CardioExchange Archive

December 22nd, 2010

Apixaban Beats Enoxaparin for Thromboprophylaxis After Hip Replacement

Larry Husten, PHD

In the ADVANCE-3 trial 5,407 hip replacement patients were randomized to receive thromboprophylaxis with either the new oral factor Xa inhibitor apixaban or enoxaparin. The rate of DVT, nonfatal PE, or death from any cause was 1.4% in the apixaban group compared to 3.9% in the enoxaparin group (RR 0.36, CI 0.22-0.54, P<0.001), thereby demonstrating […]

---

December 17th, 2010

FDA Delays Approval of Ticagrelor

Larry Husten, PHD

Despite widespread expectations of an easy approval, the FDA has issued a complete response letter to AstraZeneca for Brilinta (ticagrelor). According to a press release from the company, the FDA has asked for additional analyses of data from the pivotal PLATO trial, but did not request any additional studies. AstraZeneca said it is evaluating the […]

---

December 6th, 2010

Ticagrelor Gets European Approval

Larry Husten, PHD

Ticagrelor has received approval for marketing in Europe, according to AstraZeneca. The drug, which will go under the brand name of Brilique in Europe, will not be available in most European countries until the second half of 2011, the company said. A decision about the approval of ticagrelor in the U.S., where it will be […]

---

December 4th, 2010

Rivaroxaban Found Safe and Effective for DVT

Larry Husten, PHD

In the EINSTEIN-DVT noninferiority study, 3449 patients with acute DVT were randomized to receive open label oral rivaroxaban or conventional therapy with enoxaparin followed by warfarin or acenocoumarol for 3, 6, or 12 months. The rate of recurrent VTE, the primary efficacy outcome, was lower with rivaroxaban treatment than with enoxaparin treatment, successfully demonstrating noninferiority for […]

---

November 18th, 2010

APPRAISE-2 Apixaban in ACS Study Discontinued Due to Increased Bleeding

Larry Husten, PHD

Bristol-Myers Squibb announced on Thursday evening the discontinuation of APPRAISE-2, the phase 3 trial comparing apixaban to placebo in patients with acute coronary syndrome. The decision was based on a recommendation from the data monitoring committee based on “a clinically important increase in bleeding among patients randomized to apixaban,” according to the company press release. Robert […]

---

November 3rd, 2010

Do Your Patients Wait to Fill Their Plavix and Effient Prescriptions After Drug-Eluting Stent Implantation?

Chris Smith, RN

I recently read an article in the journal Circulation that contained an alarming finding about patients who receive drug-eluting stents. Apparently, 1 in 6 did not fill their clopidogrel prescriptions immediately after discharge from a hospital in one of three large integrated health care systems. The median delay was 3 days. Furthermore, during a median follow-up […]

---

November 2nd, 2010

Is Dabigatran More Cost-Effective Than Warfarin in AF?

Amy Herman

Dabigatran, newly approved by the FDA to prevent stroke in patients with atrial fibrillation (AF), might turn out to be a cost-effective alternative to warfarin, according to an Annals of Internal Medicine study. Using data from the RE-LY trial, James Freeman and colleagues modeled the quality-adjusted survival and cost-effectiveness of dabigatran compared with high- or low-dose warfarin […]

---

November 1st, 2010

ROCKET AF: Is Rivaroxaban Ready for Blast Off?

Harlan M. Krumholz, MD, SM

With the approval of dabigatran and now the preliminary and partial results of ROCKET AF, we’ll  need to be familiar with much more than just warfarin to address the anticoagulation needs of our patients. The early word on ROCKET AF, which will be presented at AHA, is that rivaroxaban is at least as effective as warfarin […]

---

November 1st, 2010

Rivaroxaban Equals Warfarin in ROCKET AF

Larry Husten, PHD

Rivaroxaban (Xarelto) was as effective as warfarin in patients with AF in the ROCKET AF study, according to an announcement released by Bayer on Sunday ahead of the  trial’s scheduled presentation at the AHA on November 15. ROCKET AF randomized more than 14,000 patients with nonvalvular AF to either rivaroxaban or warfarin. The goal of the […]

---

October 26th, 2010

Dabigatran to Cost $237 per Month at the Drugstore

Larry Husten, PHD

It looks like Pradaxa (dabigatran) will cost about $237 a month at the drugstore counter. A Boehringer Ingelheim representative says the wholesale acquisition cost (WAC) of the drug is set at $6.75 per day for 2 pills. The price will apply to both the 150-mg and the 75-mg capsules.  According to knowledgeable experts, the retail […]

---