Hospitalization risks between Renagel phosphate binder treated and non-Renagel treated patients.

AIM: We evaluated 152 sevelamer hydrochloride treated Medicare patients on hemodialysis in a case-controlled study matching 152 randomly selected non-sevelamer hydrochloride treated Medicare patients from the same dialysis facilities and time period. The main outcomes evaluated were the risk of all-cause hospitalization and per-member per-month (PMPM) Medicare expenditures in the follow-up period. PATIENTS AND METHODS: Medicare patients were identified from a total of 195 patients who were included in a long-term safety and efficacy clinical trial evaluating sevelamer hydrochloride [Chertow et al. 1999a]. The average serum calcium-phosphorus product as well as lipid profiles improved in the sevelamer hydrochloride treated group during the trial. Sevelamer treated patients were matched with randomly selected Medicare patients for age, gender, race, diabetic status, and geographic location. Comorbid conditions were characterized and sequential Cox regression models were applied with the outcome being risk of first hospitalization in a 17- month follow-up period. RESULTS: Across all four models, the relative risk of hospitalization was 46% to 54% less in the sevelamer hydrochloride treated group, as compared to the case control group (significant at the p-value 0.03 level). Overall, Medicare expenditures for the control patients per-member per-month were US-$4,745, compared to US-$3,368 in the sevelamer hydrochloride treated patients. CONCLUSION: Sevelamer hydrochloride treated patients had a 50% lower likelihood of hospitalization in the follow-up period after adjustments for the differences in the population. Potential bias may exist between groups because of differences in baseline characteristics that could not be adjusted for within the study design. We feel that to further advance this area, a randomized clinical trial should be performed.

Impact of disease severity and hematocrit level on reuse-associated mortality.

Prior studies on reuse-associated mortality have presented conflicting results and included few adjustments for disease severity or hematocrit levels. To evaluate the impact of patient and provider characteristics on reuse-associated mortality, we developed a period-prevalent model with a 6-month entry period. Five cohorts of Medicare hemodialysis patients surviving from July 1 through December 31 of the entry year (1991, 60,985 patients; 1992, 63,081 patients; 1993, 76,018 patients; 1994, 82,899 patients; 1995, 91,761 patients) were followed up for the next year. Using a basic Cox regression survival model (M-1) including age, sex, race, renal diagnosis, prior end-stage renal disease time, unit age, unit size, water treatment, dialysate, and germicide, results were compared with those using a more inclusive model (M-4) adding dialyzer type (conventional or high efficiency/high flux), unit designation (hospital based or freestanding), unit profit status, comorbidity, disease severity, and hematocrit. The previous association of for-profit units with increased mortality was not present after 1994. Whereas the M-1 analysis showed better survival in reuse units after 1991, the more complete M-4 analysis showed no difference in the risk for mortality between reuse and no-reuse units. We conclude that mortality rates in the United States from 1991 to 1995, when adjusted comprehensively for patient and unit characteristics, were not different in units that practiced reuse and those that did not.