EMA says no new patients should be started on Esyma for uterine fibroids

EMA says no new patients should be started on Esyma for uterine fibroids

February 13 2018 Doctors should not initiate Esyma (ulipristal acetate) in women with uterine...

New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

February 13 2018 The European Medicines Agency has issued new recommendations regarding use of...

EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

February 12 2018 The European Medicines Agency has updated advice regarding the use of retinoids...

New Drug Safety Update issued on need for contraception with mycophenolate mofetil

New Drug Safety Update issued on need for contraception with mycophenolate mofetil

February 9 2018 The medicines regulator has issued a Drug Safety Update relating to mycophenolate...

Study flags up concerns over antibiotic resistance in children's E coli in urinary infections

Study flags up concerns over antibiotic resistance in children's E coli in urinary infections

February 8 2018 Antibiotic resistance in children’s E. coli is high against many...

  • EMA says no new patients should be started on Esyma for uterine fibroids

    EMA says no new patients should be started on Esyma for uterine fibroids

    Tuesday, 13 February 2018 12:18
  • New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

    New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

    Tuesday, 13 February 2018 12:11
  • EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

    EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

    Monday, 12 February 2018 14:21
  • New Drug Safety Update issued on need for contraception with mycophenolate mofetil

    New Drug Safety Update issued on need for contraception with mycophenolate mofetil

    Friday, 09 February 2018 15:01
  • Study flags up concerns over antibiotic resistance in children's E coli in urinary infections

    Study flags up concerns over antibiotic resistance in children's E coli in urinary infections

    Thursday, 08 February 2018 10:39

Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
More inWhite Papers  

heart failureJune 22 2016

Two BMJ studies have further supported the use of alternatives to warfarin for anticoagulation needs in atrial fibrillation.

Overall, novel oral anticoagulants (NOACs) are not significantly different to warfarin in terms of risk of ischaemic stroke, but rivaroxaban was associated with a lower risk of ischaemic stroke or systemic embolism compared to warfarin, although with comparable major bleeding rates.

Meanwhile, “dabigatran and apixaban had non-significant hazard ratios compared with warfarin for ischaemic stroke or systemic embolism, whereas major bleeding rates were significantly lower with reference to warfarin.”

A study on the effects of polypharmacy in atrial fibrillation found that “apixaban was more effective than warfarin regardless of the number of concomitant drugs used.” Apibaxan also had lower bleeding rates compared to warfarin, although the researchers concluded that the size of benefit appeared to decrease as the number of concomitant medicines the patient was taking increased.

The studies, one based at Aalborg University, Denmark, and the other based at a number of centres around the world, had been assessing risks associated with NOACs.

The Danish study looked at the effectiveness and safety of the NOAC non-vitamin K antagonist oral anticoagulants dabigatran, rivaroxaban, and apixaban in comparison with warfarin in patients with atrial fibrillation who had not been given an anticoagulant previously. Outcomes were measured by ischaemic stroke, systemic embolism as well as bleeding.

Data from over 61,000 patients with non-valvular atrial fibrillation was analysed. NOACs were not significantly different to warfarin when the analysis was restricted to ischaemic stroke. However, “during one year follow-up, rivaroxaban was associated with lower annual rates of ischaemic stroke or systemic embolism (3.0% v 3.3%, respectively) compared with warfarin: hazard ratio 0.83 (95% confidence interval 0.69 to 0.99).”

The annual hazard ratios for dabigatran was 2.8% and for apixaban was 4.9%, although this was non-significant compared to warfarin. “The annual risk of death was significantly lower with apixaban (5.2%) and dabigatran (2.7%) (0.65, 0.56 to 0.75 and 0.63, 0.48 to 0.82, respectively) compared with warfarin (8.5%), but not with rivaroxaban (7.7%).”

The researchers concluded: “All NOACs seem to be safe and effective alternatives to warfarin in a routine care setting.” While there were no significant differences between NOACs and warfarin for ischaemic stroke, “the risks of death, any bleeding, or major bleeding were significantly lower for apixaban and dabigatran compared with warfarin.”

The second study looking at polypharmacy was part of the ARISTOTLE (apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation) trial. The multicentre study ran for five years from 2006 to 2011 and included 18,201 patients who either received apixaban 5mg twice daily or took warfarin with a target INR of 2.0 to 3.0.

Patients were also assessed for other treatment being used, and the median of taking six medicines was seen in almost 14,000 patients. Co-morbidities increased with increasing number of medicines taken, “as did the proportions of patients treated with drugs that interact with warfarin or apixaban.

“Mortality also rose significantly with the number of drug treatments (P<0.001), as did rates of stroke or systemic embolism (1.29, 1.48, and 1.57 per 100 patient years, for 0-5, 6-8, and ≥9 drugs, respectively) and major bleeding (1.91, 2.46, and 3.88 per 100 patient years, respectively).”

The researchers found a consistent relative risk reduction in stroke or systemic embolism for apibaxan compared to warfarin, regardless of the number of drugs being taken. There was also a small but significant reduction in major bleeding.

“In terms of a potential differential response to anticoagulation therapy in patients with atrial fibrillation and polypharmacy, apixaban was more effective than warfarin, and is at least just as safe,” concluded the researchers.

Links:

JJ Focks et al. ‘Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial’. BMJ 2016;353:i2868

TB Larsen et al. ‘Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study’. BMJ 2016;353:i3189.

Clinical News

  February 20 2018 A covert study of pharmacies has claimed that some pharmacies are failing to give adequate safety warnings when selling analgesics and cold remedies. The Consumer Association’s...
February 19 2018 Pharmacists should be receiving educational material this week on a new patient safety campaign from the Centre of Pharmacy Postgraduate Education. Resources have been mailed out ahead...