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ACP InternistWeekly



In the News for the Week of May 22, 2012




Highlights

USPSTF recommends against prostate-specific antigen screening

The U.S. Preventive Services Task Force (USPSTF) released its final recommendations on prostate-specific antigen (PSA) screening today, recommending against using the test for prostate cancer screening in men of all ages in the general population. More...

Statins associated with decreased strokes and death but not increased intracerebral hemorrhage in meta-analysis of randomized trials

Statin therapy was associated with significant reductions in all strokes and death but not with a significant increase in intracerebral hemorrhages in a meta-analysis of 31 randomized, controlled trials. More...


Test yourself

MKSAP Quiz: tachycardia and hypertension postoperatively

This week's quiz asks readers to evaluate a 59-year-old man for tachycardia and hypertension six hours after an uncomplicated open cholecystectomy under general anesthesia. More...


Sinusitis

Intranasal corticosteroids may help symptoms in acute sinusitis

Intranasal corticosteroids may help relieve symptoms in acute sinusitis, according to a new study. More...


Antibiotics

Azithromycin associated with more cardiac, all-cause mortality

Taking azithromycin can increase one's risk of cardiovascular death, especially for patients who have a high baseline risk of cardiovascular disease, a new study found. More...


Pulmonology

Combination therapy for pulmonary fibrosis appears to increase risk of death, hospitalization

A combination of prednisone, azathioprine and N-acetylcysteine (NAC) for pulmonary fibrosis prompted a trial to stop early after it showed an increased risk of death and hospitalization compared with NAC alone and with placebo. More...


Cardiology

Simplified cardiac risk score may help predict heart failure in primary care

A simplified cardiac risk score may help predict heart failure in primary care, a new study indicates. More...


From ACP Hospitalist

The May issue of ACP Hospitalist is online

The latest issue of ACP Hospitalist is online and includes stories about ethics in hospital medicine, inpatient hypercalcemia, compassion fatigue and more. More...


From the College

New ethics case study addresses the EHR

The ACP Center for Ethics and Professionalism has posted a new case study, "Copied and Pasted and Misdiagnosed (or Cloned Notes and Blind Alleys)" on Medscape. More...


Cartoon caption contest

Vote for your favorite entry

ACP InternistWeekly's cartoon caption contest continues. Readers can vote for their favorite caption to determine the winner. More...

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


Physician editor: Philip Masters, MD, FACP



Highlights


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USPSTF recommends against prostate-specific antigen screening

The U.S. Preventive Services Task Force (USPSTF) released its final recommendations on prostate-specific antigen (PSA) screening today, recommending against using the test for prostate cancer screening in men of all ages in the general population.

The USPSTF's 2008 statement on this topic recommended against PSA screening in men age 75 years or older and concluded that the evidence was insufficient to weigh benefits and harms in younger men. For the new recommendations, an expert panel reviewed two major trials of PSA testing in asymptomatic men published since 2008 to examine whether the screening saved lives and prevented symptomatic disease. Draft recommendations were posted for comment in October 2011; the final recommendations were published May 22 by Annals of Internal Medicine.

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Of the two new trials examined by the panel, the first, conducted in the U.S., demonstrated no reduction in prostate cancer mortality as a result of screening. The second trial was conducted in seven European countries and found that PSA screening reduced prostate cancer deaths by about one death prevented per 1,000 men screened in a subgroup of men aged 55 to 69 years. However, these results relied heavily on trials in two countries; five countries found no statistically significant reduction in deaths, and all-cause mortality was nearly identical in the screened and nonscreened groups. Strong evidence indicates that PSA screening is associated with significant harms, including overdiagnosis and adverse effects of treatment, the Task Force noted.

"The primary goal of PSA-based screening is to find men for whom treatment would reduce morbidity and mortality. Studies demonstrate that the number of men who experience this benefit is, at most, very small, and PSA-based screening as currently implemented in the United States produces more harms than benefits in the screened population," the Task Force wrote.

A related commentary argued that the USPSTF recommendation underestimates the benefits and overestimates the harms of prostate cancer screening. The authors noted that the USPSTF panel does not include urologists or oncologists and said that the studies on which it based its recommendations are flawed and did not include sufficient follow-up time. The USPSTF recommendations also focus only on mortality and do not address the potential benefits of screening in high-risk patients or younger men, the commentary authors wrote.

In another commentary, however, the medical director of the American Cancer Society argued that overdiagnosis can make it seem as if screening saves lives when it actually does not. Many men are diagnosed with and treated for prostate cancer that may never have progressed within their lifetime.

"We must heed science when making clinical and policy decisions about PSA-based prostate cancer screening," the commentary author wrote. "The harms are well-proven, whereas the evidence of benefit is weak. Even if one accepts that true benefits exist, the documented harms are likely greater than those small benefits."

Despite its clear recommendation against PSA screening, the Task Force noted that clinicians should make the final decision.

"The USPSTF recognizes that clinical decisions involve more considerations than evidence alone," the recommendation statement said. "Clinicians should understand the evidence but individualize decision making to the specific patient or situation."


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Statins associated with decreased strokes and death but not increased intracerebral hemorrhage in meta-analysis of randomized trials

Statin therapy was associated with significant reductions in all strokes and death but not with a significant increase in intracerebral hemorrhages (ICHs) in a meta-analysis of 31 randomized, controlled trials.

Because of a possible increased risk of hemorrhagic stroke observed in several studies of statin use for stroke prevention, study authors searched peer-reviewed literature through January 2012 for all randomized, controlled trials of statin therapy that reported ICH or hemorrhagic stroke. The primary outcome was ICH. Results were published online May 15 in Stroke.

There were 91,588 subjects in the active (statin-taking) group and 91,215 in the control group, with a median length of follow-up of 46.8 months. ICH occurred in 358 subjects (0.39%) in the active group versus 318 (0.35%) in the control group. In the primary analysis, assessing ICH risk in 30 studies of statin treatment, active therapy was not associated with an increase in ICH (odds ratio [OR], 1.08; 95% CI, 0.88 to 1.32; P=0.47).

There were 6,262 strokes in this meta-analysis. The overall stroke rate was 3.13% in the active group versus 3.72% in the control group. Statin therapy was associated with a significant reduction in total stroke (OR, 0.84; 95% CI, 0.78 to 0.91; P<0.0001).

Overall mortality was 20,195 deaths. There was a significantly lower rate of all-cause mortality in the active group (10.67%) than in the control group (11.43%; OR, 0.92; 95% CI, 0.87 to 0.96; P=0.0007). The number needed to treat with active statin therapy to prevent 1 death was 167 (absolute risk reduction=0.6%, P<0.0001).

The authors concluded, "Statin therapy was not associated with a significant increased risk of ICH. There was no effect on ICH risk related to the degree of decline in [low-density lipoprotein] or to the achieved level. The significant reduction in total stroke and all-cause mortality more than offset any slight increase in ICH risk. These findings support the current recommendations to prescribe statins in otherwise appropriate patients."



Test yourself


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MKSAP Quiz: tachycardia and hypertension postoperatively

A 59-year-old man is evaluated for tachycardia and hypertension six hours after undergoing an uncomplicated open cholecystectomy under general anesthesia. The patient had intraoperative high blood pressure and was treated postoperatively with metoprolol, 5 mg every 4 hours by intravenous bolus. The patient underwent repair of a laceration of the liver 5 years ago and had an uncomplicated intraoperative and postoperative course. He has a history of essential hypertension, and his medications are hydrochlorothiazide and metoprolol.

mksap.jpg

On physical examination, the temperature is 39.2 °C (102.5 °F), the blood pressure is 190/110 mm Hg, and the pulse rate is 115/min. There is significant rigidity of all his extremities.

Which of the following is the most appropriate therapy for this patient?

A) Alcohol sponge baths
B) Ampicillin-sulbactam
C) Corticosteroids
D) Dantrolene
E) Sodium nitroprusside

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


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Sinusitis


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Intranasal corticosteroids may help symptoms in acute sinusitis

Intranasal corticosteroids may help relieve symptoms in acute sinusitis, according to a new study.

Researchers performed a systematic review and meta-analysis to determine the effects of intranasal corticosteroids on acute sinusitis symptoms. MEDLINE, EMBASE, the Cochrane Center Register of Controlled Trials and the Centre for Reviews and Dissemination were searched up to February 2011 for studies that compared intranasal corticosteroids and placebo in children or adults with clinical signs and symptoms of acute sinusitis or rhinosinusitis in ambulatory care. Studies that examined chronic or allergic sinusitis were excluded. The study results appeared in the May/June Annals of Family Medicine.

A total of six studies with 2,495 patients were included. In five of these studies, patients were taking antibiotics in addition to intranasal corticosteroids. The authors found that intranasal corticosteroids led to a small but significant increase in resolution or improvement of symptoms, usually facial pain and congestion, at days 14 to 21 (risk difference, 0.08; 95% CI, 0.03 to 0.13). Subgroup analysis by time found that the beneficial effect was significant at 21 days but not at 14 to 15 days, and a meta-regression analysis of trials that used different doses of mometasone furoate found a significant dose-response relationship (P=0.02).

The authors noted that their analysis was limited by the frequent co-administration of corticosteroids and antibiotics. In addition, the included studies used different types, doses and durations of therapy and were underpowered to detect rare adverse effects, among other limitations. However, the authors concluded that intranasal corticosteroids offer a small benefit in improving acute sinusitis symptoms that might be greater with longer use (21 days) and at higher doses.

"Future trials in antibiotic-naïve patients that clarify the time-course of clinical benefit and the impact on work and quality of life will be important to guide management of this common condition," they wrote.

The author of an accompanying editorial, however, felt that the study did not show enough of a difference in symptom relief with intranasal steroids and that the time frame for improvement in symptoms was too long. "Most patients want to get better in a few days, not 3 weeks," he wrote.



Antibiotics


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Azithromycin associated with more cardiac, all-cause mortality

Taking azithromycin can increase one's risk of cardiovascular death, especially for patients who have a high baseline risk of cardiovascular disease, a new study found.

The cohort study of Tennessee Medicaid patients was motivated by existing evidence that azithromycin is proarrhythmic. In the study, about 350,000 patients who took azithromycin were propensity-score matched with people who took no antibiotics (about 1.4 million control periods), 1.3 million patients who took amoxicillin, 265,000 taking ciprofloxacin and 194,000 on levofloxacin. The results were published in the May 17 New England Journal of Medicine.

The risk of cardiovascular death during five days of azithromycin therapy was almost three times that of patients taking no antibiotics (hazard ratio, 2.88; 95% CI, 1.79 to 4.63; P<0.001). Azithromycin patients also had an increased risk of death from any cause (hazard ratio, 1.85; 95% CI, 1.25 to 2.75; P=0.002). The increased risk of both cardiovascular and all-cause death was also found when the azithromycin patients were compared to the amoxicillin patients, who had no increase in risk compared to non-antibiotic-taking controls. The risk associated with azithromycin also exceeded that associated with ciprofloxacin but was similar to the risk from levofloxacin.

The study authors calculated that use of azithromycin could result in 47 additional cardiovascular deaths per 1 million courses of antibiotics. The danger for patients with high baseline cardiovascular risk is even greater: 245 cases per 1 million courses. Although a specific causal mechanism cannot be established, the data from this study support previous findings about potential adverse cardiac effects of azithromycin and levofloxacin, the authors concluded. They also noted that the increase in risk does not persist after azithromycin therapy ends.

In response to the study's publication, the FDA announced that it is in the process of updating risk information on the labels of macrolide antibiotics and will review the data from this study. In the meantime, clinicians are advised to be aware of the potential for QT prolongation and arrhythmias in patients taking macrolides, the agency's press release recommended.



Pulmonology


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Combination therapy for pulmonary fibrosis appears to increase risk of death, hospitalization

A combination of prednisone, azathioprine and N-acetylcysteine (NAC) for pulmonary fibrosis prompted a trial to stop early after it showed an increased risk of death and hospitalization compared with NAC alone and with placebo.

The randomized, double-blind, placebo-controlled trial examined patients ages 35 to 85 with idiopathic pulmonary fibrosis who had mild-to-moderate lung function impairment, defined as forced vital capacity of less than 50% and a carbon dioxide diffusing capacity of less than 30%. They were randomized equally into one of three groups: combination therapy, NAC alone or placebo.

Prednisone was started at 0.5 mg/kg of ideal body weight and was tapered to 0.15 mg/kg over 25 weeks. Azathioprine was given at a maximum of 150 mg/d, while NAC was given at 600 mg orally three times a day. The primary study outcome was the change in longitudinal measurements of forced vital capacity during a 60-week treatment period.

After about half the data had been collected (with 77 patients on combination therapy and 78 in the placebo group), a planned interim analysis revealed that combination therapy patients had an increased rate of death compared with placebo (81 vs. 1; P=0.01) and hospitalization (23 vs. 7; P<0.001).

There was no evidence of physiological or clinical benefit for combination therapy. Forced vital capacity was −0.24 L in the combination-therapy group and −0.23 L in the placebo group (P=0.85).

The data and safety monitoring board recommended ending the combination therapy group. "Our data that show increased rates of death and hospitalization provide compelling evidence against the use of the combination of azathioprine, prednisone and NAC for patients with idiopathic pulmonary fibrosis who have mild-to-moderate impairment in pulmonary function," they concluded. The trial was published online May 20 by the New England Journal of Medicine.



Cardiology


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Simplified cardiac risk score may help predict heart failure in primary care

A simplified cardiac risk score may help predict heart failure in primary care, a new study indicates.

Researchers used data from the Atherosclerosis Risk in Communities (ARIC) Study cohort to test the validity and accuracy of existing heart failure risk scores, including the Framingham Heart Study score and the Health ABC score. They also derived a new, "parsimonious" score focusing on primary care, the ARIC HF risk score, and compared it with the other scores in prediction of 10-year heart failure risk. The value of biomarkers in predicting long-term risk was also evaluated. The study results were published online May 15 by Circulation: Heart Failure.

Over 15.5 years and 210,102 person-years of follow-up, 13,555 members in the ARIC Study cohort had 1,487 heart failure events. The area under the curve for the Framingham, Health ABC, and ARIC risk scores as derived in the ARIC cohort were 0.762, 0.783 and 0.797, respectively. Adding N-terminal pro-B-type natriuretic peptide (NT-proBNP) to the scores improved the overall classification by 18%, 12% and 13%, respectively. However, adding cystatin C or high-sensitivity C-reactive protein to the models did not improve risk prediction.

The authors noted that heart failure outcomes might not have been classified correctly in all cases and that few echocardiography data were available. However, they determined that the ARIC risk score is slightly better at predicting 10-year risk for heart failure than existing risk scores in the community setting, and that including NT-proBNP substantially improves risk prediction. In addition, a risk score that included fewer variables—the patient's age, race, gender, and NT-proBNP values—was as effective as the full score.

Further replication and calibration of their results are likely needed, the authors said. The risk calculators used in the study are available online.



From ACP Hospitalist


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The May issue of ACP Hospitalist is online

The latest issue of ACP Hospitalist is online and includes stories about ethics in hospital medicine, inpatient hypercalcemia, compassion fatigue and more.

Balancing quality care, best use of resources and patient involvement. ACP's recently revised Ethics Manual offers guidance on situations relevant to hospitalists, such as stewardship of resources, communicating with patients, and dealing with conflicts over treatment goals.

Diagnosing and treating inpatient hypercalcemia. Inpatient hypercalcemia is most commonly associated with a malignancy, but it can be caused by other diseases and conditions as well.

The price of caring about your patients. Compassion fatigue shares symptoms and some causes with burnout, but it's not the same. Learn to spot, treat and prevent the condition.

A MKSAP Quiz on hypercalcemia and a coding column on functional quadriplegia are also online.



From the College


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New ethics case study addresses the EHR

The ACP Center for Ethics and Professionalism has posted a new case study, "Copied and Pasted and Misdiagnosed (or Cloned Notes and Blind Alleys)" on Medscape.

The case study addresses the potential impact of the electronic health record's copy-and-paste function on issues of medical ethics and professionalism, including accurate and effective documentation, bedside evaluation skills and the education of trainee physicians. CME credit is available for completion of the case study, which can be accessed online.



Cartoon caption contest


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Vote for your favorite entry

ACP InternistWeekly's cartoon caption contest continues. Readers can vote for their favorite caption to determine the winner.

acpi-20120522-cartoon.jpg

"Don't worry—this drug is safe. It was tested on humans."

"No, I am a PRIMARY care physician."

"No, I will not prescribe you a banana bag."

Go online to pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service.


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MKSAP Answer and Critique



The correct answer is D) Dantrolene. This item is available to MKSAP 15 subscribers as item 26 in the Pulmonary and Critical Care Medicine section. MKSAP 16 will release Part A on July 31. More information is available online.

This patient likely has malignant hyperthermia, an inherited skeletal muscle disorder characterized by a hypermetabolic state precipitated by exposure to volatile inhalational anesthetics (halothane, isoflurane, enflurane, desflurane, sevoflurane) and the depolarizing muscle relaxants succinylcholine and decamethonium. Although malignant hyperthermia usually occurs at the time of exposure intraoperatively, it can occur several hours after the initial exposure and can develop in patients who were previously exposed to the drug without any effect. Increased intracellular calcium leads to sustained muscle contractions with skeletal muscle rigidity and masseter spasm, tachycardia, hypercarbia, hypertension, hyperthermia, tachypnea, and cardiac arrhythmias.

Malignant hyperthermia is life-threatening unless treated promptly and aggressively. Supportive measures include hydration and decreasing the fever. Dantrolene, a skeletal muscle relaxant, is given as a bolus of 1 mg/kg intravenously and then 2 mg/kg every 5 to 10 minutes until the symptoms resolve. Response to dantrolene is not diagnostic of the disorder but is supportive if signs and symptoms resolve quickly. For those patients with a known history, pretreatment with dantrolene before the anesthetic agent is administered prevents the development of symptoms.

Alcohol sponge baths are generally not recommended as an augmentation of evaporative cooling in any hyperthermic patient, including malignant hyperthermia, owing to the possibility of substantial alcohol absorption through the skin. Furthermore, augmented cooling (typically accomplished with water misting and forced air circulation by fans) may result in shivering which can increase body temperature unless it is suppressed with benzodiazepine administration. Ampicillin-sulbactam might be a consideration if acute ascending cholangitis were suspected; however, this is unlikely only hours after an elective cholecystectomy. Furthermore, an infection cannot account for the patient's muscular rigidity. Corticosteroids would be effective treatment for an allergic reaction, but there are no symptoms suggesting an allergic reaction such as rash, urticaria, angioedema, or wheezing. Sodium nitroprusside is indicated in patients with hypertensive emergencies. However, this patient's blood pressure is elevated secondary to malignant hyperthermia, and treatment of the underlying disorder is the preferred therapy.

Key Point

  • Malignant hyperthermia is a life-threatening skeletal muscle disorder characterized by a hypermetabolic state precipitated by exposure to volatile inhalational anesthetics or depolarizing muscle relaxants.

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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?

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