Johnson and Johnson (JNJ)

[north40000]

JNJ/Bayer:

http://cardiobrief.org/2017/02/08/enormous-rivaroxaban-study-stopped-early-for-overwhelming-efficacy/

http://www.news.bayer.com/baynews/baynews.nsf/id/BAF21410A6C41901C12580C10052A834/$File/2017-0041E.pdf?open&mod=08.02.2017_16:43:04

"Oral anticoagulant reduced CV events in patients with coronary and peripheral disease.

The very large COMPASS study has been stopped early for “overwhelming efficacy,” according to a press release issued by Bayer AG and Janssen, manufacturers of rivaroxaban (Xarelto).

The phase 3 trial randomized 27,402 patients with coronary artery disease (CAD) and peripheral artery disease (PAD) to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone. The trial was stopped a year ahead of its scheduled completion date following a recommendation by the Data Monitoring Committee. The primary endpoint of the study was the first occurrence of either MI, stroke, or CV death. The DMC said the trial had reached its prespecified criteria for superiority.

In an open-label extension trial patients enrolled in the study will be offered rivaroxaban “owing to the magnitude of effect and the confirmation of the existing safety profile of rivaroxaban,” the companies announced.

COMPASS is the first new oral anticoagulant to be studied in this patient population, the announcement said. Full results of the study will be presented later this year at a major medical meeting.

“Although there are therapies that offer significant protection for patients with coronary or peripheral artery disease, a significant risk of heart attacks, stroke or even death remains in these high-risk patients,” said Salim Yusuf (McMaster University), Principal Investigator of the COMPASS study, in a press release issued when the trial was initiated. “This is therefore an important study, designed to investigate additional, potentially complementary, cardioprotective benefits for these patients.”

Sanjay Kaul (Cedars Sinai) said that he is “not a big fan of stopping trials for efficacy unless there is a clear cut mortality benefit despite prespecified stopping rules.” However, he pointed out that it is “not unreasonable” to stop this trial early since “there is already large safety data for rivaroxaban.”

COMPASS is the second successful 27,000 patient cardiovascular study to be announced in less than a week. On February 2 Amgen reported that the FOURIER trial with the PCSK9 inhibitor evolocumab (Repatha) had successfully met its primary endpoint."