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

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ACP InternistWeekly



In the News for the Week of 11-22-11



Highlights

Niacin added to statin therapy doesn't reduce cardiovascular events, study finds

Adding niacin to statin therapy didn't reduce cardiovascular events in high-risk patients despite improvements in cholesterol levels, a new study found. More...

Survey shows potential gaps in oncologists' pain management practices

Oncologists may not always adequately treat pain in cancer patients, according to a recent survey. More...


Test yourself

MKSAP Quiz: interventions to decrease risk of surgical site infection

This week's quiz asks readers to evaluate a 55-year-old man with a history of coronary heart disease and diabetes mellitus undergoing coronary artery bypass graft surgery. More...


Blood pressure

Hypertension in young adulthood increases later mortality risk

Elevated blood pressure in early adulthood is associated with a greater risk of death decades later, including overall mortality and mortality from cardiovascular disease and coronary heart disease, although not from stroke, a study found. More...


Obesity

In-person and remote programs lead to weight loss in primary care

More than a third of obese patients successfully achieved significant weight loss in two different two-year programs led by primary care physicians and funded by the National Heart, Lung and Blood Institute. More...


Stroke

Thrombolysis may benefit acute ischemic stroke patients with diabetes and prior stroke

Thrombolysis appeared to benefit patients with acute ischemic stroke who had concomitant diabetes or a history of stroke, according to a new study. More...


Geriatrics

Draft criteria on medication use in older adults posted for public comment

The American Geriatrics Society has released an updated draft of its Beers criteria for potential inappropriate medication use in older adults and is calling for public comment. More...


CMS update

CMS delays version 5010

The Centers for Medicare & Medicaid Services (CMS) has announced that it will not initiate enforcement action related to noncompliance with the version 5010 electronic claims transaction standards until 90 days after the Jan. 1, 2012 compliance date. This effectively moves the enforcement date to March 31, 2012. More...


Practice management

P.O. boxes no longer permitted as billing provider address

Beginning in 2012, clinicians will no longer be permitted to use post office boxes or lock boxes as billing provider addresses. More...


From ACP Hospitalist

The next issue of ACP Hospitalist is online

The November issue of ACP Hospitalist is now online. More...


For the record

Correction to a previous issue

An item in the Nov. 15 ACP InternistWeekly required correction. More...


Cartoon caption contest

And the winner is …

ACP InternistWeekly has tallied the voting from its latest cartoon contest, where readers are invited to match wits against their peers to provide the most original and amusing caption. More...

Editorial note: ACP InternistWeekly will not be published next week due to the Thanksgiving holiday.


Physician editor: Darren Taichman, MD, FACP




Highlights


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Niacin added to statin therapy doesn't reduce cardiovascular events, study finds

Adding niacin to statin therapy didn't reduce cardiovascular events in high-risk patients despite improvements in cholesterol levels, a new study found.

The Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH) trial tested whether extended-release niacin added to intensive statin therapy would further reduce the risk of cardiovascular events in patients with established atherosclerotic cardiovascular disease and atherogenic dyslipidemia (low levels of HDL cholesterol, elevated triglyceride levels, and small, dense particles of LDL cholesterol).

Patients were recruited at 92 clinical centers in North America. Eligible patients were 45 years of age or older and had established cardiovascular disease. All eligible patients had low baseline levels of HDL cholesterol (<40 mg/dL [<1.03 mmol/L] for men or <50 mg/dL [<1.29 mmol/L] for women), elevated triglyceride levels (150 to 400 mg/dL [1.69 to 4.52 mmol/L]), and LDL cholesterol levels lower than 180 mg/dL (<4.65 mmol/L) if they were not taking a statin at entry.

Results appeared online Nov. 16 in the New England Journal of Medicine.

Patients in the niacin group received niacin at a dose of 1,500 to 2,000 mg per day plus simvastatin. Patients in the placebo group received simvastatin plus a matching placebo that contained a small dose (50 mg) of immediate-release niacin in each 500-mg or 1,000-mg tablet to blind treatment for patients and study personnel. In both groups, the dose of simvastatin was adjusted to achieve and maintain LDL cholesterol level in the range of 40 to 80 mg/dL (1.03 to 2.07 mmol/L). Subjects in both groups could receive ezetimibe, at a dose of 10 mg per day, to achieve the target LDL cholesterol level.

A total of 3,414 patients were randomly assigned to receive niacin (n=1,718) or placebo (n=1,696). At 2 years, niacin therapy had significantly increased the median HDL cholesterol level from 35 mg/dL (0.91 mmol/L) to 42 mg/dL (1.08 mmol/L), lowered the triglyceride level from 164 mg/dL (1.85 mmol/L) to 122 mg/dL (1.38 mmol/L), and lowered the LDL cholesterol level from 74 mg/dL (1.91 mmol/L) to 62 mg/dL (1.60 mmol/L).

The primary end point, a composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization, occurred in 282 patients in the niacin group (16.4%) and in 274 patients in the placebo group (16.2%) (hazard ratio, 1.02; 95% CI, 0.87 to 1.21; P=0.79 by the log-rank test). The trial was stopped after three years because of a lack of efficacy.

The authors wrote, "Although previous studies of niacin have shown apparent benefits both in surrogate outcome measures (improvements in carotid intima-media thickness and regression of angiographic coronary-artery stenoses) and in clinical outcomes, we observed no clinical benefit with extended-release niacin in patients with established coronary heart disease and low levels of baseline HDL cholesterol."

An editorial noted, "The disappointing results of AIM-HIGH do not provide support for the use of niacin as an add-on therapy to statins in patients with preexisting stable cardiovascular disease who have well-controlled LDL cholesterol levels. Given the lack of efficacy shown in this trial, the frequent occurrence of flushing with niacin therapy that some patients find intolerable, and the unresolved question of an increased risk of ischemic stroke, one can hardly justify the continued expenditure of nearly $800 million per year in the United States for branded extended-release niacin." A more appropriate use for niacin would be in statin-intolerant patients, the editorial noted.


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Survey shows potential gaps in oncologists' pain management practices

Oncologists may not always adequately treat pain in cancer patients, according to a recent survey.

Researchers at Beth Israel Medical Center in New York mailed an anonymous survey to 2,000 oncologists randomly chosen from the American Medical Association's 2009 Physician Master File. The intent of the survey was to determine oncologists' attitudes, knowledge and practices related to managing cancer pain. The survey was mailed four times, sequentially, with intervals of 1.5 to 2.5 months between mailings. A shortened version of the survey questionnaire was used for the third and fourth mailings to try to improve response rates.

The questionnaire asked physicians to provide information on age, sex, years in practice, state in which their practice was located, and quality of training. Numeric rating scales from 0 to 10 were used to determine physicians' attitudes and practices for pain management, while other questions assessed referral to pain or palliative medicine specialists and CME hours related to pain. The survey also included two clinical vignettes about challenging pain management situations. The first involved decision making about increasing opioid dosage when a relatively high dose was not controlling pain, and the second addressed decision making about dose titration and/or addition of a drug for breakthrough pain in a similar situation. The results of the survey were published online Nov. 15 by the Journal of Clinical Oncology.

Three hundred fifty-four oncologists responded to the initial questionnaire and 256 responded to one of the shortened versions, for an overall response rate of 32%. The median age was 56 years, and 20% of respondents were women. Respondents rated their specialty's ability to manage cancer pain relatively highly (median score, 7; interquartile range, 6 to 8) but rated their peers as more conservative than themselves in prescribing pain management (median score, 3; interquartile range, 2 to 5). Low ratings were given to quality of pain management training during medical school and residency (median scores, 3 and 5; interquartile ranges, 5 to 7 and 3 to 7, respectively). Responders' scores indicated that poor assessment (median score, 6; interquartile range, 4 to 7) and reluctance of patients to take opioids (median score, 6; interquartile range, 3 to 7) were the most important barriers to effective pain management. Physician reluctance to prescribe opioids (median score, 5; interquartile range, 3 to 7) and a perception of excessive regulation (median score, 4; interquartile range, 2 to 7) were also considered barriers. Sixty percent of oncologists responding to the first clinical vignette and 87% of those responding to the second chose treatments that pain specialists would have considered unacceptable. Only 14% and 16% of respondents reported referring patients frequently to pain and palliative care specialists.

The authors noted that their study had a relatively low response rate, which may limit the generalizability of their results, and that their survey could not address all of the factors that may relate to oncologists' pain management practices. However, they concluded that their results indicate limitations in oncologists' approaches to managing pain in cancer patients and that these limitations may be affecting care. "The longstanding acceptance for pain management as a best practice in oncology provides a foundation for renewed efforts to educate in this area," the authors wrote. They called for measures including quality improvement activities, increased screening, and electronic reminders to help improve practice.




Test yourself


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MKSAP Quiz: interventions to decrease risk of surgical site infection

A 55-year-old man with a history of coronary artery disease and diabetes mellitus will undergo elective coronary artery bypass graft surgery. His last hemoglobin A1c value was 7.8%, and his plasma glucose level 2 hours prior to scheduled surgery was 238 mg/dL (13.2 mmol/L). Hemoglobin is 11.9 g/dL (119 g/L).

His current medications include glipizide, metformin, and pioglitazone. He has no allergies.

mksap.jpg

Prior to surgery, hair is clipped from his anterior chest in the area of the anticipated surgical incision. He is scheduled to receive preoperative cefazolin with a second dose if the surgery duration is longer than 4 hours.

The addition of which of the following interventions will most likely contribute to a decreased risk of surgical site infection for this patient?

A) Blood transfusion
B) Maintenance of operative hypothermia
C) Mupirocin nasal ointment at the time of anesthesia
D) Perioperative intravenous insulin therapy

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


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Blood pressure


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Hypertension in young adulthood increases later mortality risk

Elevated blood pressure in early adulthood is associated with a greater risk of death decades later, including overall mortality and mortality from cardiovascular disease (CVD) and coronary heart disease (CHD), although not from stroke, a study found.

Researchers analyzed results from the Harvard Alumni Health Study, which tracked 18,881 male Harvard students using a physical exam at university entry (mean age, 18.3 years) between the years of 1916 and 1950 and a mailed health questionnaire at middle-age (mean age, 45.8 years) in the 1960s.

In the initial standardized physical exam, information on smoking, blood pressure, height and weight was recorded. In the mailed questionnaires, study participants were asked if they had received a physician diagnosis of hypertension. From the death certificates, the researchers determined whether the cause of death was from CVD, CHD, stroke, or another cause through 1998.

Results appeared in the Nov. 29 Journal of the American College of Cardiology.

Compared with men who were normotensive (<120/80 mm Hg), there was an elevated risk of coronary heart disease mortality (1,917 deaths) in those who were pre-hypertensive (120 to 139/80 to 89 mm Hg) (hazard ratio [HR], 1.21; 95% CI, 1.07 to 1.36), stage 1 hypertensive (140 to 159/90 to 99 mm Hg) (HR, 1.46; 95% CI, 1.25 to 1.70), and stage 2 hypertensive (≥160/100 mm Hg) (HR, 1.89; 95% CI, 1.46 to 2.45) (P for trend <0.001). The results were adjusted for age, body mass index, smoking, and physical activity at college entry. Similar associations were apparent for total and CVD mortality, but not stroke mortality.

Overall, the researchers found that standard deviation (SD) (13.1 mm Hg) increases in systolic blood pressure at the initial evaluation were associated with a 5% increase in all-cause mortality, an 8% increase in CVD mortality, and a 14% increase in CHD mortality. After the researchers accounted for middle-age hypertension, estimates were somewhat attenuated, but the pattern remained. The 1-SD elevation was associated with a 4% increased risk of CVD death after adjustment for hypertension in middle age. Hypertension status in middle age was associated with a twofold increased risk of CVD.

"The lack of an association between university blood pressure and total stroke mortality is surprising," the authors wrote. "The weaker association for stroke versus CHD mortality may reflect blood pressure-related atherosclerosis taking place earlier in adulthood compared with the antecedents of stroke." According to the researchers, the results lend weight to the idea of beginning blood pressure-lowering strategies earlier in life. "However, there is a lack of clinical trial data to assess the efficacy and potential harm of such intervention," they cautioned.

An accompanying editorial stated, "The clinical implications of this inference are potentially profound. Despite adult hypertension guidelines that recommend treatment of hypertension regardless of age, young adults with hypertension are less likely than older age groups to be aware of their hypertension, to be on treatment, and to have their hypertension adequately controlled."

Reasons why hypertension treatment may have lagged in younger patients include a lack of health insurance, a lack of usual source of care, and the tendency to seek only episodic care, the editorial speculated. Physicians may also be reluctant to label younger patients with the diagnosis and harbor concerns over treating a disease when the benefits may be several decades in the future and the long-term safety of treatment may be questioned.




Obesity


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In-person and remote programs lead to weight loss in primary care

More than a third of obese patients successfully achieved significant weight loss in two different two-year programs led by primary care physicians and funded by the National Heart, Lung and Blood Institute.

The first program compared in-person and remote interventions in a group of 415 obese patients with at least one cardiovascular risk factor. Patients were randomized to remote weight loss support (involving phone calls, a study-specific website and e-mails) or in-person group and individual sessions in addition to the remote resources. An additional control group engaged in self-directed weight loss. After two years, the control group's mean weight loss was 0.8 kg, compared to 4.6 kg in the remote-only group and 5.1 kg in the in-person support group. Overall, significant weight loss (defined as losing 5% or more from baseline) occurred in 18.8% of the control group, 38.2% of the remote group and 41.4% of the in-person group.

In the second study, 390 obese adults were also randomized to one of two interventions or usual care. Usual care consisted of quarterly visits with the patient's physician. A brief lifestyle counseling group also received monthly sessions with lifestyle coaches, and the "enhanced counseling" group received meal replacements or weight-loss medication in addition to the other resources. After two years, mean weight loss was 1.7 kg in the usual care group, 2.9 kg in the counseling group, and 4.6 kg in the enhanced group. Five percent weight loss was achieved in 21.5%, 26.0% and 34.9% of the patients in the respective trial arms. Because sibutramine, one of the weight-loss medications (the other was orlistat), was removed from the market during the trial, researchers also analyzed the data excluding that drug and found that the enhanced group still did significantly better.

Authors of both studies noted that these were pragmatic effectiveness trials, in which patient compliance was more reflective of actual practice than most study environments. Attendance was low (below half) for the in-person interventions in the second year of both trials. The inconvenience of in-person support may explain why the remote intervention was approximately as successful as the in-person one in the first study, according to an editorial published with the studies online by the New England Journal of Medicine on Nov. 15.

The results should be encouraging to primary care physicians regarding the possibility of successfully helping at least some of their obese patients lose weight, the researchers agreed. However, all noted that implementation of the programs would require either changes in medical reimbursement or patients' willingness to pay for these services. All of the counseling and medications were provided to patients for free in the studies.




Stroke


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Thrombolysis may benefit acute ischemic stroke patients with diabetes and prior stroke

Thrombolysis appeared to benefit patients with acute ischemic stroke who had concomitant diabetes or a history of stroke, according to a new study.

Guidelines in the U.S. and Europe have recommended that recombinant tissue plasminogen activator (rtPA) not be used in patients with diabetes or with prior stroke, although this is an area of some debate and these recommendations are not always followed in clinical practice. European researchers compared registry data to determine how diabetes and prior stroke affected outcomes of patients with acute ischemic stroke who received thrombolysis versus controls who did not. Ninety-day modified Rankin Scale scores, which measure function in seven categories on a scale of 0 to 6 (e.g., 0=asymptomatic, 5=bedbound and completely dependent, 6=dead) were compared after adjustment for age and National Institutes of Health Stroke Scale (NIHSS) score at baseline. The study results were published online Nov. 16 by Neurology and will appear in the Nov. 22 print issue.

Overall, data were available for 29,500 patients, 5,411 (18.5%) with diabetes, 5,019 (17.1%) with prior stroke and 1,141 (5.5%) with both. Adjusted modified Rankin Scale scores were better in treated patients than controls among those with diabetes, stroke, or both (odds ratios, 1.45, 1.55, and 1.23; P<0001 for all comparisons according to the Cochran-Mantel-Haenszel test). In the 19,939 patients without diabetes or prior stroke, the odds ratio for the adjusted modified Rankin Scale score was 1.53 (P<0.0001) for the comparison between treated patients and controls. Patient age (≤80 years or >80 years) did not affect outcomes.

The authors noted that reliable information was not available on symptomatic hemorrhage and acknowledged that the data used in their study were not randomized. However, they concluded that patients who received thrombolysis for acute ischemic stroke had better outcomes, even if they had diabetes or prior stroke, than those who did not receive the therapy. The researchers did not see a significant benefit in patients with both conditions but noted that the subgroup of these patients was small and that no interaction was observed between diabetes and prior stroke and treatment effect. Because the observed benefit of therapy in their study was similar to that seen in patients without diabetes and prior stroke, the authors concluded that there is no reason to withhold rtPA for acute ischemic stroke in patients with these conditions.

The author of an accompanying editorial reiterated the variety of opinions in this area, noting that clinicians have had many questions about how and whether recommendations about eligibility for thrombolysis should be followed. He called the current study "a concerted empirical effort" to determine whether such recommendations are valid for the significant number of patients—up to 15%—who present to the emergency department with a history of prior stroke and diabetes. "There appears to be no justification for the continued restriction of these patients from thrombolytic therapy," the editorialist concluded.




Geriatrics


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Draft criteria on medication use in older adults posted for public comment

The American Geriatrics Society has released an updated draft of its Beers criteria for potential inappropriate medication use in older adults and is calling for public comment.

The Beers criteria, which were last updated in 2003, list medications that may cause side effects linked to physiologic changes of aging. The most recent update examined three main areas:

  • potentially inappropriate medication use in older persons independent of diagnoses or conditions,
  • potentially inappropriate medication use in older persons due to drug-disease/syndrome interaction, and
  • drugs to be used with caution.

The draft criteria are available for review on the American Geriatrics Society website. The public comment period will be open until 5:00 p.m. ET on Nov. 28, 2011.




CMS update


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CMS delays version 5010

The Centers for Medicare & Medicaid Services (CMS) has announced that it will not initiate enforcement action related to noncompliance with the version 5010 electronic claims transaction standards until 90 days after the Jan. 1, 2012 compliance date. This effectively moves the enforcement date to March 31, 2012.

It is important to note that the compliance date for implementation of these updated standards remains Jan, 1, 2012. ACP strongly encourages its members to continue their version 5010 implementation programs in order to reach compliance.

CMS decided to delay enforcement after testing between some covered entities and their trading partners revealed that many would not be compliant by Jan. 1. The agency also received reports that many covered entities are still awaiting software upgrades.

For more information, view the complete CMS statement and enforcement FAQs.




Practice management


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P.O. boxes no longer permitted as billing provider address

In 2012, physicians and providers will be required to transition to version 5010 transactions standards for all electronic claims submissions. CMS announced that it will delay the enforcement of the version 5010 implementation until March 31, 2012.

In addition to other changes that vendors, billing services, or clearinghouses may be making to physician practices' management systems, clinicians will no longer be permitted to use post office boxes or lock boxes as billing provider addresses. Instead, all practices will be required to use a street address or physical location. If a practice wishes to continue having payments sent to a post office box or lock box, that address can be entered in the additional "Pay-to" address field.

Additional information about the transition to version 5010 is available from CMS and on the College website.




From ACP Hospitalist


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The next issue of ACP Hospitalist is online

The November issue of ACP Hospitalist is now online. Featured stories include the following:

acpi-20111122-cov.jpg

Top Docs. Meet our 2011 Top Hospitalists! Our fourth annual Top Docs issue recognizes leaders and teachers, innovators and mentors, researchers and pioneers.

Antipsychotics in delirium. Antipsychotics can resolve agitation in patients with delirium, but may not provide much overall benefit. Experts weigh in on best practices for their use.

Bath salts not meant for a tub. More and more patients are showing up at hospitals under the influence of a psychoactive drug mix nicknamed "bath salts." Learn to spot and treat the symptoms of use.




For the record


.
Correction to a previous issue

An item in the Nov. 15 ACP InternistWeekly required correction.

Under the heading "Infections," the item on TNF-alpha antagonists initially referred to patients with irritable bowel disease rather than inflammatory bowel disease. The error has been corrected.




Cartoon caption contest


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And the winner is …

ACP InternistWeekly has tallied the voting from its latest cartoon contest, where readers are invited to match wits against their peers to provide the most original and amusing caption.

acpi-20111122-cartoon.jpg

"Medical homeless … will work for food."

This issue's winning cartoon caption was submitted by Ronald L. Ruecker, MD, FACP, from Decatur, Ill. Readers cast 109 ballots online to choose the winning entry. Thanks to all who voted! The winning entry captured 49.5% of the votes.

The runners-up were:

"Hey lady, care to join my concierge practice?"

"My payor mix has got to change."


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MKSAP Answer and Critique



The correct answer is D) Perioperative intravenous insulin therapy. This item is available to MKSAP 15 subscribers as item 44 in the Infectious Diseases section. More information about MKSAP 15 is available online.

Prospective randomized studies have found that tight glucose control during the perioperative period in diabetic patients undergoing cardiac surgery was associated with reduced infection risk. Aggressive glucose control in the perioperative period can be achieved using a continuous intravenous insulin infusion. In these studies, serum glucose was maintained at a level of less than 200 mg/dL (11.1 mmol/L).

Evidence suggests that preoperative or postoperative anemia is associated with increased mortality and hospital length of stay. Patients who require transfusions before surgery have an increased risk of infectious complications. This patient does not require a preoperative blood transfusion, and if one were required, it might actually increase, not decrease, his risk for infection.

A randomized trial in patients undergoing urgent or cardiac surgery who were hypothermic or normothermic showed no difference in the rate of surgical site infections (SSIs). Most experts now advocate for maintenance of perioperative normothermia to reduce the risk of SSIs, and there is no evidence suggesting that maintaining hypothermia decreases SSI rates.

The use of nasal mupirocin for the prevention of SSIs is controversial and is not supported by prospective randomized studies. However, in a subgroup analysis of patients with proven staphylococcal nasal carriage, treatment with mupirocin ointment significantly reduced SSI rates compared with rates in noncarriers. Protocols describe the use of ointment in the nares for 5 days prior to surgery. It is unlikely that application of mupirocin just before surgery would have much effect on SSIs, even in staphylococcal nasal carriers. No analysis has determined if identification and treatment of nasal carriers is cost-effective.

Key Point

  • Perioperative glucose control with insulin infusion reduces the risk of surgical site infections for patients with diabetes who are undergoing cardiac surgery.

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A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?

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