In the News
for the Week of 9-15-09
- CDC, CMS offer new guidance on H1N1 flu
- Single doses of flu vaccines show efficacy in preliminary studies
- MKSAP Quiz: upper-extremity tremor
- Ticagrelor led to lower mortality rates than clopidogrel in patients with ACS, study finds
- Metabolic syndrome may raise women’s risk of getting PAD, study concludes
- Procalcitonin test can be used to guide antibiotic use
- Case management by assistants eases depression symptoms
Health care reform
- Digesting Obama's speech
From ACP Internist
- Your Thoughts Exactly: town hall meetings on health reform
From the College
- ACP reminds physicians and public: Get your seasonal flu shot
- Ethics committee seeks input for 6th edition of ACP Ethics Manual
- New boot camp to help achieve meaningful EHR use
Cartoon caption contest
- Put words in our mouth
Physician editor: Darren Taichman, ACP Member
CDC, CMS offer new guidance on H1N1 flu
The Centers for Disease Control and Prevention updated guidance on the use of antiviral drugs to treat or prevent H1N1 and seasonal flu to help clinicians prioritize their use.
Watchful waiting is a new option, said Anne Schuchat, FACP, director of the National Center for Immunization and Respiratory Diseases at the CDC. Also, to speed up treatment, physicians could write prescriptions for high-risk patients, who would fill them only after they develop symptoms, she told CNN.
Other highlights include:
- Oseltamivir (Tamiflu) or zanamivir (Relenza) is recommended for all hospitalized patients with suspected or confirmed flu.
- Oseltamivir or zanamivir is generally recommended for children younger than 5, adults 65 years and older, pregnant women, persons with certain chronic medical or immunosuppressive conditions, and children younger than 19 taking long-term aspirin.
- Any suspected flu patient presenting with warning symptoms such as dyspnea or signs such as tachypnea or unexplained oxygen desaturation for lower respiratory tract illness should promptly receive empiric antiviral therapy.
- Treatment should not wait for laboratory confirmation. Clinicians should prioritize real-time reverse transcriptase-polymerase chain reaction tests for those with suspected or confirmed flu requiring hospitalization and based on guidelines from local and state health departments.
- To reduce delays in starting treatment, tell high-risk patients to look for signs and symptoms, ensure access to phone consultation and clinical evaluation, and consider treating high-risk patients based on phone contact if hospitalization is not indicated.
More than 98% of circulating flu viruses were 2009 H1N1, susceptible to both oseltamivir and zanamivir, as of August. Most patients have had a self-limited respiratory illness similar to typical seasonal flu, and those who present with an uncomplicated febrile illness generally do not need treatment.
Outbreaks in schools, camps, workplaces and other group settings should not be managed by giving antivirals to those exposed, but instead, patients should be educated about flu symptoms and urged to consult their health care provider if severe illness develops.
CMS has also issued new guidance on billing for the H1N1 vaccine in a special edition of Medicare Learning Network Matters. The article explains the coverage and reimbursement rules for the new vaccine. The vaccine will be covered under Medicare Part B as an additional preventive immunization service.
Medicare has created two new billing codes:
- G9141—Influenza A (H1N1) immunization administration (includes the physician counseling the patient/family)
- G9142—Influenza A (H1N1) vaccine, any route of administration
Because the H1N1 vaccine will be made available to providers at no cost, there is no need for reimbursement for the vaccine itself. Aside from the cost of the vaccine, the procedure is the same as billing for seasonal influenza virus vaccine..
Single doses of flu vaccines show efficacy in preliminary studies
Single doses of H1N1 vaccines in development create the desired immune response of 1:40 titers, according to preliminary data released online.
An Australian study published early online Sept. 10 by the New England Journal of Medicine reported on a monovalent, unadjuvanted, split-virus 2009 H1N1 flu vaccine given to 240 subjects randomized to two scheduled doses of either 15 µg or 30 µg. By 21 days after the first dose, 116 of 120 who'd received the 15-µg dose and 112 of 120 who'd received the 30-µg dose achieved titers of 1:40.
"These results will help to inform pandemic planning, especially in light of widespread concern about vaccine availability because of low manfucaturing yields," the authors wrote. "The robust response to the H1N1 vaccine after a single dose was unanticipated."
A second trial in the U.K. of a monovalent MF59-adjuvanted vaccine showed that the vaccine generated antibody responses associated with protection within 14 days of the first dose. The trial was also published early online by the New England Journal of Medicine.
The study assessed the response of 175 adults to the adjuvanted and nonadjuvanted forms of the vaccine by randomly assigning them to two injections of MF59-adjuvanted vaccine, both on day 0 or the first on day 0 and and the second on day 7, 14, or 21; two 3.75-µg doses of MF59-adjuvanted vaccine; or 7.5 µg or 15 µg of nonadjuvanted vaccine.
Interim analyses 14 days and 21 days after the first injection showed that antibody titers were generally higher at day 14 among subjects who had received two 7.5-µg doses of the MF59-adjuvanted vaccine than among those who had received only one. By 21 days after vaccination with the first dose of 7.5 µg of MF59-adjuvanted vaccine, the rates of seroconversion, as measured with the use of a hemagglutination-inhibition assay and a microneutralization assay, were 76% and 92% of subjects, respectively, who had received only one dose, and 88% to 92% and 92% to 96% of subjects, respectively, who had already received both doses (P=0.11 and P=0.64, respectively).
There were no serious adverse events reported; minor events included mild to moderate systemic symptoms or injection site discomfort. Adjuvant vaccines would have to clear FDA approval before being used in the U.S.
An editorial considering the preliminary evidence found the results "welcome and reassuring" because a one-dose schedule doubles the number of people who can be vaccinated from a fixed supply, as well as reduces costs and logistics of vaccination.
"In our current global situation, in which demand for influenza vaccine greatly exceeds supply, dose-sparing strategies are needed," the editorialist noted. "Fewer or partial doses and the use of adjuvants can all contribute to increased global vaccine supply."
MKSAP Quiz: upper-extremity tremor
A 76-year-old man is evaluated for right upper-extremity tremor of 1 year's duration. The patient is right-handed, and the tremor occurs when he walks and when he sits with his hand resting in his lap. He also has decreased dexterity involving the right hand and impaired handwriting. Over the past 6 months, he has needed help dressing.
On examination, he has mildly hypophonic speech and decreased facial expression, as well as slowness, rigidity, and reduced arm swing on the right side. His balance is normal.
Which of the following is the most appropriate management for this patient?
Click here or scroll to the bottom of the page for the answer and critique.
Ticagrelor led to lower mortality rates than clopidogrel in patients with ACS, study finds
Treatment with ticagrelor in patients with acute coronary syndrome significantly reduced the rate of death from cardiovascular causes compared with clopidogrel, without raising the rate of overall major bleeding, a recent study concluded.
The multicenter, double-blind industry-sponsored randomized trial compared outcomes in 18,624 patients admitted with acute coronary syndrome (ACS), with or without ST-segment elevation, who were treated with either ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300- to 600-mg loading dose, 75 mg thereafter). After 12 months, the primary end point of death from vascular causes, myocardial infarction or stroke had occurred in 9.8% of ticagrelor patients compared with 11.7% in the clopidogrel group. There was no significant difference in the rate of major bleeding between the two groups (11.6% vs. 11.2%, respectively; P=0.43), but ticagrelor was associated with a higher rate of major bleeding not related to coronary artery bypass grafting (4.5% vs. 3.8%; P=0.03). The results appear in the Sept. 10 New England Journal of Medicine.
An accompanying editorial noted that the availability of three agents for antagonizing platelet ADP receptors gives physicians more options, such as switching patients from clopidogrel or prasugrel to ticagrelor five to seven days before elective surgery. However, ticagrelor, like prasugrel, should be avoided in patients with a history of stroke or transient ischemic attacks and in patients with an excessively high risk of bleeding.
Ticagrelor or prasugrel may be the preferred treatments for all remaining patients with ACS, the editorial continued, until there are data comparing these two agents. Future studies should evaluate the adverse effects of ticagrelor in a much larger number of patients, and patients who are given this drug should be carefully monitored for side effects, the editorialist said..
Metabolic syndrome may raise women’s risk of getting PAD, study concludes
Otherwise healthy, middle-aged women with metabolic syndrome may be at increased risk of developing symptomatic peripheral artery disease, according to the results of a large prospective study.
Researchers studied a cohort of 27,211 women enrolled in the Women’s Health Study who were free of cardiovascular disease at baseline for a median of 13 years. Using Cox proportional hazards models to compare risk, researchers determined that women with metabolic syndrome had a 62% increased risk of future PAD. The findings persisted after adjusting for age, smoking status, cholesterol and exercise. Excess risk was mediated by heightened inflammation and endothelial activation. The study was published online Sept. 8 and appears in the Sept. 22 Circulation.
Researchers said their findings suggest that inflammation and endothelial activation may be potential mediators of PAD risk in relatively healthy middle-aged women. In addition, their data highlight the importance of smoking as a risk factor as women who smoked had an almost 13% increased risk of developing PAD compared with nonsmokers. More prospective data are needed, they concluded, to corroborate the results and shed more light on the links between the cluster of risk factors characterizing metabolic syndrome and onset of PAD..
Procalcitonin test can be used to guide antibiotic use
Fewer antibiotics were used to treat lower respiratory infections when treatment decisions were based on a measurement of procalcitonin instead of standard guidelines, a new study found.
The randomized controlled trial included 1,359 patients seen in Swiss emergency rooms for lower respiratory tract infections. Physicians treated the patients according to either standard guidelines or a new algorithm that used serum procalcitonin (PCT) levels to determine the likelihood of a bacterial infection. Patients who were admitted to the hospital received repeat PCT tests to determine when to discontinue antibiotic therapy.
The intervention group had a lower mean duration of exposure to antibiotics (5.7 days vs. 8.7; 95% CI for difference, −40.3% to −28.7%). Even greater differences in treatment duration were seen in the subgroups of patients who had community-acquired pneumonia, exacerbation of chronic obstructive pulmonary disease and acute bronchitis. Antibiotic-associated adverse events were less frequent in the PCT group (19.8% vs. 28.1%, 95% CI, −12.7% to −3.7%), but overall adverse events were similar and the PCT patients had a slightly higher mortality rate.
The use of the PCT algorithm had different effects depending on the patients' diagnoses, the researchers noted. In patients with community-acquired pneumonia, the algorithm shortened treatment duration, while antibiotics were less likely to be used at all in treatment of acute bronchitis. A reduction in antibiotic use would help to reduce individual antibiotic-associated costs and adverse events as well as discourage the growth of drug-resistant organisms, the researchers concluded. They noted that point-of-care testing for PCT is becoming more available in the U.S.
An accompanying editorial cautioned that more generalizable data on effectiveness and safety will be needed before the algorithm can be widely adopted. The editorialist expressed concern about the mortality difference between the groups, and noted that the study did not assess the cost-effectiveness of PCT testing as a means to reduce antibiotic overuse. The research was published in the Sept. 9 Journal of the American Medical Association..
Case management by assistants eases depression symptoms
Case management provided by health care assistants improved depression more than usual care in a recent study of small primary care practices.
The trial included 626 patients with major depression who were treated by 74 small primary care practices in Germany. Patients were randomly assigned to usual care or a year of case management by a health care assistant. The assistants received 17 hours of training on depression, communication skills, telephone monitoring and behavioral activation. The assistants then contacted the patients in the intervention group by phone twice a week for the first month and monthly for the rest of the study period. The study was published in the Sept. 15 Annals of Internal Medicine.
Quality of life scores did not differ between the groups, but patients who received the intervention had lower scores on a test of depression symptoms (P=0.014), more favorable assessments of care (P=0.011), and increased treatment adherence (P=0.042). The effect size was small, but similar to that in other case management trials on depression, study authors said. Most other trials have been conducted in academic or highly structured health care settings, so this study showed that a case management intervention can work in small primary care settings without extensive staff training.
The findings are probably not generalizable to other types of depression seen in primary care, such as minor depression, and success may depend on patients' responsiveness to such an intervention, the researchers said. However, similarities between U.S. and German primary care practices make it likely that results would translate into American settings, they noted. The researchers concluded that involving health care assistants in care for depressed patients may improve care without placing excessive demands on the limited resources of small primary care practices..
Health care reform
Digesting Obama's speech
Bob Doherty, ACP's senior vice president of governmental affairs and public policy, reviews President Obama's recent speech to Congress on health care reform on his blog, ACP Advocate. Visit ACP Advocate to read an analysis of which goals the speech could accomplish—and which it probably won't..
From ACP Internist
Your Thoughts Exactly: town hall meetings on health reform
In August, members of Congress and the White House held town hall meetings to discuss health care reform. The meetings were sometimes productive but often contentious. Tell us: Were the meetings more of a success or a failure in terms of making progress on the issue?.
From the College
ACP reminds physicians and public: Get your seasonal flu shot
ACP is advising that many adults, including all health care professionals, get vaccinated for seasonal flu. ACP President Joseph W. Stubbs, FACP, is stressing the impact of seasonal flu and the importance of physicians immunizing themselves, their patients, and their staff members in accordance with the CDC's Recommended Adult Immunization Schedule. More immunization resources from ACP are available online..
Ethics committee seeks input for 6th edition of ACP Ethics Manual
The ACP Ethics, Professionalism and Human Rights Committee (EPHRC) is asking for member feedback as it prepares to develop the sixth edition of the ACP Ethics Manual over the next year.
The committee intends to use the peer feedback to keep the manual relevant and useful to ACP membership. Comments and suggestions for changes or new topics can be sent to EPHRC vice-chair Dr. Fins at email@example.com or Lois Snyder, director of the ACP Center for Ethics and Professionalism, at firstname.lastname@example.org. The current edition of the manual is available online..
New boot camp to help achieve meaningful EHR use
The American Medical Informatics Association (AMIA) is holding a four-day boot camp to provide chief medical information officers with an opportunity to make sure their organizations are using their electronic health records systems to their full advantage. The boot camp will use an experimental learning approach to familiarize attendees with the scientific principles that underlie applied health informatics.
The program faculty for the boot camp includes Paul C. Tang, FACP, a member of ACP’s Medical Informatics Subcommittee, who will serve as the program chair. The faculty will also include James M. Walker, FACP, the current chair of the subcommittee.
The boot camp will be Oct. 7 to 10 in Scottsdale, Ariz., and the registration fee is $2,500. For additional information and registration instructions, please visit the AMIA Web site..
Cartoon caption contest
Put words in our mouth
ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.
E-mail all entries by to email@example.com by Sept. 24. ACP staff will choose three finalists and post them in the Sept. 29 issue of ACP InternistWeekly for an online vote by readers. The winner will appear in the Oct. 6 edition..
MKSAP answer and critique
The correct answer is B) Carbidopa-levodopa. This item is available online to MKSAP subscribers in the Neurology section, Item 71.
ACP's Medical Knowledge Self-Assessment Program (MKSAP) allows you to:
- Update your knowledge in all areas of internal medicine
- Prepare for ABIM certification or recertification
- Support your clinical decisions in practice
- Assess your medical knowledge with 1,200 multiple-choice questions
To order the latest edition of MKSAP, go online.
The symptoms and signs in this patient are consistent with Parkinson's disease. His disease is associated with limitations in his activities of daily living and pain. Carbidopa-levodopa is the first-line treatment for patients older than 70 years with new-onset Parkinson's disease. Dopamine agonists like pramipexole are used as initial monotherapy in younger patients, in whom the side effect profile is milder. Complications associated with the use of dopamine agonists, such as somnolence, drug-induced psychosis, and dizziness, are more common in patients older than 70 years. Amantadine is not as potent as carbidopa-levodopa and should not be used as first-line therapy in the elderly. Selegiline has a weak symptomatic effect and will likely not substantially affect this patient's functional status.
- Carbidopa-levodopa is the first-line treatment for patients older than 70 years with new-onset Parkinson's disease.
- Complications associated with the use of dopamine agonists, such as somnolence, drug-induced psychosis, and dizziness, are more common in patients older than 70 years.
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Copyright 2009 by the American College of Physicians.
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