Bayer and J&J wrap positive PhIII cardio study for Xarelto


February 8, 2017

Bayer and its part­ners at J&J, back in the fall of 2012, started a mas­sive study to see if the drug Xarelto (ri­varox­a­ban) could help pre­vent major car­dio­vas­cu­lar events like my­ocar­dial in­farc­tion, stroke, and death in high risk pa­tients with coro­nary artery dis­ease or pe­riph­eral artery dis­ease.

Very recently, a lit­tle more than 4 years and 27,000-plus pa­tients later, in­ves­ti­ga­tors say that they hit the pri­mary end­point well ahead of sched­ule. Now they’re end­ing the trial early and launch­ing an ex­ten­sion study where they will con­tinue to dose pa­tients.

Pa­tients randomly re­ceived ei­ther ri­varox­a­ban 2.5 mg twice daily with as­pirin 100 mg once daily, ri­varox­a­ban 5 mg twice daily alone, or as­pirin 100 mg once daily alone.

There’s no data yet, but the com­pany says that the huge study de­liv­ered “over­whelm­ing” ev­i­dence of the ef­fi­cacy of the drug.

“De­spite es­tab­lished and ef­fec­tive treat­ments, an unmet med­ical need in this pa­tient pop­u­la­tion still ex­ists with rates of CAD and PAD ris­ing glob­ally. Bayer is com­mit­ted to an on­go­ing clin­i­cal de­vel­op­ment pro­gramme that ad­dresses such unmet med­ical needs. We are ex­cited about these re­sults and look for­ward to mak­ing ri­varox­a­ban avail­able to pa­tients with CAD and PAD to re­duce their risk of major ad­verse car­diac events,” said Dr. Joerg Moeller, a mem­ber of the ex­ec­u­tive com­mit­tee of Bayer AG’s Phar­ma­ceu­ti­cal Di­vi­sion and Head of De­vel­op­ment.


Bayer and J&J wrap positive PhIII cardio study for Xarelto last edit: 2017-02-13T16:36:25+00:00 da Luca
  • Janine Müller
    Posted 18 February 2017 11:59 0Likes

    And what a success: The COMPASS-study has already been prematurely terminated as the criteria for clinical superiority are met. The participants of the study maintain receiving Rivaroxaban in an open-label extension study now.

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