Context: The clinical course of secondary hyperparathyroidism (sHPT) in patients on hemodialysis is not well described, and the effect of the calcimimetic cinacalcet on disease progression is uncertain.
Objective: Our objective was to describe 1) the clinical course of sHPT in patients treated with phosphate binders and/or vitamin D sterols and 2) the impact of cinacalcet on the occurrence of severe unremitting HPT, defined by the persistence of markedly elevated PTH concentrations together with hypercalcemia or parathyroidectomy (PTX).
Design And Setting: This was a randomized, double-blind, placebo-controlled, global, multicenter clinical trial.
Objective: To examine the safety of anakinra when added to a background of standard rheumatoid arthritis (RA) medications in patients with RA with active disease.
Methods: This analysis further evaluates data from the first 6 months of a blinded, placebo controlled safety trial that had a subsequent 30 month, open label portion (not reported here). Patients with RA with a wide range of comorbid conditions, disease activity, and background medications were randomly assigned in a 4:1 allocation ratio to treatment with anakinra 100 mg or placebo administered daily by injection.
Arthritis Rheum
April 2003
Objective: To evaluate the safety of anakinra (a recombinant human interleukin-1 receptor antagonist) in a large population of patients with rheumatoid arthritis (RA), typical of those seen in clinical practice.
Methods: A total of 1,414 patients were randomly assigned to treatment with 100 mg of anakinra or placebo, administered daily by subcutaneous injection. Background medications included disease-modifying antirheumatic drugs, corticosteroids, and nonsteroidal antiinflammatory drugs, alone or in combination.