Lanthanum carbonate treatment, for up to 6 years, is not associated with adverse effects on the liver in patients with chronic kidney disease Stage 5 receiving hemodialysis.

Aims: The efficacy and tolerability of the phosphate binder, lanthanum carbonate, have been evaluated in long-term comparative studies and subsequent open-label extensions. Animal studies show that lanthanum has a very low bioavailability and absorbed lanthanum is primarily excreted in bile. A specified subset of data from four Phase III clinical trials and subsequent extension studies is presented, in order to assess the effects of lanthanum carbonate on the liver.

Improvements in renal osteodystrophy in patients treated with lanthanum carbonate for two years.

Aims: To investigate the evolution of renal osteodystrophy in patients on maintenance dialysis, treated with lanthanum carbonate (LC) vs. standard phosphate-binder therapy (Stx).

Materials And Methods: This was a 2-year, randomized, prospective, open-label study during which patients on dialysis received LC titrated to a maximum of 3,000 mg/day or their previous phosphate binder treatment with the aim to achieve target phosphorus levels of < or = 5.

Long-term efficacy and safety profile of lanthanum carbonate: results for up to 6 years of treatment.

Background/aims: Lanthanum carbonate (LC, FOSRENOL) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy.

Methods: Patients from four previous trials entered this study.

A last resort modality using cryofiltration apheresis for the treatment of cold hemagglutinin disease in a Veterans Administration hospital.

Cold hemagglutinin disease is a cold autoimmune hemolytic anemia (cAIHA) caused by an autoantibody, such as IgM, directed against the I-antigen present on the surface of erythrocytes. Cold exposure can activate this system causing hemolysis, hemagglutination, microvascular thrombosis, or acrocyanosis. Thus, surgical procedures requiring hypothermia, such as coronary artery bypass surgery, present a significant problem in patients with cAIHA.

The current status of therapeutic apheresis devices in the United States.

Over the last 40 years, plasmapheresis technology and its indications for use have been continually evolving. With the growing incidence for autoimmune diseases, unsatisfactory therapeutic options, side effects of drug therapy, and economic relevance, apheresis clinicians have been leaning toward more selective plasmapheresis techniques through the use of plasma fractionators and immunoadsorption columns. Plasma fractionators are mostly used in Asia, and rarely utilized in the U.

Clinafloxacin versus piperacillin/tazobactam in the treatment of severe skin and soft-tissue infections in adults at a Veterans Affairs medical center.

Background: Severe skin and soft-tissue infections (SSTIs), particularly diabetic foot infections, are a source of considerable morbidity and mortality. Inappropriate antimicrobial therapy may contribute to the increasing emergence of bacterial resistance, as well as to increased health care costs. Thus, there is a continuing search for reasonably safe, well-tolerated, and effective antimicrobial agents that are less susceptible to the development of resistance than older agents.

Membrane plasmapheresis in the United States: a review over the last 20 years.

Plasmapheresis is a general term involving extracorporeal plasma separation by centrifugation or primary membrane plasma separator (MPS). Further plasma processing can be accomplished by the use of secondary membrane plasma fractionation (PF), as in double filtration plasmapheresis, also called cascade filtration, low-density lipoprotein pheresis, thermofiltration, and cryofiltration apheresis. Otherwise, the separated plasma is replaced by colloid solution as in plasma exchange (PE).

Current topics on cryofiltration technologies.

In the last 40 years, therapeutic plasmapheresis techniques have been improving considerably. These include cryofiltration technologies providing novel ways of removing large amounts of cryoproteins from plasma. The concept of cryofiltration involves exposure of plasma to below core (37 degrees C) and room temperatures (25 degrees C) without freezing.

Clinafloxacin versus piperacillin-tazobactam in treatment of patients with severe skin and soft tissue infections.

Patients (n = 409) with severe skin and soft tissue infections (SSTIs) were randomized to receive clinafloxacin or piperacillin-tazobactam (plus optional vancomycin for methicillin-resistant cocci), administered intravenously, with the option to switch to oral medication. Most patients had cellulitis, wound infections, or diabetic foot infections. Staphylococcus aureus, Enterococcus faecalis, and Pseudomonas aeruginosa were the most common baseline pathogens.

Plasmapheresis by using secondary membrane filters: twelve years of experience.

Over 1,600 plasmapheresis procedures have been performed by using secondary on-line membrane plasma filters in 62 patients over the past 12 years in our institution. The disease categories treated include cryoprotein induced diseases such as cryoglobulinemia, immune mediated disorders, and familial type II-A hypercholesterolemia (FHC). Depending upon the molecular size of the offending agent, we used plasma filters (PF) with different pore sizes ranging from 0.

Intensive tandem cryofiltration apheresis and hemodialysis to treat a patient with severe calciphylaxis, cryoglobulinemia, and end-stage renal disease.

This is the first report on tandem cryofiltration apheresis (CFA) and hemodialysis (HD). A 44 year old white man with Type II mixed cryoglobulinemia, hepatitis C virus (HCV), severe skin lesions, and end-stage renal disease (ESRD) on maintenance hemodialysis was air-transferred for CFA, which is only available at our medical center. The patient failed to respond to high dose steroids, immunosuppression, intravenous immunoglobulin (IVIG), and plasma exchange for the treatment of his cryoglobulinemia, and he failed alpha-interferon therapy for his HCV.

Cryofiltration apheresis in the United States.

There are approximately 2,000 cases of cryoglobulinemia reported each year in the United States. The number of cases has been and is expected to continue growing exponentially since the advent of its association with the hepatitis C virus (HCV). Cryofiltration apheresis is a specific therapy for the treatment of cryoprotein induced diseases that selectively removes cryoprecipitates.

Cryofiltration apheresis and plasma fractionation causing anaphylactoid reactions in patients receiving angiotensin converting enzyme inhibitors.

Severe anaphylactoid reactions and even death have been reported in hemodialysis patients using certain membrane dialyzers while receiving angiotensin converting enzyme (ACE) inhibitors. We report mild to moderate anaphylactoid reactions in 4 patients receiving plasmapheresis with on-line membrane filters after being placed on ACE inhibitors. Of 21 patients receiving 497 plasma fractionation procedures, only the 2 patients who were receiving ACE inhibitors developed anaphylactoid reactions.

Plasmapheresis and paraproteinemia: cryoprotein-induced diseases, monoclonal gammopathy, Waldenström's macroglobulinemia, hyperviscosity syndrome, multiple myeloma, light chain disease, and amyloidosis.

Therapeutic plasmapheresis has been in widespread use as either a primary or adjunctive therapy in the United States since the 1960s. There are several types of plasmapheresis procedures used to treat various diseases. Plasma exchange with a centrifugal plasma separator using replacement fluid such as human albumin solution is the most widely used method in the United States.

Efficacy of oral ciprofloxacin vs. clarithromycin for treatment of acute bacterial exacerbations of chronic bronchitis. The Bronchitis Study Group.

In this prospective, multicenter, double-blind study, the efficacy of ciprofloxacin was compared with that of clarithromycin as therapy for patients with acute bacterial exacerbations of chronic bronchitis (ABECB) from whom a pretherapy pathogen was isolated; the efficacy was measured by the infection-free interval. Clinical and microbiological responses at the end of therapy were secondary efficacy variables. Patients randomly received either ciprofloxacin or clarithromycin (500 mg twice a day for 14 days).

Cryofiltration apheresis in the treatment of cryoprecipitate induced diseases.

Cryoprecipitates include cryoglobulins, cryofibrinogen, cryoparaproteins, and some cold hemagglutinins. We used 3 different methods: plasma exchange (PE), plasma filter (PF), and cryofilter (CF) to remove cryoproteins. Twenty-four patients received more than 800 CF, PF, and PE treatments.

Cryofiltration apheresis for treatment of cryoglobulinemia associated with hepatitis C.

Cryofiltration apheresis (CA) is a specific therapy for treatment of patients with cryoglobulinemia. We evaluated the safety and efficacy of CA in patients with mixed cryoglobulinemia associated with hepatitis C. As reported previously, the Cryoglobulin Filter comprises a membrane module inside a refrigeration unit on-line with a Spectra Apheresis System (COBE, Denver, CO).

Clinical trials of a cryoglobulin filter.

The authors report the results of clinical trials of a high capacity cryoglobulin filter (Cryofilter) in seven patients with cryoglobulinemia unresponsive to high doses of prednisone or immunosuppressive drugs who required plasmapheresis. The objective of this study was to test the safety and efficacy of the cryofilter in a limited patient population according to the investigational Device Exemption guidelines of the FDA. The cryoglobulins were selectively filtered from plasma at 4 degrees C by a cryofilter characterized by a membrane surface area of 0.

Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group.

Intravenously administered ciprofloxacin was compared with imipenem for the treatment of severe pneumonia. In this prospective, randomized, double-blind, multicenter trial, which included an intent-to-treat analysis, a total of 405 patients with severe pneumonia were enrolled. The mean APACHE II score was 17.

Are selective macromolecule removal plasmapheresis systems useful for autoimmune diseases or hyperlipidemia?

Although technical limitations exist with existing selective removal systems, very few products are available and no major clinical trials have demonstrated the superiority or equivalence of selective removal systems over plasma exchange. It is generally recognized that selective removal systems are preferable, and that selective macromolecule removal plasmapheresis systems are useful for autoimmune diseases or hyperlipidemia. In the treatment of a disease with a selective removal device, the disease pathogen should be identified and the efficacy of removal demonstrated.

Evaluation of the effect of intravenous L-carnitine therapy on function, structure and fatty acid metabolism of skeletal muscle in patients receiving chronic hemodialysis.

Chronic hemodialysis (HD) leads to significant losses of carnitine from plasma and muscle. Because L-carnitine is important in the production of energy from fatty acid oxidation (FAO) in muscle, we examined the role of carnitine replacement by administering therapeutic doses of intravenous carnitine to 14 male patients receiving HD. Placebo or carnitine was given 2 g i.