atrial fibrillation

Blood-Thinner Pradaxa: What You Should Know

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Blood-Thinner Pradaxa: What You Should Know.

Concerns about Pradaxa surfaced 2 years ago, he says, when doctors began reporting a larger number of serious and sometimes fatal bleeding problems in older patients on the drug.

The claim by the company that the drug needs no blood-level monitoring is misguided, Moore says. “It turns out the company has had data for several years, showing the amount of anticoagulation [blood thinning] varied [from patient to patient] more than five-fold.”

That means, Moore says, that “the same dose could produce widely varying effects on blood clotting. Some patients would be at extremely high risk of bleeding. Others would not get a strong enough blood clotting effect to serve its purpose, reduce the risk of stroke.”

Do the phrases “serious and sometimes fatal bleeding problems”  combined with the drug maker’s withholding of data bother anyone?  And yet another example of putting profits before people.

Update 07.27.14

I found another fine article on the Pradaxa mess.  Follow the link to The Poison Review. There you will find more details on this story and more links for further reading, including a link to the full text BMJ article.

The Institute for Safe Medication Practices reported that in 2011 there were 3781 serious adverse effects and 542 patient deaths reported in the United States in association with dabigatran. In comparison, warfarin (Coumadin) was associated with only 72 deaths during that same time period. – See more at: http://www.thepoisonreview.com/2014/07/27/must-read-marketing-vs-medicine-in-the-case-of-pradaxa-dabigatran/#sthash.tpAapuE6.dpuf

Must-read: marketing vs. medicine in the case of Pradaxa dabigatran | The Poison Review.

Update 08.22.14

Getting the dabigatran Pradaxa story right… Correcting four common mistakes..

If you’re not totally confused by now you should be.

Bisphosphonates Raise Afib Risk

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Bisphosphonate use was associated with significantly increased risks of atrial fibrillation and serious atrial fibrillation, researchers found.

A systematic review of randomized controlled studies and observational studies showed use of bisphosphonates was associated with a 27% increased risk of atrial fibrillation (95% CI 1.16-1.39) in observational studies and, in randomized controlled trials alone, with a 40% increased odds of serious atrial fibrillation (95% CI 1.02-1.93), according to Abhishek Sharma, MD, of Maimonides Medical Center in Brooklyn, N.Y., and colleagues.

via Bisphosphonates Raise Afib Risk.

Afib Linked to Silent Stroke

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MRI indicated silent cerebral ischemia lesions in 89% patients with paroxysmal Afib and 92% with persistent Afib compared with 46% of controls, which wasn’t significantly different between the two types of Afib but was for both versus controls (P<0.01).

The number of these lesions averaged 41 in persistent Afib, 33 in paroxysmal Afib, and 12 in controls, which was significantly different for all three groups.

The high prevalence of these lesions in the control group compared with what has been reported in the general population may have reflected the moderate to high cardiovascular risk among these patients referred for cardiovascular prevention or treatment, the researchers suggested.

The lesions can have either ischemic and embolic origins, but the peculiar “spotted” distribution of “small sharply demarcated lesions, often in cluster, with bilateral distribution, prevalently in the frontal lobe” seen in 50% and 67% of the paroxysmal and persistent Afib patients, respectively, strongly supported an embolic mechanism, they noted.

via Afib Linked to Silent Stroke.

If these findings are replicated in future studies, the question for underwriters is should any Afib risk be Standard mortality?

Afib Linked to Sudden Cardiac Death

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Atrial fibrillation may raise the risk of sudden cardiac death, according to findings from two large population-based cohorts.

The risk of sudden cardiac death was elevated 3.26-fold with incident atrial fibrillation in multivariate analysis of the ARIC (Atherosclerosis Risk in Communities) study, Lin Y. Chen, MD, MS, of the University of Minnesota Medical School in Minneapolis, and colleagues found.

via Afib Linked to Sudden Cardiac Death, Too.