The FDA approved angiotensin-II (Giapreza) as a new intravenous vasopressor for septic shock and other forms of distributive shock. The first new FDA-approved vasopressor in decades, angiotensin-II could significantly change the management of severe septic shock. FDA based its expedited approval (under priority review) on the ATHOS-3 trial enrolling 321 patients with shock refractory to [… read more]
The long-term management of recurrent venous thromboembolism continues to evolve with the FDA’s approval of once-daily low-dose rivaroxaban, now indicated for patients with recurrent deep venous thrombosis or pulmonary embolism who have completed at least six months of anticoagulation. FDA approved low-dose rivaroxaban based on data from 3,395 patients in the EINSTEIN-CHOICE study. Both 20 [… read more]
Combination inhalers for asthma and COPD containing long-acting beta agonists (LABA) drugs along with inhaled corticosteroids can lose their black-box warnings about their previously-theorized risk of asthma-related death, the FDA announced. The original boxed warning came in 2011 in the wake of a small number of asthma-related deaths among patients taking LABA monotherapy (without inhaled [… read more]
Jon-Emile S. Kenny MD [@heart_lung] Background If venous pressure were always the downstream pressure of an artery, then when flow is zero, the arterial pressure should equal the venous pressure. For example, if one were to measure the coronary artery pressure and coronary sinus pressure at zero flow, their pressures should be equal. Yet, this [… read more]
Most good medical intensive care units have incorporated interruptions in sedation (so-called ‘sedation vacations’) into standard care for patients receiving mechanical ventilation. Avoiding excessive sedation in general is believed to reduce prolonged mechanical ventilation in ICUs. However, there is surprisingly little data about effects of sedation (or over-sedation) on critically ill postoperative patients in the [… read more]
New-generation oral anticoagulants (NOACs) like dabigatran, rivaroxaban, and apixaban all had similar efficacy and bleeding risk compared to warfarin in the randomized trials that led to their FDA approval. That didn’t stop trial lawyers from filing bundles of lawsuits on behalf of patients experiencing hemorrhages after taking NOACs. (The large brand-name pharmaceutical manufacturers advertising new [… read more]
Intensivists have another antibiotic combination to treat severe infections caused by gram-negative bacteria with the FDA’s approval of Vabomere (meropenem, combined with the beta-lactamase inhibitor called vaborbactam). FDA approved Vabomere only for the treatment of complicated urinary tract infections (such as pyelonephritis). However, licensed U.S. physicians routinely prescribe FDA-approved antibiotics “off-label” for other indications. Meropenem-vaborbactam [… read more]
by Salynn Boyles, Contributing Writer, MedPage Today The FDA approved a nebulized formulation of glycopyrrolate (Lonhala Magnair) for long-term maintenance treatment of patients with moderate-to-severe COPD, said manufacturer Sunovion Pharmaceuticals. It’s the first long-acting muscarinic antagonist (LAMA) to be sold in this form. Recommended dosing is 25 mcg twice daily. The approval was made on the strength [… read more]
Jon-Emile S. Kenny MD [@heart_lung] -What is the world record for longest breath hold? -Why does the diagnosis of brain death require a rise in PaCO2 to at least 60 mmHg? -What minute ventilation can a human achieve? -What’s the difference between an elevated PaCO2 in someone who ‘won’t’ versus ‘can’t’ breathe? I’d like to [… read more]
Physicians and patients alike tend to avoid frank discussions about “code status” — whether a patient would want CPR or mechanical ventilation in the event of a cardiac or respiratory arrest. When doctors address code status at all, they tend to phrase the questions in such a way to cut off any thoughtful discussion: “If [… read more]
Jon-Emile S. Kenny MD [@heart_lung] with illustrations by Carla M Canepa MD “… And you may ask yourself … well, how did I get here? … And you may tell yourself … my God! What have I done?” -David Byrne A 92 year old woman is transferred to the coronary care unit for treatment of pulmonary edema. She [… read more]
The common cold is aptly named, with an estimated 500 million infections annually in the United States. Adults in the U.S. average two to three colds per year, and preschool children five to seven. Colds create a huge economic burden from missed work days, health care visits and medications, an estimated $17 billion directly and [… read more]
Oral corticosteroids are frequently prescribed for persistent cough after the common cold in patients without respiratory disease. Like much of what physicians offer or advise, steroids for ordinary cough are traditionally provided not based on evidence, but on the premise that “it might help.” A new study in JAMA substantially undermines that premise. Authors randomized [… read more]
In pulmonary embolism (PE), right ventricular (RV) strain on transthoracic echocardiography increases the likelihood of shock and mortality. One study showed among patients with PE and normal blood pressure, 10% of those with RV strain on echocardiogram developed shock, and 5% died in hospital. Those without RV strain maintained their blood pressure and survived (but important [… read more]
This would be a very informative case report (and it’s true and unexaggerated), but I anticipate staunch editorial resistance (even sans puns), so I’ll describe it here and have some fun with it. Background: The author has anecdotally observed for many years that so-called “septic shock” follows rather than precedes intubation and sedation. This raises [… read more]
Jon-Emile S. Kenny MD [@heart_lung] In the last few weeks I have been contacted by curious clinical physiologists craving my conceptions of ‘venous excess’ [1]. These words will address this model, concisely and – I pray – clearly. The Myth of Venous Return The roots of venous excess took hold within the fertile soil of [… read more]
The US Food and Drug Administration (FDA) approved an implanted phrenic nerve-stimulator device as a new treatment for moderate-to-severe central sleep apnea (CSA). The remedē System (Respicardia) consists of a pacemaker-like battery pack that’s surgically implanted in the upper chest beneath the skin. Wires electrically stimulate the phrenic nerve as it travels from the neck [… read more]
The injectible monoclonal antibody mepolizumab (Nucala, GSK) is FDA-approved for severe asthma with blood eosinophilia, uncontrolled with standard controller inhaler treatments. Two randomized placebo-controlled trials keep alive for GSK the possibility of an FDA indication to reduce exacerbations in people with chronic obstructive pulmonary disease (COPD) with high blood eosinophil counts, expanding the drug’s market. The ~1,500 [… read more]
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