AIM: We evaluated 152 sevelamer hydrochloridetreated 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 evaluatingsevelamer 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. Sevelamertreated 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.
RCT Entities:
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.