consequences of high hematocrit maintenance among hemodialysis patients

1
CONSEQUENCES OF HIGH HEMATOCRIT MAINTENANCE AMONG mMOD:ALYSIS PATIENTS. Ya-Chen Tina Sbih, m L,&& UNC School of Pharmacy, Chapel Hill, NC. EPO was approved for the treatment of anemia in-renal dialysis patients in 1989. In 1991, Medicare changed the way it reimbursed for EPO, and, in response, there was an increase in average EPO dosages from2793 units to 3200 units in the six month period following the policy change (POW et al, 1993). The change in policy, while meant to improve apparently low BP0 dosing, may have had the unintended consequence of maintaining some patients at unnecessarily high hamatocrit levels. ‘These patients may experience probtems associated with relativefv hi& bematocrits. Thus, while some patients may have received too Ike EPO prior to the policy change, now they may be receiving too much. Another recent change in EPO reimbursement policy indicates this may be the case. After July 1, 1997 Medicare will reimburse EPO based on a g&day rolling average henatocrit measurement. If the average is above 36,5%, Medicare will not pay for the EPO. This policy implicitly assumes &at high hematocrit levels are dkecectiy related to ioapprop~atety high doses of EPO. This study uses data from the United States Renal Data System (USRDS) to examine the incidence of complications resulting from abno~afly high hemat~dts, such as vascular shunt thrombosis (VST), among patients with End-Stage Renal Disease (ESRD). WC use logistic regression tomodel the incidence ofadverse events as a function of hemat&rit level while controlling for confounding factors such as age, gender, ethnic@, weight, comorbidities, facility characteristics, dialysis modality, and dialysis history. Preliminary results suggest that the incidence of VST has increased since 1991. This study will provide Medicare with information concerning the appropriateness of the 36.5% cutoff and the projected impact ofthe change in reimbursement. CONPARISON OF QUALITY OF LIFE (QoL} MEASURES AND BIOCHEMICAL MARKERS WITH MORTALITY IN CHRONIC DIALYSIS (CD) PATIENTS (PTS). Susan Smith, Betty McMahon, Mable Barringer, Beverly Washington, Connie Voll, Alfred Kraus, Sergio Acchiardo, Linda Moore. UT Medical Group Dialysis Center, Memphis, TN. Biochemical markers alone have been traditional predictors of mortality. We evaluated QoL in 125 CD pts using the Rand KDQOLTM instrument. The tool was self-administered. One year later, responses of survivors (Su) (n= 104) were compared to those of non-survivors (NSu) (n=Zl) to determine if there was any correlation between mortality and perceived QoL or mortality and bi~hemicai markers. Pts were receiving CAPD (n= 41), home hemodialysis (n=lZ), and incenter hemodialysis (ICI-I) (n=72). There were 70 males, 109 were black. Mean age was 47 rt: 1 yr (mean + SEM) and etiology of renal disease was 49% HTN and 19% diabetes. Length of time on CD was 60 F 5 mo. KtN was 1.17 t 0.03 (ICH) and 1.74 zlz0.08 (CAPD), nPCR was 1.03 f 0.03 gm pm/kg/day (al pts), Average days to death after completing questionnaire was 246 +_ 26. Comparing responses of Su to NSu indicated that Su had more positive responses to questions relating to Social Function (67 + 3 vs. 5 1 & 6, p=O.O26), Physical Function (57 ir 3 vs. 34 ?; 4, p=O.O53), Energy and Fatigue (49 f 2 vs. 41 ?r 4, p=O.O7), and Burden of kidney disease (55 2 3 vs. 43 2 6, p=O.O9). Responses are coded on a O-100 scale with 100 as the most positive response. Of biochemical parameters compared (BUN, Cr, Chol, Alb, Bet, Kfl, nPCR), only Chol (182 _+ 6 vs. 137 + 20, p=O.O3) and Alb (3.8 + 0.05 vs. 3.5 f 0.14, p=O.O9) were different with Su having higher values. Specific QoL interventions could be designed to influence a better outcome. Furthermore, we conclude that the KDQOLTM is a good qualitative measure of how the patient is feeling and shouId be implemented along with biochemical markers to assist identi~cation of pts at risk for mortality. 'TS 231 EFFECT OF MEGESTROL ACETATE ON THE NUTRITIONAL STATUS OF ~ALNOU~ISH~D HEMODIALYSIS PATIENTS Jeffrey L..William$ Mark Perius, Angela Humble, Diana Sigler, Aris Urbanes, and Howard S.Shapiro, Providence Hospital, Southfield, MI and Michigan Kidney Centers-Total Renal Care, Pontiac, MI Megestrol acetate in high doses has been used to increase appetite in patients with various malignancies and in patients with AIDS. It has been used effectively in these settings in doses of 160 mg./day, and with greater efficacy using doses of 800 to 1600 mg/day. Low serum albumin is the most important determinant of mortality in dialysis patients. Megestrol is excreted by the kidney and is not removed by hemodialysis. ft was therefore tested in a group of hemodialysis patients with poor appetite and hypoalbuminemia (~4.0 gm./dl.). Patients were treated with three ~eatments~eekiy using polysulfone dialyzers, with a KTiV which averaged 1.56. A double-blinded crossover study was carried out in 24 dialysis patients; 3 months using megestrol 160 mg./d and 3 months using placebo. Patients were monitored with monthly blood studies and with bioalectrical impedance studies for the determination of lean body mass. Four patients withdraw for adverse effects (principally diarrhea).Two died during the study from their underiying medical problems. in the 18 patients completing the study, this dose of megestroi did not significantly increase either the serum albumin or the fat-free body mass. Of note is the cost of megestroi. &I its least expensive (liquid) form, the cost per patient is estimated at $69/mon~ using a dose of 160 mg./d., and 5287/month at a dose of 600 mg.lday. We conclude that in the malnourished chronic dialysis population, low-dose megestrol therapy is ineffective in impro~ng nut~tional status.

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Page 1: Consequences of high hematocrit maintenance among hemodialysis patients

CONSEQUENCES OF HIGH HEMATOCRIT MAINTENANCE AMONG mMOD:ALYSIS PATIENTS. Ya-Chen Tina Sbih, m L,&& UNC School of Pharmacy, Chapel Hill, NC.

EPO was approved for the treatment of anemia in-renal dialysis patients in 1989. In 1991, Medicare changed the way it reimbursed for EPO, and, in response, there was an increase in average EPO dosages from 2793 units to 3200 units in the six month period following the policy change (POW et al, 1993).

The change in policy, while meant to improve apparently low BP0 dosing, may have had the unintended consequence of maintaining some patients at unnecessarily high hamatocrit levels. ‘These patients may experience probtems associated with relativefv hi& bematocrits. Thus, while some patients may have received too Ike EPO prior to the policy change, now they may be receiving too much. Another recent change in EPO reimbursement policy indicates this may be the case. After July 1, 1997 Medicare will reimburse EPO based on a g&day rolling average henatocrit measurement. If the average is above 36,5%, Medicare will not pay for the EPO. This policy implicitly assumes &at high hematocrit levels are dkecectiy related to ioapprop~atety high doses of EPO.

This study uses data from the United States Renal Data System (USRDS) to examine the incidence of complications resulting from abno~afly high hemat~dts, such as vascular shunt thrombosis (VST), among patients with End-Stage Renal Disease (ESRD). WC use logistic regression tomodel the incidence ofadverse events as a function of hemat&rit level while controlling for confounding factors such as age, gender, ethnic@, weight, comorbidities, facility characteristics, dialysis modality, and dialysis history.

Preliminary results suggest that the incidence of VST has increased since 1991. This study will provide Medicare with information concerning the appropriateness of the 36.5% cutoff and the projected impact ofthe change in reimbursement.

CONPARISON OF QUALITY OF LIFE (QoL} MEASURES AND BIOCHEMICAL MARKERS WITH MORTALITY IN CHRONIC DIALYSIS (CD) PATIENTS (PTS). Susan Smith, Betty McMahon, Mable Barringer, Beverly Washington, Connie Voll, Alfred Kraus, Sergio Acchiardo, Linda Moore. UT Medical Group Dialysis Center, Memphis, TN.

Biochemical markers alone have been traditional predictors of mortality. We evaluated QoL in 125 CD pts using the Rand KDQOLTM instrument. The tool was self-administered. One year later, responses of survivors (Su) (n= 104) were compared to those of non-survivors (NSu) (n=Zl) to determine if there was any correlation between mortality and perceived QoL or mortality and bi~hemicai markers.

Pts were receiving CAPD (n= 41), home hemodialysis (n=lZ), and incenter hemodialysis (ICI-I) (n=72). There were 70 males, 109 were black. Mean age was 47 rt: 1 yr (mean + SEM) and etiology of renal disease was 49% HTN and 19% diabetes. Length of time on CD was 60 F 5 mo. KtN was 1.17 t 0.03 (ICH) and 1.74 zlz 0.08 (CAPD), nPCR was 1.03 f 0.03 gm pm/kg/day (al pts), Average days to death after completing questionnaire was 246 +_ 26.

Comparing responses of Su to NSu indicated that Su had more positive responses to questions relating to Social Function (67 + 3 vs. 5 1 & 6, p=O.O26), Physical Function (57 ir 3 vs. 34 ?; 4, p=O.O53), Energy and Fatigue (49 f 2 vs. 41 ?r 4, p=O.O7), and Burden of kidney disease (55 2 3 vs. 43 2 6, p=O.O9). Responses are coded on a O-100 scale with 100 as the most positive response. Of biochemical parameters compared (BUN, Cr, Chol, Alb, Bet, Kfl, nPCR), only Chol (182 _+ 6 vs. 137 + 20, p=O.O3) and Alb (3.8 + 0.05 vs. 3.5 f 0.14, p=O.O9) were different with Su having higher values.

Specific QoL interventions could be designed to influence a better outcome. Furthermore, we conclude that the KDQOLTM is a good qualitative measure of how the patient is feeling and shouId be implemented along with biochemical markers to assist identi~cation of pts at risk for mortality.

'TS 231

EFFECT OF MEGESTROL ACETATE ON THE NUTRITIONAL STATUS OF ~ALNOU~ISH~D HEMODIALYSIS PATIENTS Jeffrey L..William$ Mark Perius, Angela Humble, Diana Sigler, Aris Urbanes, and Howard S.Shapiro, Providence Hospital, Southfield, MI and Michigan Kidney Centers-Total Renal Care, Pontiac, MI

Megestrol acetate in high doses has been used to increase appetite in patients with various malignancies and in patients with AIDS. It has been used effectively in these

settings in doses of 160 mg./day, and with greater efficacy using doses of 800 to 1600 mg/day.

Low serum albumin is the most important determinant of mortality in dialysis patients. Megestrol is excreted by the kidney and is not removed by hemodialysis. ft was therefore tested in a group of hemodialysis patients with poor appetite and hypoalbuminemia (~4.0 gm./dl.). Patients were treated with three ~eatments~eekiy using polysulfone dialyzers, with a KTiV which averaged 1.56.

A double-blinded crossover study was carried out in 24 dialysis patients; 3 months using megestrol 160 mg./d and 3 months using placebo. Patients were monitored with monthly blood studies and with bioalectrical impedance studies for the determination of lean body mass. Four patients withdraw for adverse effects (principally diarrhea).Two died during the study from their underiying medical problems. in the 18 patients completing the study, this dose of megestroi did not significantly increase either the serum albumin or the fat-free body mass. Of note is the cost of megestroi. &I its least expensive (liquid) form, the cost per patient is estimated at $69/mon~ using a dose of 160 mg./d., and 5287/month at a dose of 600 mg.lday.

We conclude that in the malnourished chronic dialysis population, low-dose megestrol therapy is ineffective in impro~ng nut~tional status.