Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial.

Background: The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration. Methods: FIND-CKD (ClinicalTrials.gov number NCT00994318) was a 1-year, open-label, multicenter, prospective study of patients with nondialysis-dependent CKD, anemia and iron deficiency randomized (1:1:2) to IV ferric carboxymaltose (FCM), targeting higher (400-600 µg/L) or lower (100-200 µg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCM versus oral iron over an extended period. Results: The safety population included 616 patients. The incidence of one or more adverse events was 91.0, 100.0 and 105.0 per 100 patient-years in the high ferritin FCM, low ferritin FCM and oral iron groups, respectively. The incidence of adverse events with a suspected relation to study drug was 15.9, 17.8 and 36.7 per 100 patient-years in the three groups; for serious adverse events, the incidence was 28.2, 27.9 and 24.3 per 100 patient-years. The incidence of cardiac disorders and infections was similar between groups. At least one ferritin level ≥800 µg/L occurred in 26.6% of high ferritin FCM patients, with no associated increase in adverse events. No patient with ferritin ≥800 µg/L discontinued the study drug due to adverse events. Estimated glomerular filtration rate remained the stable in all groups. Conclusions: These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD

Body pain during daily activities in patients on peritoneal dialysis

Objective. To review the prevalence of body pain during daily activities in patients on peritoneal dialysis (PD) and to correlate it with various demographic and renal osteodystrophy markers such as calcium (Ca), phosphorus (P), intact parathyroid hormone (iPTH), and vitamin D 3 levels. Methods. A cross-sectional study was conducted involving 530 chronic PD patients (44.3% female, 55.6% male) from 24 centers in Canada, Greece, and Turkey. Pain severity scoring during daily activities was performed using the pain scoring table of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results. The overall prevalence of pain was 52.9% (61.3% in females and 49.5% in males, p < 0.05). Morning stiffness was reported by 23.6% of the patients, and diminished range of movement by 20%. The mean age, weight, and body mass index were higher in patients with pain than in those without (p < 0.05). There was no statistically significant difference between patients with pain and those without pain with respect to their mean serum iPTH, Ca, P, Ca x P, ionized Ca, or bone alkaline phosphatase levels (p > 0.05). Mean serum 25-hydroxyvitamin D 3 [25(OH)D 3] levels were lower in patients with pain compared to those without pain (p < 0.05). Conclusions. A high percentage of the PD patients (53%) had body pain; iPTH levels and other biochemical parameters of renal osteodystrophy were not different between those with and without pain. Patients with pain had lower 25(OH)D 3 levels than did those without. Factors such as age, gender, obesity, and metabolic factors may interact to cause varying degrees of articular/bone pain in patients on PD. Since vitamin D deficiency aggravates the signs and symptoms of joint disease such as pain and stiffness, one should attempt to correct levels of 25(OH)D 3, as well as 1,25(OH) 2D 3 levels, in these patients