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

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ACP InternistWeekly



In the News for the Week of July 29, 2014




Highlights

Paracetamol (acetaminophen) no better than placebo for low back pain

Researchers are questioning the use of paracetamol (the name for acetaminophen frequently used in other countries) for acute episodes of lower back pain or for improving pain levels, function, sleep, or quality of life after finding it fared no better than placebo, a study found. More...

New guidelines on HIV prevention, treatment released

The International AIDS Society-USA released clinical guidelines on preventing and treating HIV, noting that the 2 approaches should complement each other on reducing the spread of the disease. More...


Test yourself

MKSAP Quiz: sore throat, daily fever for 5 days

A 19-year-old man is evaluated for a sore throat, daily fever, frontal headache, myalgia, and arthralgia of 5 days' duration. He also has severe discomfort in the lower spine and a rash on his trunk and extremities. He returned from a 7-day trip to the Caribbean 8 days ago. The remainder of the history is noncontributory. Following a physical exam and lab studies, what is the most likely diagnosis? More...


Anticoagulation

BMJ investigation claims safety info about dabigatran withheld by manufacturer

The makers of dabigatran allegedly failed to share information with regulators that would make using the drug safer—specifically, that monitoring plasma levels of the drug and adjusting doses accordingly could significantly reduce major bleeding, a new BMJ investigation found. More...

Early hormone therapy in menopause doesn't seem to affect atherosclerosis progression

Hormone therapy begun early in menopause improved some markers of cardiovascular disease (CVD) risk but did not appear to affect atherosclerosis progression, a study found. More...


Continuing education

Using ultrasound—register now for November course

The American Institute of Ultrasound in Medicine and the Wake Forest School of Medicine, in cooperation with ACP, are offering a course on bedside ultrasound use, Nov. 13-15, 2014, at Wake Forest Biotech Place in Winston-Salem, N.C. More...


From the College

Call for families in Internal Medicine

2015 will mark 100 years of the ACP as the professional home for internists. To help celebrate this milestone, the College would like to profile a few families with multiple generations of internists or internal medicine subspecialists in the medical student publication, ACP IMpact. More...

Moving annual visits into the 21st century

Yul Ejnes, MD, MACP, continues his monthly column at KevinMD.com by looking at the annual visit on average risk, asymptomatic adults that most internal medicine specialists perform. More...

ACP Annual Report from the Executive Vice President

The 2013-2014 ACP Report of the Executive Vice President (EVP) is now available on ACP's website. More...

ACP submits statement on the use of race in university admissions

A federal court ruled July 15 that race can be taken into consideration in university admissions. More...


Cartoon caption contest

Put words in our mouth

ACP InternistWeekly wants readers to create captions for our new cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service. More...


Physician editor: Philip Masters, MD, FACP



Highlights


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Paracetamol (acetaminophen) no better than placebo for low back pain

Researchers are questioning the use of paracetamol (the name for acetaminophen frequently used in other countries) for acute episodes of lower back pain or for improving pain levels, function, sleep, or quality of life after finding it fared no better than placebo, a study found.

The Paracetamol for Low-Back Pain Study (PACE) was a double-blinded, randomized trial across 235 primary care centers in Sydney, Australia, from November 2009 to March 2013. Researchers randomized 1,652 individuals (average age 45 years) with acute low back pain in a 1:1:1 ratio to receive up to 4 weeks of regular doses of paracetamol (3 times per day; equivalent to 3,990 mg per day), as-needed doses (maximum 4,000 mg paracetamol per day), or placebo in addition to best-evidence advice on management of back pain. Patients were followed for 3 months.

The primary outcome was the number of days it took to recover from low-back pain, with recovery defined as a pain score of 0 or 1 (on a 0 to 10 pain scale) sustained for 7 consecutive days. Secondary outcomes were pain intensity, disability, function, global rating of symptom change, sleep quality, and quality of life. Funding was provided by the National Health and Medical Research Council of Australia and GlaxoSmithKline Australia. Results appeared early online July 24 at The Lancet.

There were no differences in the number of days to recovery between the groups (adjusted P=0.79). Median time to recovery was 17 days (95% CI, 14 to 19) in the regular group, 17 days (95% CI, 15 to 20) in the as-needed group, and 16 days (95% CI, 14 to 20) in the placebo group (regular doses vs. placebo: hazard ratio (HR)=0.99; 95% CI, 0.87 to 1.14 / as-needed doses vs. placebo: HR=1.05; 95% CI, 0.92 to 1.19 / regular doses vs. as-needed: HR=1.05, 95% CI, 0.92 to 1.20).

Authors wrote that it is too soon to completely dismiss paracetamol as a treatment, because it has a favorable safety profile compared to other analgesics such as nonsteroidal anti-inflammatory drugs.

"Because these other medicines have not been shown to provide additional benefit beyond that of paracetamol, and are only marginally better than is placebo, it is not clear which drug should be preferred for management of low-back pain," they wrote. "Our results convey the need to reconsider the universal endorsement of paracetamol in clinical practice guidelines as first-line care for low-back pain, and suggest that advice and reassurance, rather than analgesics, should be the focus of first-line care."

An editorial lauded the study, but added, "Although the findings from this high-quality trial are clear, the content of guidelines should not be changed on the basis of a single trial; more robust and consistent evidence, including verification of the results in other populations, is needed."


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New guidelines on HIV prevention, treatment released

The International AIDS Society-USA released clinical guidelines on preventing and treating HIV, noting that the 2 approaches should complement each other on reducing the spread of the disease.

The guidelines and an accompanying editorial appeared in a special issue on HIV and AIDS in the Journal of the American Medical Association.

Prevention guidelines state:

  • All adults and adolescents should be tested for HIV at least once. Those at increased risk of infection should undergo repeated testing;
  • If diagnosed, a person should start antiretroviral therapy;
  • Patients should be supported via individualized risk assessment and counseling, help with partner notification, and periodic screening for other common sexually transmitted infections;
  • People at high risk of HIV infection should undergo preexposure prophylaxis and individualized counseling on risk reduction. The recommended regimen is daily emtricitabine/tenofovir disoproxil fumarate. High-risk populations include those living in areas with high HIV incidence rates, a recent diagnosis of incident sexually transmitted infections (STIs), users of injection drugs or shared needles, or recent use of non-occupational postexposure prophylaxis;
  • Injection drug users should receive clean needles and use syringe exchange programs, supervised injection, and available medically assisted therapies, including opioid agonists and antagonists, and participate in detoxification and drug cessation programs; and
  • Postexposure prophylaxis is recommended for anyone who has sustained a mucosal or parenteral exposure to HIV from a known infected source. It should begin as soon as possible.

Treatment guidelines state:

  • Recommended initial regimens for infected individuals include 2 nucleoside reverse transcriptase inhibitors (NRTIs; abacavir/lamivudine or tenofovir disoproxil fumarate/emtricitabine) and a third single or boosted drug, which should be an integrase strand transfer inhibitor (dolutegravir, elvitegravir, or raltegravir), a nonnucleoside reverse transcriptase inhibitor (efavirenz or rilpivirine), or a boosted protease inhibitor (darunavir or atazanavir);
  • An alternative regimen of boosted protease inhibitor monotherapy is generally not recommended, but NRTI-sparing approaches may be considered;
  • Suspected treatment failures should be rapidly confirmed while the patient is receiving the failing regimen. Clinicians should evaluate reasons for failure before switching therapy; and
  • Switching regimens due to adverse effects, convenience, or to reduce costs should not jeopardize potency of the antiretroviral drugs.

An editorial about integrating these guidelines into practice stated that prevention and treatment approaches should be complementary. Behavioral approaches should support the effectiveness of antiretroviral therapy, preexposure prophylaxis, and postexposure prophylaxis, while treatments should contribute to prevention through mechanisms that behavioral interventions cannot.

"Established community-led approaches can support and be used in delivering biomedical interventions. Incorporating prevention within services that have historically focused on treatment may be challenging in some cases," the editorial states. "The 2014 IAS-USA recommendations reinforce the need for physicians, other clinicians, and health care workers to be supported so they can fulfil their responsibilities in effectively providing patients with behavioral and biomedical strategies for HIV prevention."



Test yourself


.
MKSAP Quiz: sore throat, daily fever for 5 days

A 19-year-old man is evaluated for a sore throat, daily fever, frontal headache, myalgia, and arthralgia of 5 days' duration. He also has severe discomfort in the lower spine and a rash on his trunk and extremities. He returned from a 7-day trip to the Caribbean 8 days ago. The remainder of the history is noncontributory.

mksap.gif

On physical examination, temperature is 38.3 °C (100.9 °F), blood pressure is 104/72 mm Hg, pulse rate is 102/min, and respiration rate is 16/min. His posterior pharynx is notably injected but without exudate. He has a maculopapular rash on his chest, arms, and legs that spares the palms and soles. There is no palpable lymphadenopathy. The remainder of the examination, including cardiopulmonary and abdominal examinations, is normal.

Laboratory studies:

Leukocyte count 3100/µL (3.1 x 109/L)
Platelet count 85,500/µL (85.5 x 109/L)
Hemoglobin 13.9 g/dL (139 g/L)
Alanine aminotransferase 114 units/L
Aspartate aminotransferase 154 units/L
Total bilirubin 1.2 mg/dL (20.5 µmol/L)

Which of the following is the most likely diagnosis?

A: Dengue fever
B: Leptospirosis
C: Malaria
D: Syphilis
E: Yellow fever

Click here or scroll to the bottom of the page for the answer and critique.


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Anticoagulation


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BMJ investigation claims safety info about dabigatran withheld by manufacturer

The makers of dabigatran allegedly failed to share information with regulators that would make using the drug safer—specifically, that monitoring plasma levels of the drug and adjusting doses accordingly could significantly reduce major bleeding, a new BMJ investigation found.

An investigator used previously confidential company documents (later released in a lawsuit) from dabigatran manufacturer Boehringer Ingelheim (BI) in her investigation. From the start, she noted, dabigatran has been marketed as a more convenient anticoagulant for stroke prevention in non-valvular atrial fibrillation patients because, unlike warfarin, it is taken in a fixed-dose regimen and doesn't need to be monitored or titrated.

However, she continued, internal company documents show that dabigatran monitoring and dose adjustment could reduce major bleeding by 30-40% compared with well-controlled warfarin, without affecting stroke risk—information that wasn't shared with regulators or physicians. The article was published online by BMJ on July 23.

A BI employee e-mail about monitoring dabigatran plasma levels that was released during litigation said "This may not be a onetime test and could result in a more complex message (regular monitoring) and a weaker value proposition," the BMJ investigator wrote. She also reported the company's response to her findings, which was to reiterate that dabigatran doesn't need to be monitored, that the company didn't share the information in question with regulators because it didn't provide "a reliable prediction of patient outcomes", and that the FDA's own post-marketing analysis concluded that dabigatran's bleeding rates don't seem to be higher than warfarin's.

BMJ editorialists noted the investigation raised "serious questions" about the risks of dabigatran and that data integrity issues surrounding the drug are "equally unsettling." They advised doctors to share decisions on anticoagulation with patients, taking into account "tolerance of unknown risks … of routine laboratory monitoring and dose adjustment, and their risk of stroke ….Patients and doctors tolerant of unknown risk and close monitoring will have to choose which drives them more strongly, with the more conservative option being warfarin," they wrote.


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Early hormone therapy in menopause doesn't seem to affect atherosclerosis progression

Hormone therapy begun early in menopause improved some markers of cardiovascular disease (CVD) risk but did not appear to affect atherosclerosis progression, a study found.

annals.jpg

Researchers performed a randomized, controlled trial at 9 U.S. academic medical centers to examine CVD risk factors and progression of atherosclerosis after hormone therapy was begun in early menopause. Healthy menopausal women who were 42 to 58 years of age and were 6 to 36 months from their last menses were included. Other inclusion criteria were no previous CVD events, a coronary artery calcium score below 50 Agatston units, and at least 90 days without receipt of estrogen or lipid-lowering drugs.

The patients were randomly assigned to receive oral conjugated equine estrogens (o-CEE), 0.45 mg/d, plus 200 mg of oral progesterone for 12 days each month; transdermal 17beta-estradiol (t-E2), 50 mcg/d, plus 200 mg of oral progesterone for 12 days each month; or placebo. Duration of treatment was 48 months. The primary end point was annual change in carotid artery intima-media thickness, while secondary end points included changes in CVD risk markers. The study results were published early online July 29 by Annals of Internal Medicine.

Seven hundred twenty-seven women were randomly assigned, 230 (31.6%) to the o-CEE group, 222 (30.5%) to the t-E2 group, and 275 (37.8%) to the placebo group. The mean age was 52.7 years, and patients were an average of 1.4 years past menopause. Among those who reported education and income, 72% had college degrees or higher and 62% earned more than $60,000 annually. Of the 727 women in the study, 89.3% had at least one follow-up measurement of carotid artery intima-media thickness and 79.8% had carotid artery intima-media thickness measured at 48 months. The mean increase in carotid artery intima-media thickness, 0.0076 mm/year, was similar across the study groups. Changes in blood pressure from baseline were not observed in either active treatment group compared with placebo.

A total of 85.7% of women reported hot flushes at baseline. At 6 months, moderate or severe hot flushes were reported by 28.3% of women in the placebo group, compared with 4.2% and 7.4%, respectively, in the o-CEE and t-E2 groups (P<0.001). Levels of low- and high-density lipoprotein improved in patients taking o-CEE, and levels of C-reactive protein and sex hormone-binding globulin increased; however, levels of interleukin-6 did not. Patients taking t-E2 experienced a decrease in insulin resistance.

Although the placebo group reported more vasomotor symptoms throughout the study, the differences between those taking hormones and those taking placebo attenuated, and the t-E2 group no longer differed significantly from the placebo group at 48 months. Over 48% of the women in the study reported at least 1 adverse event, most commonly skin and hair changes. Sixteen, 9, and 12 women, respectively, withdrew from the o-CEE, t-E2, and placebo groups after experiencing adverse events, half of which were considered possibly or probably study-related in the t-E2 and placebo groups and almost two-thirds of which were considered possibly or probably study-related in the o-CEE group.

The authors noted that their study was too short and too small to allow them to determine the implications of clinical CVD or other adverse events. In addition, they said, the study's power for the end point of coronary artery calcium score was limited, and other factors associated with CVD risk such as oxidation, inflammation, and thrombosis, were not considered. They also pointed out that their study sample, which included mainly well-educated white women, was not fully representative of the overall postmenopausal population in the U.S. Because the women in the current study were relatively healthy, moreover, the results may not apply to those at higher risk for CVD, such as women who smoke.

The authors concluded that in women who have low CVD risk and who have recently become menopausal, 4 years of therapy with low-dose oral or transdermal estrogen and cyclic oral progesterone improved vasomotor symptoms of menopause with no deleterious effects on blood pressure and no apparent effect on progression of atherosclerosis. They pointed out that these findings provide reassurance of the relative cardiovascular safety of hormone therapy for relief of menopausal symptoms recommended in guidelines by the North American Menopause Society and other groups in women with low risk for CVD complications.

"Although some markers for CVD improved, [menopausal hormone therapy] neither improved nor worsened atherosclerosis progression," the authors wrote. "The long-term effects of early initiation of [menopausal hormone therapy] on risk for CVD are uncertain."



Continuing education


.
Using ultrasound—register now for November course

The American Institute of Ultrasound in Medicine and the Wake Forest School of Medicine, in cooperation with ACP, are offering a course on bedside ultrasound use, Nov. 13-15, 2014, at Wake Forest Biotech Place in Winston-Salem, N.C.

The course will feature hands-on sessions, lectures by national experts, cadaver experience for procedures and applications, cutting-edge simulation, and live model scanning.

Attendees can earn up to 24 AMA PRA Category 1 Credits™ (accepted by the ARDMS) or ARRT Category A Credits. Space is limited. Learn more and register by Sept. 10 to save.



From the College


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Call for families in Internal Medicine

2015 will mark 100 years of the ACP as the professional home for internists. To help celebrate this milestone, the College would like to profile a few families with multiple generations of internists or internal medicine subspecialists in the medical student publication, ACP IMpact. Families interested in sharing their story can contact Membership Development.


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Moving annual visits into the 21st century

Yul Ejnes, MD, MACP, a past chair of ACP's Board of Regents, a practicing internist in Cranston, R.I., and a member of ACP Internist's editorial board, continues his monthly column at KevinMD.com. In this post, Dr. Ejnes looks at the annual visit (a.k.a. yearly physical, annual exam) on average risk, asymptomatic adults that most internal medicine specialists perform.


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ACP Annual Report from the Executive Vice President

The 2013-2014 ACP Report of the Executive Vice President (EVP) is now available on ACP's website. The report is a review of ACP's activities and accomplishments over the past fiscal year in the areas of education, clinical standards, advocacy, practice support, and collaboration. A letter to ACP members and a short video with a recorded message from EVP and CEO Steven Weinberger, MD, FACP, are also included.

The report has been produced in a digital format that is easy to view and accessible from all mobile devices. A tabbed menu and scrolling feature make it easy to move around the report and content is enhanced with photos, graphic images, and embedded links that direct viewers to more detailed sources of information.


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ACP submits statement on the use of race in university admissions

A federal court ruled July 15 that race can be taken into consideration in university admissions. The case, Fisher v. the University of Texas Austin, was filed by a student who was denied undergraduate admission in 2008.

Prior to the decision, ACP joined with the Association of American Medical Colleges and other health care organizations in submitting a statement to the court in favor of the continued use of affirmative action in increasing diversity in the nation's health care workforce in order to reduce health care disparities. This decision is in keeping with long-standing ACP policy to encourage minority enrollment in medical and health professional schools to make for a diverse health care workforce that is more representative of the patients it serves.



Cartoon caption contest


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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.

acpi-20140729-cartoon.jpg

E-mail all entries to acpinternist@acponline.org. ACP staff will choose finalists and post them online for an online vote by readers. The winner will appear in an upcoming edition.


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MKSAP Answer and Critique



The correct answer is A: Dengue fever. This item is available to MKSAP 16 subscribers as item 55 in the Infectious Disease section. More information is available online.

Dengue fever, a flavivirus infection transmitted by the bite of the Aedes aegypti mosquito, is the most prevalent mosquito-borne viral illness in the world. Dengue is endemic to many parts of the world, especially Southeast Asia and tropical geographic areas. A significant rise in the incidence of dengue has occurred recently in the Caribbean islands and Latin America, resulting from the reestablishment of the A. aegypti vector in these areas. On several occasions, domestically acquired (autochthonous) cases in the United States, generally limited to the southern states, have been reported. Classic manifestations in symptomatic persons present after an incubation period of 4 to 7 days. Typically, patients experience abrupt fever with chills, severe frontal headache, retro-orbital pain, and musculoskeletal pain, characteristically severe in the lumbar spine, earning dengue the name "break-bone fever." A nonspecific macular or maculopapular rash, sparing the palms and soles, often develops within 3 to 4 days of onset of illness, tending to coincide with the resolution of fever. Referred to as a "saddle-back" pattern, a second episode of fever and symptoms may occur in some patients. Abnormal laboratory findings include leukopenia, neutropenia, thrombocytopenia, and mildly elevated liver aminotransferase concentrations, with the serum aspartate aminotransferase level often higher than the serum alanine aminotransferase level. The febrile illness may be followed by a prolonged episode of fatigue. Full recovery is expected in all infected persons. The diagnosis of dengue fever remains mainly clinical. During the early phase of illness, real-time reverse transcriptase polymerase chain reaction can be useful in detecting virus in the blood. However, acute and convalescent serologic testing is commonly used to confirm a diagnosis in returning travelers. Treatment of dengue fever involves symptomatic relief. Currently, no vaccine is clinically available to protect against infection.

Leptospirosis, caused by infection with pathogenic spirochetes belonging to the genus Leptospira, is endemic throughout the world. Infection occurs through direct or indirect contact with urine or tissues of infected animals, most often rodents and other small mammals. In most infected patients, a self-limited illness characterized by high fever, myalgia, abdominal pain, and conjunctival suffusion occurs, with a rash developing infrequently.

Malaria does not cause a rash and is not endemic to the Caribbean islands except for the Dominican Republic and Haiti.

Yellow fever, another flavivirus infection contracted through the bite of the A. aegypti mosquito, occurs mostly in areas of sub-Saharan Africa and South America, but is not endemic to the Caribbean islands.

Key Point

  • Classic manifestations of dengue infection in symptomatic persons include fever with chills, severe frontal headache, retro-orbital pain, and musculoskeletal pain that is characteristically severe in the lumbar spine, as well as a nonspecific macular or maculopapular rash sparing the palms and soles.

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Test yourself

A 66-year-old man comes for a preoperative evaluation before total joint arthroplasty of the left knee. He has a 25-year history of rheumatoid arthritis. He has had progressive pain in his left knee with activity, which limits his ability to hike. The patient has similar pain in the right knee, but it is less severe. He reports no recent morning stiffness. He is able to climb two or three flights of stairs without chest pain or shortness of breath. He has no other medical problems and reports no additional symptoms. Medications are methotrexate and folic acid. Following a physical exam and lab tests, what is the next best step in management?

Find the answer

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