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When used for their approved indications, drug-eluting stents (DES) probably do not increase the risk of death or myocardial infarction (MI) compared with bare metal stents (BMS), an FDA advisory panel concluded at a meeting in Gaithersburg, Md, last month.

The chronic and excessive use of alcohol adversely affects the healthcare system, work productivity, and familial and social relationships. Alcohol misuse accounts for 85,000 deaths per year in the United States, and the overall financial costs related to alcohol dependence are more than $100 billion annually. The reduction of alcohol misuse can be measured as an increase in the frequency of abstinence or a reduction in the frequency of relapses. The recommendation for alcohol dependence treatment is a combination of psychosocial support therapy and pharmacologic treatment. Currently, there are only 3 FDA-approved agents for the treatment of alcohol dependence: naltrexone, acamprosate, and disulfiram.

Men who suffer from migraines are at increased risk for cardiovascular (CV) events, according to new data from the Physicians' Health Study. These observations follow similar reports that women with symptoms associated with migraines are at higher risk for CV disease.

Data indicate that oral rifaximin can prevent recurrences of Clostridium difficile-associated diarrhea (CDAD) in patients treated previously with vancomycin, said presenters at the American College of Gastroenterology Annual Scientific Meeting (ACG) in Las Vegas, Nev.

A once-daily formulation of mesalamine that relies on multimatrix (MMX) technology is effective at inducing and maintaining remission in patients with ulcerative colitis (UC), with no significant gender difference in the response rate, according to studies presented at Digestive Disease Week (DDW) 2006 in Los Angeles, Calif, and at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nev.

Combination therapy with ezetimibe and simvastatin for 6 weeks provides greater reductions in low-density lipoprotein cholesterol (LDL-C) compared with rosuvastatin at the usual starting, next highest, and maximum doses of each drug, according to a randomized, double-blind, parallel-group, multicenter trial published in the journal Current Medical Research and Opinion.

According to an observational study recently published in the American Journal of Cardiology, use of a statin was associated with a 46% decrease in patients' odds of death compared with the risk of death in those not receiving a statin, despite the fact that statin users were in general at a higher risk for death. Furthermore, the magnitude of the observed mortality benefit associated with statin use appeared to increase as a patient's number of coronary heart disease risk factors increased.

A large, propensity score-adjusted cohort study recently published in the Journal of the American Medical Association (JAMA) demonstrated that statins were associated with a statistically significant reduction in the risks of death and hospitalization for heart failure when administered to patients with chronic heart failure (CHF). Although the ability of statins to lower cholesterol and prevent coronary heart disease in the general population is well known, the current finding that statins can reduce both morbidity and mortality in this broad CHF population is novel.

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17 alpha-hydroxyprogesterone (Gestiva, Adeza) for the prevention of preterm labor

Paroxetine oral suspension 10 mg/5 mL equiv base (equiv to Paxil oral suspension 10 mg/5 mL equiv base)

FDA Actions in Brief

FDA granted tentative approval to a combination of valsartan and amlodipine (Exforge, Novartis) for the treatment of hypertension (approval pending the expiration of market exclusivity and patent protection for amlodipine).

Bevacizumab

Angiogenesis inhibitor approved as part of combination therapy for first-line treatment of nonsquamous NSCLC

Kunecatechins

Botanical agent approved for topical treatment of external genital and perianal warts

Imatinib (Gleevec, Novartis) was approved for relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, certain forms of myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome and/or chronic eosinophilic leukemia, and unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans.

Telbivudine

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.

The Oklahoma City Veterans Affairs Medical Center restructured its formulary system in 2003, creating a system of restrictive criteria for certain drugs to improve pharmaceutical cost effectiveness by enforcing evidence-based indications in the prescription system. The new criteria-restriction system required the use of formulary drugs as first-line therapy; prescriptions for nonpreferred, criteria-restricted drugs had to be justified by the prescriber at the time of prescription in accordance with the criteria established by the pharmacy and therapeutics (P&T) committee. To determine the effects of the system on cost avoidance and prescriber opinion, we analyzed drug utilization statistics and surveyed prescribers. Analysis demonstrated that the criteria-restriction system was an effective cost-avoidance tool because inappropriate prescriptions for restricted, high-cost drugs were curtailed in favor of lower-cost formulary alternatives. The total cost avoidance observed after placing 15 outpatient drugs in..

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.