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ACP InternistWeekly



In the News for the Week of 12-13-11




Highlights

NIH panel advocates delaying treatment for low-grade prostate cancer

Men with localized, low-risk prostate cancer should be closely monitored until disease progression warrants treatment, concluded an independent panel of the National Institutes of Health. More...

Shorter treatment for latent TB effective, recommended by CDC

Latent tuberculosis infection can be effectively treated with just a few months of therapy, according to a new study and updated recommendations from the CDC. However, commonly used tests for the disease have a high rate of false positives, according to another study published last week. More...


Test yourself

MKSAP Quiz: 10-month history of increasingly frequent headache

This week's quiz asks readers to evaluate a 38-year-old woman who presents with a 10-month history of increasingly frequent headache. More...


Cardiology

Statins may be more cost-effective than stress testing to determine primary CHD prevention in some patients

Treating all intermediate-risk patients with high-potency generic statins to prevent coronary heart disease may be more cost-effective than basing treatment on noninvasive stress testing, a new study indicates. More...


Arthritis care

Bisphosphonate use associated with extended implant survival in knee, hip replacements

Bisphosphonate use was associated with an almost twofold increase in implant survival time in patients undergoing lower limb arthroplasty, researchers found. More...


Transitions of care

Readmissions frequent, one-quarter related to new problem

Rates and causes of hospital readmissions, and the infrequency of follow-up care, were quantified in a new research brief from the National Institute for Health Care Reform. More...


FDA update

Bleeding risk of dabigatran under scrutiny

Serious bleeding events have been reported in patients taking dabigatran (Pradaxa), according to a new FDA MedWatch alert. 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: Darren Taichman, MD, FACP



Highlights


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NIH panel advocates delaying treatment for low-grade prostate cancer

Men with localized, low-risk prostate cancer should be closely monitored until disease progression warrants treatment, concluded an independent panel of the National Institutes of Health.

The panel issued a draft statement calling for standard definitions and for more multi-center studies to clarify which monitoring strategies are most likely to optimize patient outcomes.

The panel identified emerging consensus in the medical community on a definition for low-risk prostate cancer including a prostate-specific antigen (PSA) level less than 10 ng/mL and a Gleason score of 6 or less. Using this definition, the panel estimated that more than 100,000 men diagnosed with prostate cancer each year would be candidates for active monitoring rather than immediate treatment. About 10% of men who are eligible for active surveillance choose it, most often because of physician recommendation. About a quarter of patients who choose observation will subsequently undergo therapy within two to three years, and about half by five years.

The panel found that protocols to manage active monitoring still vary widely, hampering evaluation and comparison of research findings. For example, published studies show that PSA and digital rectal exams were variably assessed every three to 12 months, but no consensus exists as to the optimal schedule. Repeat biopsy is included in all U.S. studies of active surveillance, but frequency varies from one to four biopsy procedures during the initial four-year period, with surveillance continuing indefinitely.

"Predicting whether a particular individual's cancer will progress is difficult," the report states. "The only clear current indicator of disease progression is an increase in Gleason score. The value of PSA doubling time is uncertain. New indicators of disease progression are needed, potentially including imaging techniques to identify clinical important tumors, molecular classification of cancers, and genetic classification of a patient's risk for progression."

How clinicians frame disease management options is an important factor in patient decision-making, the panel said. The panel recommended against future federal funding for single-site studies, preferring multisite clinical research studies. The panel also supports creating registry-based cohort studies that collect longitudinal data on active monitoring participants, including clinical and patient-reported outcomes.

Finally, because of the very favorable prognosis of PSA-detected, low-risk prostate cancer, the panel recommended that strong consideration be given to avoiding the term "cancer" when talking to patients, because of the anxiety it creates.

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Shorter treatment for latent TB effective, recommended by CDC

Latent tuberculosis (TB) infection can be effectively treated with just a few months of therapy, according to a new study and updated recommendations from the CDC. However, commonly used tests for the disease have a high rate of false positives, according to another study published last week.

The treatment study was an open-label, noninferiority trial in which patients at high risk for TB (most had close contact with a TB patient and positive skin tests) who lived in the U.S., Canada, Brazil or Spain were randomized to either nine months of self-administered daily isoniazid (300 mg) or three months of directly observed once-weekly therapy with rifapentine (900 mg) plus isoniazid (900 mg). Each group had almost 4,000 subjects and they were followed for 33 months for the development of confirmed tuberculosis. The results appeared in the Dec. 8 New England Journal of Medicine.

In a modified intention-to-treat analysis, researchers found that the shorter, combined therapy was as effective as the isoniazid-alone regimen; tuberculosis developed in 7 (or 0.19%) of the combination-therapy group compared to 15 (or 0.43%) of the isoniazid group. The combined group was also more likely to complete treatment: 82.1% vs. 69.0% (P<0.001). However, despite having lower rates of hepatotoxicity (0.4% vs. 2.7%), participants in the combination group were more likely to discontinue therapy due to an adverse event (4.9% vs. 3.7%; P=0.009).

The study authors noted that the higher rate of adverse-event-related discontinuation could be due to more frequent interactions with study clinicians during the directly observed therapy. The direct observation, along with the shorter duration of treatment, also probably explains the higher completion rate in the combined group than the isoniazid group. They concluded that the combination regimen could be used effectively in settings such as the studied ones, although additional safety monitoring should be conducted. An accompanying editorial called for more research into the duration of protection for patients against TB from this regimen, particularly in high-incidence settings and among HIV-positive patients.

Based on the results of the study, the CDC added a new treatment option to their recommendations for latent TB: 12 once-weekly doses of rifapentine and isoniazid taken under the supervision of a health care worker. The regimen is recommended for otherwise healthy people aged 12 and older who have had recent exposure to contagious TB, conversion from negative to positive on a test for TB, or a chest X-ray indicating prior TB disease. Patients with HIV who are otherwise healthy and not taking antiretrovirals may also use this regimen. The regimen is not recommended for use among children under 2, women who are pregnant or planning to become pregnant, and HIV-infected people taking antiretrovirals. Patients on the regimen should be monitored for possible adverse effects and undergo a clinical assessment at least monthly, the CDC said.

In the second study, researchers tested about 2,000 U.S. Army recruits in South Carolina for TB. Each recruit completed a risk-factor questionnaire and underwent the tuberculin skin test (TST) and two interferon gamma release assays (IGRAs): the QuantiFERON-TB Gold In-Tube test and the TSPOT TB test. The study found that the specificities of the tests were not significantly different, at least in this low-risk population, even though the IGRAs were designed to increase specificity.

Of the 88 subjects with a positive test, only 10 (11.4%) were positive on all three tests. Twenty of the subjects (22.7%) were positive on two tests. Based on the results, the researchers concluded that in a low-prevalence population, most positive results from any of the tests would be false positives. The findings support the use of risk stratification to guide interpretation of both TSTs and IGRAs, and the CDC's recommendation not to target low-risk people for testing, the authors concluded. The study was published early online by the American Journal of Respiratory and Critical Care Medicine on Dec. 9.

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Test yourself


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MKSAP Quiz: 10-month history of increasingly frequent headache

A 38-year-old woman is evaluated in the office for a 10-month history of increasingly frequent headache. The headache is often worse in the morning on awakening. She has recently started keeping a headache diary, which reveals episodes on approximately 25 days of each month. The headache varies from a near-daily bilateral frontal dull throbbing to a severe left hemicranial throbbing associated with nausea, photophobia, and phonophobia. The patient has a 20-year history of migraine without aura and a history of depression. Her mother also has a history of migraine and depression, and her sister has a history of migraine. The patient has been taking propranolol for 3 months; a mixed analgesic containing butalbital, caffeine, and acetaminophen for mild or moderate headache at least 3 days per week for 9 months; rizatriptan for severe headache at least 2 days per week for 4 months; and citalopram for 1 year. Rizatriptan has become increasingly ineffective over the past month.

mksap.jpg

Physical examination findings, including neurologic examination findings, are normal.

Which of the following is the most likely diagnosis for her current symptoms?

A) Chronic migraine
B) Chronic tension-type headache
C) Idiopathic intracranial hypertension
D) Medication overuse headache

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

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Cardiology


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Statins may be more cost-effective than stress testing to determine primary CHD prevention in some patients

Treating all intermediate-risk patients with high-potency generic statins to prevent coronary heart disease (CHD) may be more cost-effective than basing treatment on noninvasive stress testing, a new study indicates.

Researchers used a computer-simulated model of CHD in U.S. adults 35 to 84 years of age to perform a cost-effectiveness analysis of the following four strategies for primary prevention:

  1. The status quo, which simulated current use of aspirin and statins in the U.S.;
  2. Treatment based on the Adult Treatment Panel (ATP III) guidelines, that is, low-potency statins in patients with a low-density lipoprotein cholesterol level of at least 130 mg/dL (≥3.36 mmol/L);
  3. "Treat all," in which all intermediate-risk men and women received statins and all men also received aspirin; and
  4. "Test and treat," in which intermediate-risk men and women received high-potency statins and men also received aspirin only after a positive result on a noninvasive stress test (stress electrocardiography, stress electrocardiography plus a nuclear perfusion scan, or stress echocardiography).

The model projected health care costs, CHD events and quality-adjusted life-years from 2011 to 2040. The study results were published early online Dec. 5 by Circulation.

The model initially included all U.S. men and women who were 45 years of age and 55 years of age, respectively, in 2011 and had a 10% to 20% risk for a CHD event in the next 10 years, per the ATP III guidelines. Additional intermediate-risk men and women 45 and 55 years of age were added to the model each year, while men and women who died or were reclassified as high risk before their next 10-year screening but did not first develop CHD were removed. People who were at intermediate risk and developed CHD were followed until 2040 or until they died, whichever event occurred first.

Overall, the authors found that the "treat all" strategy was most effective and cost the least. In the "test and treat" strategies, stress testing with electrocardiography was the most effective and least expensive method, but was still more expensive than "treat all" unless statins were assumed to cost more than $3.16 per pill and if adherence increased from under 22% to over 75% after testing. Stress testing with electrocardiography could be cost-effective in patients who initially didn't adhere to statin and aspirin treatment if it increased adherence to 5% and could save money if it increased adherence to 13%.

The study used data from published studies to model sensitivity and specificity of noninvasive testing and assumed that all patients who were between 45 and 65 years of age would be physically able to perform a stress test that would yield definitive results, among other limitations. However, the authors concluded that prescribing high-potency generic statins is more cost-effective than basing primary CHD prevention on results of noninvasive stress tests, except in cases where such tests can significantly increase adherence to drug therapy. The authors recommended that these strategies be compared with other and perhaps more cost-effective methods of increasing medication adherence.

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Arthritis care


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Bisphosphonate use associated with extended implant survival in knee, hip replacements

Bisphosphonate use was associated with an almost twofold increase in implant survival time in patients undergoing lower limb arthroplasty, researchers found.

Researchers conducted a population-based retrospective cohort study using data from the General Practice Research Database of 3 million primary care patients in the United Kingdom. They identified all patients over the age of 40 undergoing knee (n=18,726) or hip (n=23,269) replacement surgery from 1986-2006 for osteoarthritis. Bisphosphonate users were defined as patients with at least six prescriptions of bisphosphonates or at least six months of prescribed bisphosphonate treatment with more than 80% adherence before surgery. Patients were excluded for a history of hip fracture before surgery or rheumatoid arthritis and for being younger than 40 years of age at surgery. Results were published Dec. 6 at BMJ.

Of the nearly 42,000 patients, 1,912 took bisphosphonates. They had a lower rate of revision at five years than non-users: 0.93% (95% CI, 0.52% to 1.68%) versus 1.96% (95% CI, 1.80% to 2.14%).

At five-year follow-up, 522 (1.2%) participants had revision surgery. There were 511 (1.3%) revisions (296 hip and 215 knee) in non-users of bisphosphonates. There were only 11 (0.6%) revisions in bisphosphonate users—eight hip and three knee. Bisphosphonate use had a strongly protective effect on implant survival throughout the study (adjusted hazard ratio 0.54; 95% CI, 0.29 to 0.99; P=0.047), with a significant increase in median prosthesis survival (time ratio 1.96; 95% CI, 1.01 to 3.82).

Assuming an accumulated incidence of failure of 2% over five years, researchers calculated that the number needed to treat to avoid one revision was 107 for patients ages 40 years or older.

"If, in addition to fracture reduction, bisphosphonate use leads to a reduced risk of implant failure and therefore an extension of implant survival, its use should be assessed in clinical settings," the researchers wrote. "If these findings are replicated in other observational cohorts, a randomized clinical trial is needed to test the efficacy and cost effectiveness of bisphosphonate use at or before the time of surgery to improve implant survival and reduce fracture risk."

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Transitions of care


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Readmissions frequent, one-quarter related to new problem

Rates and causes of hospital readmissions, and the infrequency of follow-up care, were quantified in a new research brief from the National Institute for Health Care Reform.

About a third of adults discharged from the hospital were rehospitalized within one year, according to the brief, which used data from the 2000-2008 Medical Expenditure Panel Survey Household Component. The 5,805 participants, all with at least one overnight hospital stay, underwent five rounds of interviews covering their insurance and health status and health care utilization and expenditures.

Overall, 8.2% of the participants were readmitted within 30 days. More than a quarter of those readmissions (26.1%) were for conditions unrelated to the cause of their initial admission. When the analysis was extended to all readmission within a year, the percentage of admissions unrelated to the original one was 37.4%. This finding could be explained by patients not receiving adequate treatment for all their comorbidities, the researchers suggested.

The study also found that one-third of the patients did not see an outpatient clinician for follow-up within 30 days after discharge. About 7% of patients visited an emergency department within 30 days of discharge, and this statistic was approximately the same among both patients who did have a follow-up appointment and those who didn't. The study did find that patients who didn't follow up tended to be healthier and younger. There were no significant differences in follow-up rates associated with patients' type of insurance, despite the fact that patients with public insurance were typically sicker, researchers noted.

Private insurance paid for 47% of the 30-day readmissions, while Medicare paid for 40%. This statistic is interesting because more focus has been placed on changing Medicare policy to decrease readmissions, the researchers noted. The authors also discussed how other proposed health care reforms could potentially improve readmission and follow-up rates, including bundled payments, patient-centered medical homes and interoperative health information technology. They called for additional research on effective care for high-risk patients with multiple comorbidities.

The National Institute for Health Care Reform is a nonprofit organization established by the International Union UAW, Chrysler Group LLC, Ford Motor Company and General Motors that contracts with the Center for Studying Health System Change to conduct health policy research.

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FDA update


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Bleeding risk of dabigatran under scrutiny

Serious bleeding events have been reported in patients taking dabigatran (Pradaxa), according to a new FDA MedWatch alert.

Labeling for the drug has not changed, and the FDA continues to believe that dabigatran provides an important health benefit when used as directed, but the agency will be investigating the drug's bleeding risk. The drug label currently contains a warning about significant and sometimes fatal bleeds, an FDA press release noted.

Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. In a large clinical trial (18,000 patients) comparing dabigatran and warfarin, major bleeding events occurred at similar rates with the two drugs. However, the FDA is working to determine whether the reports of bleeding are occurring more commonly than would be expected.

In the meantime, the agency recommends that clinicians who prescribe dabigatran follow the recommendations in the drug label and patients not stop the drug without talking to their health care professional.

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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-20111213-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 D) Medication overuse headache. This item is available to MKSAP 15 subscribers as item 49 in the Neurology section. More information about MKSAP 15 is available online.

This patient has medication overuse headache. She has a 20-year history of migraine but a 10-month history of chronic daily headache on more than 15 days per month. She has been using an acute headache medication (butalbital, caffeine, and acetaminophen) more than 10 days per month and a combination of this medication and rizatriptan on some of these days. These features define a medication overuse headache.

Although the patient does have chronic migraine, her current symptoms most likely result from her overuse of acute medications and not from her long history of migraine. Medication overuse headache typically presents when or soon after a patient awakens, and the efficacy of migraine-specific therapy in patients with medication overuse headache is intermittent or poor. Furthermore, some of this patient's headaches lack the classic features of migraine, including a pounding, unilateral headache of approximately 1 day's duration associated with nausea and disability (taking to bed).

Despite the patient's depression, her headaches are not fully characteristic of chronic tension-type headache, which is typically mild to moderate in severity, lasts from 30 minutes to 7 days, and is often described as a "band-like" constriction around the head. Tension-type headaches are not associated with nausea and vomiting, photophobia, or phonophobia.

Idiopathic intracranial hypertension is a disturbance of increased intracranial pressure without evidence of intracranial disease, such as mass lesion, hydrocephalus, or venous sinus thrombosis. This disorder occurs most commonly in obese women of childbearing age but also may be associated with tetracycline therapy, oral contraceptive use, and hypervitaminosis A. Affected patients typically develop new onset of daily nonthrobbing headaches that may worsen with coughing and sneezing or in the supine position. Other clinical symptoms may include diplopia, transient episodes of monocular or binocular visual loss, and pulsatile tinnitus. Characteristic findings in patients with this condition are papilledema, an enlarged blind spot or visual field abnormalities, and possible sixth cranial nerve palsy. This patient's findings are not consistent with idiopathic intracranial hypertension.

Key Point

  • Medication overuse headache is generally defined as a headache for more than 15 days per month and the use of acute headache medication on more than 10 days per month.

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Test yourself

A 50-year-old man is evaluated in follow-up for a recent diagnosis of cirrhosis secondary to nonalcoholic steatohepatitis. He has a history of asthma, type 2 diabetes mellitus, hyperlipidemia, and obesity. His current medications are inhaled fluticasone, montelukast, insulin glargine, insulin lispro, simvastatin, and lisinopril. Following a physical exam, lab studies, and upper endoscopy, what is the most appropriate treatment?

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