Category: NEW DRUGS

Antioxidants for the Critically Ill: Better Sooner Than Later

Giving critically ill patients supplemental antioxidants before they appear to need them can help keep organs from failing, say researchers from Harborview Medical Center in Seattle, Washington.

Of 595 patients, 310 were randomly assigned to receive alpha-tocopherol and ascorbate and 294 were assigned to standard care. By day 28, 44 (15%) of the patients receiving standard care had developed pneumonia, compared with 36 (12%) of the patients in the group receiving antioxidants. In the same time period, 53 (18%) standard-care patients had developed acute respiratory distress syndrome (ARDS), versus 47 (16%) of the antioxidant group. Seven (2.3%) of the patients receiving standard care and four (1.3%) of the patients receiving anti-oxidants died.
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Overall, only 26 (4%) patients had multiple organ failure, but the antioxidant group had a 57% lower incidence. The patients receiving antioxidants also had, on average, one less day of mechanical ventilation, more ventilator-free days, shorter stays in the intensive-care unit (by 1.2 days), and shorter hospital stays (by 0.4 day).

The researchers suggest that anti-oxidants might reduce both the amount of oxidative tissue injury and the early inflammatory response, possibly because of their effects on gene activation.

New Tool for Hospital Pharmacies

The Formulary Advisor™ is a new product that is expected to simplify the development and management of online formularies in hospitals. It allows prescribing clinicians to view, create, manage, and update a complete formulary on a desktop or laptop computer or on a personal digital assistant (PDA).

The device provides immediate access to current information and should benefit prescribing clinicians, pharmacists, and, eventually, patients. Hospital personnel will be able to access the information with a minimal disruption of workflow, thus saving time.
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The Formulary AdvisorTM also displays prices for each medication in the formulary; posts documents, Web links, policies, or news needed by hospital staff; and prints hard copies of the entire formulary. It is expected that using the product will lead to a reduced number of drug-delivery delays, which are a primary cause of medication errors.

Alteplase: How Low Can a Dose Go


Alteplase has replaced urokinase as the first choice in restoring blood flow through hemodialysis catheters, but the lowest effective dose has not been established. Reports have documented effectiveness with doses ranging from 2 to 45 mg.
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In a retrospective study of 27 patients given alteplase and 10 given urokinase between June 1997 and December 2000, researchers from Grady Health System in Atlanta, found that 1 mg/ml per port of alteplase and 5,000 U per port of urokinase worked equally well. However, patients with alteplase-treated catheters were twice as likely to achieve hemodialysis blood flow rates of greater than 300 ml/ minute and were more likely to complete hemodialysis during the session (90% compared with 70%). In addition to the effectiveness of alteplase, the researchers cite its potential cost savings. Using 1 mg rather than 2 mg per port saved approximately $2,000 for the 43 doses of alteplase administered in the study.

Methadone Link to Torsades de Pointes?

There is some concern that methadone, used in very high doses, might be linked to torsades de pointes, an atypical form of ventricular tachycardia (rapid heartbeat) that can lead to ventricular fibrillation. Methadone is used in the treatment of opioid dependency and pain.

Researchers at Denver Health Medical Center performed a retrospective study of patients in methadone treatment programs in the U.S. and in a pain management center in Canada. The mean daily methadone dose was 397 + 283 mg. The mean corrected QT interval (QTc) was 615 + 77 msec. Of the 17 patients who developed torsades de pointes, 14 had a predisposing risk factor for arrhythmia. A pacemaker or cardiac defibrillator was placed in 14 patients; all 17 survived.
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A methadone derivative, levacetyl-methadol, was withdrawn from the European market after being associated with torsades de pointes, the researchers say, but to date no association has been reported between methadone and the arrhythmia. The investigators have called for further research into their findings, given that methadone treatment is likely to expand into primary care.

HAART Safe for Patients with HIV and Hepatitis C

Hepatitis C

Hepatitis C has no effect on the outcomes of patients with human immunodeficiency virus (HIV) who are treated with highly active antiretroviral therapy (HAART), according to researchers from Johns Hopkins University. The researchers said that the liver infection does not decrease the response to anti-AIDS drugs or speed progression of the illness.

The researchers followed 1,955 HIV-infected patients for at least two years. Nearly half of the patients had been exposed to hepatitis C. Patients who had both an HIV infection and hepatitis C seropositivity were less likely to have been prescribed antiretroviral therapy. The researchers explained that physicians were less likely to prescribe anti-retroviral therapy to these patients, whom they believed were more likely to experience liver complications from such medications.
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This study was presented at the 14th International AIDS Conference.

Patient-Friendly OTC Labels

As of May 16, 2002, most over-the-counter (OTC) drug manufacturers have begun using “consumer-friendly” labeling. The new Drug Facts label—patterned after the Nutrition Facts food label—features simpler language and an easier-to-read format. In addition to a larger type size and other changes to enhance readability, the label must include the drug’s information in the following order:

Age, Not Gender, Bias Found in Heart Attack Study

Heart Attack Study

According to a new study published in the June 19, 2002 issue of the Journal of the American College of Cardiology, the difference in treatment for heart attacks in men and women might be caused by age rather than by gender.
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The Institute for Clinical Evaluative Sciences in Toronto, Ontario, Canada, studied data from 25,697 heart attack patients hospitalized in Ontario between April 1992 and December 1993. They examined the association of age and gender with treatment intensity and five-year survival. The researchers found that rates of angiography (an invasive imaging technique) fell 17.5% for women relative to men with every 10-year increase in age. Although care became progressively less aggressive for women as they aged, their long-term survival rates nevertheless improved compared to those of the men; the relative survival rate in women rose 14.2% for every 10-year increase in age. These results suggest an age bias rather than a gender bias in the treatment of heart attack patients.