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

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ACP InternistWeekly



In the News for the Week of September 11, 2012




Highlights

Discontinuing LABAs in combination therapy may increase asthma symptoms, meta-analysis suggests

In asthma patients receiving combination therapy with an inhaled corticosteroid and a long-acting β2-agonist (LABA), discontinuing the latter after asthma is controlled may worsen outcomes, according to a new meta-analysis. More...

Guidelines recommend judicious use of testing, antibiotics, children's tonsillectomies for strep

Most sore throats are caused by a virus, not streptococcus bacteria, and shouldn't be treated with antibiotics, suggest guidelines published this week by the Infectious Diseases Society of America. More...


Test yourself

MKSAP Quiz: 4-month history of skin lesions

This week's quiz asks readers to evaluate a 40-year-old woman for a 4-month history of symmetrically distributed, severely pruritic, grouped erosions on her elbows, knees, back, and buttocks. More...


Diabetes

Clopidogrel associated with decreased benefit in diabetics post-MI

Diabetics benefit less from receiving clopidogrel after myocardial infarction (MI) than non-diabetics, a study found. More...


Rheumatology

No associated increase in short-term malignancy risk with biologic therapy for rheumatoid arthritis

Biologic therapy does not appear to increase risk for malignancy in patients with rheumatoid arthritis, according to a new study. More...


Ovarian cancer

Task Force reaffirms recommendation against routine screening for ovarian cancer

Annual ovarian cancer screening with transvaginal ultrasonography and testing for the serum tumor marker cancer antigen (CA)-125 does not reduce the number of deaths from the disease in asymptomatic women, a review found. More...


Education

Course offered in addiction medicine

The American Society of Addiction Medicine (ASAM) is offering a review course this month. More...


CMS update

ICD-10 delayed to 2014

On Aug. 24, the Department of Health and Human Services announced that it would delay the compliance date for the switch to ICD-10 diagnosis codes until October 2014. More...


Annals of Internal Medicine

iPad edition now available

Physicians can now access the latest research, guidelines, reviews, commentaries, educational news, and clinical news through the new Annals of Internal Medicine iPad edition. More...


For the record

Correction to a previous issue

An item in the Aug. 28 ACP InternistWeekly required correction. More...


From the College

Yul Ejnes, MD, MACP, blogs at KevinMD.com

Yul Ejnes, MD, MACP, immediate past chair of ACP's Board of Regents and a practicing internist in Cranston, R.I., grades his EHR in a post at KevinMD.com. 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: Daisy Smith, MD, FACP



Highlights


.
Discontinuing LABAs in combination therapy may increase asthma symptoms, meta-analysis suggests

In asthma patients receiving combination therapy with an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA), discontinuing the latter after asthma is controlled may worsen outcomes, according to a new meta-analysis.

Because of safety concerns, the FDA issued a black-box warning in 2010 stating that LABAs should be withdrawn in patients receiving combination therapy with an ICS once their asthma is controlled. However, there is concern that this approach may increase risk for asthma-related complications. The authors of the current study performed a meta-analysis to answer the following clinical question: "Should LABAs be discontinued after achieving control of symptoms in patients with asthma who required combined therapy with an ICS and a LABA because of inadequate control of symptoms with an ICS alone?"

The meta-analysis included randomized, controlled trials published through August 2010 involving asthma patients age 15 and older who required combination therapy for symptom control. Included trials compared discontinuation of a LABA but continued therapy with an ICS after symptom control versus no change in treatment. The study results were published online Aug. 27 by Archives of Internal Medicine.

A total of 1,492 articles were evaluated, but only five trials met prespecified inclusion criteria. Compared with no change in treatment, discontinuing the LABA resulted in increased asthma-related impairment, as shown by worse scores on the Asthma Quality of Life Questionnaire and the Asthma Control Questionnaire, fewer days without symptoms, and higher risk for study withdrawal because of lack of efficacy or asthma control (risk ratio, 3.27; 95% CI, 2.16 to 4.96). Patients whose LABA was discontinued also required a mean of 0.71 more puffs of a rescue bronchodilator per day (95% CI, 0.29 to 1.14). Not enough data were available to evaluate risk for exacerbations or death.

"In contrast to FDA recommendations of stepping off LABA therapy when asthma is controlled, our analysis supports the continued use of LABAs to maintain asthma control," the authors wrote. They noted that their results are limited by the limitations of the included studies, including short duration, high withdrawal rates, and little information on treatment adherence, among others. They also noted that only a small number of existing trials address this subject, and stressed that more studies are needed to help settle the question of whether withdrawing LABAs is safe.

"Until those data are available, physicians need to evaluate the risk-benefit ratio of LABAs for their individual patients," the authors wrote.

The authors of an accompanying invited commentary wrote that the study's findings "help to shift the burden of proof" in the debate about LABA safety. "The core issue of this debate is not how to completely eliminate risk but rather how to manage and value competing risks," they wrote.

The commentary authors also noted that although a large FDA trial on the safety of LABAs is currently under way, physicians need to make decisions now about how to manage their patients. "We hope that this meta-analysis helps to lift some of the black clouds in the debate surrounding LABAs," they wrote. "Physicians must now reevaluate the contents of the black box for LABAs, particularly in individuals whose asthma is well controlled with combination LABA and ICS therapy."

In other news, a related industry-funded study in the Sept. 2 New England Journal of Medicine found that adding tiotropium to combination therapy with inhaled glucocorticoids and LABAs appeared to increase time to first exacerbation and promote modest, sustained bronchodilation in patients with poorly controlled asthma. The full text of the study is available online.


.
Guidelines recommend judicious use of testing, antibiotics, children's tonsillectomies for strep

Most sore throats are caused by a virus, not streptococcus bacteria, and shouldn't be treated with antibiotics, suggest guidelines published this week by the Infectious Diseases Society of America (IDSA).

The IDSA's newly revised guidelines for group A streptococcal pharyngitis also advise that when a strep infection is confirmed by testing, it should be treated with penicillin or amoxicillin in nonallergic patients and not an antibiotic such as a cephalosporin.

Penicillin and amoxicillin are very effective and safe in those without allergies, and there is increasing resistance of strep to the broader-spectrum and more expensive macrolides, including azithromycin, said the study's lead author in a press release.

The guidelines were published in Clinical Infectious Diseases.

The guidelines noted that children and adults do not need to be tested for strep throat if they have a cough, runny nose, hoarseness and mouth sores, which are strong signs of a viral throat infection. A sore throat is more likely to be caused by strep if the pain comes on suddenly, swallowing hurts and the patient has a fever without the above features, but strep should be confirmed through testing before antibiotics are prescribed, the guidelines noted.

If strep is suspected, the guidelines recommend physicians use the rapid antigen detection test, which provides results in a few minutes. If that test is negative, a follow-up throat culture is recommended for children and adolescents, but not for adults. Although results of the culture can take up to several days, antibiotics should not be prescribed unless results are positive, the guidelines note. Because strep throat is uncommon in children three years old or younger, they don't need to be tested, the guidelines recommend.

Also, the guidelines recommend against tonsillectomy for children with repeated throat infection except in very specific cases, such as a child who has obstructive breathing, because the risks of surgery are generally not worth the transient benefit, the lead author stated. Serious complications from strep throat, particularly rheumatic fever, have diminished in the United States but occasionally do occur, so accurate diagnosis is key, he said.



Test yourself


.
MKSAP Quiz: 4-month history of skin lesions

A 40-year-old woman is evaluated for a 4-month history of symmetrically distributed, severely pruritic, grouped erosions on her elbows, knees, back, and buttocks. The skin lesions began as red spots that developed into papules and then vesicles, which broke down as she scratched them. She reports normal bowel habits. She has no other medical problems and takes no medications.

mksap.jpg

A biopsy reveals neutrophilic infiltrate at the tips of the dermal papillae causing subepidermal separation. Diffuse immunofluorescence shows granular deposition of IgA at the dermal papillae.

Which of the following is the most appropriate management option for this patient?

A) Cyclosporine
B) Dapsone
C) Dapsone and a gluten-free diet
D) Intravenous immune globulin
E) Lactose-free diet

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


.

Diabetes


.
Clopidogrel associated with decreased benefit in diabetics post-MI

Diabetics benefit less from receiving clopidogrel after myocardial infarction (MI) than non-diabetics, a study found.

To estimate the clinical effectiveness associated with clopidogrel treatment after MI in patients with diabetes, Danish researchers reviewed registry data for patients hospitalized for their heart attack who had survived 30 days after discharge and had not undergone coronary artery bypass surgery.

Results appeared in the Sept. 5 Journal of the American Medical Association.

Of the 58,851 patients included in the study, 7,247 (12%) had diabetes and 35,380 (60%) received clopidogrel. In total, 1,790 patients (25%) with diabetes and 7,931 patients (15%) without diabetes met the composite end point of recurrent MI and all-cause mortality.

In the overall study population, 978 patients with diabetes (80%) and 4,100 patients without diabetes (76%) died of cardiovascular events. Diabetics who were treated with clopidogrel had an unadjusted mortality rate of 13.4 events per 100 person-years (95% CI, 12.8 to 14.0 events per 100 person-years) compared to 29.3 events per 100 person-years (95% CI, 28.3 to 30.4 events per 100 person-years) for untreated diabetics. Non-diabetics treated with clopidogrel had unadjusted mortality rates of 6.4 events per 100 person-years (95% CI, 6.3 to 6.6 events per 100 person-years) compared to 21.3 events per 100 person-years (95% CI, 21.0 to 21.7 events per 100 person-years) for those not treated.

The researchers concluded that clopidogrel was associated with:

  • less reduction in all-cause mortality in diabetics compared to non-diabetics (hazard ratio [HR], 0.89 [95% CI, 0.79 to 1.00] vs. 0.75 [95% CI, 0.70 to 0.80]; P for interaction, 0.001),
  • less reduction in cardiovascular mortality in diabetics compared to non-diabetics (HR, 0.93 [95% CI, 0.81 to 1.06] vs. 0.77 [95% CI, 0.72 to 0.83]; P for interaction, 0.01) and
  • no reduction in the composite end point compared to some increase in non-diabetics (HR, 1.00 [95% CI, 0.91 to 1.10] vs. 0.91 [95% CI, 0.87 to 0.96]; P for interaction, 0.08).

Although head-to-head trials are needed, the study authors wrote, "[P]rasugrel may constitute an attractive alternative to clopidogrel in patients with diabetes with acute coronary syndromes, especially if recurrent ischemic events have occurred during clopidogrel treatment."

An editorialist noted that evidence on the effects of various antiplatelet options in diabetics is still developing, but that it's clear these patients face a higher risk of adverse events after MI. "At least a portion of this excess risk appears due to platelet activity and function and to the effects of antiplatelet medications in patients with diabetes. Therefore, in appropriately selected patients, intensification of the antiplatelet regimen may be one method by which their outcomes might be markedly improved," the editorial concluded.



Rheumatology


.
No associated increase in short-term malignancy risk with biologic therapy for rheumatoid arthritis

Biologic therapy does not appear to increase risk for malignancy in patients with rheumatoid arthritis, according to a new study.

Researchers performed a meta-analysis of randomized, controlled trials published through July 9, 2012, that evaluated abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab and tocilizumab in patients with rheumatoid arthritis and compared their safety with that of placebo or traditional disease-modifying antirheumatic drugs. Included studies were also required to have a follow-up of at least 24 weeks. The results of the meta-analysis appeared in the Sept. 5 Journal of the American Medical Association.

Overall, 63 randomized, controlled trials involving 29,423 patients were included in the analysis. A total of 15,989 patients received biologic therapy plus methotrexate with or without disease-modifying antirheumatic drugs, 3,615 received biologic therapy alone, and 9,819 were controls. Two hundred eleven malignancies developed, of which 118 were solid tumors, 48 were skin cancer, 14 were lymphomas, five were hematologic nonlymphomas and 26 were unspecified. During the first year of therapy, the incidence rates for malignancy were 0.77% in patients receiving biologic therapy plus methotrexate, 0.64% in patients receiving biologic therapy alone, and 0.66% in controls. No statistically significant risk for malignancy was found.

The authors noted that they could not always assess risk for bias, that their data abstraction was not blinded, and that most of the included trials were industry-funded, among other limitations. However, they concluded that patients with rheumatoid arthritis receiving biologic therapy do not appear to have an increased risk for malignancy in the first 24 weeks of therapy. They called for additional reviews of observational studies to help establish long-term risk.

"Although the findings suggest that [biologic response modifiers] may be generally safe with respect to risk of malignancy in the short term, the risk of recurrence in patients with [rheumatoid arthritis] with history of cancer or cancer risk factors remains unknown," they wrote.



Ovarian cancer


.
Task Force reaffirms recommendation against routine screening for ovarian cancer

Annual ovarian cancer screening with transvaginal ultrasonography and testing for the serum tumor marker cancer antigen (CA)-125 does not reduce the number of deaths from the disease in asymptomatic women, a review found.

annals.jpg

The U.S. Preventive Services Task Force affirmed its 2004 and 2008 recommendations. The most recent affirmation, published in the Sept. 11 Annals of Internal Medicine, is based on a bridge literature search of randomized, controlled trials that was conducted in 2011. This is a grade D recommendation (moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits). The recommendation was published online Sept. 11 by Annals of Internal Medicine.

Women with known risk factors for ovarian cancer (e.g., genetic mutations such as BRCA, Lynch syndrome, family history) should discuss the benefits and harms of screening with their doctors. Use of oral contraceptives, pregnancy and breastfeeding, bilateral tubal ligation, and removal of the ovaries all reduce the risk for ovarian cancer.

Among the new evidence considered, the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial of 78,216 American women found a nonstatistically significant increase in ovarian cancer diagnoses and no difference in either stage at diagnosis or death rate from ovarian cancer associated with screening, the Task Force said.

PLCO found that about 10% of participants in the screening arm received a false-positive result and that the positive predictive value of CA-125 testing and transvaginal ultrasonography screening was just over 1% across all screening rounds. One-third of women with a false-positive result had an oophorectomy, with an overall ratio of surgeries to screen-detected ovarian cancer of about 20 to 1. There were nearly 21 major complications per 100 surgical procedures performed on the basis of false-positive screening results.

A randomized trial set within the Shizuoka Cohort Study of Ovarian Cancer Screening evaluated the use of transvaginal or transabdominal ultrasonography in conjunction with serum CA-125 testing (positive threshold of >35 U/mL) and reported that an estimated 33 surgeries were required to diagnose one case of screen-detected ovarian cancer.

The U.K. Collaborative Trial of Ovarian Cancer Screening pilot trial and the baseline (prevalence) screening round of the full trial found that about 9% of women receiving baseline multimodal screening required repeat testing for abnormal results, and less than 1% of women had surgery. Among women having surgery for a false-positive result (47 of 97 women [48%]), about 4% experienced a major complication.



Education


.
Course offered in addiction medicine

The American Society of Addiction Medicine (ASAM) is offering a review course this month.

The 2012 Review Course in Addiction Medicine is intended for health care professionals preparing for a career in addiction medicine and primary care clinicians looking to increase their skill in identifying and managing patients with substance use disorders. The three-day course, to be held Sept. 20-22 in Nashville, Tenn., will cover topics including prescribing for pain, challenges in pain management, pharmacology of commonly abused drugs, medical conditions and complications, and co-occurring psychiatric disorders.

More information on the course is available online.



CMS update


.
ICD-10 delayed to 2014

On Aug. 24, the Department of Health and Human Services (HHS) announced that it would delay the compliance date for the switch to ICD-10 diagnosis codes until October 2014.

ACP has previously advocated for a delay, recommending that HHS allow at least another year beyond the original 2013 compliance date for physicians, developers and vendors to have a chance to better develop and integrate the new codes into their practices and facilities.

A summary of the new announcement is available on the CMS website.



Annals of Internal Medicine


.
iPad edition now available

Physicians can now access the latest research, guidelines, reviews, commentaries, educational news, and clinical news through the new Annals of Internal Medicine iPad edition.

Users can read current Annals issues and articles and access 12 months of Annals issues offline, including In The Clinic and ACP Journal Club, as well as view CME quizzes, watch videos and listen to audio summaries. The Annals iPad app is free to download through iTunes.



For the record


.
Correction to a previous issue

An item in the Aug. 28 ACP InternistWeekly required correction.

Under the heading "Perioperative care," the item on transfusions initially referred to eltrombopag as an oral thrombopoietin-receptor antagonist rather than an oral thrombopoietin-receptor agonist. The error has been corrected.



From the College


.
Yul Ejnes, MD, MACP, blogs at KevinMD.com

Yul Ejnes, MD, MACP, immediate past chair of ACP's Board of Regents and a practicing internist in Cranston, R.I., is the College's new monthly contributor to KevinMD.com, one of the Web's leading destinations for provocative physician commentary.

In his first post, Dr. Ejnes grades his EHR in the areas of time, practice finances, quality of care, interoperability, and reliability and safety.



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.

acpi-20120911-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.


.


MKSAP Answer and Critique



The correct answer is C) Dapsone and a gluten-free diet. This item is available to MKSAP 15 subscribers as item 32 in the Dermatology section.

MKSAP 16 released Part A on July 31. More information is available online.

Most, if not all, patients with dermatitis herpetiformis have gluten sensitivity, even when they have no evidence of enteropathy. Treatment with a gluten-free diet is successful in greater than 70% of patients with dermatitis herpetiformis, but excellent adherence to the diet is required for a minimum of 3 to 12 months. In the interim, initial suppression of symptoms with dapsone is usually necessary for more rapid relief of symptoms.

Continued compliance with the gluten-free diet will allow a decrease in the dapsone, and it can often be discontinued. A gluten-free diet treats the cause, rather than the symptoms, of the disease. Dapsone treatment requires careful monitoring. Hemolysis is the most common side effect of treatment and may be severe in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Pretesting for G6PD deficiency prior to initiating therapy with dapsone is generally recommended. Additional adverse reactions include toxic hepatitis, cholestatic jaundice, psychosis, and both motor and sensory neuropathy. Patients with dermatitis herpetiformis and their first-degree relatives are at increased risk for other autoimmune diseases, including thyroid disease, rheumatoid arthritis, and lupus erythematosus.

There is no role for cyclosporine, a lactose-free diet, or intravenous immune globulin in the treatment of dermatitis herpetiformis.

Key Point

  • Treatment with a gluten-free diet is successful in greater than 70% of patients with dermatitis herpetiformis, even in the absence of symptomatic enteropathy.

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Test yourself

A 69-year-old woman is evaluated for a lump under her arm found on self-examination. She is otherwise healthy and has no other symptoms. Medical and family histories are unremarkable, and she takes no medications. A needle aspirate of the right axillary mass reveals adenocarcinoma. Bilateral mammography and breast MRI are normal. CT scan of the chest, abdomen, and pelvis demonstrates the enlarged axillary lymph node and no other abnormalities. What is the most appropriate initial treatment?

Find the answer

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