June 25th, 2012
FDA Once Again Delays Approval of Apixaban (Eliquis)
Larry Husten, PHD
The FDA has once again delayed approval of apixaban (Eliquis), the much-anticipated oral anticoagulant. Bristol-Myers Squibb and Pfizer announced today that it had received a a Complete Response Letter (CRL) to the New Drug Application (NDA) for the drug for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The two companies reported […]
June 25th, 2012
Selections from Richard Lehman’s Literature Review: June 25th
Richard Lehman, BM, BCh, MRCGP
This week’s topics includes articles on industry regulation, the chronically comorbid, population risk for CV disease, and recombinant tissue plasminogen activator (rt-PA) for ischemic stroke.
June 25th, 2012
What Constitutes a Professional Society’s Endorsement?
Harry Peled, md
Harry Peled directly questions the Heart Rhythm Society about its logo on a sudden cardiac arrest protocol that mentions wearable cardioverter-defibrillator vests.
June 22nd, 2012
Olmesartan Use Associated With GI Disorder That Mimics Celiac Disease
Larry Husten, PHD
A gastroenterologist at the Mayo Clinic has uncovered a rare but potentially serious association between the angiotensin II receptor antagonist (ARB) olmesartan and severe gastrointestinal problems that resemble Celiac disease. The report has been published online in Mayo Clinic Proceedings. In the U.S., olmesartan is sold as Benicar and, in combination with other drugs, as Azor, Benicar […]
June 22nd, 2012
FDA Rejects ACS Indication for Rivaroxaban (Xarelto)
Larry Husten, PHD
The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) in patients with acute coronary syndrome (ACS). The action was expected, since last month the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against recommending the new indication, which was based on the pivotal ATLAS […]
June 21st, 2012
PTSD Relatively Common Among Patients with Heart Disease
Roughly 1 in 8 patients with acute coronary syndromes subsequently suffers from post-traumatic stress disorder, according to a meta-analysis in PLoS ONE.
June 20th, 2012
C3 Global Summit, June 20, 2012
Aaron C. Earles, DO
The coronary track this morning began with discussions of the rationale for CTO interventions in “the era of appropriate use criteria” and of how to recognize unfavorable features for CTO PCI. The session concluded with two live case transmissions. The first case was of a 55-year-old man, an exsmoker with a history of diabetes mellitus […]
June 20th, 2012
Reality Check: The ORIGIN of Spin in a Randomized Trial
Steven Coca, DO, MS
When the facts from a randomized controlled trial don’t match the spin, what’s the takeaway for clinicians in the trenches?
June 19th, 2012
C3 (Complex Cardiovascular Catheter Therapeutics) 2012
Aaron C. Earles, DO
Greetings from Orlando, Florida! I am in town for the C3 therapeutics global summit being held at the Rosen Shingle Creek Resort. This afternoon had some very interesting topics for interventionalists and fellows-in-training. I attended a preconference symposium, Imaging: Moving Beyond Angiography. Throughout the first year of fellowship, I recall multiple cases where angiography alone […]
June 19th, 2012
Is Chronic Kidney Disease a CHD Risk Equivalent?
Larry Husten, PHD
A study published in the Lancet provides new data about whether chronic kidney disease (CKD) should, like diabetes, be considered a coronary heart disease (CHD) risk equivalent. Marcello Tonelli and colleagues analyzed data from a population of 1.25 million people in Alberta, Canada. During a median follow-up of 4 years, 11,340 people were admitted to the […]