
FDA actions in brief as reported February 1, 2002
New combination: Fixed niacin/statin combination for second-line lipid therapy
NME: Topical nonsteroid for second-line eczema Tx
NME: 5-alpha reductase inhibitor for treatmentof benign prostatic hyperplasia
NME: Loratadine successor for symptoms of seasonal allergic rhinitis
as reported February 1, 2002
Atypical antipsychotics withstand strong Geodon debut; Reminyl slices into formulary presence of Alzheimer rivals
With its FDA approval in November, valdecoxib becomes the hird COX-2 inhibitor to gain US market clearance. This Focus article examines valdecoxib's pharmacologic, pharmacokinetic, and therapeutic aspects and considers its role in relation to other COX-2 inhibitors and traditional NSAIDs. Special attention is devoted to its comparative COX-1:COX-2 inhibitory ratio and an array of unpublished efficacy and safety trials.
This 287-study meta-analysis aimed to address unanswered questions about antiplatelet therapy in patients at high risk for occlusive vascular events. It yielded several new findings or clarifications, including these: (1) Antiplatelets protect against vascular events in patients with unstable angina, intermittent claudication, and atrial fibrillation. (2) Antiplatelet therapy can be started promptly during acute ischemic stroke and continued long-term. (3) Daily aspirin doses of 75 to 150 mg seem to be as effective as higher doses for long-term treatment.
Fluoroquinolones and nitrofurantoin have surpassed trimethoprim-sulfamethoxazole (TMP-SMZ) as the most frequently prescribed antibiotics for uncomplicated urinary tract infections (UTIs) in women, according to a new national analysis. This is despite well-established recommendations (from the Infectious Disease Society of America and others) that TMP-SMZ is the drug of choice for UTIs due to cost and concerns about antibiotic resistance.
A three-tier pharmacy benefit can reduce prescription drug spending without increasing other medical resource use or fueling medication discontinuation rates. So concludes the fully published report of an analysis whose preliminary results were presented last year and reported by Formulary (2001;36:522). It is the first well-designed, controlled study to explore such consequences of three-tier benefits.
Clinicians must use caution in adopting newly revised national guidelines for treating elevated cholesterol, concludes a new study from the University of Maryland Pharmaceutical Health Services Research Department.
An experimental antiviral medication can shorten the duration of colds and reduce the severity of cold symptoms, reported Frederick Hayden, MD. He presented a pooled analysis of data from two phase III trials of the drug at the 41st annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), held recently in Chicago.
Emerging data are continually refining our understanding of the risks and benefits of hormone replacement therapy (HRT) in postmenopausal women. This review assesses the current state of evidence on these various risks and benefits, concluding with an outline of what's established and where varying degrees of uncertainty remain. Algorithms for use of HRT for several established indications are featured.
While government agencies and private health plans struggle to deal with rising pharmacy bills, the federal government is expanding support for biomedical research and FDA
Idaho State University, Pocatello-Evidence in the literature has suggested that a pharmacist-run clinic provides quality care in chronic disease state management. In addition
VA Medical Center, Miami-ACE inhibitor therapy is recognized as the gold standard treatment for congestive heart failure (CHF) as well as diabetic nephropathy due to its effect on the morbidity and mortality associated with these conditions.
Ranked by total HMO enrollment, January 1, 2001
Spending $1 per member on CRM can reap huge rewards in competitive markets
Dental, vision and hearing programs are surviving the recession, but they might not be out of the woods yet
They say that if you love something, you should set it free. If it comes back to you, it's yours. If it doesn't, it never was.
As health care costs and pharmaceutical expenditures continue to climb, the effect of these trends on health care coverage and economic development is emerging as a central issue for 2002.
Prime Therapeutics, St. Paul, MN-Do quantity limits on abortive migraine medications (ie, triptans) and educational efforts to increase the use of prophylactic therapy reduce total health care costs over the long term?
ValleyCare Health System, Pleasanton, CA-The expansion of decentralized clinical pharmacy services at this health system served as the impetus to improve their clinical intervention documentation process.
Two new real-world comparisons of the tumor necrosis factor (TNF) blockers infliximab (Remicade) and etanercept (Enbrel) show that the two agents are highly comparable treatments for rheumatoid arthritis
While tiered benefit plans aim to spur use of lower-cost alternative drugs, they may leave patients in the dark about what those alternatives are and how much out-of-pocket savings they can bring.
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.