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PulmCCM Roundup #2
Etomidate for intubation in sepsis: what's the risk, really?
Etomidate has been suspected of causing adrenal insufficiency and potentially death in patients with severe sepsis, when used as an anesthesia-induction agent prior to intubation. This suspicion has been based on subgroup analyses of 2 randomized trials not powered to answer this question. A large retrospective analysis of an eICU research database published by McPhee et al muddies the waters further. Among 8,063 patients receiving etomidate (2,014 with sepsis), the drug was not associated with worse outcomes in patients with or without sepsis. (Crit Care Med)
FDA approves telavancin (Vibativ) for ventilator-associated pneumonia and HCAP
In 2013, the FDA granted the antibiotic telavancin (Vibativ) an indication for ventilator associated pneumonia and health care associated pneumonia due to Staph aureus. Televancin has activity against methicillin-resistant Staphylococcus aureus (MRSA). In its approval, the FDA also advised against using televancin as first-line therapy for any pneumonia not due to MRSA. Televancin has been approved since 2009 for skin and soft tissue infections. In clinical trials, more patients with chronic kidney disease treated with Vibativ died as compared to those receiving vancomycin. Televancin got a black box warning to this effect.
New once-daily combination inhaler, Anoro Ellipta approved for COPD
Anoro Ellipta is GSK's new once-daily inhaler combining a long-acting antimuscarinic (umeclidinium) and long-acting beta agonist (vilanterol). It was approved by the U.S. FDA for COPD in the United States in December 2013. In a randomized trial among >1,500 patients lasting 6 months, Anoro Ellipta was superior to individual agents both in control of symptoms and in improved pulmonary function. There was no significant harm signal reported. The new drug joins Breo Ellipta (fluticasone/vilanterol, also by GSK) in what will be a growing class of new generation once-daily inhalers for COPD (and expect them to seek asthma indications, as well). Respir Med. 2013 Oct;107(10):1538-46. Epub 2013 Jul 2.
Futile care in the ICU: Less Common than You Thought
In 5 ICUs in a single academic health system, 36 physicians followed 1,100 patients over 3 months and noted whether their care seemed futile. 11% of patients were deemed to be receiving futile care, totaling 7% of patient days in the ICUs. Another 9% were perceived to be receiving "probably futile" care. At 6 month follow-up, 85% of those receiving perceived futile care had died, and many of the survivors had chronic critical illness or severe debility. The 123 patients getting care their doctors saw as futile rang up $2.6 million total in estimated health care costs. JAMA Intern Med. 2013 Nov 11;173(20):1887-94.
Graduated Compression Stockings Didn't Prevent Post-Thrombotic Syndrome
Elastic compression stockings (sometimes called graduated because they get tighter from the thighs to the ankles) have been believed to prevent post-thrombotic syndrome after DVT. However, this was based on small, single center trials without placebo controls. Kahn et al performed a proper multicenter randomized trial in Canada and the U.S. on 410 patients with a first acute DVT, using placebo/sham stockings as the control. Elastic graduated compression stockings did not prevent post-thrombotic syndrome (~13.5% in each arm). Lancet 2014 Mar 8;383(9920):880-8.
Risk of DVT and Other Clots in Postpartum Women
Pregnant women are at increased risk for thrombotic events, including deep venous thrombosis. The risk continues after delivery and has been thought to be highest during the first 6 weeks postpartum. When does it return to baseline? Kamel et al examined a large database of 1.7 million pregnant women. About 1 in 1,700 had a thrombotic event (DVT, PE, stroke, or MI) within 1.5 years of delivery. The risk of thrombus (of any type) was 10 times higher in the first 6 weeks postpartum as compared to one year later. The thrombotic risk remained elevated through 12 weeks postpartum, then declined to that of the general population. Even during the highest risk period postpartum, a woman's risk of a blood clot was an absolute ~1 in 4,000. NEJM epub February 2014.
FDA warns against doripenem (Doribax) for ventilator-associated pneumonia
In March 2014, the FDA issued a warning statement that Doribax (doripenem) "carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin," and changed the Doribax label to reflect this. FDA emphasized that Doribax is "not approved to treat any type of pneumonia" (it's approved for intra-abdominal infections and complicated UTIs), and warns against doing so off-label: "Health care professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators." This was all based on a randomized trial that was stopped early when all cause mortality was higher with Doribax than with Primaxin (imipenem-cilastatin) (23% vs 17%), and clinical cure rates were also lower among patients treated with doripenem.
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