DRugwatch BlogRSS 2.0

DRugwatch Blog > September 2011 > Apixaban Emerges Victorious from ARISTOTLE

Apixaban Emerges Victorious from ARISTOTLE

Matt KileenContributor: Matthew Killeen, Ph.D.

The anticoagulant market will undergo a sustained period of significant growth over the next 10 years as a series of new oral agents, with vastly superior clinical profiles to warfarin, launch for lucrative indications, such as stroke prevention in atrial fibrillation (SPAF) and venous thromboembolism treatment. The race for dominance in the SPAF market is already underway; dabigatran became the first of a wave of new agents to launch for this indication in October 2010 and rivaroxaban is poised for launch later this year. Although the positive results from Phase III trials of dabigatran and rivaroxaban for SPAF have already established high barriers to entry to this indication, apixaban’s astounding performance in its pivotal ARISTOTLE trial have secured its ability to effectively compete in this arena.

ARISTOTLE, a double-blind Phase III trial of apixaban versus warfarin showed, unequivocally, that apixaban has several major advantages over warfarin that set it apart from rivals. The trial’s primary efficacy end point, ischemic or hemorrhagic stroke or systemic embolism, occurred in 212 patients given apixaban compared to 265 assigned to warfarin (P=0.01). Additionally, the rate of death from any cause was significantly lower in the apixaban arm of the study (603 vs. 669 warfarin-treated patients; P=0.047). While both dabigatran’s and rivaroxaban’s mortality data trended towards statistical significance, thus far only apixaban can claim a clear mortality benefit over warfarin. With regards to safety, apixaban’s data were equally impressive; rates of major bleeding were significantly lower with apixaban, relative to warfarin (major bleeding was documented in 327 vs. 462 patients, respectively; P<0.001)

How do the data from the ARISTOTLE study align with the clinical expectations for new oral anticoagulants for SPAF? A 2011 study by Decision Resources surveyed U.S. cardiologists to develop physician-built target product profiles based on a major drug development opportunity: an anticoagulant with a lower rate of major bleeding than warfarin (1). Our results showed that, at a price point similar to that of dabigatran, physicians would expect major improvements over warfarin’s efficacy in addition to less major bleeding. Based on the results from ARISTOTLE, apixaban is the only oral anticoagulant to satisfy the vast majority of these clinical expectations.

Given apixaban’s powerful Phase III data, how will the SPAF landscape evolve and how will the fortunes of dabigatran and rivaroxaban be impacted? In a forthcoming study, Decision Resources surveyed over 120 U.S. cardiologists and pharmacy directors to gauge perceptions towards Phase III data of the new oral anticoagulants and to determine potential prescribing trends and formulary placement for these agents (2). Our study showed that, by 2012, apixaban’s superior stroke prevention efficacy and significantly lower rates of major bleeding compared to warfarin would fuel its uptake and profoundly impact the use of dabigatran and rivaroxaban. Additionally, our payer research indicated that this clinical profile would result in the most favorable tier placement on formularies of all of the new oral anticoagulants.

With the combined results from the ARISTOTLE and AVERROES trials, apixaban represents an important step-change in therapeutic options for AF patients. We believe that these powerful data will enable apixaban to surpass dabigatran and rivaroxaban to emerge as the sales-leading new oral anticoagulant for SPAF following its launch in 2012.

---

(1) Atrial Fibrillation: Opportunity Exists for New Antiarrhythmics That Reduce Mortality and Can Be Used in Patients With Heart Failure. DecisionBase, Decision Resources, 2011.

(2) Pradaxa, Xarelto, and Apixban for Atrial Fibrillation: How Have Phase III Data Informed Physicians and Payer Perceptions of These New Anticoagulants? A Survey of Non-Interventional Cardiologists and Managed Care Organization Pharmacy Directors. Physician & Payer Forum, Decision Resources, September 2011.


Posted on: 9/6/2011 3:30:35 PM | with 0 comments


Tags: Cardiovascular, Matt Killeen

Trackback URL: http://decisionresources.com/trackback/88e7938f-58ab-4ba3-bd99-7e78494151e5/Apixaban-Emerges-Victorious-from-ARISTOTLE.aspx?culture=en-us

Comments
Blog post currently doesn't have any comments.
Leave comment Subscribe



What is the abbreviation for Accountable Care Organization?

 

rss twitter linkedin

 

DRugwatch Blog

Quick insight on intriguing drug market developments from Decision Resources’ analysts.

Recent posts

Post title:
What’s going to be Hot at the 2014 AHA Scientific Sessions?
Post date:
10/22/2014 5:22:24 PM
Post Summary:
  Contributor: Conor Walsh

 This year’s line-up of Late-Breaking Clinical Trial sessions looks very interesting; with many trials having the   potential to significantly impact clinical practice. The trial results will be presented over four days in separate sessions focusing on:

  • Risk and benefit of dual antiplatelet therapy (DAPT),
  • Anti-lipid therapy and prevention of coronary artery disease,
  • Treatment of structural heart disease
  • Drugs, devices and systems of care for ischemic heart disease.

Post title:
Advancing the Treatment of TKI-refractory NSCLC
Post date:
10/9/2014 1:33:46 PM
Post Summary:
Contributor: Orestis Mavroudis-Chocholis

NSCLC is considered by many to be the poster child for personalized medicine in oncology. The approval of TKIs for the treatment of EGFR-mutation-positive and ALK-translocation-positive NSCLC patients has redefined the NSCLC treatment algorithm and developers are now in fierce competition to be the first to market novel, more efficacious and better tolerated TKIs which can be used as follow-on treatment options or replacements for currently approved front-line TKIs.

Post title:
Realizing the Potential of HPV-associated Cancer Prevention
Post date:
10/8/2014 10:15:17 AM
Post Summary:
Contributors: Kirsha Naicker and Dan Roberts

HPV vaccinations were voted by ASCO this year to be one of the top five advances in modern oncology in the past 50 years.

Post title:
Gastric Cancer: The Ghosts of Past, Present and Future
Post date:
10/7/2014 9:06:40 AM
Post Summary:
Contributor: Sehrish Rafique

Companies are now striving towards developing targeted therapies for advanced gastric cancer. Exploiting biomarkers is a dominant strategy and clinical data presented at the recent ESMO conference highlighted significant advances in the treatment of gastric cancer.

Post title:
EASD 2014: SGLT-2 inhibitors, GLP-1 agonists, insulins, long-term study results, and speculations about triple combination therapies
Post date:
10/1/2014 3:05:08 PM
Post Summary:
Contributor: Stefanie Hoffart

Between September 15 and 19, the European Association for the Study of Diabetes (EASD) meeting took place in Vienna, Austria, celebrating its 50th anniversary.

Decision Resources Group brands include: