Public Release: 

Embargoed news from Annals of Internal Medicine

Annals of Internal Medicine tip sheet for April 19

American College of Physicians

1. Off-label use of Recombinant Factor VIIa Rampant in U.S. Hospitals

Off-label Use Provides No Mortality Benefit, Increases Risk for Thromboembolism

Recombinant factor VIIa (rFVIIa) is an expensive and powerful procoagulant specifically approved for the treatment of bleeding in patients with hemophilia. Despite this indication, physicians are using rFVIIa for the off-label treatment or prevention of bleeding in other conditions. Researchers in one study being published on April 19 reviewed hospital records for 12,644 patients who received rFVIIa during a hospital stay between 2000 and 2008. They found that 96 percent of all in-hospital cases of rFVIIa use from 2000 to 2008 and 97 percent in 2008 were for off-label indications, including cardiovascular surgery, trauma, and intracranial hemorrhage. In a second study, researchers evaluated published research to determine the benefits and harms of in-hospital, off-label use of rFVIIa. The researchers studied 64 articles published from inception through 2010. They found that off-label use of rFVIIa for several common uses had no mortality benefit and increased risk for thromboembolism. The author of an accompanying editorial suggests that hospitals and the government take measures to prevent the "runaway use, uselessness, and risk for this expensive treatment," including criminal charges against drug companies actively marketing the off-label use and organizational oversight in hospitals so that patients are advocated for and protected.

2. Troponin Levels May Help Docs Identify Perioperative MI in Asymptomatic Patients

Millions of patients who undergo major noncardiac surgery will suffer a myocardial infarction (MI or heart attack) within 30 days after surgery. It is known that some patients have an MI without symptoms, but the frequency of this silent complication is unknown. Researchers examined records for 8,351 patients at 190 centers in 23 countries to determine the characteristics and short-term outcomes associated with perioperative MI. The researchers measured four cardiac biomarkers or enzyme assays within three days of surgery to identify MI. MI was defined by either autopsy findings or an elevated level of a cardiac biomarker or enzyme, and at least one of five specific features. Data showed that 415 (5.0%) patients suffered a perioperative MI, 74% of MIs occurred within 48 hours of surgery, and 65% did not experience MI symptoms. Patient with MI had an equally poor prognosis whether symptomatic or asyptomatic. The authors speculate that routine monitoring of troponin levels in at-risk patients may be warranted.

3. Earlier Treatment with Combined Antiretroviral Therapy May Increase AIDS-free Survival Time

When to initiate combined antiretroviral therapy (cART) in HIV patients is difficult to determine. Early cART initiation may stave off symptoms, prevent HIV transmission, and prolong survival, but it also may result in adverse drug effects and the development of drug resistance, which may decrease survival. Researchers reviewed data for 20,971 HIV-infected people who had not yet undergone treatment at the time cART was initiated. The patients had a baseline CD4 cell count above 0.500 x 109 cells/L and no previous AIDS-defining illnesses. The analysis included 8,392 of the patients whose CD4 cell counts had decreased into the range of 0.200 to 0.499 x 109 cells/L. The data support early initiation of cART. The researchers reported that for preventing AIDS-defining illness or death, cART should be initiated when CD4 cell counts dip below 0.500 x 109 cells/L. However, they also found that delaying therapy until CD4 cell counts decrease below 0.350 x 109 cells/L did not affect outcomes. The author of an accompanying editorial writes that expanded use of cART could substantially curtail the future HIV epidemic, as decreasing viral load decreases transmission risk. The author suggests the funding of additional cART studies that clarify the absolute benefits, risks, and costs of expanding indications. These studies could help to inform both individual treatment and public policy decisions.

4. Opinion: Social Media Use Leads to New Professional Concerns for Physicians

The prevalence of social media platforms combined with a wealth of opportunity to access and interact online has presented a new professional concern for physicians and physicians in training: How can physicians use social media personally and professionally without damaging their credibility or endangering patient privacy? The author of an opinion piece argues that physicians, their institutions, and the bodies that govern the profession must identify and communicate common standards that physicians and physicians in training should employ when using social media. While formal guidelines on social media professionalism are already in development, more work is needed so that medical professionals can have clear policies in place to help them utilize social media in a positive and constructive way both professionally and personally.


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