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Medicines Update

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Medicines Update

Drug may have statin-like benefits

Australian endocrinologists have welcomed the results of a new study that shows empagliflozin could slash mortality rates and cardiovascular problems in patients with type 2 diabetes who are at high CV risk.

The EMPA-REG OUTCOME trial of over 7000 patients shows patients taking empagliflozin with standard treatment report a 38% relative risk reduction of death from cardiovascular causes compared with patients on placebo.

Empagliflozin, marketed as Jardiance by Boehringer Ingelheim, was also linked to a 35% relative risk reduction in hospitalisation for heart failure and a 32% reduction from all-cause mortality, according to results published in the New England Journal of Medicine.

Associate Professor Michael d’Emden, director of endocrinology at Queensland Health and a senior investigator in the study, says “we are seeing an almost statin-like improvement in cardiovascular outcomes.”

Dr d’Emden says empagliflozin could even become the alternative drug of first choice alongside metformin, given the study’s results were more “robust and sound” than studies into the CV benefits of metformin.

At the very least it should overtake DPP-4 inhibitors or sulfonylureas as preferred second-line treatment, says Dr d’Emden, who has previously received honoraria from Boehringer Ingelheim.

Arthritis treatment on PBS

Xeljanz (tofacitinib citrate), a new oral treatment for patients with moderate to severe rheumatoid arthritis, will be available on the PBS from 1 October.

It is approved for treating adults with moderate to severe active rheumatoid arthritis, who have had an inadequate response to conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate.

Xeljanz belongs to a new class of medicines known as Janus kinase (JAK) inhibitors. JAK inhibitors work inside cells by blocking the signalling of proteins called cytokines, which modulate aspects of the immune response leading to inflammation.

At a recommended dosage of 5mg twice daily, Xeljanz can be used alone or in combination with non-biological DMARDs, including methotrexate.

Real world success

Results of the XANTUS trial shows that rivaroxaban is performing ‘in the real world’ much as it did in the pivotal ROCKET AF trial, says a vascular physician.

The observational trial results, for 6784 patients with non-valvular atrial fibrillation taking rivaroxaban taking the drug for a mean of 329 days, show that treatment-emergent major bleeding occurred in 128 patients (2.1 events per 100 patient years).

This was lower than the 3.6 events per 100 patient years recorded in the ROCKET AF trial.

“This gives us confidence that the results of ROCKET AF seem applicable in the real world,” says Associate Professor Harry Gibbs, of the Alfred Hospital in Melbourne.

Pradaxa antidote on the way

The European Medicines Agency has recommended granting a marketing authorisation, following accelerated assessment, for Praxbind (idarucizumab) as a specific antidote to the anticoagulant medicine Pradaxa (dabigatran etexilate), when rapid reversal of its effect is required.

Praxbind is to be used when a patient taking Pradaxa needs to undergo an emergency surgery or when life-threatening or uncontrolled bleeding occurs. It is the first medicine designed to specifically neutralise the anticoagulant effect of Pradaxa.

Unlike older oral anticoagulants such as warfarin, up until now there has been no specific means of rapidly neutralising Pradaxa’s effect. Praxbind could help patients in some emergency cases where a quick reversal of the anticoagulant effect of Pradaxa is needed.

In clinical studies carried out in 283 healthy volunteers and 123 patients who had uncontrolled bleeding or required emergency surgery or procedures, Praxbind enabled complete reversal of Pradaxa's anticoagulant effect within 5 minutes of administration with a long-lasting action allowing emergency management of patients as needed, and an overall good safety profile.



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