Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium or phosphate levels reached an upper threshold. Unfortunately, due to a period effect, only the initial 16-week intervention period for 80 patients was statistically analyzed. The proportion of patients achieving a 30% decrease in parathyroid hormone levels over the last four weeks of study was statistically indistinguishable between the two groups. Paricalcitol was more efficient at correcting low than high baseline parathyroid hormone levels, whereas alfacalcidol was equally effective at all levels. There were no differences in the incidence of hypercalcemia and hyperphosphatemia. Thus, alfacalcidol and paricalcitol were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range.
We compared the angiotensin II receptor antagonist valsartan to losartan as an antihypertensive agent in an 8-week trial. Adults with uncomplicated essential hypertension (baseline seated diastolic blood pressure < 115 mm Hg and > or = 95 mm Hg) were randomized to receive 80 mg valsartan, 50 mg losartan, or placebo once daily. After 4 weeks doses of active medication and placebo were doubled. Seated systolic and diastolic blood pressures were measured and the response rate evaluated. Tolerability was assessed by the incidence of adverse events. Both angiotensin II receptor antagonists produced similar significant reductions in mean blood pressures at 4 and 8 weeks compared to placebo. Valsartan produced a significantly higher number of responders (62%) than losartan (55%, P = .02) at the 8 week treatment endpoint. The incidence of adverse experiences (AE) was similar in all three groups, with headache and dizziness reported most often. Valsartan (80/160 mg) monotherapy in this trial was as effective and well tolerated as 50/100 mg losartan in treating mild to moderate essential hypertension, and at 160 mg has a significantly higher responder rate than 100 mg losartan.
Antibodies to hepatitis C virus (anti-HCV) were determined in an unselected group of 340 patients with chronic renal failure treated with maintenance dialysis. A second generation hepatitis C virus (HCV) enzyme-linked immunosorbent assay (ELISA) was used and confirmation made by a second generation recombinant immunoblot assay (RIBA). Sixteen patients (4.7%) were anti-HCV positive and 8 (2.4%) were anti-HCV indeterminate. All anti-HCV positive and anti-HCV indeterminate patients had received blood transfusions. No statistically significant differences were found between anti-HCV positive and indeterminate patients considering blood transfusions, dialysis and liver disease. The combined group of anti-HCV positive and indeterminate patients had had more blood transfusions (P < 0.005) and had been on dialysis for a longer period (P < 0.01) compared with anti-HCV negative patients. Further, significant correlation with elevation of transaminases and anti-HCV was observed (P < 0.001). Thirty patients (8.8%) had elevated transaminase levels and 13 (43%) of these were anti-HCV positive or indeterminate. In conclusion, HCV infection accounts for a substantial proportion of liver disease in dialysis patients, probably most often transmitted by blood transfusions but other routes of transmission could not be excluded.
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