American College of Physicians: Internal Medicine — Doctors for Adults ®

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In the News for the Week of 3-14-06

Clinical news in the headlines

FDA update

Annual Session 2006


Clinical news in the headlines

New antiviral proves effective in treating hepatitis B

A newly published study reported that the latest antiviral agent approved for hepatitis B was more effective than other drugs and led to fewer cases of resistance.

In the study, 648 patients with hepatitis B received either 0.5 mg of entecavir or 100 mg of lamivudine once daily for at least 52 weeks. After 48 weeks, patients taking entecavir had significantly higher rates of histologic improvement, virologic response and normalization of alanine aminotransferase levels than those treated with lamivudine. The study appears in the March 9 New England Journal of Medicine (NEJM).

Both drugs have good safety records, an accompanying editorial said, but entecavir showed a lower rate of antiviral resistance. Resistance to lamivudine develops at a rate of between 15% and 25% of patients a year, reaching between 70% and 80% after four years, said the editorial. Another drug, adefovir, reaches between 15% and 20% resistance after four years. The editorial cautioned, however, that there is a lack of long-term data on entecavir.

The problem with all hepatitis B therapies is that no drug cures the infection, as is the case with hepatitis C, the editorial said. In most patients, drugs only suppress the virus, and relapses—often more severe than the initial onset—occur if treatment is stopped. Long-term treatment is an option, the editorial continued, but such a course is expensive and long-term safety has not been established.

Both entecavir and adefovir are appropriate first-line treatments for hepatitis B and likely should be continued indefinitely, said the editorial. These oral antivirals have the advantage of being easy to administer with few side effects and can be given to all patients with the virus, including those with liver decompensation.

Chronic hepatitis B accounts for up to half of all cases of cirrhosis, end-stage liver disease and hepatocellular carcinoma worldwide, the editorial noted. This study suggests that entecavir may be the most effective treatment, but physicians should be aware of the probable need for long-term use and that once started, the drug is difficult to stop.

The NEJM abstract and editorial are online.

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ACP Journal Club: Lorazepam most effective in treating epilepsy

A recent review found that lorazepam was more effective than other anticonvulsants in treating patients with status epilepticus (SE).

Researchers looked at 11 randomized controlled trials involving patients with premonitory, established, refractory and mixed SE. Lorazepam was better than phenytoin, diazepam or placebo in stopping seizures and preventing SE. The review is abstracted in the March-April ACP Journal Club.

The results are in line with standard practice and reinforce guidelines published more than 10 years ago, said reviewers J. Craig Henry, MD, and Robert Holloway, MD, of the University of Rochester Medical Center in Rochester, N.Y. While the review doesn’t provide new guidance on treatment, they said, it does highlight the need for standardized approaches in trials.

For example, different trials had different ways of classifying SE and different outcome measures, they said. Also, the different trials had no standardized approach to dosing and route of administration.

The review did not compare different administration routes, but the reviewers noted that intravenous formulations are still the route of choice, followed by rectal formulations and intramuscular as a last resort. While the review did not address what to do when treatments fail, a related review suggests that the best outcomes were achieved with continuous intravenous pentobarbital, titrated to electroencephalographic background suppression.

Peer ratings for this review: emergency medicine, hospitalists, neurology: 6/7 stars; general internal medicine, family medicine, general practice: 4/7 stars.

ACP Journal Club is online.

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FDA update

Panel advises bringing back banned MS drug

An FDA advisory panel last week recommended that a multiple sclerosis drug taken off the market last year be made available to patients, with certain restrictions.

The panel recommended that natalizumab, marketed by Biogen Idec and Elan Corp., go back on sale, according to the March 9 New York Times. However, the panel recommended that only patients enrolled in a mandatory registry should be eligible to receive it, allowing the government to track any incidence of a rare brain infection that led to the product’s removal.

Natalizumab was taken off the market four months after it was approved because three patients, two of whom died, were diagnosed with progressive multifocal leukoencephalopathy (PML), said the New York Times. About one in every 1,000 users is thought to run the risk of getting the infection.

Patients had pushed for the drug's return because it is the best option for some patients with nerve damage due to MS, the article said. Recent studies found that natalizumab cut the rate of relapse by as much as two-thirds and slowed disease progression in some patients.

PML is caused by a virus that typically lies dormant but could strike people with AIDS or others with weak immune systems, said the New York Times. The advisory panel cautioned that the risks of getting the infection could prove to be higher than originally thought because clinical trials included fairly young patients with less severe MS cases. In addition, PML symptoms can look very similar to an MS relapse.

According to the panel, patients who take natalizumab—in addition to enrolling with the registry—would have to be experiencing a relapse, taking no other MS drugs and receiving natalizumab only in specially designated infusion centers, said the New York Times. While the drug’s return is not guaranteed, the FDA typically follows the panel’s recommendations.

The New York Times is online.

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Annual Session 2006

Two networking events focus on women physicians

Women physicians attending Annual Session 2006 in Philadelphia will have the opportunity to network with ACP colleagues and leaders, as well as to hear how to set up networking programs themselves. Both events are free, and no advance registration is required.

At an informal networking luncheon on Friday, April 7, women physicians are invited to share their experience, meet new friends and discuss concerns. Women in ACP leadership roles will participate, provide feedback and relay important issues to ACP staff and leadership. The luncheon is designed to primarily address topics of concern to physicians who have completed residency and/or fellowship training.

And on Saturday morning, April 8, a panel of experienced leaders from ACP chapter women’s groups will share how their groups got started, with tips on how to start chapter groups or tap into already-existing area groups. Women at all training and career stages are welcome.

The Networking Luncheon for Women Physicians will be held Friday, April 7, 12:45-2:15 p.m., in the Marriott Hotel Grand Ballroom, Salon D. The "Networking for Women Physicians: Designing and Doing It" panel will be on Saturday, April 8, 8:15-9:15 a.m. in Room 112 of the Pennsylvania Convention Center.

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Sign up now for free brunch focusing on volunteerism

Come learn about medical volunteerism at a free Annual Session 2006 networking brunch sponsored by the ACP Volunteerism Subcommittee. The deadline to sign up for the brunch is March 31.

The event will give physicians an opportunity to share their plans, past experiences and general information about medical volunteering. Physicians, residents and medical students interested in using their medical skills for volunteer activities are welcome to attend.

The interactive session format will feature small group discussions led by ACP Volunteerism Subcommittee members. To ensure that topics discussed are of value to attendees, be sure to indicate topics of interest when registering.

The brunch will be held Saturday, April 8, 9:30–11:15 a.m., in the Independence Ball Room of the Philadelphia Marriott. Because space is limited, register for the free brunch by completing the online response form by March 31, 2006. For more information, contact Amy Allen Collins at ACP headquarters.

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Copyright 2006 by the American College of Physicians.

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