some studies on newer anticoagulants AFIB ONLY

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Lynlw

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There are a couple of interesting articles about the newer anticoags studies in A FIB patients

this is from 0ct 3rd
http://www.theheart.org/article/1454823.do
Consistent benefit of apixaban, even in patients at highest risk of bleeding: ARISTOTLE

Durham, NC - An analysis of Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) has demonstrated consistent stroke and major bleeding reductions with apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) compared with warfarin in patients with differing levels of baseline risk [1]. In an analysis stratified by baseline risks of stroke and bleeding with CHADS2, CHA2DS2-VASc, and HAS-BLED scores, researchers found that apixaban consistently outperformed warfarin in terms of reducing the risk of clinical events, including stroke, bleeding, and mortality.

Apixaban also appeared to be even more effective in reducing the risk of intracranial bleeding in patients with higher HAS-BLED scores. In individuals with HAS-BLED scores of >3, apixaban reduced the risk of intracranial bleeding 78% compared with warfarin, whereas the risk of intracranial bleeding was reduced 34% compared with warfarin in patients with HAS-BLED scores of 0 to 1.

"This is very important to highlight," lead investigator Dr Renato Lopes (Duke Clinical Research Institute, Durham, NC) told heartwire, "because every time we decide to give an anticoagulant to patients with atrial fibrillation, the risk of intracranial bleeding is always a major concern. It is a devastating complication. Here, we showed that in patients with a HAS-BLED score of 3 or greater—in other words, the patients at a high risk for bleeding in clinical practice—the magnitude of the reduction in bleeding risk was even greater than in patients at lower risk for bleeding. Apixaban resulted in less intracranial bleeding than warfarin regardless of the patients' risk for bleeding, but it caused even less bleeding than warfarin in patients with higher HAS-BLED scores."

This, say the researchers, is one of the major findings of the study, one that should help physicians in their daily decision-making when treating AF patients.

In an editorial accompanying the study [2], Drs Vassilis Vassiliou and Paul Flynn (Cambridge University National Health Service Trust, UK) note that the decision to give an anticoagulant to a patient with atrial fibrillation is a difficult one, with thromboembolism being pitted against hemorrhage, and both risks imperfectly predicted by even the best risk-stratification scores. Given the reduction in hemorrhage among apixaban-treated patients with a HAS-BLED score of >3, the latest analysis suggests that "after many years of searching, physicians might now face a less agonizing choice on behalf of high-risk patients who have not been managed well in the past."
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and here is a meta analysis from 12 studies Oct 18 th
http://www.theheart.org/article/1460611.do

New anticoagulants beat warfarin in AF meta-analysis

Varese, Italy - A meta-analysis of 12 randomized trials of novel anticoagulants in atrial fibrillation (AF) patients shows that replacing warfarin with the new drugs could save one life for every 244 patients [1].

Dr Francesco Dentali (UO Medicina Interna, Varese, Italy) and colleagues searched through all the published studies of anticoagulant agents for reducing the risk of thromboembolic and/or major bleeding events in AF patients. They narrowed the selection down to 12 studies with a total of 54 875 patients comparing warfarin with novel anticoagulants (three dabigatran [Pradaxa, Boehringer Ingelheim], four rivaroxaban [Xarelto, Bayer/Johnson & Johnson], two apixaban [Eliquis, Bristol-Myers Squibb/Pfizer], and three edoxaban [Lixiana, Daiichi Sankyo] trials).

Comparing the novel anticoagulants with warfarin, the meta-analysis found a statistically significant 11% relative risk reduction in the incidence of total mortality and cardiovascular mortality. According to this analysis, one death from any cause could be prevented for every 244 patients treated with the new anticoagulants instead of warfarin. The number needed to treat to avoid one cardiovascular death is 500, according to the study. The observed advantage of the newer drugs was consistent for all outcomes, including stroke, systemic embolism, and major bleeding.

The study is published online October 15, 2012 in Circulation.

Although dabigatran, rivaroxaban, and apixaban have performed well in individual clinical trials, their cost-effectiveness in atrial-fibrillation patients remains "unclear," according to Dentali et al, largely because the single studies have not been able to show statistically significant improvements over warfarin for hard end points such as overall mortality and vascular mortality.

"We believe that our study could provide more accurate estimates of the expected clinical benefits of the novel anticoagulants," Dentali et al argue. "Taken together, our results suggest that the use of the novel anticoagulants not only provide practical advantages over the vitamin-K antagonists, but it is also associated with an overall clinical benefit, suggesting their cost-effectiveness." The authors believe that the introduction of these new drugs will lead to an overall reduction in AF-related strokes, not only because they are more effective than warfarin but because of "their potential to be used more widely as compared with the vitamin-K antagonists. "
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Thanks Lyn...as always, you are a great source for research. Interestingly, Apixaban has met multiple delays in the FDA approval process, in contrast to what was expected to be smooth sailing. From what I've read, the exact reason is still a bit of a mystery, just some unknown data requests still pending. The hypothesis of one source was that the well publicized adverse events of Pradaxa (the statistical significance of which is still in question, but no matter, headlines are being made nonetheless) might be leading to additional caution for drugs such as Apixaban that are now next in line. But who knows for sure...it will be interesting to see how these competing drugs shake out over time.
 

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