Two Drugs Approved for Social Phobia

Two drugs that are commonly used to treat depression and generalized anxiety, venlafaxine HCl (Tablet Effexor® XR, Wyeth) and sertraline HCl (Drug Zoloft®, Pfizer), have now been approved by the Food and Drug Administration (FDA) for the treatment of Social Anxiety Disorder, sometimes called “social phobia.”

Social Anxiety Disorder affects 13% of Americans and is marked by overwhelming and disabling fear of scrutiny, embarrassment, or humiliation in social situations, which the person often avoids or endures with dread. It is the third most common psychiatric disorder in the U.S. Adults with this mood disorder usually recognize that their fear is excessive. Patients have a 40% to 50% lifetime prevalence of coexisting major depressive disorder.

Venlafaxine works by increasing the levels of two different chemicals in the brain that are thought to be deficient in depressed or anxious patients, according to the manufacturer. In two 12-week studies, the drug significantly reduced symptoms associated with Social Anxiety Disorder, compared with placebo, within only four to six weeks, with continued improvement seen up to week 12.

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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.

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Fast Relief for Breakthrough Cancer Pain

Fast Relief

“Breakthrough” pain, a transitory exacerbation of pain that has been generally stable, can be unpredictable and can escalate rapidly in patients with cancer. Oral opioid agents are not always the answer because they may act too slowly.

A nasal morphine-chitosan solution might be a fast, reliable, convenient way to tame breakthrough pain, say British researchers who conducted a pilot study of the drug combination. The nose offers advantages to enhance drug absorption, because it is a large, highly vascularized surface area and the venous blood drains from the nose directly into the systemic circulation, thus avoiding hepatic first-pass metabolism.

Chitosan, a bioadhesive material that binds to mucous membranes, provides other benefits. Morphine, a hydrophilic drug, is poorly absorbed nasally. Chito-san delays clearance and gives the drug more time to work. Adding chito-san to morphine boosts its nasal bioavailability from 10% to 54%, with a time to maximum concentration of 15 minutes. In contrast, even “immediate-release” morphine can take 20 to 30 minutes to begin relieving pain, with peak analgesia reached after one hour or more.
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In the study of 14 patients, the researchers observed 20 episodes of breakthrough pain. The patients were given 5 to 80 mg of nasal morphine-chitosan in addition to their regularly prescribed analgesics. Nearly all of the patients rated the treatment as “good” to “excellent”; two found it only “fair.” Morphine-chitosan acted rapidly, with pain relieved or reduced after only five minutes and with maximal improvement reached after 45 minutes.

Side effects were slight and transient. Four patients reported “severe” taste disturbance, which was apparently dose-related. The most common adverse effect was sedation, reported during 16 episodes.

The researchers suggest that the formulation allows morphine to be given more conveniently, which might benefit patients at home and those who are vomiting or unable to swallow.

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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.

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Cardiac Medication Available in I.V. Form

Amiodarone hydrochloride intravenous injection (Faulding Pharmaceuticals) is now available to initiate treatment for, and to prevent, frequently occurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients who have not responded to other therapies. Patients for whom oral amio-darone is indicated but who cannot take drugs orally are also suitable candidates for the injectable form. generic protonix

The drug is available in packages of 10 ampules, each at a dose of 150 mg/3 ml.

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Statins after Heart Transplantation

Heart Transplantation

Statins may help keep heart-transplant patients alive longer, say researchers from Munich-Bogenhausen, University Hospital Munich-Grosshadern, and University Hospital Leipzig. According to an eight-year prospective, randomized, unmasked study of 72 patients, 89% of those who were given simvastatin (Zocor medication, Merck) four days after transplantation survived, in contrast to 60% of patients who didn’t start a statin regimen until four years later. All patients had been given a strict low-cholesterol diet after surgery. Thirty-five patients were receiving daily statin treatment, and 37 were receiving dietary therapy alone.

The average ages of patients were 49 in the simvastatin group and 47 in the control group. The average donor age was 30 for the simvastatin transplant recipients and 34 for the control-arm recipients.

After four years, the benefits of sim-vastatin were so much better that all of the patients were offered the drug. The long-term effects might be explained, in part, the researchers say, by the drug’s efficacy in lowering cholesterol levels and thereby reducing the incidence of transplant vasculopathy, a major complication of heart transplantation characterized by thickening of the coronary artery. Early simvastatin treatment halved the incidence of vessel thickening; by eight years after the surgery, transplant vasculopathy occurred in only 24% of the patients taking statins but developed in 55% of the patients being treated with diet alone. There was no difference in organ function between the two groups.

Four patients in the diet-alone (control) group died as a result of transplant vasculopathy, whereas only one transplant patient died in the group receiving simvastatin. No severe adverse effects from the therapy were documented up to the end of the eight-year observation period.

The researchers suggested that sim-vastatin might be successful in reducing not only cholesterol levels but also the growth of smooth muscle cells, which contribute to vessel thickening.

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Soy Protein and Warfarin

If patients who are taking the anticoagulant generic warfarin suddenly have a lower International Normalized Ratio (INR), health care providers are advised to determine whether they are also consuming soy protein.

A pharmacist at Fallon Clinic, in Webster, Massachusetts, described a patient who was stable with warfarin therapy until he started drinking soy milk daily as part of his treatment for hypertriglyceri-demia. Within five days, his INR values began dropping, from 2.5 to 2.3. The patient drank approximately 480 ml of soy milk daily for three weeks while taking his prescribed medications as directed. After four weeks, his INR was 1.6.

A target INR range of 2.0 to 3.0 is recommended for most indications, such as treatment or prevention of deep vein thrombosis, prevention of excess clotting, and other preventive measures for patients with atrial fibrillation. The risk of an embolism or related event doubles if the INR decreases to 1.7, and the risk of hemorrhage rises if the INR is above a range of 4.0 to 5.0.

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