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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.
Intra-arterial administration of thrombolytic therapy (mainly tissue-plasminogen activator [t-PA]) has demonstrated significant and immediate clinical improvement, dubbed the "Lazarus phenomenon," in about one-fourth of patients with acute ischemic stroke. Factors associated with the Lazarus phenomenon are a shorter time to treatment, a high reperfusion score, and formation of good pial collaterals.
A panel of former FDA commissioners convened recently to exchange ideas on improvements to the agency, tackling issues ranging from restructuring FDA funding to enhancing the agency's legal authority to ensure drug safety.
Enoxaparin is superior to unfractionated heparin (UFH) for prevention of venous thromboembolism (VTE) in acute ischemic stroke patients with partial paralysis, according to David G. Sherman, MD, lead investigator of a trial known as PREVAIL (Prevention of VTE After Acute Ischemic Stroke with LMWH Enoxaparin).
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Measures in Florida and Massachusetts that require paramedics to transport qualifying patients to certified stroke centers helped to increase the number of patients who received tissue plasminogen activator (t-PA) for the treatment of ischemic stroke in both states.
Emergency physician-directed treatment of patients with acute stroke using tissue plasminogen activator (t-PA) is as safe as treatment directed by an acute stroke team, according to the results of a retrospective study presented at the American Heart Association's (AHA's) International Stroke Conference 2007 in San Francisco, Calif.
A meta-analysis published in the journal Current Medical Research and Opinion suggests that women may not achieve the same cardiovascular (CV) benefits from statins as men.
In a systematic review and meta-analysis published in the Annals of Pharmacotherapy, oral phenylephrine was demonstrated to be ineffective for the treatment of nasal congestion as measured by nasal airway resistance (NAR).
Two randomized, controlled trials published in the New England Journal of Medicine (NEJM) demonstrate that posaconazole may be considered a first-line option for prophylaxis of fungal infections in patients with severe graft versus host disease (GVHD) after allogeneic hematopoietic stem-cell transplantation as well as in immunosuppressed patients undergoing chemotherapy for acute myelogenous leukemia or the myelodysplastic syndrome.
In a randomized, double-blind, parallel-group trial published in the American Journal of Respiratory and Critical Care Medicine, the combination of fluticasone and salmeterol (SAL) statistically significantly reduced the number of chronic obstructive pulmonary disease (COPD) exacerbations by 35% compared with SAL alone.
Two studies published in the journals Lancet (Elliott et al) and the Archives of Internal Medicine (Barzilay et al) help to answer questions about the effect some antihypertensive agents can have on the development of diabetes mellitus, but these studies have also raised some new concerns about cardiovascular disease.
In a multi-center, randomized, double-blind, controlled trial, use of rosiglitazone in patients with type 2 diabetes was found to delay the progression to monotherapy failure (fasting plasma glucose >180 mg/dL) more effectively than using metformin or glyburide.
In a large, multi-center, randomized, open-label, prospective trial named the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, monotherapy with the anti-thrombotic agent bivalirudin, when administered to patients experiencing an acute coronary syndrome (ACS) (eg, unstable angina or myocardial infarction without ST-segment elevation), was demonstrated to be as efficacious as the current standard-of-care therapy but with nearly a 50% lower risk of bleeding. The results of the trial were published in the New England Journal of Medicine (NEJM).
Aprotinin has demonstrated a 48% increase in the risk of 5-year mortality following coronary artery bypass graft (CABG) surgery, according to a study published in the Journal of the American Medical Association (JAMA).
First-time generic approvals
FDA approved 3 mg drospirenone/20 mcg ethinyl estradiol (Yaz, Berlex) for the treatment of moderate acne vulgaris in women who desire an oral contraceptive for birth control. This agent was previously approved for oral contraception and for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder in women who desire an oral contraceptive.
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Once-daily oral formulation of anti-inflammatory agent approved for the induction of remission in patients with active, mild-to-moderate ulcerative colitis
Sterile, lyophilized powder concentrate of antihemophilic factor and von Willebrand factor complex for surgical and/or invasive procedures in patients with von Willebrand disease
Many Americans suffer from insomnia regularly, but clinicians often do not address this issue. A variety of factors may contribute to insomnia, including medical conditions such as gastroesophageal reflux disease, Parkinson disease, and heart failure. Medications such as amphetamines, theophylline, and beta agonists could also precipitate insomnia.
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