Non-Clinical Topics   /   Pharmacy

Newly-Approved Anticoagulants Offer More Options, Different Risks

By US Medicine

Annette M. Boyle

Dr. Alan Jacobson, MD, Director of the anti-coagulation services at the Loma Linda, CA, Veterans Administration Medical Center

BOSTON – While newer anticoagulants provide options for many patients with atrial fibrillation (AF) who are at risk for stroke and not currently on blood thinners, real-world challenges accompany their strong clinical results.

“About half of patients with atrial fibrillation who should be on anticoagulants to prevent strokes are not. There’s a great opportunity now to treat those who are ineligible to take warfarin, or prefer not to be on it, with the new drugs,” Kenneth Bauer, MD, head of hematology at the Boston VAMC, told US Medicine.

The rate of stroke among adults with AF ranges from 1% to 20%, depending on patient-specific variables, according to the American Heart Association and American Stroke Association (AHA/ASA). Warfarin poses a bleeding risk of 1% to 12%, so it typically is reserved for patients at greatest thromboembolic risk.

The novel oral anticoagulants (NOACs) — dabigatran, rivaroxaban and apixaban — performed as well or better than warfarin in clinical trials.

“Overall, the new anticoagulants are clearly superior to warfarin. They are more efficacious and have fewer safety concerns, particularly in terms of intracranial hemorrhage,” said Bauer. Consequently, they may offer a reasonable treatment option for a broader band of AF patients.

The intensive management needed for warfarin also contributes to a high drop-off rate among those who do start anticoagulation treatment.

“Patients with atrial fibrillation have an increased risk of stroke for 10 to 20 years but typically stay on blood thinners for just two or three years,” noted Alan Jacobson, MD, director of the anti-coagulation services at the Loma Linda, CA, Veterans Administration Medical Center. “Our ability to control their risk goes out the window if they won’t stay on the medication.”

The newer drugs generally require less monitoring and have predictable effects with fixed dosages, unlike warfarin, making them more appealing to many patients.

Treatment Issues

The newer drugs have their own issues, ranging from the need for clear expectations to irreversible bleeding in an emergency.

“In the clinical trial setting, you have selected, well- supervised patients, all seen once a month. If I have a 30 second conversation with you and see you in six months, you won’t see the same safety or effectiveness seen in the trials,” Jacobson cautioned.

Within the VHA system, however, the outcomes on NOACs may be better than average. “If you go on one of the new drugs, you will be followed with warfarin patients and seen once every three months. Patients will be monitored for kidney function. They’ll be seen in a visit that focuses on blood thinners, with a clinician looking for signs of bleeding and monitoring for drug-drug interactions,” Bauer pointed out.

Unlike warfarin, which is metabolized in the liver, the NOACs are cleared by the kidneys. Consequently, patients with impaired renal function might not be good candidates for the newer drugs, particularly dabigatran, Bauer noted.

Because the kidneys excrete as much as 80% of dabigatran, impaired functioning increases the risk of serious hemorrhage. The Food and Drug Administration (FDA) advises physicians to assess renal function prior to prescribing the drug and periodically thereafter.

Drug interactions also can pose problems.

“Dabigatran has one pathway and three drugs to monitor for interaction. For the others, there are eight major drugs and multiple pathways to monitor,” Bauer observed. “There are a lot of moving parts in the equation when deciding which anticoagulant to recommend.”

Patient education with the new drugs is also very important.

“While the risk of bleeding is the same or less than warfarin, you have to keep in mind that warfarin is the No. 1 drug that causes older patients to go to the ER,” Jacobson said. “The new drugs reduce the risk by about 30%, but it would take a 60% drop for anticoagulants to drop below the No. 2 cause — insulin. We have to educate patients that, if they fall and hit their heads, they risk a hemorrhage and need to go to the ER.”

Warfarin causes 33% of emergency hospitalizations as a result of drug reactions among the general population over the age of 65.1


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