Background Elevated calcium and phosphorus levels after therapywith injectable vitamin D for secondary hyperparathyroidismmay accelerate vascular disease and hasten death in patientsundergoing long-term hemodialysis. Paricalcitol, a new vitaminD analogue, appears to lessen the elevations in serum calciumand phosphorus levels, as compared with calcitriol, the standardform of injectable vitamin D.
Methods We conducted a historical cohort study to compare the36-month survival rate among patients undergoing long-term hemodialysiswho started to receive treatment with paricalcitol (29,021 patients)or calcitriol (38,378 patients) between 1999 and 2001. Crudeand adjusted survival rates were calculated and stratified analyseswere performed. A subgroup of 16,483 patients who switched regimenswas also evaluated.
Results The mortality rate among patients receiving paricalcitolwas 3417 per 19,031 person-years (0.180 per person-year), ascompared with 6805 per 30,471 person-years (0.223 per person-year)among those receiving calcitriol (P<0.001). The differencein survival was significant at 12 months and increased withtime (P<0.001). In the adjusted analysis, the mortality ratewas 16 percent lower (95 percent confidence interval, 10 to21 percent) among paricalcitol-treated patients than among calcitriol-treatedpatients. A significant survival benefit was evident in 28 of42 strata examined, and in no stratum was calcitriol favored.At 12 months, calcium and phosphorus levels had increased by6.7 and 11.9 percent, respectively, in the paricalcitol group,as compared with 8.2 and 13.9 percent, respectively, in thecalcitriol group (P<0.001). The two-year survival rate amongpatients who switched from calcitriol to paricalcitol was 73percent, as compared with 64 percent among those who switchedfrom paricalcitol to calcitriol (P=0.04).
Conclusions Patients who receive paricalcitol while undergoinglong-term hemodialysis appear to have a significant survivaladvantage over those who receive calcitriol. A prospective,randomized study is critical to confirm these findings.
Source Information
From Fresenius Medical Care North America, Lexington, Mass. (M.T., E.L., N.O., J.M.L.); and the Renal Unit, Massachusetts General Hospital, Harvard Medical School, Boston (M.W., R.T.).
Address reprint requests to Dr. Thadhani at Bullfinch 127, 55 Fruit St., Massachusetts General Hospital, Boston, MA 02114, or at thadhani.r{at}mgh.harvard.edu.
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