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In the News

for the Week of 3-2-11



Highlights

Update released on using dabigatran to manage atrial fibrillation

Several cardiology specialty societies have released a focused update on managing patients with atrial fibrillation to include the option of using dabigatran, the first new oral anticoagulant available for clinical use in more than 50 years. More...

Acid suppression benefits don't outweigh harms

Acid-suppressive medication does reduce patients' risk of nosocomial gastrointestinal tract bleeding, but the incidence is so low in non-critically ill hospitalized patients that prophylactic treatment should not be used routinely in patients outside of the intensive care unit, a new study concluded. More...


Urinary tract infections

IDSA updates guidelines for uncomplicated UTIs in premenopausal, non-pregnant women

The Infectious Diseases Society of America updated its clinical practice guidelines for treating women with acute uncomplicated cystitis and pyelonephritis. More...


Cardiac rehabilitation

Automatic prompts, clinician discussions boost cardiac rehab referral, enrollment

Automatic referral combined with a clinician discussion can increase patients' use of cardiac rehabilitation after hospital discharge, new research suggests. More...


FDA news

Jantoven and other meds recalled

A number of medications manufactured by Upsher-Smith Laboratories are being recalled after a bottle labeled as Jantoven warfarin sodium 3 mg tablets was found by a pharmacy to contain 10 mg tablets. More...


Regulatory news

New home health rules to be enforced starting April 1

A new rule from CMS now requires that the initial certification for home health services must include a face-to-face encounter with the patient. More...


From ACP Internist

The latest issue is online

The March issue of ACP Internist features stories on parrying patient requests, treating the metabolic syndrome, and managing hypertension. More...


Cartoon Caption Contest

And the winner is …

ACP HospitalistWeekly 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...


Physician editor: A. Scott Keller, FACP




Highlights


.
Update released on using dabigatran to manage atrial fibrillation

Several cardiology specialty societies have released a focused update on managing patients with atrial fibrillation to include the option of using dabigatran, the first new oral anticoagulant available for clinical use in more than 50 years.

The update contains a recommendation saying dabigatran is a useful alternative to warfarin to prevent stroke and systemic thromboembolism "in patients with paroxysmal to permanent atrial fibrillation and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (<15 mL/min), or advanced liver disease (impaired baseline clotting function)." The recommendation is Class I, meaning the treatment is useful/effective, and the level of evidence is B, meaning it came from a single randomized trial or nonrandomized studies. It was jointly released by the American College of Cardiology Foundation, the American Heart Association, and the Heart Rhythm Society, and was published online Feb. 14 by the Journal of the American College of Cardiology.

The FDA approved dabigatran on Oct. 19, 2010, at doses of 150 mg twice daily for patients with a creatinine clearance higher than 30 mL/min, and a dose of 75 mg twice daily for patients with a creatinine clearance between 15 and 30 mL/min. There are no dosing recommendations for patients with a creatinine clearance below 15 mL/min or for patients on dialysis.

Approval of the higher dose was based on results of the RE-LY trial, which included more than 18,000 patients with a creatinine clearance of 30 mL/min or greater and a mean score of 2.1 on the CHADS2, a clinical prediction rule for stroke risk in atrial fibrillation patients. The trial compared dabigatran doses of 110 mg twice daily or 150 mg twice daily with open-label warfarin dosed to a target international normalized ratio (INR) of 2 to 3. The 110-mg dose was found to be noninferior, and the 150-mg dose superior, to warfarin for the outcome of stroke or systemic embolism. Results were published Sept. 17, 2009 in the New England Journal of Medicine (NEJM).

Patients who already take warfarin and have excellent INR control "may have little to gain by switching to dabigatran," the update said, since it involves taking the medication twice a day, and carries a higher risk of nonhemorrhagic side effects. When thinking about the use of dabigatran, clinicians should consider "individual clinical features, including the ability to comply with twice-daily dosing, availability of an anticoagulation management program to sustain routine monitoring of INR, patient preferences, cost, and other factors," the update said.

The upcoming March issue of ACP Hospitalist will include an article on choosing between dabigatran and warfarin in hospitalized patients.

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Acid suppression benefits don't outweigh harms

Acid-suppressive medication does reduce patients' risk of nosocomial gastrointestinal tract bleeding, but the incidence is so low in non-critically ill hospitalized patients that prophylactic treatment should not be used routinely in patients outside of the intensive care unit, a new study concluded.

The cohort study used the records of more than 78,000 admissions to one academic medical center between 2004 and 2007. All patients were hospitalized for three or more days, and 59% of them were prescribed acid-suppressive medications. Overall, nosocomial gastrointestinal (GI) bleeding occurred in 224 or 0.29% of admissions. After adjustment, use of acid-suppressive medications was associated with decreased odds of bleeding (odds ratio, 0.63, 95% CI, 0.42 to 0.93). However, given the rarity of GI bleeding, the number needed to treat with medication to prevent one episode of bleeding was 770. The results were published online by the Archives of Internal Medicine on Feb. 14.

This study did not quantify the potential harms of acid-suppressive medication. However, other studies have found numbers needed to harm of 533 (for hospital-acquired Clostridium difficile) and 111 (for hospital-acquired pneumonia), the authors noted. The finding that the number needed to treat is greater than the number needed to harm lends support to current guidelines, which recommend against prophylactic acid-suppressive medication for patients outside of the intensive care unit, the study authors concluded. Clinicians should balance the potential benefits against the risks and costs in deciding whether to use acid-suppressive medications, they recommended.

The study was not sufficiently powered to investigate the effects of histamine-2 receptor antagonists compared to proton-pump inhibitors. However, since the former drugs are less potent than the latter, it's unlikely that the number needed to treat would be more favorable, the authors concluded. An accompanying commentary noted that patients who are prescribed acid-suppressive medications in the hospital often remain on them after discharge, and thus, inpatient use of the drugs could also lead to later adverse events.

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Urinary tract infections


.
IDSA updates guidelines for uncomplicated UTIs in premenopausal, non-pregnant women

The Infectious Diseases Society of America updated its clinical practice guidelines for treating women with acute uncomplicated cystitis and pyelonephritis.

The guidelines are limited to premenopausal, non-pregnant women with no known urological abnormalities or co-morbidities. Full recommendations are in the March 1 Clinical Infectious Diseases , as is an executive summary.

IDSA published its previous guidelines in 1999. Since then, antimicrobial resistance, collateral damage (referring to the adverse effects of antimicrobial therapy, including the selection of drug-resistant organisms associated with broad-spectrum cephalosporins and fluoroquinolones), newer agents and different durations of therapy have been studied. Women with drug-resistant uropathogens have been included in some studies, allowing for estimations of expected response rates in real-life clinical settings.

Recommendations for acute uncomplicated cystitis include the following:

  • Nitrofurantoin monohydrate/macrocrystals (100 mg twice daily for 5 days) has minimal resistance and collateral damage, with efficacy comparable to 3 days of trimethoprim-sulfamethoxazole. Trimethoprim-sulfamethoxazole (160/800 mg [1 double-strength tablet] twice-daily for 3 days) is appropriate if local resistance rates do not exceed 20%, or if the infecting strain is susceptible. Ofloxacin, ciprofloxacin and levofloxacin are highly efficacious in 3-day regimens, but have a propensity for collateral damage and should be reserved for important uses other than acute cystitis.
  • β-Lactam agents in 3- to 7-day regimens are appropriate when other recommended agents cannot be used. Amoxicillin or ampicillin should not be used because of poor efficacy and very high antimicrobial resistance.

Recommendations for acute pyelonephritis include the following:

  • A urine culture and susceptibility test should always be performed, and initial empirical therapy should be tailored to the infecting uropathogen.
  • Cases requiring hospitalization should be initially treated with an intravenous antimicrobial regimen, such as a fluoroquinolone; an aminoglycoside with or without ampicillin; an extended-spectrum cephalosporin or extended-spectrum penicillin with or without an aminoglycoside; or a carbapenem. The choice between these agents should be based on local resistance data, and the regimen should be tailored on the basis of susceptibility results.
  • Oral trimethoprim-sulfamethoxazole (160/800 mg [1 double-strength tablet] twice-daily for 14 days) is appropriate if the uropathogen is known to be susceptible. If trimethoprim-sulfamethoxazole is used when the susceptibility is not known, an initial intravenous dose of a long-acting parenteral antimicrobial, such as 1 g of ceftriaxone or a consolidated 24-hour dose of an aminoglycoside, is recommended.
  • Oral β-lactam agents are less effective than other agents. If an oral β-lactam agent is used, an initial intravenous dose of a long-acting parenteral antimicrobial, such as 1 g of ceftriaxone or a consolidated 24-hour dose of an aminoglycoside, is recommended.

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Cardiac rehabilitation


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Automatic prompts, clinician discussions boost cardiac rehab referral, enrollment

Automatic referral combined with a clinician discussion can increase patients' use of cardiac rehabilitation after hospital discharge, new research suggests.

In a prospective, observational study of 2,635 inpatients with coronary artery disease, clinicians from 11 community and academic hospitals in Ontario, Canada used one of four referral strategies: automatic referral via electronic records or standard discharge orders as a prompt before discharge; referral via a personal discussion with a clinician, like a nurse or physiotherapist; a combination of the two; or "usual" referral at the clinician's discretion. Patients completed a sociodemographic survey, and clinical data were extracted from their medical charts. A year later, 1,809 patients completed a survey that assessed their cardiac rehabilitation (CR) referral, enrollment and participation. Results were published in the Feb. 14 Archives of Internal Medicine.

CR referral was significantly greater for all intervention strategies compared to usual care (P<0.001). The greatest use of CR came from combining automatic referral and personal discussion (85.8% referral, 73.5% enrollment; odds ratio [OR], 8.41), then automatic referral alone (70.2% referral, 60% enrollment; OR, 3.27), then personal discussion alone (59% referral, 50.6% enrollment; OR, 3.35). Usual care resulted in 32.2% referral and 29% enrollment. Enrollment (P=0.34) and degree of participation once enrolled (P=0.88) didn't differ by referral strategy, with patients attending a mean of 82.87% of classes (standard deviation was 27.2%).

All centers with CR referral strategies had had them in place a couple of years, on average, before the study started, but the time varied by ward and wasn't controlled, which may have biased results, the authors noted. CR referral and usage rates were also self-reported by patients, which may have biased results as well, though self-reports have been shown to be congruent with CR-site report data in the past, the authors noted. Also, CR coverage in this geographic area is fully covered; results may differ in areas where patients pay out-of-pocket for CR, they noted. Still, the results suggest that combined automatic and personal discussion referral strategies should be more widely adopted, as this strategy could raise CR use by 45%, the authors concluded. The combination approach may be most effective because it involves both the clinician and the patient, with the discussion aspect facilitating clinician endorsement and the chance to clear up potential misconceptions or barriers to CR use, they said.

ACP Hospitalist ran a story about boosting cardiac rehabilitation referrals in its December 2010 issue.

Top




FDA news


.
Jantoven and other meds recalled

A number of medications manufactured by Upsher-Smith Laboratories are being recalled after a bottle labeled as Jantoven warfarin sodium 3-mg tablets was found by a pharmacy to contain 10-mg tablets.

The recall includes batches of amantadine, amlodipine, Androxy, baclofen, bethanechol, Jantoven and oxybutynin. The recalled drugs were packaged on the same packaging line as the mislabeled bottle between May 17, 2010 and Nov. 17, 2010, and were distributed to wholesalers, retail chains and independent pharmacies throughout the United States. A list of the specific batches of medication affected by the recall is online.

Any adverse reactions related to the recall may be reported to the FDA's MedWatch Adverse Event Reporting program.

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Regulatory news


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New home health rules to be enforced starting April 1

A new rule from CMS now requires that the initial certification for home health services must include a face-to-face encounter with the patient.

While the rule has technically been in effect since Jan. 1, CMS announced earlier this year that they would not start enforcement of the requirement until April 1. The requirement can be satisfied by a non-physician practitioner, as long as the practitioner is working with the physician and not for a home health agency. It can also be satisfied by an encounter with a hospitalist.

As part of the encounter, physicians must provide documentation of who saw the patient, the date of the visit, and a description of how the clinical findings of the visit support the need for home health services. Further details will be included in the April issue of ACP Internist . In the meantime, information can be found on the CMS website.

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From ACP Internist


.
The latest issue is online

The latest issue of ACP Internist is online, featuring the following stories:

acph-20110302-treatment.jpg

Learning to parry patient requests. Negotiating the doctor-patient relationship requires understanding what a patient expects from treatment, instead of outright saying "no." There are easier ways to sort out what a request really means, and how to quickly address the real underlying issue.

Treat metabolic syndrome's many causes. Metabolic syndrome's prevalence has rapidly advanced in just the past decade. But medical societies don't recommend treating it as a distinct entity. They'd rather that physicians address the individual components of the illness, and encourage lifestyle modifications as the primary way to achieve such a goal.

Simple tools, teamwork manage depression in primary care. Embedding mental health professionals directly into a primary care setting threatens to add complexity to primary care's already hefty "to do" list. Clinics that have accomplished that task explain how it was not only easier than expected, but added tremendous benefits to the practice.

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Cartoon Caption Contest


.
And the winner is …

ACP HospitalistWeekly 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.

acph-20110302-cartoon.jpg

"Congratulations! You're my first mouse call."

This issue's winning cartoon caption was submitted by Kenneth G. Combs, FACP, from Evansville, Ind. Readers cast 114 ballots online to choose the winning entry. Thanks to all who voted! The winning entry captured 42.1% of the votes.

The runners-up were:

"You've got a virus. Let me write you a script for Norton."

"That wasn't a seizure. That was a power surge."

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