Background and objectives The calcimimetic cinacalcet reduced the risk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older ($65 years, n=1005) and younger (,65 years, n=2878) patients.Design, setting, participants, & measurements Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified.Results Older patients had higher baseline prevalence of diabetes mellitus and CV comorbidity. Annualized rates of kidney transplantation and parathyroidectomy were .3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups. ConclusionsIn the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone.

Peritoneal eosinophil counts were investigated in 61 intermittent dialysis patients over the course of 1 year. The peritoneal eosinophil percentage fell from 18 ± 2% (mean ± SEM) in the first 2 months of dialysis to 3 ± 0.4% after 6 months of dialysis. Absolute eosinophils per cubic millimeter fell from 586 ± 126 to 61 ± 18 (p < 0.01 for both percentage and absolute values). There was a wide range in the mean eosinophil percentages per patient in the first 6 months of dialysis (0–84%) that narrowed to 0–9% after 6 months. The majority of the high initial eosinophil counts resolved after 2 months. Peripheral eosinophilia was seen in 8 of the 10 patients with the highest mean peritoneal eosinophil percentages during the first 2 months of dialysis. Patients who developed peritonitis had a significantly lower percentage of eosinophils in the first 1.5 months of dialysis than patients who did not develop peritonitis. At the time of diagnosis of peritonitis, the peritoneal eosinophil count was near zero. 4 cases of peritoneal eosinophilia which developed after antibiotic therapy are described.

Objective. To demonstrate the efficacy and safety of once-monthly (QM) darbepoetin alfa administration in maintaining haemoglobin (Hb) 11.0-13.0 g dL )1 in subjects with chronic kidney disease (CKD) not receiving dialysis and previously treated with darbepoetin alfa every other week (Q2W).Subjects. This open-label study enrolled subjects ‡18 years of age who had glomerular filtration rate ‡15 and £60 mL min )1 /1.73 m 2 , had Hb 11.0-13.0 g dL )1 , and were receiving Q2W darbepoetin alfa. Design. Subjects were switched to QM darbepoetin alfa therapy for 28 weeks; the QM dose was titrated to maintain Hb levels. Primary end-point:proportion of subjects maintaining Hb ‡11.0 g dL )1 during the final 8 weeks of the study (evaluation phase). Secondary end-points: Hb concentration during evaluation, darbepoetin alfa dose during the study, adverse events, laboratory parameters, and blood pressure. Results. The study enrolled 152 subjects (female 52%, white 64%). Mean Hb ‡11.0 g dL )1 during evaluation was achieved by 76% of the 150 subjects who received at least one dose of darbepoetin alfa [95% confidence interval (CI): 68%, 83%]. Mean (SD) Hb during evaluation was 11.71 (0.92) g dL )1 . Eighty-five per cent of 129 subjects who completed the study (95% CI: 78%, 91%) had Hb ‡11.0 g dL )1 during evaluation. The dose of darbepoetin alfa over the study period was median (95% CI) 124.4 lg (106.2, 140.0). Darbepoetin alpha administered QM was well tolerated in study subjects. Conclusion. Darbepoetin alpha administered QM maintained Hb in study subjects with CKD not receiving dialysis.

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