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

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ACP InternistWeekly



In the News for the Week of June 11, 2013




Highlights

Medicare prescribers use twice as many brand-name drugs as VA

Medicare beneficiaries with diabetes take many more brand-name drugs than similar patients treated in the Veterans Affairs (VA) system, adding as much as $1 billion per year to health care costs, a recent study found. More...

Vascular risks may vary among nonsteroidal anti-inflammatory drugs

High doses of diclofenac and possibly ibuprofen have comparable vascular risks to coxibs, whereas high-dose naproxen was associated with less vascular risk than other nonsteroidal anti-inflammatory drugs (NSAIDs), a meta-analysis found. More...


Test yourself

MKSAP Quiz: 3-day history of lower abdominal pain, watery diarrhea

A 26-year-old man is evaluated for a 3-day history of fever, lower abdominal pain, tenesmus, hematochezia, and watery diarrhea. Seven months ago, he underwent a cadaveric kidney transplantation from a transplant donor who was seropositive for cytomegalovirus. Following a physical exam and lab studies, what is the most likely diagnosis? More...


Sleep apnea

Guideline issued on assessing sleep apnea and driving risk

The American Thoracic Society has issued an updated guideline on assessing sleep apnea, sleepiness and driving risk in noncommercial drivers. More...


Heart failure

AHA and ACC update heart failure guidelines

New and revised recommendations on the treatment of heart failure were released last week jointly by the American College of Cardiology Foundation and American Heart Association. More...


Bariatric surgery

Bariatric surgery leads to short-term improved glycemic control and weight loss in moderately obese diabetics

Bariatric surgery in diabetic patients with a body mass index of 30 to 35 kg/m2 is associated with more short-term weight loss and better intermediate outcomes than nonsurgical treatments, but data on long-term effects are limited, a review found. More...


Practice management

Physician & Practice Timeline helps physicians track key requirements and opportunities

ACP has launched Physician & Practice Timeline: Professional Requirements & Opportunities, a valuable online tool to help physicians stay on top of important dates and track deadlines for a variety of regulatory, payment, educational, and delivery system changes, requirements and opportunities. More...

Free webinar series on omnibus rule

Starting June 14, the Department of Health and Human Services Office for Civil Rights and the Workgroup for Electronic Data Interchange (WEDI) will be launching a series of webinars about the Omnibus HIPAA Rule. More...


From ACP Hospitalist

Who's tops at your hospital?

ACP Hospitalist is seeking candidates for its sixth annual Top Hospitalists issue in November, which will feature the best and brightest in hospital medicine. Let us know what your colleagues have accomplished in 2013. More...


From the College

The Doctors Company announces 2013 dividend for ACP members

The Doctors Company, the nation's largest physician-owned medical malpractice insurer and the exclusively sponsored carrier for ACP, has announced a $21 million dividend, which is made possible by the excellent claims experience of The Doctors Company's members. 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


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Medicare prescribers use twice as many brand-name drugs as VA

Medicare beneficiaries with diabetes take many more brand-name drugs than similar patients treated in the Veterans Affairs (VA) system, adding as much as $1 billion per year to health care costs, a recent study found.

annals.jpg

Researchers conducted a retrospective cohort study using 2008 prescription data on more than 1 million Medicare Part D beneficiaries with diabetes and more than 500,000 similar veterans. Results were published online June 11 by Annals of Internal Medicine.

In all the studied categories of drugs, Medicare patients were two to three times more likely to be taking a brand-name drug. Specifically, 35.3% of Medicare patients took brand-name oral hypoglycemics versus 12.7% of veterans. For statins, the rates were 50.7% of Medicare patients versus 18.2% of VA patients. For angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers, the rates were 42.5% versus 20.8%, and for insulin analogues, the rates were 75.1% versus 27.0%.

The researchers calculated that reducing brand-name drug usage among these Medicare patients to levels seen in the VA system would have saved $1.4 billion in 2008. They theorized that the difference may be attributable to the VA's national formulary, which encourages therapeutic substitution, or the interchange of a generic drug in the same class for a brand-name drug with no exact generic equivalent (e.g., generic simvastatin for Lipitor). The VA also has a national electronic medical record with electronic prescribing, limits on pharmaceutical representative visits, and salaried physicians.

Medicare Part D plans, on the other hand, have incentives to allow greater use of brand-name drugs because they compete to enroll patients. As an example policy difference, only about 10% of studied Part D patients faced step therapy requirements to take atorvastatin or valsartan, while the VA requires step therapy and prior authorization for both those drugs. Even the VA, however, showed substantial geographic variation in brand-name drug use, which the study authors attributed to local adjudication of prior authorizations and local physician practice patterns.

The VA scores as well as or better than Medicare on quality measures for diabetes care, the authors noted, and the system's lower rates of brand-name usage should be attainable by Medicare. "These potential savings could be realized through policies that promote Part D plan efficiency and by encouraging physicians to consider costs and value in their prescribing," they concluded.


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Vascular risks may vary among nonsteroidal anti-inflammatory drugs

High doses of diclofenac and possibly ibuprofen have comparable vascular risks to coxibs, whereas high-dose naproxen was associated with less vascular risk than other nonsteroidal anti-inflammatory drugs (NSAIDs), a meta-analysis found.

Researchers reviewed results from 280 trials of NSAIDs versus placebo, totaling 124,513 patients and 68,342 person-years, as well as results from 474 trials comparing one NSAID to another, totaling 229,296 participants and 165,456 person-years.

Results were published online by The Lancet on May 30.

Compared to placebo, major vascular events increased by about a third with a coxib (rate ratio [RR], 1.37, 95% CI, 1.14 to 1.66; P=0.0009) or diclofenac (RR, 1.41, 95% CI, 1.12 to 1.78; P=0.0036), mainly due to an increase in major coronary events (coxibs: RR, 1.76; 95% CI, 1.31 to 2.37; P=0.0001 and diclofenac: RR, 1.70; 95% CI, 1.19 to 2.41; P=0.0032). Ibuprofen also significantly increased major coronary events (RR, 2.22; 95% CI, 1.10 to 4.48; P=0.0253) but did not have a significant effect on major vascular events (RR, 1.44; 95% CI, 0.89 to 2.33).

Compared with those on placebo, the 1,000 patients allocated to a coxib or diclofenac for a year had three more major vascular events, one of which was fatal. Naproxen did not significantly increase major vascular events (RR, 0.93, 95% CI, 0.69 to 1.27). Vascular death increased significantly with coxibs (RR, 1.58; 99% CI, 1.00 to 2.49; P=0.0103) and diclofenac (RR, 1.65; 95% CI, 0.95 to 2.85; P=0.0187) and increased nonsignificantly with ibuprofen (RR, 1.90; 95% CI, 0.56 to 6.41; P=0.17) but did not increase with naproxen (RR, 1.08; 95% CI, 0.48 to 2.47; P=0.80).

All NSAID regimens increased upper gastrointestinal complications (coxibs: RR, 1.81; 95% CI, 1.17 to 2.81; P=0.0070; diclofenac: RR, 1.89, 95% CI, 1.16 to 3.09; P=0.0106; ibuprofen: RR, 3.97, 95% CI, 2.22 to 7.10; P<0.0001; and naproxen: RR, 4.22; 95% CI, 2.71 to 6.56; P<0.0001).

The researchers concluded, "Our meta-analysis, which is unaffected by selection and other biases inherent in observational studies, showed clearly that the vascular risks of diclofenac, and possibly ibuprofen, are similar to coxibs, but that naproxen is not associated with an increased risk of major vascular events. However, it also showed that the excess risk of both vascular and gastrointestinal events can be predicted once the baseline risks of such hazards are known, which could help clinical decision-making."

An accompanying editorial noted that for 1,000 patients at moderate risk of heart disease, there would be about three major vascular events, including one death, due to a year of high-dose NSAIDs except for naproxen. For 1,000 patients at moderate risk of gastrointestinal complications, a year of high-dose NSAIDs would result in four to 16 gastrointestinal complications.



Test yourself


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MKSAP Quiz: 3-day history of lower abdominal pain, watery diarrhea

A 26-year-old man is evaluated for a 3-day history of fever, lower abdominal pain, tenesmus, hematochezia, and watery diarrhea. Seven months ago, he underwent a cadaveric kidney transplantation. At the time of transplantation, the transplant donor was seropositive for cytomegalovirus, and the patient was seronegative for this virus. Current medications are tacrolimus, mycophenolate mofetil, prednisone, and trimethoprim-sulfamethoxazole. Valganciclovir was discontinued 1 month ago after 6 months of prophylaxis as per standard protocol.

mksap.gif

On physical examination, temperature is 38.8 °C (101.8 °F), blood pressure is 100/70 mm Hg, pulse rate is 104/min, and respiration rate is 18/min. BMI is 24. Cardiopulmonary examination is normal. Abdominal examination reveals increased bowel sounds but no tenderness to palpation. There is no organomegaly.

Laboratory studies:

Leukocyte count 2100/µL (2.1 × 109/L)
Alanine aminotransferase 72 units/L
Aspartate aminotransferase 60 units/L
Serum creatinine 1.4 mg/dL (124 µmol/L)

Chest radiograph is normal.

Which of the following is the most likely diagnosis?

A: Clostridium difficile infection
B: Cytomegalovirus infection
C: Mycophenolate mofetil toxicity
D: Tacrolimus toxicity

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


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Sleep apnea


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Guideline issued on assessing sleep apnea and driving risk

The American Thoracic Society has issued an updated guideline on assessing sleep apnea, sleepiness and driving risk in noncommercial drivers.

The guideline, which updates the society's 1994 guideline on this topic, was developed by a multidisciplinary panel. Existing evidence was systematically reviewed, and recommendations were made and graded according to the Grading of Recommendations, Assessment, Development and Evaluation approach. Crash-related mortality and real crashes were considered critical outcomes, while near-miss crashes and driving performance were considered important outcomes. The guideline, which is intended for practitioners who encounter patients with sleep disorders, was published in the June 1 American Journal of Respiratory and Critical Care Medicine.

The panel determined that obstructive sleep apnea (OSA) is associated with increased overall risk for motor vehicle crashes compared with non-OSA but that it is difficult to predict risk in an individual. A high-risk driver was defined as someone who has moderate to severe sleepiness in the daytime plus a recent unintended motor vehicle crash or near-miss due to sleepiness, fatigue or inattention.

The panel noted that no compelling evidence supports restriction of driving privileges in patients with sleep apnea who have not had a motor vehicle crash or a similar event. It also noted that treating OSA improves driving simulator performance and could help reduce the risk of drowsy driving and related crashes.

The panel's recommendations to clinicians included the following:

  • Patients with a high clinical suspicion of OSA who are high-risk drivers should undergo polysomnography and, if indicated, treatment should be initiated as soon as possible instead of delayed until convenient (weak recommendation, very low-quality evidence). The panel suggested not using empiric continuous positive-airway pressure (CPAP) solely for reducing driving risk (weak recommendation, very low-quality evidence).
  • Patients with confirmed OSA who are high-risk drivers should receive CPAP therapy to reduce driving risk rather than no treatment (strong recommendation, moderate-quality evidence).
  • Patients with suspected or confirmed OSA who are high-risk drivers should not use stimulant medications solely for reducing driving risk (weak recommendation, very low-quality evidence).

The panel also recommended the following measures to improve clinical practice:

  • Clinicians should develop a practice-based plan to inform patients and their families about drowsy driving and other risks of excessive sleepiness, as well as behavioral methods that may reduce risk.
  • Clinicians should routinely ask patients with suspected OSA about non-OSA causes of excessive daytime sleepiness (e.g., sleep restriction, alcohol, and sedating medications), comorbid neurocognitive impairments (e.g., depression or neurological disorders), and diminished physical skills, since these factors may contribute to crash risk and affect OSA treatment efficacy.
  • Clinicians should know their local and state statutes or regulations about required reporting of high-risk drivers with OSA.


Heart failure


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AHA and ACC update heart failure guidelines

New and revised recommendations on the treatment of heart failure were released last week jointly by the American College of Cardiology Foundation and American Heart Association.

The 2013 joint guideline updates definitions and classifications for heart failure, with recommendations on all steps of care from initial evaluation, including testing and risk scoring, to outpatient, inpatient and interventional treatment. It increases emphasis on patient-centric outcomes such as quality of life, shared decision making, care coordination, transitions and palliative care.

Changes were made in recommendations on heart failure with preserved ejection fraction, inpatient care and stage D heart failure, among other issues. The guideline also provides new advice on the best approach to dilated cardiomyopathies, expanded use of aldosterone antagonism and more discriminate use of cardiac resynchronization therapy. The document also discusses performance measures and quality measures, including some recommendations to reduce readmissions.

The guideline includes tables of recommendations, classified by their level of evidence support, and a new designation of certain treatments as guideline-directed medical therapy or GDMT.

The document was developed in collaboration with the American Academy of Family Physicians, American College of Chest Physicians, Heart Rhythm Society, and the International Society for Heart and Lung Transplantation and was published online by the Journal of the American College of Cardiology and appeared in Circulation on June 5.



Bariatric surgery


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Bariatric surgery leads to short-term improved glycemic control and weight loss in moderately obese diabetics

Bariatric surgery in diabetic patients with a body mass index of 30 to 35 kg/m2 is associated with more short-term weight loss and better intermediate outcomes than nonsurgical treatments, but data on long-term effects are limited, a review found.

Researchers reviewed 32 surgical studies and 11 systematic reviews on nonsurgical treatments, as well as 11 large nonsurgical studies published after those reviews, for data on weight loss, metabolic outcomes and adverse events. Results appeared in the June 5 Journal of the American Medical Association.

In three randomized clinical trials totaling 290 subjects, surgery was associated with greater weight loss (range, 14.4 to 24 kg) and glycemic control (range, 0.9 to 1.43 point improvements in hemoglobin A1c levels) during one to two years of follow-up compared to nonsurgical treatment. Indirect comparisons of evidence from observational studies of about 600 bariatric procedures and meta-analyses of more than 300 randomized, controlled trials of nonsurgical therapies support this finding as far out as two years of follow-up.

However, the authors wrote, there are no robust surgical data beyond five years of follow-up on outcomes such as glucose control and macrovascular and microvascular outcomes. Randomized controlled trial data on nonsurgical therapies show benefits at 10 years of follow-up or more.

In 14 studies reviewed for patient safety, surgeon-reported adverse events were low, but data were from select centers and surgeons. Only one death was reported in a patient receiving gastric banding with complications of a gastric perforation. Cardiovascular, respiratory, gastrointestinal and metabolic adverse events were relatively rare. Other complications included infections or seroma, incisional hernias, stricture, anastomotic leaks, and ulcers. Several complications specific to gastric banding were reported: band slippage in 3% of 361 patients, port or tube problems in about 1.9% of 462 patients, band removal in 3.3% of 210 patients and pouch dilation in 5.4% of 240 patients.

Researchers noted that these studies may represent best-case outcomes, since they were often small-population and single-site reports without long-term follow up.

"In contrast, behavior and medication interventions have been studied extensively in a wide variety of clinical settings; several large, long-term randomized clinical trials have found improved [hemoglobin]A1c levels for up to 10 years," researchers wrote. "Therefore, the evidence for longer-term control of glucose in patients with diabetes is stronger for behavioral and medication therapies than for surgery."



Practice management


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Physician & Practice Timeline helps physicians track key requirements and opportunities

ACP has launched Physician & Practice Timeline: Professional Requirements & Opportunities, a valuable online tool to help physicians stay on top of important dates and track deadlines for a variety of regulatory, payment, educational, and delivery system changes, requirements and opportunities.

The Physician & Practice Timeline allows clinicians to track and find useful resources for everything from eRx and PQRS data collection periods to ICD-10 preparation and meaningful use reporting periods. The Timeline also provides information on new opportunities that physicians in practice can take advantage of, such as transitional care management (TCM) codes.

The Timeline will be continually updated to reflect all new or revised target dates, deadlines, and incentives.


.
Free webinar series on omnibus rule

Starting June 14, the Department of Health and Human Services Office for Civil Rights and the Workgroup for Electronic Data Interchange (WEDI) will be launching a series of webinars about the Omnibus HIPAA Rule.

The 90-minute programs are designed to help physicians in small practices with implementing the changes related to this rule. The omnibus rule contains the last set of regulations in the HIPAA rules. Registration is available on the WEDI website.



From ACP Hospitalist


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Who's tops at your hospital?

ACP Hospitalist is seeking candidates for its sixth annual Top Hospitalists issue in November, which will feature the best and brightest in hospital medicine. Let us know what your colleagues have accomplished in 2013. Did they take charge of a key quality or safety initiative? Do they always go out of their way to educate patients or help new physicians? Maybe they are amazing at tricky diagnoses, or selfless about volunteer outreach. Whatever the contribution, if it helped further hospital medicine, we'd like to hear about it.

Recommending a physician is easy: Just visit our online form and tell us which physicians you think we should feature and why. We look forward to receiving your suggestions!

Note: ACP Hospitalist's Top Hospitalist issue is not part of the ACP National Awards Program. Self-nomination is not permitted. Candidates need not be ACP members. The selection process is not scientific. Editorial board members are solely responsible for determining those profiled in the Top Hospitalists issue.



From the College


.
The Doctors Company announces 2013 dividend for ACP members

The Doctors Company, the nation's largest physician-owned medical malpractice insurer and the exclusively sponsored carrier for ACP, has announced a $21 million dividend, which is made possible by the excellent claims experience of The Doctors Company's members.

Since 1976, The Doctors Company has paid $287 million in dividends, and 2013 marks the seventh consecutive year that the company has awarded dividends. The 2013 dividend credit, approved by The Doctors Company's Board of Governors, will provide a premium reduction of 6% to eligible ACP members. Dividend distributions will appear as premium reductions effective with renewals on or after July 1, 2013. More information about The Doctors Company is available online.



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-20130611-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 B: Cytomegalovirus infection. This item is available to MKSAP 16 subscribers as item 10 in the Nephrology section. More information is available online.

The most likely diagnosis is cytomegalovirus (CMV) infection. Despite advances in immunosuppressive therapy and infection prophylaxis, more than 50% of kidney transplant recipients develop at least one infection during the first year after transplantation. CMV infection is particularly common in these patients. CMV infection is often suspected when patients have leukopenia and fevers during the posttransplant period. Viremia is best detected by polymerase chain reaction (PCR), a fast, sensitive, and reliable technique compared with serology, culture, or early antigen or CMV antigenemia detection. CMV infection can result in CMV disease, with organ involvement manifesting as retinitis, pneumonia, encephalitis, hepatitis, and gastrointestinal tract ulceration.

This patient underwent kidney transplantation 7 months ago and discontinued his CMV prophylaxis therapy 1 month ago as per standard protocol. Kidney transplantation from a donor who is seropositive for CMV to a recipient who is seronegative for this virus places the recipient at high risk for developing this condition. Furthermore, this patient's fever, leukopenia, and diarrhea are consistent with CMV infection, and his elevated liver chemistry studies raise suspicion for CMV-related hepatitis. Diagnosis of CMV infection is confirmed with a positive serum PCR test for viremia, and disease is confirmed by the presence of mucosal ulcers or erosion and CMV inclusion bodies seen on a biopsy specimen from the wall of the bowel obtained during colonoscopy.

Clostridium difficile infection may cause diarrhea and fever but does not explain this patient's leukopenia or elevated aminotransferase levels.

Mycophenolate mofetil can cause diarrhea and leukopenia but is rarely associated with elevated liver chemistry studies and does not explain this patient's fever. In addition, toxicity associated with mycophenolate mofetil usually occurs after a recent dosage change.

Tacrolimus toxicity can cause diarrhea but does not manifest as fever, leukopenia, or abnormal findings on liver chemistry studies.

Key Point

  • Cytomegalovirus infection is particularly common in kidney transplant recipients and may manifest as fever, leukopenia, and diarrhea.

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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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