News

Ranolazine, the first in a new class of antianginal agents called the partialfatty acid oxidation (pFOX) inhibitors, improves exercise performance andreduces angina frequency in patients who still have symptoms despite treatmentwith other antianginal medications, according to Bernard Chaitman, MD. Hereported the results of a Phase III study called the Combination Assessmentof Ranolazine in Stable Angina (CARISA).

An agent developed specifically for the treatment of angina reduces theincidence of major coronary events, reported Henry Dargie, MD, who presentedthe results of a trial known as the Impact of Nicorandil in Angina (IONA).It is believed to be the first large-scale trial to report on the effectsof a specific antianginal drug on clinical outcome.

Anaheim, CA-The largest trial of cholesterol-lowering therapy ever conducted extends the current indications for statin therapy, reported Rory Collins, MD.

The selective serotonin reuptake inhibitors (SSRIs) fluoxetine, sertraline,and paroxetine are equally effective and tolerated in depressed patientsacross a broad range of outcome measures. So finds an open-label, randomizedstudy in 573 patients treated for depression for 9 months in a primary caresetting.

A step-down approach from proton pump inhibitor (PPI) therapy is successful in most patients with uncomplicated GERD, reducing costs without compromising quality of life. So concludes a new prospective study.

Differences among oral selective serotonin agonists (triptans) are small but clinically relevant for the individual patient, according to a comprehensive meta-analysis.

Pipeline Preview for January 1, 2002

FDA Actions in Brief as reported January 1, 2002

Although sensitivity analysis is a widely used technique for testing the uncertainty in pharmacoeconomic modeling parameters, it does have limitations. This month's column introduces probabilistic sensitivity analysis as an alternative method for examining uncertainty.

Tenofovir disoproxil fumarate (Viread) recently gained accelerated FDA approval. It is the first member of a new antiretroviral class and also the first antiretroviral approved on the basis of efficacy trials conducted almost exclusively in treatment-experienced patients. This Focus article reviews these studies and considers how other pending and planned trials may refine tenofovir's role.

Like their older counterparts, the newer anticonvulsants gabapentin, lamotrigine, and topiramate show promise for treating various off-label psychiatric and neurologic disorders. This review examines the quality of current evidence for these new uses, identifies where gaps in the evidence lie, and discusses which emerging uses of individual agents appear most justified.

Clinicians at Nebraska Methodist Hospital, a not-for-profit acute care facility, developed and implemented an automatic interchange program for the ACE inhibitor class of drugs. This article presents the ACE inhibitor review upon which the formulary decisions were based as well as the initial clinical and economic results of the interchange program. (This pdf version includes an appendix that was not included in the print issue)

Despite the bad reputation from consumer publications, MCOs should be proud of their successes

Perhaps the greatest criticism leveled at America's healthcare system is the fact that millions of people have no healthcare insurance at all. Our physicians are among the best trained in the world, and the equipment and technology they work with is state of the art. But those things are meaningless to patients who fall between the cracks of the system and can't access that care.

Part 2 follows certain projects through to conclusion while providing more advanced concepts to those considering the application of Six Sigma principles at their organization.

Ranked by consumer response to NRC study, 2001

Fondaparinux, the first in a new class of antithrombotics that selectively target factor Xa, has been deemed approvable by the FDA for prevention of venous thromboembolism following orthopedic surgery. Four phase III trials have suggested that it may be more effective than enoxaparin in this setting with little to no additional bleeding risk. This Focus review examines data from these trials and others in an effort to sketch out this pending agent's likely therapeutic role.

New Formulations/Combinations: Pediatric-specific albuterol formulation; fixed-dose bronchodilator combination

New Indication: Light-activated ophthalmic cleared for CNV due to two additional causes

New Indication: Injectable PPI cleared for hypersecretion due to Zollinger-Ellison syndrome

NMEs/biologics: 5-HT receptor agonist for Tx of migraine

Uncle Sam is poised to authorize more than $1 billion to buy medicines and vaccines for the national pharmaceutical stockpile, and federal agencies are gearing up to spend millions more on research related to infectious disease. In response, the pharmaceutical industry is assessing how these developments may alter the way it does business.

Pipeline Preview for December

How diabetes works and who it targets.

Third-party physician credentialing could keep providers focused on their core businesses

MCOs and voluntary health agencies collaborate to improve care, perception

Achieving clinical excellence has always been the goal of the U.S. healthcare industry, even on the payer side.

Ranked by total HMO enrollment as of July 1, 2000

Third-party physician credentialing could keep providers focused on their core businesses

In less than 2 weeks after the launch of generic fluoxetine in August, Merck-Medco had switched 85% of its mail-order Prozac prescriptions to generic versions of the antidepressant. It says its generic switch rate for retail Prozac scripts was 69% over the same time period.