 Calcium in follow-up period, change in quintiles, reference: no changef

  

  Increase

1.24 (1.16, 1.32)

1.07 (1.02, 1.13)

  Decrease

0.94 (0.88, 1.00)

1.04 (0.99, 1.10)

Comorbidities

 Congestive heart failure in baseline period

1.06 (0.99, 1.13)

0.96 (0.91, 1.01)

 Congestive heart failure in follow-up period

1.01 (0.90, 1.14)

1.11 (0.94, 1.31)

 Coronary artery disease/atherosclerosis in baseline period

1.01 (0.95, 1.09)

0.93 (0.88, 0.99)

 Cerebrovascular disease in baseline period

0.94 (0.86, 1.02)

1.00 (0.93, 1.07)

 Stroke in follow-up period

1.30 (1.05, 1.60)

0.82 (0.55, 1.20)

 Hypertension in baseline period

1.12 (1.05, 1.19)

1.03 (0.98, 1.08)

 Peripheral vascular disease in baseline period

1.02 (0.94, 1.11)

1.11 (1.03, 1.19)

 Peripheral vascular disease in follow-up period

0.99 (0.85, 1.16)

0.91 (0.76, 1.09)

 Hyperlipidemia in baseline period

1.01 (0.95, 1.07)

1.06 (1.01, 1.12)

 Chronic obstructive pulmonary disease and asthma in baseline period

1.00 (0.93, 1.08)

1.00 (0.94, 1.06)

 Diabetes in baseline period

1.05 (0.98, 1.14)

0.98 (0.92, 1.04)

 Nausea, vomiting, diarrhea in follow-up period

1.09 (0.91, 1.32)

1.05 (0.85, 1.31)

 Seizure in follow-up period

1.18 (0.93, 1.49)

1.11 (0.82, 1.50)

Dialysis care

 Intravenous vitamin D in baseline periodh

1.01 (0.98, 1.05)

0.98 (0.96, 1.00)

 Intravenous vitamin D in follow-up periodh

0.94 (0.91, 0.97)

1.02 (0.99, 1.04)

 Phosphorus binder drug in baseline periodi

1.02 (0.95, 1.10)

1.12 (1.06, 1.18)

 Phosphorus binder drug in follow-up periodi

0.77 (0.73, 0.82)

1.03 (0.98, 1.08)

 Catheter access in baseline period

0.97 (0.89, 1.07)

1.07 (0.99, 1.15)

 Catheter access in follow-up period

1.10 (1.00, 1.21)

0.83 (0.77, 0.90)

 Most recent dose of cinacalcet, reference: 30 mg

  

  60 mg

1.07 (1.00, 1.15)

n/a

  90 mg

1.15 (1.03, 1.29)

n/a

 Days in the hospital in follow-up period, reference: 0 days

  

  1-4 days

2.02 (1.84, 2.22)

0.85 (0.75, 0.96)

  ≥5 days

1.90 (1.73, 2.08)

0.79 (0.69, 0.89)

  1. Note: Conversion factors for units: Calcium in mg/dL to mmol/L, x0.2495; phosphorus in mg/dL to mmol/L, x0.3229
  2. aBaseline characteristics were identified using information from Medicare Part A or B claims. A characteristic was considered present if at least one inpatient, home health, or skilled nursing facility claim, or at least two outpatient or physician/supplier claims separated by at least 7 days, were identified during the 6-month baseline period. Additional information concerning baseline characteristics can be found in Additional file 1: Table S4. Time-varying (follow-up) characteristics were evaluated at 30-day intervals following the start of follow-up. Additional information concerning time-varying (follow-up) characteristics can be found in Additional file 1: Table S2
  3. bConcomitant medications are the number of concomitant medications at the time of cinacalcet discontinuation or reinitiation
  4. cChanges in co-pay were based on increments of $100. The last co-pay prior to discontinuation was used to predict cinacalcet reinitiation
  5. dBenefit phase reflects the status of Medicare Part D coverage at the time of the fill of cinacalcet
  6. eChanges in parathyroid hormone level were based on increments of 100 pg/mL
  7. fDistributions of parathyroid hormone and calcium were examined across all of follow-up and quintiles were based on these distributions. Increase indicates an increase to another quintile and trend of increasing laboratory levels. Decrease indicates a decrease to another quintile and a trend of decreasing laboratory levels
  8. gResults presented for prediction of reinitiation associated with follow-up calcium levels are those from the sensitivity analysis utilizing a lag time of 14 days. The calcium level recorded 14 days prior to the date of the laboratory value most proximal to discontinuation was used to predict reinitiation. All other results were not significantly changed when lag times were considered
  9. hMean intravenous vitamin D dose was assessed in the last month of the baseline period. Changes in intravenous vitamin D dose were based in increments of 10mcg. Paricalcitol and doxercalciferol doses were converted to calcitriol-equivalent doses according to the following conversion ratios: 4.6: 1 for paricalcitol: calcitriol and 3.1: 1 for doxercalciferol: calcitriol
  10. iPhosphate binders included in the analysis: Sevelamer hydrochloride, sevelamer carbonate, lanthanum carbonate, and calcium acetate