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PubMed2003

Developing a human immunodeficiency virus/acquired immunodeficiency syndrome therapeutic research agenda for resource-limited countries: a consensus statement.

To develop a research agenda for use of antiretroviral therapy (ART) in countries with highly limited resources for health, research questions focused on 3 areas: when therapy should be initiated, what therapies should be used, and the most appropriate methods for patient monitoring. Participants from 23 countries and 6 continents were clinical and academic researchers, health care practitioners, policy authorities, pharmaceutical experts, and health care advocates. The conference attendees reviewed background materials and participated in 13 state-of-the-art presentations on ART provision in resource-limited countries, treatment access, ethics, community issues, and sustainability. Conferees separated into smaller groups to identify priorities for specific research agendas. Existing multinational human immunodeficiency virus (HIV) clinical trials networks, such as the HIVNAT (The Netherlands, Australia, and Thailand) Network, were studied as infrastructure models for research into affordable, sustainable treatment and monitoring strategies suitable for resource-limited settings. The delivery of ART in resource-limited countries is a vital priority for health care providers and the millions of people living with HIV disease. To achieve sustainable approaches to HIV/acquired immunodeficiency syndrome care, research relevant to resource-limited settings must involve local researchers and community representatives to promote development of local capacity.

Clinical Trials as Topic↗
PubMed1999

International Consensus Statement on Testing and Reporting of Antineutrophil Cytoplasmic Antibodies (ANCA)

Antineutrophil cytoplasmic antibody (ANCA) tests are used to diagnose and monitor inflammatory activity in the primary systemic small vessel vasculitides. ANCA is best demonstrated in these diseases by using a combination of indirect immunofluorescence (IIF) of normal peripheral blood neutrophils and enzyme-linked immunosorbent assays (ELISAs) that detect ANCA specific for proteinase 3 (PR3) or myeloperoxidase (MPO). For ANCA testing in "new" patients, IIF must be performed on all serum samples. Serum samples containing ANCA, any other cytoplasmic fluorescence, or an antinuclear antibody (ANA) that results in homogeneous or peripheral nuclear fluorescence then should be tested in ELISAs for PR3-ANCA and MPO-ANCA. Optimally, ELISAs for PR3-ANCA and MPO-ANCA should be performed on all serum samples. Inclusion of the most recent positive sample in the IIF or ELISA may help demonstrate a change in antibody level. Reports should use recommended terms. Any report of positive neutrophil fluorescence issued before the ELISA results are available should indicate that positive fluorescence alone is not specific for the diagnosis of Wegener granulomatosis or microscopic polyangiitis and that decisions about treatment should not be based solely on the ANCA results.

Antibodies, Antineutrophil Cytoplasmic↗
PubMed2001

ASHP therapeutic position statement on the safe use of pharmacotherapy for obesity management in adults. Developed by the ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on April 23, 2001.

Obesity is a chronic disease that may require pharmacologic treatment in select patients at high risk in whom lifestyle modifications alone were unsuccessful. Although long-term therapy may be indicated in these patients, long-term safety and efficacy data for the current agents are not available. Patients should be informed of all known risks of therapy and, together with their health care providers, carefully consider the risks and benefits of treatment. Patients should be informed that pharmacotherapy has been proven to produce modest weight loss (10% weight loss) when used in conjunction with lifestyle modifications. The health benefits of modest weight loss should be stressed, and lifestyle changes should be continuously encouraged. Pharmacists can take an active role in the management of obesity by assisting in the selection of weight-loss agents and providing appropriate counseling and monitoring to ensure safe and effective drug therapy outcomes for patients using prescription and nonprescription products. Further evaluation of current and future therapies will be necessary to determine the role of long-term pharmacotherapy for the management of obesity.

Adult↗
PubMed2001

ASHP therapeutic position statement on the identification and treatment of Helicobacter pylori-associated peptic ulcer disease in adults. Developed by the ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on November 11, 2000.

ASHP supports the identification and treatment of H. pylori infection in appropriate patients as an effective method of reducing the morbidity and mortality associated with peptic ulcer disease. Successful and safe therapy requires extensive patient education and monitoring by qualified health care professionals to maximize patient understanding of and compliance with medication regimens and to minimize adverse events. Pharmacists are key to ensuring that patients use prescribed regimens appropriately so that H. pylori is eradicated and that clinical outcomes of associated peptic ulcer disease are optimal.

Adult↗
PubMed2005

Pathogenesis, diagnosis and treatment of Rasmussen encephalitis: a European consensus statement.

Rasmussen encephalitis (RE) is a rare but severe immune-mediated brain disorder leading to unilateral hemispheric atrophy, associated progressive neurological dysfunction and intractable seizures. Recent data on the pathogenesis of the disease, its clinical and paraclinical presentation, and therapeutic approaches are summarized. Based on these data, we propose formal diagnostic criteria and a therapeutic pathway for the management of RE patients.

Adolescent↗
PubMed2005

Consensus statement on the bio-safety of urinary-derived gonadotrophins with respect to Creutzfeldt-Jakob disease.

Human transmissible spongiform encephalopathies (TSE) encompass a group of rare neurodegenerative diseases. In April 2004, a group of international experts and regulators met in Buenos Aires, Argentina, to review the safety and to reach consensus on the use of urinary-derived gonadotrophins with respect to TSE. Iatrogenic transmission of Creutzfeldt-Jakob Disease (CJD) from pituitary-derived gonadotrophins has been reported, no infectivity in urine has been demonstrated, and no definite cases of transmission via urine have been reported. It is currently not possible to monitor donor urine or finished product for the presence of prions. Therefore the assessment of risk has to be based on the likelihood of infection in urine, the source of the urine, and the capacity of the manufacturing process to remove any adventitious infection. Urine for the production of medicinal products should be obtained from sources that minimize the possible presence of materials derived from subjects suffering from human TSE. As no strong evidence for TSE infectivity in urine exists, it can be concluded that the risk of disease-generating prions and TSE infectivity being present in donor urine is low. Current evidence indicates that, with respect to the risk of TSE infection, urinary-derived gonadotrophins appear to be safe.

Animals↗