News

Ranolazine extended-release significantly reduced the level of hemoglobin (Hb) A1c in patients with diabetes, allowing more of them to achieve the clinical HbA1c treatment target of less than 7.0%.

Two new studies presented during the American Hospital Association Scientific Sessions, Nov. 3-7, 2007, in Orlando, could speed the replacement of abciximab by eptifibatide in cardiac patients. EVA-AMI showed similar outcomes between the two drugs when used in percutaneous coronary intervention (PCI) and BRIEF-PCI showed that a two-hour infusion of eptifibatide can be as effective as the standard 18-hour course following uncomplicated PCI procedures.

Bystanders and automated external defibrillators (AEDs) are a life-saving combination.

Prasugrel, a new antiplatelet agent in Phase 3 clinical trials, is superior to clopidogrel in preventing major adverse cardiac events in patients undergoing percutaneous coronary intervention (pCI), but is associated with an increase in the risk of major bleeding.

Real-time pharmacogenetic-guided dosing of warfarin does not lead to a reduction in prothrombin time international normalized ratios (INRs) out of the therapeutic range compared with standard warfarin dosing, although it did lead to smaller and less frequent warfarin dosing changes, reported Jeffrey L. Anderson, MD.

In older patients with advanced systolic heart failure, rosuvastatin added to standard heart failure medications failed to significantly reduce incidence of a composite of cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke compared with placebo, although it did reduce the incidence of all-cause and cardiovascular-related hospitalizations.

Asymptomatic peripheral artery disease (PAD) is becoming more prevalent, and at least among women, is associated with a significantly higher prevalence of obesity, Andrew D. Sumner, MD, said.

Parkinson disease (PD) is a chronic, progressive neurodegenerative disorder affecting approximately 1% of people aged >60 years. Levodopa has long been the cornerstone of PD treatment, but many patients receiving long-term levodopa therapy experience dyskinesia and motor fluctuations. Dopamine agonists act directly on dopamine receptors and are associated with a lower incidence of dyskinesias. There are 2 subclasses of dopamine agonists: ergot-derived and nonergot-derived. The use of ergot-derived dopamine agonists has declined in recent years due to the agents' association with valvular heart disease. Nonergot-derived dopamine agonists such as ropinirole and pramipexole are used more widely in the treatment of PD. Rotigotine is a nonergot-derived dopamine agonist that was approved by FDA on May 9, 2007, for the treatment of early-stage idiopathic PD. Rotigotine is the first approved nonergot-derived dopamine agonist that is delivered continuously through a transdermal silicone-based patch that is replaced..

A summary of agents in late-stage development for the treatment of Alzheimer's disease (November 2007).

An investigational drug that combines niacin extended-release (ER) and laropiprant, a prostaglandin D2 receptor antagonist, reduces the flushing that often leads to niacin ER discontinuation while preserving the agent's beneficial effects on lipids, according to lead author Darbie Maccubbin, PhD, Merck Research Laboratories, Rahway, New Jersey, et al. The results of this research were presented at the European Society of Cardiology Congress 2007 in Vienna, Austria, September 1 to 5, 2007. The drug is pending FDA approval.

In a randomized, controlled, open-label trial in patients with peripheral arterial disease (PAD), it was demonstrated that antiplatelet therapy plus an oral anticoagulant was no better at preventing major cardiovascular complications than antiplatelet therapy alone. The combination therapy was also associated with a significant increase in life-threatening bleeding complications compared with monotherapy.

In a prespecified secondary analysis of the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes (MERLIN)-TIMI 36 trial, ranolazine was associated with a reduction in the number of episodes of ventricular tachycardia and supraventricular tachycardia. The results of the analysis were presented at the European Society of Cardiology Congress 2007 in Vienna, Austria.

Questions about the safety of drug-eluting stents (DES) versus bare metal stents (BMS) persisted after 2 studies presented at the European Society of Cardiology (ESC) Congress 2007 in Vienna, Austria, demonstrated varying effects of DES and BMS on long-term mortality.

In the Blue Mountains Eye Study published in the American Journal of Ophthalmology, statin use was demonstrated to be protective against the development of cataracts, reducing a patient's risk by nearly half.

In 2 large, case-control studies published in the New England Journal of Medicine (NEJM), researchers demonstrated that, overall, a woman's use of a selective serotonin-reuptake inhibitor (SSRI) in early pregnancy was not associated with significantly increased risks of congenital heart defects or most other types of birth defects.

Throughout 2007, Formulary's "Focus on" articles have examined 9 newly approved or investigational drugs of interest to pharmacy and therapeutics committee members. Because many readers have said that they frequently reference this column when making formulary decisions for their hospitals, health systems, or managed care organizations, the editors have compiled this review of these agents, along with updates on the regulatory status of each. Of the 9 agents reviewed in 2007, 4 have received final FDA approval; the remaining 5 agents have not yet been approved by FDA.

FDA approval information regarding zoledronic acid (Reclast injection), somatropin (rDNA origin) injection (Norditropin), clopidogrel 300-mg loading dose (Plavix), IV and oral levofloxacin (Levaquin), thrombin, topical (human) (Evithrom), amlodipine/olmesartan (Azor), and docetaxel injection concentrate (Taxotere)

The latest FDA action (through November 2007) related to anecortave depot suspension (Retaane), lamotrigine extended-release (Lamictal XR), pramlintide injection (Symlin), frovatriptan (Frova), lumiracoxib (Prexige), PI-88, C1 inhibitor (Cinryze), Etravirine, IPI-504, Parathyroid hormone (rDNA origin) for injection (Preos), and pafuramidine

Raloxifene was approved on September 13, 2007, for the additional indication of the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.

FDA has approved doripenem, a carbapenem antibiotic, for the treatment of complicated intra-abdominal and urinary tract infections, including pyelonephritis

The important role of Medicaid health plans in states where landmark healthcare reform efforts are under way is highlighted in a new report, Medicaid Health Plans: A Turnkey Solution for Expanding Health Insurance Coverage for the Uninsured. Sponsored by the Association for Community Affiliated Plans (ACAP), the report focuses on health plans in California and Massachusetts – two states breaking ground in expanding coverage to uninsured residents.

To define e-visits, CPT code 0074T was adopted in 2004, says Lynn Gonzalez Monson, director of health information technology for Blue Cross and Blue Shield of Florida. The code requires documentation of history, system review and complexity of medical decision-making similar to those for office visits and consultations, establishing a firm basis for review. Reimbursement is limited to established patients. The Florida Blues allowed payment for the code since its inception, even for fully insured clients, and have reviewed every case it has been billed.

With transparency becoming a given, pharmacy benefit managers (PBMs) have taken a new approach to marketing their services. The primary marketing/sales strategy for Express Scripts, headquartered in St. Louis, is direct sales with a reliance on intermediary consultants and advisors.

Today, hospitals and other facilities are implementing forms of pay for performance in previously unimaginable ways. Such programs typically use established ratings methods and indicators to measure levels of quality, then offer incentives or compensation to entities or providers who are rated highly based on these indicators.

An effective use of hospitalists is to have them available to free up general practitioners from hospital rounds. Appropriate use of hospitalists can also enable physicians to visit patients more than once a day in the hospital setting.

Regardless of the structural framework of any nation's healthcare system, a critical measure of its success will depend upon the aligned incentives and objectives of its key constituents.

Pharmacy Benefits Managers (PBMs) have long gotten a bad rap, taking heat for lack of transparency in their dealings with pharmaceutical manufacturers. Some agreements leave health plans in the dark about the true value of their PBMs. Touting benefits, from clinical-based formularies and lower drug costs and to specialty pharmacy benefits and retail networks, may not be enough today to attract business in a competitive marketplace.

Ambulatory Surgical Centers (ASC) represent an unparalleled snapshot of the evolution of healthcare delivery, experts say. The surge in growth of ASCs nationwide affords patients the opportunity for non-emergent surgical and procedural services outside the hospital structure while also yielding cost-effective benefits for managed care organizations.

Earlier this year Susan Andrews, MD, evaluated a broken arm for a long-time patient in her family practice. Without leaving her Memphis office, Dr. Andrews conducted a complete history, assessed the injury and arranged a referral to an orthopedist, even though the patient was actually 2,000 miles away vacationing in the Caribbean.

Private sector organizations are pitching the government on new business, such as the recently embraced special needs plans (SNPs), designed for the costliest populations of seniors. Prompted by the Medicare Modernization Act, there are three SNP models: dual-eligible, institutional care and chronic condition.