News

The first-ever anticoagulant drug-plus-antidote system has passed initial safety trials at Duke University in Durham, N.C. The new platform combines a short nucleic acid chain that quickly blocks clotting with an antidote that removes the clotting blockage in minutes.

Researchers in Japan have created the first heart valves using the recipients' own tissues-in rabbits. Growing replacement valves in a host with host tissue could virtually eliminate rejection when the valve is implanted.

A series of analyses offers no consensus on the safety of drug-eluting stents (DES) compared with bare metal stents. Depending on the study, DES either result in an increase in major adverse coronary events (MACE) or a decrease in subsequent need for coronary artery bypass graft (CABG) surgery and repeat percutaneous coronary intervention without an excess of adverse clinical events.

A comparison of the investigational COX-2 inhibitor etoricoxib and diclofenac found no increase in the risk of cardiovascular events over 3 years with etoricoxib.

Screening for coronary calcium may provide an impetus for physicians to initiate preventive cardiovascular therapies in patients who have coronary calcium, but persistence with the medications is no better than in patients who are started on therapies without a coronary calcium test, said Allen J. Taylor, MD

Implanting a pacemaker or a cardiac defibrillator is the beginning of treatment, not the end. That was the message from a panel of researchers who spoke yesterday at the AHA Scientific Sessions.

Healthcare is a disaster in progress. That was the stark warning from AHA president Raymond Gibbons, MD, during his presidential address yesterday at the American Heart Association (AHA) Scientific Sessions.

A cost-effectiveness analysis suggests that restricting the use of drug-eluting stents (DES) is prudent. In the analysis, the substitution of DES for bare metal stents appears to be cost-effective only when the target vessel revascularization (TVR) rate with bare metal stents is high, which is typically the case in small vessels and longer stenoses, said Sanjay Kaul, MD, MPH.

Two studies confirm that chronic kidney disease (CKD) is associated with coronary heart disease (CHD) and its severity. In one of the studies, anemia was also a predictor of CHD and its severity.

The city of Chicago offers a host of activities, museums, shopping and cultural activities for attendees of the American Heart Association (AHA) Scientific Sessions 2006.

Welcome to Conference Update, highlights from the American Heart Association's Scientific Sessions in Chicago, Illinois, Nov. 12-15, 2006.

Review of agents in late-stage development for the treatment of juvenile idiopathic, psoriatic, and rheumatoid arthritis (November 2006).

Dose consolidation is receiving mixed reviews as a cost-cutting strategy, according to pharmacy benefit managers (PBMs). Although a study by Express Scripts, based in St. Louis, Mo, indicates that savings opportunities are limited, other PBMs have realized more value. With prescription drugs accounting for 10% of total healthcare expenditures according to the California Healthcare Foundation's third Health Care Costs 101 report, various cost-cutting strategies are worth exploring.

Wal-Mart recently announced a pilot program in Florida to sell 30-day prescriptions of approximately 300 generic medications for $4 each. At press time, Wal-Mart announced it will be rolling out the $4 generic prescription program in 26 additional states-3 months earlier than expected-reportedly because of consumer demand. Wal-Mart said 88,235 new prescriptions were filled in the 10 days after the initial rollout.

FDA's withdrawal of rofecoxib (Vioxx, Merck) in 2004 and other controversies have prompted numerous reports from legislators, the scientific community, and others calling for substantial changes in FDA's and its Center for Drug Evaluation and Research's (CDER's) roles as the nation's overseers of medication safety. The outcry for FDA reform reached another peak in late September when a committee convened by the Institute of Medicine (IOM) of the National Academies released its report, "The Future of Drug Safety," which recommended a "coherent and integrative approach" to transform the agency and a pharmaceutical industry that the committee says has had its credibility "compromised" in the eyes of the public.

This selective long-acting beta2-adrenergic receptor agonist causes relaxation of bronchial smooth muscle and has 2-fold greater potency than racemic formoterol. Arformoterol was approved on October 6, 2006, for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

A once-daily transdermal patch containing the dopamine receptor agonist rotigotine appears to be well tolerated, provides sustained relief from motor symptoms associated with Parkinson disease (PD), and has few dopaminergic adverse effects, particularly among elderly patients, reported Ray L. Watts, MD, and colleagues at the American Neurological Association 131st Annual Meeting, and Jack J. Chen, PharmD, and colleagues at the 2006 American College of Clinical Pharmacy Annual Meeting. Transdermal rotigotine is currently being reviewed by FDA for the treatment of early PD.

A secondary analysis of data from the Stroke Prevention with Aggressive Reduction in Cholesterol Levels (SPARCL) trial demonstrated that statin treatment can significantly reduce the severity of a second ischemic stroke in patients who had no history of coronary heart disease. With statin treatment, there were fewer fatal and severe strokes, fewer moderate and mild strokes, fewer transient ischemic attacks (TIAs), and more patients who had no events, said Larry B. Goldstein, MD, at the American Neurological Association (ANA) 131st Annual Meeting.

Administration of inhaled corticosteroids (ICS) within 90 days of hospital discharge is effective in reducing mortality in chronic obstructive pulmonary disease (COPD) patients, especially among those aged 35 to 64 years, according to a recent study published in the journal Chest.

Although use of the cyclooxygenase (COX)-2 inhibitor celecoxib has demonstrated benefit in preventing premalignant colorectal adenomas, generally the agent should not be recommended for this purpose due to the risk of cardiovascular events, according to 1 recent trial. In a second study of celecoxib use and adenomas, treatment with celecoxib 400 mg/d markedly lowered the incidence of colorectal adenomas within 2 years after the removal of polyps.

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have developed a consensus algorithm for the management of hyperglycemia in type 2 diabetes. The statement, published in the August issue of Diabetes Care, was created for several reasons.

In a randomized, double-blind, placebo-controlled trial recently published in Lancet, the thiazolidinedione (or "glitazone") rosiglitazone statistically significantly reduced the incidence of new-onset diabetes when given to patients diagnosed with prediabetes but lacking a prior history of cardiovascular disease. The benefits of using thiazolidinediones in the treatment of patients with diabetes are well known, but the current finding that thiazolidinediones can prevent prediabetics from progressing to diabetes is novel.

Intensive statin therapy administered to patients within 14 days of hospitalization for acute coronary syndrome (ACS) can reduce the risk of death and certain cardiovascular events by nearly 20%, according to a meta-analysis by Eddie Hulten, MD, MPH, and colleagues recently published in Archives of Internal Medicine.

So far this year, Formulary has examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics committee members through our "Focus on" articles. Because many readers have expressed that this information is useful when making formulary decisions for their hospitals, health systems, or managed care organizations, Formulary has compiled this late-year review of these new and emerging agents, along with updates on the regulatory status of each.

Obesity is on the rise in the United States, with 60.5% of the adult population overweight and 23.9% obese as of 2005. Up to 10% of an industrialized country's healthcare budget often can be spent on obesity and associated comorbidities.

Lisdexamfetamine (NRP104, Shire/New River Pharmaceuticals) for the treatment of pediatric attention-deficit/hyperactivity disorder (ADHD)

FDA granted 2 additional indications for rituximab (Rituxan, Genentech/Biogen Idec) in the treatment of patients with CD-20-positive, B-cell non-Hodgkin's lymphoma (NHL). The agent is now approved as first-line treatment of previously untreated patients with follicular NHL in combination with cyclophosphamide, vincristine, and prednisolone (CVP) chemotherapy, and in the treatment of patients with low-grade NHL with stable disease, or in those with partial or complete response following first-line treatment with CVP chemotherapy.

Infliximab acts through the inhibition of tumor necrosis factor (TNF)-alpha, which is responsible for the induction of inflammatory cytokines, the enhancement of leukocyte migration, and the activation of neutrophil and eosinophil functional activity. Infliximab was approved on September 27, 2006, for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.