News

The thiazolidinedione pioglitazone has a beneficial effect on carotid intima media thickness (CIMT) compared with glimepiride in patients with type 2 diabetes, said Theodore Mazzone, MD, lead investigator of the CHICAGO (Carotid Intima Media Thickness in Atherosclerosis Using Pioglitazone) study.

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.

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

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.

Chicago: Things to do

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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.

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.

Arformoterol

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.

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.

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.

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.

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

FDA Actions in Brief

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.