Drug Pipeline

Methicillin-resistant Staphylococcus aureus (MRSA) strains showing reduced susceptibility to vancomycin (minimum inhibitory concentration [MIC] of 2 mcg/mL) and requiring aggressive empiric vancomycin dosing are highly prevalent among those that cause invasive infections, according to a prospective cohort study.

The American Heart Association (AHA) Scientific Sessions comprise the world's largest conference for scientists and healthcare professionals focusing on cardiovascular disease. The 2006 AHA Scientific Sessions, which took place Nov. 12–15 in Chicago, Ill, featured invited lectures and investigative reports. The conference included presentations on trials that evaluated investigational therapeutic agents, existing drugs and drug-related devices, and approved agents in alternative regimens or for alternative indications.

Women who take prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy, specifically the first trimester, may increase their risk of giving birth to a child with congenital anomalies, especially cardiac septal anomalies, compared with women who do not take NSAIDs during this period, according to a recent study published in Birth Defects Research (Part B).

Adverse drug events (ADEs) led to the treatment of an estimated 701,547 patients in US emergency departments (EDs) in 2004 and 2005, according to a recent study in the Journal of the American Medical Association (JAMA). Significantly, those patients ?65 years of age were 2 times more likely to have ED treatment for an ADE and approximately 7 times more likely to need hospitalization than their younger counterparts.

Infliximab was approved on October 13, 2006, for the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and elimination of corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Pramipexole was approved on November 7, 2006, for the treatment of moderate-to-severe primary restless legs syndrome (RLS).

Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Men who suffer from migraines are at increased risk for cardiovascular events, according to researchers. The new findings follow similar reports that women with migraines are at higher risk for cardiovascular disease.

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Pharmacist-directed education combined with prepackaging of medications increases compliance with medication schedules, leading to improvements in blood pressure and cholesterol levels among elderly patients, according to a study headed by Allen J. Taylor, MD.

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.

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.

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

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.

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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.

Two studies of the effects of famotidine in patients with chronic heart failure (CHF) have demonstrated that the treatment improves cardiac symptoms of CHF, including ventricular remodeling. Famotidine has not been approved by FDA for treatment of CHF.

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.

In a randomized, double-blind, placebo-controlled trial, the angiotensin-converting enzyme (ACE) inhibitor ramipril, when administered to patients with prediabetes but no previous cardiovascular disease, failed to demonstrate a statistically significant reduction in the primary composite end point of new-onset diabetes or death.

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.

FDA recently released an information sheet advising healthcare professionals about a potential pharmacodynamic interaction between low-dose aspirin (81 mg/d) and ibuprofen 400 mg when they are dosed concomitantly. This interaction may attenuate aspirin's anti-platelet cardioprotective effect in patients taking aspirin for secondary prevention of myocardial infarction.