With three new anticoagulants now demonstrating superiority to warfarin in clinical trials of AF patients, a leading cardiologist has raised concern they may be withheld from Australian patients who could benefit.
Professor Graeme Hankey, head of the stroke care unit at the Royal Perth Hospital, presented results from trials with rivaroxaban (Xarelto), dabigatran (Pradaxa) and apixaban (Eliquis) at CSANZ 2011.
Weighing into the debate over the Federal Government’s delays in PBS listing dabigatran, he estimated there were around 120,000 high risk patients with AF in Australia who were not optimally controlled on warfarin.
These patients had a stroke rate of about 5% a year, he said, equivalent to “several hundred strokes a year”.
“The longer the government delays [in PBS listings]... the more dead and disabled stroke patients we’ve got to care for,” he told Cardiology Update.
“Dabigatran might seem a costly drug, but it’s more costly to look after the patients having strokes it could prevent.”
Professor Hankey presented new findings from the ROCKET-AF trial in 14,264 patients with AF, which found 20mg rivaroxaban daily was superior to warfarin, reducing annual rates of stroke from 2.2% to 1.7%, with comparable rates of major bleeding. http://www.nejm.org/doi/full/10.1056/NEJMoa1009638
However, in an intention-to-treat analysis the difference was not statistically significant, he noted.
Meanwhile, preliminary results from the two-year ARISTOTLE trial suggested oral apixaban was non-inferior to warfarin and also met key secondary endpoints for superiority, he said.
He also cited evidence from the well-known RE-LY trial showing the superiority of the TGA-approved drug dabigatran over warfarin.
With these results now available, Professor Hankey said attention needed to turn to the different adverse effects and costs of the drugs.
He noted rivaroxaban was once-daily while dabigatran was twice-daily, which may have relevance for patient compliance.
Renal effects were also likely to differ between the drugs, he said, as 80% of dabigatran was excreted in the kidney, compared with only a third of rivaroxaban.
Dr Hankey has received consulting fees from Sanofi Aventis, Schering Plough, and Boehringer Ingelheim and lecture fees from Sanofi Aventis and Pfizer.