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ACP InternistWeekly



In the News for the Week of January 15, 2013




Highlights

Combining diuretics, anti-hypertensives and NSAIDs may pose risk of kidney injury

Combining diuretics with angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers and nonsteroidal anti-inflammatory drugs (NSAIDs) increased risk of acute kidney injury, a study found. More...

Generic-based antiretroviral therapy may be cost-effective, mathematical simulation model indicates

Three-pill generic-based antiretroviral therapy is cost-effective and could offer cost savings compared with a branded single-pill regimen, a new study indicates. More...


Test yourself

MKSAP Quiz: a 6-month history of low back pain

This week's quiz asks readers to evaluate a young man with a 6-month history of low back pain and prolonged morning stiffness. More...


Women's health

IUD for menorrhagia improved quality of life more than medical therapy

A levonorgestrel intrauterine device (IUD) improved quality of life more for women with menorrhagia than usual medical treatments did, a recent study found. More...


Cardiac rehabilitation

Discharge summaries from cardiac rehab often fail to reach primary care clinicians in Canada, study finds

Primary care clinicians often don't receive their patients' discharge summaries from cardiac rehabilitation, according to a new study. More...


Deep venous thrombosis

Selective use of D-dimer based on pretest probability identified first suspected DVTs with less testing

More selective use of D-dimer testing allowed physicians to safely and efficiently diagnose first episodes of deep venous thrombosis (DVT), a new study found. More...


CMS update

Medicare participation deadline extended for 2013

Due to the last-minute action by Congress on the Physician Fee Schedule, the Centers for Medicare and Medicaid Services is extending Medicare's 2013 Annual Participation Enrollment Program. More...


From ACP Internist

The next issue of ACP Internist is online

The January issue of ACP Internist is online and coming to your mailbox. More...

Call for cases

Have you as a physician been a patient? If so, ACP Internist wants to hear from you. More...


From the College

Call for fall 2013 Board of Governors resolutions

The deadline for submitting new resolutions to be heard at the fall 2013 Board of Governors meeting is March 20, 2013. 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...

Editorial note: ACP InternistWeekly will not be published next week due to the Martin Luther King Jr. Day holiday


Physician editor: Daisy Smith, MD, FACP



Highlights


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Combining diuretics, anti-hypertensives and NSAIDs may pose risk of kidney injury

Combining diuretics with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) and nonsteroidal anti-inflammatory drugs (NSAIDs) increased risk of acute kidney injury, a study found.

Researchers conducted a nested, case-control study of data from primary care records in the U.K. that identified 487,372 people who received antihypertensive drugs from 1997 to 2008. Patients were tracked for a mean of 5.9 ± 3.4 years, generating more than 3 million person-years of follow-up. During this time, 2,215 were diagnosed with acute kidney injury that prompted hospital admission or dialysis (7 in 10,000 person-years).

Study results appeared online Jan. 8 at BMJ.

Taking a double-therapy combination of diuretics or ACE inhibitors or ARBs with NSAIDs was not associated with an increased rate of acute kidney injury. However, a triple-therapy combination of a diuretic with an ACE inhibitor or ARB and an NSAID was associated with a higher rate of kidney injury (rate ratio [RR], 1.31; 95% CI, 1.12 to 1.53). The risk was particularly elevated in the first 30 days of treatment (RR, 1.82; 95% CI, 1.35 to 2.46) and progressively decreased, becoming insignificant after more than 90 days of use (RR, 1.01; 95% CI, 0.84 to 1.23; P<0.001 for interaction).

The authors wrote, "Given that NSAIDs are widely used (40-60% as lifetime prevalence in the general population) and that a greater incidence rate of acute kidney injury was estimated among antihypertensive drugs users than in the general population, increased vigilance may be warranted when diuretics and angiotensin converting enzyme inhibitors or angiotensin receptor blockers are used concurrently with NSAIDs. In particular, major attention should be paid early in the course of treatment, and a more appropriate use and choice among the available anti-inflammatory or analgesic drugs could therefore be applied in clinical practice."

An accompanying editorial noted that the study's confidence intervals were wide, that over-the-counter NSAID use could be unreported, that doctors who monitored for this effect may have stopped treatment before kidney injury occurred, and that drug-associated acute kidney injury is often a complication of other illnesses. Clinicians should talk to patients about risks and be vigilant for drug-associated acute kidney injury, the editorial stated, because, "The jury is still out on whether double drug combinations are indeed safe."


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Generic-based antiretroviral therapy may be cost-effective, mathematical simulation model indicates

Three-pill generic-based antiretroviral therapy (ART) is cost-effective and could offer cost savings compared with a branded single-pill regimen, a new study indicates.

Current U.S. guidelines for first-line treatment of HIV infection recommend a once-daily regimen of a branded pill containing efavirenz, emtricitabine, and tenofovir. However, because a generic version of efavirenz is expected to be approved soon, researchers performed a mathematical simulation to compare the clinical effect, costs and cost-effectiveness of standard therapy and a once-daily three-pill regimen containing generic efavirenz, generic lamivudine and tenofovir. The latter regimen would be less expensive but could decrease adherence and virologic suppression.

annals.jpg

Three regimens were compared: no ART, three-pill generic-based ART (generic efavirenz and lamivudine plus branded tenofovir) and one-pill branded ART (efavirenz, emtricitabine and tenofovir). The main outcome measures were quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY). The hypothetical cohort entered into the mathematical model was similar to patients newly diagnosed with HIV infection in the U.S. in 2009. Eighty-four percent were assumed to be men, and mean CD4 cell count at presentation was assumed to be 0.317 × 109 cells/L. Study results were published in the Jan. 15 Annals of Internal Medicine.

Generic-based ART had an ICER of $21,000/QALY compared with no ART. Branded ART versus generic-based ART increased lifetime costs by $42,500 and increased survival gains per person by 0.37/QALY, leading to an ICER of $114,800/QALY. The authors estimated that if all eligible U.S. patients started or switched to generic-based ART, $920 million would be saved in the first year of treatment. Branded ART consistently showed an ICER greater than $100,000/QALY.

The authors noted that the efficacy of and price reduction with generic drugs are unknown, and that their estimates were conservative. They also noted that the tradeoff between cost savings and health benefits may be controversial and that higher willingness-to-pay thresholds could make the higher cost of branded regimens more acceptable. However, they concluded that the generic-based regimen offered substantial cost savings compared with the branded regimen, although it was slightly less effective clinically. "Starting or switching to generic-based regimens would initially yield annual savings approaching $1 billion for programs that fund HIV treatment in the United States," the authors wrote.

The author of an accompanying editorial pointed out that recent changes related to the Affordable Care Act may make generic antiretroviral drugs more attractive to some stakeholders. "HIV advocates and caregivers might more readily embrace generic antiretrovirals if…the savings were diverted to address other funding needs within the field of HIV medicine," he wrote. Regardless, he concluded, "The era of generic antiretrovirals in the United States has come."



Test yourself


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MKSAP Quiz: a 6-month history of low back pain

A 20-year-old man is evaluated for a 6-month history of low back pain accompanied by prolonged morning stiffness. His symptoms improve over the course of the day, but he is now unable to play recreational soccer. Rest, physical therapy, and acupuncture have not improved his symptoms. Use of ibuprofen or diclofenac provides only partial relief. He has no other pertinent medical history and takes no additional medications.

mksap.gif

On physical examination, vital signs are normal. There is loss of normal lumbar lordosis, and flexion of the lumbar spine is decreased. The low back and pelvis are tender to palpation. Pain increases when the patient crosses his legs. Reflexes and muscle strength are intact.

Radiographs of the lumbar spine and sacroiliac joints are normal.

Which of the following studies is most likely to establish the diagnosis in this patient?

A: Bone scan
B: CT of the sacroiliac joints
C: MRI of the lumbar spine
D: MRI of the sacroiliac joints

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


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Women's health


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IUD for menorrhagia improved quality of life more than medical therapy

A levonorgestrel intrauterine device (IUD) improved quality of life more for women with menorrhagia than usual medical treatments did, a recent study found.

The trial assigned 571 British women who presented to primary care with menorrhagia to treatment with the levonorgestrel IUD or one or more medical therapies (including tranexamic acid, mefenamic acid, combined estrogen-progestogen or progesterone alone). The primary outcome was the patients' change in score on the Menorrhagia Multi-Attribute Scale (MMAS), which ranges from 0 to 100 and includes domains of practical difficulties, social life, family life, work and daily routines, psychological well-being and physical health. The study was published in the Jan. 10 New England Journal of Medicine.

After six months, women in the IUD group and the usual treatment group both showed significantly greater improvements in MMAS scores (mean increase, 32.7 points and 21.4 points, respectively; P<0.001 for both comparisons). The patients were followed for two years, and the greater benefit seen in the IUD group was maintained (mean between-group difference, 13.4 points; 95% CI, 9.9 to 16.9 points). The IUD group had bigger improvements in all of the MMAS domains and seven of eight studied quality-of-life domains. A higher percentage also kept the device for two years compared with the percentage of those in the usual treatment group who continued treatment for two years (64% vs. 38%), although researchers noted this could have related to the need for a medical visit to discontinue use of an IUD. The groups did not differ significantly in surgical intervention rates, sexual activity scores or serious adverse events.

Study authors concluded that the IUD was more effective than usual medical treatment in reducing the impact of heavy menstrual bleeding on patients' quality of life. Most previous trials have been smaller and used the reduction of menstrual blood lost as an outcome. The outcomes used in this study—the MMAS, quality-of-life measures, and sexual activity scores—may be more relevant to patients. The authors did note that a subgroup analysis showed that the IUD was relatively less beneficial in women with a body mass index below 25 kg/m2 than in heavier ones, perhaps because medical treatments have greater efficacy for them.

An accompanying editorial pointed out that the medical treatments most commonly used in the study (tranexamic acid, mefenamic acid or both) are rarely used in the U.S. Still, the study adds to evidence that the IUD is superior to medical treatments for menorrhagia. The success of the study's primary care approach also suggests that women could benefit from more involvement of generalist physicians in treatment of this condition. More training in IUD insertion and FDA approval of the levonorgestrel IUD for heavy bleeding (rather than just contraception) may be appropriate, the editorial concluded.



Cardiac rehabilitation


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Discharge summaries from cardiac rehab often fail to reach primary care clinicians in Canada, study finds

Primary care clinicians often don't receive their patients' discharge summaries from cardiac rehabilitation, according to a new study.

Researchers performed an observational, cross-sectional study to determine how often and when primary care clinicians received cardiac rehab discharge summaries, as well as their perception of and satisfaction with them. Between September 2008 and March 2011, consecutive enrollees at eight cardiac rehab programs in Toronto, Canada, were asked to give their consent to participate in the study and to provide the names of their primary care clinicians. Clinicians were mailed an information letter and a consent form and were in turn asked to participate. The researchers tracked the progress of discharge summaries to the clinicians' offices, and those who received discharge summaries were sent a survey asking them to rate their satisfaction on a five-point Likert scale. The study results were published online Jan. 8 by Circulation: Cardiovascular Quality and Outcomes.

Of the 577 clinicians invited to participate, 138 (24.0%) accepted. A total of 71 clinicians (51.5%) received cardiac rehab discharge summaries, and of these 64 (90.1%) completed the survey. All of the clinicians in the study said they wanted to receive discharge summaries, preferably (61.3%) by fax. Forty-seven (77.1%) reported they had used or planned to use information from the discharge summary in patient care, but those who didn't receive the summary before a patient's first post-rehab visit (n=7) were significantly less likely to ever use it (P<0.01). The researchers used a five-point Likert scale to assess the items considered most important to include in a discharge summary and found that PCPs most valued information on medication (4.65±0.74), patient care plan (4.43±0.87), and clinical status (4.33±0.94). However, 18.8%, 4.7%, and 22.2% of summaries, respectively, did not provide this information.

The study authors acknowledged that the clinician response rate was low, that the generalizability of the results was not known, and that the cardiac rehab sites were aware of the study objectives, among other limitations. However, they concluded that a large percentage of primary care clinicians do not receive their patients' discharge summaries after cardiac rehab and that this discrepancy reveals "a large gap in continuity of patient care." The results of their study suggest "that more standardized strategies for [cardiac rehab] summary information gathering, generation, and transmission are required," they wrote.



Deep venous thrombosis


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Selective use of D-dimer based on pretest probability identified first suspected DVTs with less testing

More selective use of D-dimer testing allowed physicians to safely and efficiently diagnose first episodes of deep venous thrombosis (DVT), a new study found.

The randomized, controlled trial included more than 1,500 patients who presented to Canadian hospitals with symptoms of DVT. Physicians used the 9-point Wells clinical prediction rule to assess whether patients' clinical pretest probability of DVT was low, moderate or high. Then patients were randomized to one group in which all patients were uniformly given D-dimer tests (and given ultrasonography based on those results) or one in which pretest probability determined testing.

annals.jpg

In the latter group, patients who had a low pretest probability and a D-dimer level below 1.0 µg/mL had DVT excluded as their diagnosis. For patients with a moderate pretest probability, the D-dimer cutoff was 0.5 µg/mL. Patients who scored below either of these levels did not receive ultrasonography. Outpatients with high pretest probability and all inpatients were not given D-dimer tests and instead all received ultrasonography. Patients were followed for three months, and results were published in the Jan. 15 Annals of Internal Medicine.

At three months, the selective and uniform testing groups had equal incidence of symptomatic VTE: 0.5% (difference between groups, 0 percentage points; 95% CI, −0.8 to 0.8 percentage point). Selective testing reduced the proportion of patients getting D-dimer tests by 21.8 percentage points (95% CI, 19.1 to 24.8 percentage points) and ultrasonography by 7.6 percentage points (95% CI, 2.9 to 12.2 percentage points). Outpatients with low pretest probability had a particularly steep drop in ultrasonography: 21 percentage points (95% CI, 14.2 to 27.6 percentage points).

Study authors concluded that the selective testing was as safe as and more efficient than uniform testing and resulted in a similar number of patients being diagnosed with VTE during testing. They noted that none of the patients with D-dimer levels between 0.5 and 1.0 µg/mL were diagnosed with VTE during the study and that a very small percentage of the high-risk patients in the control group had DVT excluded by D-dimer testing (15% of outpatients with high pretest probability and 2% of inpatients).

They cautioned that the results may not be generalizable to patients with a history of DVT or to other D-dimer tests but called for research on using selective testing in patients who present with suspected recurrences. For first suspected episodes of DVT, the results support basing testing choices on pretest probability, they concluded.



CMS update


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Medicare participation deadline extended for 2013

Due to the last-minute action by Congress on the Physician Fee Schedule, the Centers for Medicare and Medicaid Services (CMS) is extending Medicare's 2013 Annual Participation Enrollment Program.

The participation enrollment period will now end Feb. 15, 2013, instead of Dec. 31, 2012. This allows extra decision making time for those who may still be considering their options. For more information about declaring your Medicare participant/nonparticipant status, please visit the CMS website.



From ACP Internist


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The next issue of ACP Internist is online

The January issue of ACP Internist is online and coming to your mailbox. Featured stories include the following:

acpi-20130115-internist.jpg

Taking a drink: what patients should know. Alcohol is associated with so many benefits and harms that it's hard to know where to start talking to patients about using it. One place might be alcohol misuse and abuse. Teach patients where they fall on the continuum of drinking behavior. Take our poll on the topic.

Finesse required to treat anxiety in the elderly. Elderly patients may have many concerns on their mind, including maintaining their independence and managing their finances. But when does worry become anxiety? And how can internists not only manage chronic diseases but also ensure that patients are able to care for themselves?

A few tips can improve older patients' memory. Most complaints of memory problems aren't signs of serious cognitive impairment and thus can be alleviated with a few simple tips.

These stories and the latest Test Yourself question from the MKSAP Quiz on a 67-year-old man evaluated for a 3-year history of low back pain are now online.


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Call for cases

Have you as a physician been a patient? If so, ACP Internist wants to hear from you.

Our new column, "Doctor as Patient," will look at physicians' thinking as applied to their own health and wellness, based on real stories from readers. It will be written by Jerome Groopman, MD, FACP, and Pamela Hartzband, MD, FACP, coauthors of the bestseller "Your Medical Mind: How to Decide What Is Right for You." Both are on the Harvard Medical School faculty and serve as staff physicians at Boston's Beth Israel Deaconess Medical Center.

If your submission is chosen for print, you'll receive a $50 gift certificate good toward any ACP product, program or service. Contact us if you have a story to tell. We look forward to receiving your submissions!



From the College


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Call for fall 2013 Board of Governors resolutions

The deadline for submitting new resolutions to be heard at the fall 2013 Board of Governors meeting is March 20, 2013.

Initiating a resolution provides ACP members an opportunity to focus attention at the ACP national level on a particular issue or topic that concerns them. When drafting a resolution, don't forget to consider how well it fits within ACP's Mission and Goals. In addition, be sure to use the College's Strategic Plan to guide you when proposing a resolution topic. Members must submit resolutions to their Governor and/or chapter council. A resolution becomes a resolution of the chapter once the chapter council approves it.

In accordance with the ACP Board of Governors Resolutions Process, resolutions should clearly distinguish the action requested within its resolved clause(s) as either a policy resolve ("Resolved that ACP policy…") or a directive, which requests action/study on an issue ("Resolved that the Board of Regents…"). If more than one action is proposed, each should have its own resolved clause. Please contact your Governor if you have any questions regarding the resolution format.

The Board of Governors votes on new resolutions, which are then presented to the Board of Regents for action. Members are encouraged to use the Electronic Resolutions System (ERS) to research the status of past resolutions before proposing a new resolution. Visit your chapter website and link to the ERS under the "Advocacy" heading.



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-20130115-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: MRI of the sacroiliac joints. This item is available to MKSAP 16 subscribers as item 41 in the Rheumatology section.

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

This patient most likely has ankylosing spondylitis, and MRI of the sacroiliac joints is most likely to establish a diagnosis. Radiographic evidence of sacroiliitis is required for definitive diagnosis and is the most consistent finding associated with this condition. Onset of ankylosing spondylitis usually occurs in the teenage years or 20s and manifests as persistent pain and morning stiffness involving the low back that is alleviated with activity. This condition also may be associated with tenderness of the pelvis.

Typically, the earliest radiographic changes in affected patients involve the sacroiliac joints, but these changes may not be visible during the first few years from onset; therefore, this patient's normal radiographs of the sacroiliac joints do not exclude sacroiliitis. MRI findings of the sacroiliac joints can include bone marrow edema, synovitis, and erosions. Bone marrow edema is the earliest finding and can precede the development of erosions. MRI, especially with gadolinium enhancement, is considered a sensitive method for detecting early erosive inflammatory changes in the sacroiliac joints and spine and can assess sites of active disease and response to effective therapy.

Bone scan can demonstrate increased uptake of the sacroiliac joints in patients with ankylosing spondylitis but is less sensitive and specific than MRI.

CT is the most sensitive modality available to demonstrate bone changes such as erosions; however, it cannot detect early changes such as bone marrow edema that precede erosive change in patients with ankylosing spondylitis.

In the diagnosis of early ankylosing spondylitis, sacroiliac joint MRI is more sensitive than lumbar spine MRI. Although changes to the lumbar spine can be detected on MRI, they are usually preceded by changes in the sacroiliac joints. Therefore, if imaging of the lumbar spine is negative, subsequent imaging of the sacroiliac joints would still be necessary to exclude ankylosing spondylitis.

Key Point

  • MRI is considered the most sensitive method for detecting early erosive inflammatory changes in the sacroiliac joints when radiographs are normal.

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Test yourself

A 66-year-old man is evaluated for vague abdominal pain of several months' duration and a 10-kg (22-lb) weight loss. He drinks alcohol socially but does not smoke. The patient is otherwise well, has good performance status, and takes no medications. Following a physical exam, lab studies, and a CT scan, what is the most appropriate initial management of this patient?

Find the answer

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