Formulary Watch

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A summary of agents in late-stage development for the prevention and/or treatment of osteoporosis.

According to the results of a prospective cohort study of 1,005 patients with new-onset atrial fibrillation (AF), women who are treated with amiodarone are at greater risk for bradyarrhythmia requiring pacemaker insertion than men who are treated with the drug.

First-time generic approvals: rivastigmine capsules

The 2007 American Heart Association (AHA) Scientific Sessions took place November 3 to 7, 2007, in Orlando, Florida. Among the new data presented were the much anticipated results of a phase 3 trial of prasugrel versus clopidogrel in patients scheduled for percutaneous coronary intervention (PCI). Other clinical trials of note were the first prospective study of a statin in patients with ischemic heart disease and heart failure and a comparison of eptifibatide with abciximab on ST-segment resolution in patients with myocardial infarction (MI) who are undergoing primary PCI. This AHA Special Report details these and other trials.

Anecdotal reports of hospital readmissions secondary to adverse drug events (ADEs) prompted the pharmacy & therapeutics (P&T) committee at University Hospital, SUNY Upstate Medical University, to authorize a pharmacy-led retrospective review of patient records.

Doripenem is a carbapenem antibiotic recently approved for the treatment of complicated intra-abdominal infections (IAIs) and complicated urinary tract infections (UTIs), including pyelonephritis. An NDA has also been submitted for the use of doripenem in the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP). Doripenem is the fourth carbapenem approved for use in the United States and exhibits many pharmacologic similarities with imipenem/cilastatin and meropenem. Doripenem has a broad spectrum of activity against various gram-positive and gram-negative aerobic and anaerobic bacteria, including many multidrug-resistant gram-negative pathogens. Improved potency against nonfermentative gram-negative bacteria has also been demonstrated with doripenem compared with other carbapenems. In clinical trials, doripenem was generally well tolerated; headache, nausea, diarrhea, and phlebitis were the most commonly reported drug-related adverse events. Because doripenem exhibits..

Labeling updates and warnings related to rosiglitazone, erythropoiesis-stimulating agents, and aprotinin (December 2007)

FDA-related information through December 2007 on Guaifenesin/codeine extended-release, delayed-release valproic acid, telavancin, Endeavor, oral beclomethasone, and R7128

This oral formulation of topotecan was approved on October 12, 2007, for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response who are ≥45 days from the end of first-line chemotherapy.

Ixabepilone was approved on October 16, 2007, as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine; and in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.

FDA approved raltegravir on October 12, 2007, for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication and HIV-1 strains that are resistant to multiple antiretroviral agents.

The use of prophylactic granulocyte colony-stimulating factors (G-CSF) in adult patients with cancer who are receiving chemotherapy is associated with a reduced risk of early death and febrile neutropenia, according to a systematic review and meta-analysis published in the Journal of Clinical Oncology.

In a retrospective cohort study of 162 primary care practices in the United Kingdom, the use of antibiotics was demonstrated to be effective in preventing serious complications following upper respiratory tract infection (URTI), sore throat, or otitis media; however, the authors stated that the number needed to treat (NNT) to prevent 1 such complication is too high to justify prescription of the drugs for this purpose.

Congress approved the FDA Amendments Act of 2007 (FDAAA) in September after a lengthy debate that resulted in compromises on many issues. The resulting law contains numerous provisions designed to better inform the public about drug safety and provides new tools for FDA to reduce risks and unsafe drug use.

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Primary care physicians and pediatricians who do not measure childhood body mass index (BMI) are missing a prime opportunity to prevent cardiovascular disease later in life.

Researchers in Japan have found that dark chocolate can have a positive impact on coronary circulation.

Persistence with statins is only approximately 50% by 12 months after therapy is started, with Spanish-speaking patients at highest risk of discontinuing therapy, said Michael H. Davidson, MD, during the American Heart Association Scientific Sessions, Nov. 3-7, 2007, in Orlando.

Therapeutic choices in interventional cardiology are often complicated by factors, such as gastrointestinal (GI) bleeding, left anterior descending coronary artery stenosis, thrombocytopenia, and uncontrollable angina.

A leading expert on global inequalities in cardiovascular healthcare challenged the American Heart Association to take the lead in reducing the burden of cardiovascular disease worldwide.

Antihypertensive treatment that works in the summer may not be sufficient for wintertime blood pressure (BP) control.

Ranolazine extended-release significantly reduced the level of hemoglobin (Hb) A1c in patients with diabetes, allowing more of them to achieve the clinical HbA1c treatment target of less than 7.0%.

Two new studies presented during the American Hospital Association Scientific Sessions, Nov. 3-7, 2007, in Orlando, could speed the replacement of abciximab by eptifibatide in cardiac patients. EVA-AMI showed similar outcomes between the two drugs when used in percutaneous coronary intervention (PCI) and BRIEF-PCI showed that a two-hour infusion of eptifibatide can be as effective as the standard 18-hour course following uncomplicated PCI procedures.

Bystanders and automated external defibrillators (AEDs) are a life-saving combination.

Prasugrel, a new antiplatelet agent in Phase 3 clinical trials, is superior to clopidogrel in preventing major adverse cardiac events in patients undergoing percutaneous coronary intervention (pCI), but is associated with an increase in the risk of major bleeding.

Real-time pharmacogenetic-guided dosing of warfarin does not lead to a reduction in prothrombin time international normalized ratios (INRs) out of the therapeutic range compared with standard warfarin dosing, although it did lead to smaller and less frequent warfarin dosing changes, reported Jeffrey L. Anderson, MD.

In older patients with advanced systolic heart failure, rosuvastatin added to standard heart failure medications failed to significantly reduce incidence of a composite of cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke compared with placebo, although it did reduce the incidence of all-cause and cardiovascular-related hospitalizations.