Pharmaceutical

VA hospital patients sought for intervention involving blood thinner Pradaxa

pradaxa VA hospital patients sought for intervention involving blood thinner PradaxaVA Hospital patients in the Denver, Colorado, area with a common heart condition who are taking the blood thinner Pradaxa (dabigatran) are eligible to participate in an intervention designed to determine why patients take and don’t take their medications.

Atrial fibrillation is a common heart rhythm abnormality. It can cause blood clots, which can lead to stroke. Therefore, patients are treated with the blood thinner warfarin, which requires frequent lab monitoring and dose adjustment. The majority of veterans on warfarin are managed in anti-coagulation clinics staffed by pharmacists who routinely contact patients to remind them to get blood draws, to reinforce taking their medication, and to adjust warfarin dose based on lab test values.

Not having adequate anti-coagulation increases the risk of clotting and is most commonly due to not taking medications as prescribed.

The Department of Veterans Affairs, which is sponsoring the study, anticipates that many patients will be switched from warfarin to Pradaxa following recent publication of criteria of Pradaxa use from the VA National Pharmacy Benefits Management Program. Pradaxa was approved in 2010 as the first alternative to warfarin and may lower the risk of stroke and blood clots in patients with atrial fibrillation. Pradaxa also has fewer interactions than warfarin and does not require patients to be monitored.

Both Pradaxa and warfarin can cause internal bleeding, which can be dangerous and life threatening. Unlike warfarin, there is no antidote to reverse the anti-clotting agent in Pradaxa.

Following the doctor’s instructions for taking Pradaxa is important because it is a twice-a-day medication and requires monthly refills, both of which are strong factors for not following the prescribed instructions. In addition, patients who use Pradaxa are not followed in anti-coagulation clinics because there is no lab value to monitor. Therefore, patients do not benefit from the support provided by these clinics.

For the study, researchers will first perform interviews with patients and pharmacists to better understand reasons why people take or do not take their medicine. Informed by the interviews and the literature on interventions to improve people taking their medicine, researchers will develop and test and intervention to improve taking Pradaxa among patients recently started on the drug.

The primary goals of the study are to interview patients to determine why they do or do not take their medications; interview pharmacists in anti-coagulation clinics to understand their opinions why patients do or do not take their medications; and from those interviews, develop and test an intervention targeting patients and pharmacists to improve patients taking Pradaxa.

Participants are still being gathered for the study, which runs through January 2013.

Source: ClinicalTrials.gov