In the News
for the Week of 7-28-09
- Flu vaccine approvals, trials underway
- Healthy lifestyle reduces chance of heart failure, hypertension
- MKSAP quiz: Managing seasonal allergies
- White-coat and masked hypertension predict long-term risk
- Hepatitis C regimens show comparable efficacy, safety
- FDA analysis finds electronic cigarettes contain carcinogens, toxins
- Safety review of omalizumab targets cardiovascular, cerebrovascular effects
- Propofol injectable, pneumococcal vaccine recalled
- American Joint Committee on Cancer holds annual conference
From ACP Hospitalist
- Global hospitalists, aortic dissection, pregnant patients and MKSAP
From the blogs
- Internists object to "provider" label
Cartoon caption contest
- Vote for your favorite entry
Flu vaccine approvals, trials underway
The federal government announced the start of trials for a vaccine against the pandemic swine-origin H1N1 influenza virus and approved a new vaccine for seasonal influenza.
The trials will include about 2,400 healthy adult volunteers at eight U.S. sites, the July 23 New York Times reported. Patients will be given one or two injections, each containing 15 or 30 micrograms of vaccine. The recipients will be monitored for side effects and tested for the development of antibodies to the pandemic virus.
Officials told the New York Times that trials would take about two months, after which a more widespread vaccination program could begin. Even if approval moves quickly, it will not be possible to create enough vaccine for everyone in the U.S. by fall, however. Vaccines are being produced by Sanofi-Pasteur and CSL Biotherapies for the tests, which are being overseen by the National Institute of Allergy and Infectious Diseases. Novartis also is testing a vaccine for the FDA, the newspaper reported.
All three companies, along with three others, are also working on the 2009-2010 seasonal influenza vaccine approved by the FDA last week. The seasonal vaccine comprises three virus strains that U.S. and international officials believe are likely to cause the most illness during the upcoming flu season: an A/Brisbane/59/2007 (H1N1)-like virus, an A/Brisbane/10/2007 (H3N2)-like virus and a B/Brisbane/60/2008-like virus.
Although the seasonal vaccine will not protect against the pandemic flu strain, vaccination will still be important this year for those Americans for whom it is recommended, including health care personnel, the FDA said.
ACP Internist compiled a list of resources to help internists and their patients stay up-to-date about the outbreak of swine-origin (H1N1) influenza A..
Healthy lifestyle reduces chance of heart failure, hypertension
New data from the Physicians' and Nurses' Health Studies confirm that maintaining a healthy lifestyle reduces the risks of heart failure and hypertension, respectively.
The Physicians' Health Study included 20,900 men, of whom 1,200 developed heart failure during 22.4 years of follow-up. Researchers assessed the participants on six modifiable lifestyle factors and compared their behavior to their risk of heart failure.
The healthy habits—normal body weight, not smoking, regular exercise, moderate intake of alcohol, consumption of breakfast cereals and consumption of fruits and vegetables—were individually and jointly associated with lower risk. Study participants who adhered to none of the behaviors had a 21% risk of heart failure, similar to the average risk found for men in other studies. Those who made four or more of the healthy choices had only a 10% risk.
The Nurses' Health Study included 83,882 women, with 12,319 incident cases of hypertension appearing over 14 years. The studied lifestyle factors were body mass index (BMI) of less than 25 kg/m2, a daily mean of 30 minutes vigorous exercise, the Dietary Approaches to Stop Hypertension diet, modest alcohol intake, less than weekly use of nonnarcotic analgesics and use of supplemental folic acid.
For the 0.3% of the group who had all six low-risk factors, the hazard ratio for incident hypertension was 0.22. Based on that finding, researchers calculated that if all women were to conform to these behaviors, 78% of new-onset hypertension might be prevented or delayed. The most powerful individual predictor of hypertension was BMI. In fact, among obese women, adherence to the other low-risk behaviors did not confer a lower risk of hypertension.
Both studies, which appeared in the July 22/29 Journal of the American Medical Association, were conducted among homogeneous populations, and thus may not be entirely applicable to other groups. However, authors of both studies and the writer of the accompanying editorial recommended that authorities consider the potential for using these factors to improve public health.
MKSAP quiz: Managing seasonal allergies
A 28-year-old woman is evaluated for a two-week history of cough productive of yellowish sputum, sneezing, tearing and gritty sensation in the eyes, nasal and sinus congestion, and postnasal drainage. Her medical history includes seasonal allergies. She has not had any recent contacts with sick or febrile persons. She is requesting antibiotics because her previous doctor prescribed them during allergy season to prevent bacterial sinusitis.
On physical examination, temperature is 37.0° C (98.6° F). The conjunctivae are mildly injected without drainage, and the oropharynx is clear except for the presence of clear postnasal discharge.
Sinus examination by transillumination and percussion is negative. There is no cervical lymphadenopathy, and the lungs are clear to auscultation except for end-expiratory wheezes.
Which of the following is the most appropriate management?
A) Oral antibiotics, nasal decongestant, and cough suppressant
B) Oral antibiotics, nasal decongestant, and inhaled β-agonist
C) Inhaled β-agonist, oral antihistamine, and cough suppressant
D) Oral antihistamine, nasal corticosteroid, and inhaled β-agonist
Click here or scroll to the bottom of the page for the answer and critique.
White-coat and masked hypertension predict long-term risk
White-coat and masked hypertension predict the onset of sustained hypertension and should be managed appropriately, Italian researchers reported.
Among 1,412 subjects, researchers measured office blood pressure (BP), 24-hour ambulatory BP and home BP in 1990-1992 and then again in 2001-2002. They reported results in the August 1 issue of Hypertension.
White-coat hypertension was defined as office BP >140/90 mm Hg and 24-hour BP mean <125/79 mm Hg or home BP <132/82 mm Hg. Masked hypertension was defined as office BP <140/90 mm Hg, 24-hour BP >125/79 mm Hg, and home BP >132/82 mm Hg. Patients with true normotension, white-coat hypertension or masked hypertension at the first examination were classified as having developed sustained hypertension at the second examination if their office and 24-hour or home BPs were in the hypertensive range.
At the first examination, 758 patients (54.1%) were normotensive, 225 (16.1%) had white-coat hypertension, 124 (8.9%) had masked hypertension and 293 (20.9%) had sustained hypertension. At the second examination, 136 patients from the initial normotensive group (18.2%), 95 from the initial white-coat hypertension group (42.6%) and 56 from the initial masked hypertension group (47.1%) had converted to sustained hypertension. After adjustment for age and sex, the risk of developing sustained hypertension was significantly higher for patients with white-coat and masked hypertension (odds ratios, 2.51 and 1.78, respectively; P<0.0001).
Researchers concluded that white-coat and masked hypertension "cannot be regarded as innocent phenomena but as clinical states that require accurate diagnosis and follow-up."
Hepatitis C regimens show comparable efficacy, safety
Two standard hepatitis C regimens and an experimental low-dose regimen are comparable in efficacy and tolerability. Outcomes did not differ significantly between peginterferon alfa-2b or peginterferon alfa-2a, both combined with ribavirin, according to a trial.
Researchers enrolled 3,070 U.S. patients 18 years of age or older with hepatitis C genotype 1 infection who had not been previously treated. They reported results in the July 22 New England Journal of Medicine. The trial was supported by grants from Schering-Plough.
Patients were randomized to three treatment groups and stratified according to hepatitis C RNA levels of more than 600,000 IU/mm3 or 600,000 IU/mm3 or less and race (black or non-black). All underwent 48 weeks of treatment with standard-dose peginterferon alfa-2b (1.5 µg/kg of body weight per week) or low-dose peginterferon alfa-2b (1.0 µg/kg per week) plus oral ribavirin at a dose of 800 to 1,400 mg per day depending on body weight, or peginterferon alfa-2a, 180 µg per week, plus oral ribavirin at a dose of 1,000 to 1,200 mg per day depending on body weight.
The primary end point was undetectable hepatitis C RNA levels 24 weeks after ending therapy. Sustained virologic response was 39.8% in the standard-dose peginterferon alfa-2b group, 38.0% in the low-dose peginterferon alfa-2b group and 40.9% in the peginterferon alfa-2a group (P=0.20 for standard-dose vs. low-dose peginterferon alfa-2b; P=0.57 for standard-dose peginterferon alfa-2b vs. peginterferon alfa-2a).
Estimated response rate differences were similar between the standard-dose and low-dose peginterferon alfa-2b groups (1.8% [95% CI, -2.3% to 6.0%] and -1.1% [95% CI, -5.3% to 3.0%], respectively). Relapse rates were 23.5% (95% CI, 19.9% to 27.2%) for standard-dose peginterferon alfa-2b, 20.0% (95% CI, 16.4% to 23.6%) for low-dose peginterferon alfa-2b and 31.5% (95% CI, 27.9% to 35.2%) for peginterferon alfa-2a.
"Surprisingly, reducing the ribavirin dose because of treatment-related anemia (as was done in 30% of patients) did not appear to reduce the likelihood of sustained virologic response," the researchers wrote.
Despite reducing ribavirin by as much as half in patients receiving peginterferon alfa-2a, patients with anemia had a higher rate of sustained virologic response than did those without, suggesting anemia is a pharmacodynamic marker of drug exposure. Authors concluded that the initial ribavirin dose should be at least 13 mg/kg per day and that managing anemia by reducing ribavirin maintains safety and efficacy.
FDA analysis finds electronic cigarettes contain carcinogens, toxins
A lab analysis of electronic cigarette samples found they contain carcinogens and toxic chemicals like diethylene glycol, an ingredient used in antifreeze, the FDA said last week.
Electronic cigarettes, or “e-cigarettes,” are battery-operated devices that usually contain nicotine, flavor and other chemicals, which are turned into a vapor that is inhaled. They haven’t been submitted to the FDA for evaluation or approval, and don’t carry health warnings like other nicotine replacement products.
The agency analyzed the ingredients in a small sample of cartridges from two leading electronic cigarette brands. In one sample, the analyses detected diethylene glycol, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. Aside from this limited testing, the FDA said it has no way of knowing the levels of nicotine or the amounts or kinds of other chemicals that various brands of electronic cigarettes deliver.
The FDA has been examining and detaining shipments of e-cigarettes at the border and said the products it has examined so far meet the definition of a combination drug-device product under the Federal Food, Drug and Cosmetic Act. The agency has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The FDA is planning additional activities to address its concerns about these products, it said in the release..
Safety review of omalizumab targets cardiovascular, cerebrovascular effects
The FDA is evaluating the interim findings of an ongoing study of omalizumab (Xolair) that suggests an increase in several adverse cardiovascular and cerebrovascular conditions in patients treated with the drug, the agency said.
The conditions include ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events. The study is called “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma,” or EXCELS.
Omalizumab is approved for people aged 12 years and older with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids. The FDA isn’t advising patients to stop taking the drug, nor is it recommending changes to prescribing information at this time, but urges providers to be aware of the potential risks..
Propofol injectable, pneumococcal vaccine recalled
The following items were voluntarily recalled by their manufacturers:
- Propofol Injectable Emulsion 10 mg/mL 100-mL vials, lot numbers 31305429B and 31305430B, due to the presence of elevated endotoxin levels in some vials with these lot numbers. At least 41 propofol-treated patients have reported post-operative fever, chills and other flu-like symptoms, reactions that appear to have been self-limiting with spontaneous resolution, an FDA notice said. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels. For use as an anesthetic, propofol should be used only by professionals trained in administering general anesthesia. For sedation of intubated, mechanically ventilated patients in the ICU, propofol should be administered only by persons skilled in the management of critically ill patients, the notice said.
- Lot number D50002 of Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197Protein), single-dose pre-filled syringes. A portion of a bulk lot of the syringes, which wasn’t meant for commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002. Manufacturer Wyeth has performed a medical assessment and concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate, an FDA notice said.
American Joint Committee on Cancer holds annual conference
The American Joint Committee on Cancer will hold its Annual State-of-the Science Conference September 11-12 in Baltimore. Titled "The AJCC Prepares for Personalized Medicine: Molecular Markers Meet Anatomic Staging," the conference will address the current science in molecular marker development and explore the clinical use of biomarkers in conjunction with cancer staging. Additional information, including registration details, is available at the conference Web site..
From ACP Hospitalist
Global hospitalists, aortic dissection, pregnant patients and MKSAP
The next issue of ACP Hospitalist is live online, including articles on the following:
- Hospital medicine around the world: The field is catching on in several countries outside the U.S., Canada and Europe. Supporters’ reasons for wanting hospital medicine to flourish there are often the same, and the barriers are often similar, as well.
- On the front lines of aortic dissection: A leading cardiologist explains why hospitalists are key to improving long-term outcomes.
- Caring for the pregnant patient: Every hospitalist is likely to encounter a pregnant patient during his or her career and needs to be versed in the diagnosis and treatment of hypertension, preeclampsia, asthma, venous thromboembolism and diabetes.
- Test yourself on acute kidney injury cases excerpted from ACP’s Medical Knowledge Self-Assessment Program.
From the blogs.
Internists object to "provider" label
Guest contributor Toni Brayer, FACP, questions being called a name by a colleague: a "provider." And internists are diving into social media professionally and even finding clinical purposes for them, although they raise privacy as a concern. Follow the discussion at ACP Internist's blog.
Cartoon caption contest.
Vote for your favorite entry
ACP InternistWeekly's cartoon caption contest continues. ACP staff has selected three finalists for the latest contest and is now asking readers to vote for their favorite caption to determine the winner.
"I'm afraid we may have to do a C-section."
"So, I guess you won't be breastfeeding?"
"And you thought 'OctoMom' got a lot of headlines ... "
Go online to view the cartoon and pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service. Voting continues through Aug. 3, with the winner announced in the Aug. 4 issue..
MKSAP answer and critique
The correct answer is D) Oral antihistamine, nasal corticosteroid, and inhaled β-agonist. This item is available online to MKSAP subscribers in the General Internal Medicine section, Item 96.
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 most likely diagnosis in this patient is allergic rhinitis with associated bronchospasm; therefore, treatment with oral antihistamine and nasal corticosteroids is appropriate. In addition, inhaled β-agonists are also appropriate in this patient as they appear beneficial only in patients with wheezing or airflow limitation with end-expiratory wheezes. Antibiotics are not indicated for allergic rhinitis or viral upper respiratory infection. Although the patient has yellowish sputum, the absence of fever, chills, and progressive illness argues against current bacterial infection. Nasal decongestants may be of some symptomatic benefit, but direct treatment of the underlying allergic disorder with a nasal corticosteroid and oral antihistamine is the indicated treatment. In general, antitussives or cough suppressants are indicated only for cough that is painful, causes sleep disruption, or is debilitating in frail, elderly patients. Recent systematic reviews conclude that no antitussive is clearly superior to another for cough in adults, and elderly patients are most vulnerable to adverse effects of antitussive agents, such as confusion, nausea, and constipation.
- Inhaled β-agonists appear beneficial only in patients with wheezing or airflow limitation with end-expiratory wheezes on examination.
- Antibiotics are not indicated for allergic rhinitis or viral upper respiratory infection. Although the patient has yellowish sputum, the absence of fever, chills, and progressive illness argues against current bacterial infection.
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Copyright 2009 by the American College of Physicians.
A 67-year-old man is evaluated for a 6-month history of worsening exertional dyspnea. He has severe COPD, previously with minimal exertional symptoms, but now notes activity-limiting shortness of breath when walking short distances. He does not have chest pain, gastrointestinal symptoms, or sleep-related symptoms. Medical history is otherwise unremarkable. Medications are a twice-daily fluticasone/salmeterol inhaler and an as-needed albuterol/ipratropium metered-dose inhaler. He has a 55-pack-year smoking history but quit when COPD was diagnosed. Following a physical exam, chest radiograph, and transthoracic echocardiogram, what is the most appropriate diagnostic test to perform next?
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