Chronic kidney disease (CKD) affects 20 million Americans, and an additional 20 million are at increased risk for developing CKD. Anemia is a common complication in patients with CKD. Continuous erythropoiesis receptor activator (CERA) is a new erythropoiesis-stimulating agent (ESA) that is undergoing FDA review for the treatment of anemia in patients with CKD, including in those undergoing dialysis.
The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires September 30, 2007, has set the stage for congressional action on broader legislation to improve the handling of drug safety issues. Bills under consideration aim to expand FDA oversight by establishing new requirements for postmarket risk assessment, for posting active clinical trials and resulting study data, and for completing postmarket studies.
We propose using the results of pharmacodynamic Monte Carlo simulation studies as a surrogate marker for potential efficacy of antibiotic dosage regimens and applying these end points to the calculation of an incremental cost-effectiveness ratio (ICER).
One of the numerous factors shaping pharmacy and therapeutics (P&T) committees' operations and decisions is the push for electronic health information systems, including electronic prescribing (e-prescribing). E-prescribing is expected to help prescribers comply with plan formularies and formulary policies.
In patients with metastatic renal cell carcinoma, treatment with sunitinib yields longer progression-free survival rates and a better health-related quality of life than does the standard treatment, interferon alfa therapy, according to the results of a phase 3 trial published in the New England Journal of Medicine (NEJM). A total of 750 patients aged ≥18 years participated in this international, multicenter, randomized trial.
Maintaining treatment with imatinib as initial therapy in patients with chronic myeloid leukemia (CML) may yield positive outcomes, including increased overall survival to ≥5 years, according to a study published in the New England Journal of Medicine (NEJM). The follow-up study of the International Randomized Study of Interferon and ST1571 (IRIS), a multicenter, international, randomized, phase 3 trial, included patients aged 18 to 70 years diagnosed with Ph-positive CML in chronic phase within 6 months before the start of the study.
In a randomized double-blind, parallel- group trial, salmeterol plus fluticasone failed to reduce all-cause death in patients with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) compared with each of the agents alone or placebo. The results of the Towards a Revolution in COPD Health (TORCH) trial were published in the New England Journal of Medicine (NEJM).
Healthcare professionals assembled at the 56th Annual Scientific Session of the American College of Cardiology (ACC) from March 24 to 27, 2007, in New Orleans, La, to exchange information and updates about new and continuing research in cardiovascular disease.
A discussion of FDA-requested boxed warnings and medication labeling changes
The rate of anticoagulant-associated intracerebral hemorrhage has increased dramatically since 1988, according to an observational study published in the journal Neurology. Researchers identified all patients hospitalized with first-ever intracerebral hemorrhage (ICH) in the 5-county Greater Cincinnati, Ohio/Northern Kentucky area during 3 unique time periods.
A discussion of new FDA-approved indications and formulations of drugs
A discussion of generic drugs recently approved by FDA
A discussion of drugs under consideration/review for FDA approval
Recombinant monoclonal antibody approved for reducing the signs and symptoms and inducing and maintaining clinical remission of moderately-to-severely active Crohn's disease
Recombinant monoclonal antibody approved for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis
4-anilinoquinazoline kinase inhibitor approved in combination with capecitabine for the treatment of advanced or metastatic breast cancer
Oral renin inhibitor approved as monotherapy or in combination with other antihypertensive agents for the treatment of hypertension
If your patients are considering hormonal treatment they can also register to receive materials that explain in detail the risk for breast cancer recurrence and how hormonal treatment works. This information will help your patients during your discussions about treatment options.
The Breast Cancer Atlas brings you dozens of clinical, radiographic and histologic images that will transform your presentations and lectures. Each image is accompanied by expert information and perspectives on topical issues, written and reviewed by distinguished editors. With this tool you can select images for your use in presentations, save them in a personal folder, and receive the PowerPoint? file containing your selected images via e-mail.
The AstraZeneca Cancer Support Network (AZ CSN) provides comprehensive, up-to-date medical and reimbursement information for AstraZeneca oncology products. The AZ CSN is available is available to patients and health care professionals.
Postmenopausal women with hormone-sensitive early-stage breast cancer who have received at least 2 years of adjuvant treatment with tamoxifen can benefit in overall survival from a switch to anastrozole, according to the results of a meta-analysis published in the journal Lancet.
A review of agents in late-stage development for the treatment of genitourinary disorders (March 2007).
The Institute of Medicine (IOM) issued a report in September 2006 urging FDA to make major changes to better balance the agency's assessment of the risks and benefits of new drugs. FDA commissioner Andrew von Eschenbach, MD, has responded with a report that details the agency's plans to improve procedures for detecting and assessing drug safety problems. "The Future of Drug Safety" describes proposals for developing safety "report cards" on new drugs to better inform prescribers and patients about new safety concerns and to more quickly detect drug safety signals.
Due to pressure from regulators, the pharmaceutical industry is working to implement Radio Frequency Identification (RFID) technology in pharmacies, hospitals, and healthcare facilities to help prevent medication errors. This technology is also being used in a variety of ways to help meet FDA drug pedigree requirements.
Drugs that act to increase dopamine activity are the mainstay of pharmacologic treatment for restless legs syndrome (RLS), a sensomotor disorder that usually manifests as an urge to move the legs, with or without other uncomfortable sensations.
Cardiovascular disease afflicts more than 71.3 million people in the United States and accounts for more deaths annually than any other cause. The estimated direct and indirect costs associated with cardiovascular disease in 2006 ($403 billion) were more than double the costs associated with cancer ($190 billion), which is the second-leading cause of death in the United States.
