News

Two studies evaluating the efficacy and long-term safety of the inhalable, rapid-acting dry powder insulin formulation (Exubera, Pfizer/Aventis) demonstrate that the drug was able to sustain glycemic control and pulmonary function in patients with type 2 diabetes

Etanercept/anakinra combination therapy for the treatment of rheumatoid arthritis (RA) provides no added benefit and has an increased risk compared to etanercept alone, according to a study published in Arthritis & Rheumatism, the journal of the American College of Rheumatology (ACR).

Four commonly prescribed antidepressants carry an equal risk of quadrupling the chance of suicidal behavior during the first 9 days of treatment, according to a study from the United Kingdom published in the Journal of the American Medical Association. The authors cautioned, however, that the risk is likely only temporary and may be attributed to the time period in which the drugs have not yet taken effect in those patients already considering suicide.

FDA's paperless e-labeling initiative will allow manufacturers to transmit labeling information electronically to prescribers, pharmacists, and patients.

Although the mechanism of action of imiquimod is unknown, an open-label study suggests that the drug may act by increasing the filtration of lymphocytes, dendritic cells, and macrophages into the tumor lesion. Imiquimod was approved on July 14, 2004, for an expanded indication to include the treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults.

A newly released update to the National Cholesterol Education Program's (NCEP) guidelines on cholesterol management recommend that clinicians consider more intensive treatment options for patients at high and moderately high risk for heart attack. These evidence-based recommendations include setting lower treatment goals for low-density lipoprotein cholesterol (LDL-C) and initiating cholesterol-lowering drug therapy at lower LDL thresholds.

Although warfarin is an effective drug in the treatment and prevention of thromboembolism, dosing complexities and drug interactions have led to its underutilization and a desire for an alternative agent. Ximelagatran (Exanta, AstraZeneca) is a novel oral anticoagulant that can be taken in standardized doses without the use of periodic blood monitoring to determine the level of anticoagulation. Large prospective clinical trials have shown ximelagatran to be similar in efficacy compared to the standard of therapy in the prevention and treatment of thromboembolism with similar or lower rates of bleed. Of concern, however, is the fact that that ximelagatran may elevate hepatic enzymes. An NDA was filed for ximelagatran on December 23, 2003, and FDA’s Cardiovascular and Renal Drugs Advisory Committee is scheduled to review the drug for the prevention of stroke and thromboembolism at a meeting on September 10, 2004. This article reviews ximelagatran’s chemistry and pharmacology, pharmacokinetics, clinical trials, adverse effects, drug interactions, and dosage and administration.

The number of patients presenting with typical gastroesophageal reflux disease (GERD) symptoms and the prevalence of GERD symptoms in the general population make the prescription of proton-pump inhibitors (PPIs) by primary-care physicians commonplace. An active medication use evaluation (MUE) program that places symptom control as a primary concern can help rationalize PPI drug therapy and improve patient care. A treatment guideline that follows the current practice of empiric therapy, recommends periodic monitoring, and encourages further gastroesophageal evaluation (ie, endoscopy and pH monitoring) for assessing adequacy of treatment and treatment failures is a key component of a successful program.

The demand for consumer-directed healthcare (CDH) is growing. Once justan idea tossed around in health plan boardrooms and industry think tanks,CDH is now taking root, with an increasing number of national and regionalhealth plans offering a variety of consumer-directed products and services.

Is it legal to ask health plan members their race and ethnicity? Accordingto the Civil Rights Act of 1964, it is; however, California, New Jersey,New Hampshire and Maryland restrict the use and collection of racial data.With the go-ahead from the federal government, health insurers are usingthe data to design strategies to improve care for specific populations.

In the past 15 years, with the introduction of largemolecule, biologically engineered therapies, the treatment of multiple sclerosis (MS) has been revolutionized. While still not curable, today MS is eminently treatable.

Some conditions better lend themselves to remote monitoring, but others produce false positives

August Desktop Resource Chart

FDA actions and new molecular entities

The human immunodeficiency virus (HIV) attacks the immune system, particularly white blood cells known as CD4 T-cells. As a result, the immune system becomes less able to fight off infection and disease. The final stage of HIV infection is acquired immunodeficiency syndrome (AIDS), but some people live with HIV for years or even decades before the disease progresses to AIDS.

Health insurers learned long ago that one size doesn't fit all. As a result, they tailor care delivery to members based on specific disease states, gender, age and risk status. But today, that simply is not sufficient-not with the U.S. Bureau of Census' prediction that by 2035, Americans of color will comprise more than 40% of the population.

HealthPartners CEO Mary K. Brainerd pushes the limit on healthcare process, structure and environment

On June 21, a unanimous U.S. Supreme Court held that state law is completely pre-empted by the Employee Retirement Income Security Act (ERISA)of 1974 with respect to disputes over denial of benefits under ERISA-regulated health benefit plans. The Court's ruling appears to insulate managed care organizations from punitive and extra-contractual damages related to denial of benefits. In its decision, the Court overruled two lower court rulings.

The proposal would offset the cost of tax incentives by setting a cap on employers' tax exclusions.

HHS could decide in the future to pay for gastric bypass surgery.

I have learned over the years that I am, for better or worse, a fairly risk-averse person. Given the choice between steady production and a high-risk/high-reward opportunity, I'll almost always choose the former.

Consumer-driven healthcare will greatly influence benefit and co-pay structures over the next decade, HealthTrans leaders predict.

Proposals to allow Medicare to negotiate prices similar to those available to the VA are unjustified, according to PhRMA.

According to a study published in the New England Journal of Medicine, short-term use of estrogen plus progestin significantly decreased the risk of colorectal cancer among postmenopausal women; however, for unknown reasons, the colorectal cancers that did develop in the hormone-treated group were diagnosed at a more advanced stage.

Pioglitazone was also significantly superior to the other 2 treatment groups in decreasing triglycerides.

A recent study found that atorvastatin at its starting dosage reduces the risk of a first major cardiovascular event in patients with type 2 diabetes, said Helen Colhoun, MD, at the 64th scientific sessions of the American Diabetes Association (ADA) in Orlando.

Release of GLP-1 in responseto an ingested meal and glucose load plays a major role in the development of impaired insulin secretion.

At Digestive Disease Week in New Orleans, Steve Flamm, MD, associate professor of medicine and medical director of liver transplantation, Northwestern University, Chicago, Ill, presented study findings indicating that patients with chronic hepatitis C virus (HCV) infection and persistently normal liver enzymes derive as much benefit from pegylated interferon-alfa 2b plus ribavirin therapy as do patients with elevations in serum alanine aminotransferase (ALT). According to Dr Flamm, lead investigator for the study, "... a fraction of patients with normal liver enzymes do have aggressive liver disease on liver biopsy despite their liver tests being normal."