Heart Drug Trial 'Glowing Success'
Pinehurst has the potential to become one of the leading treatment centers for atrial fibrillation after local health-care providers released promising results in a drug trial earlier this month.
Pinehurst Medical Clinic and FirstHealth Moore Regional Hospital were among several facilities across the United States to participate in a drug trial sponsored by Boehringer Ingelheim for dabigatran, a new drug that could make medication for atrial fibrillation safer and easier to take.
Pinehurst has received a lot of attention related to advancements in treatment for atrial fibrillation since Drs. Andy Kiser and Mark Landers performed their ground-breaking Convergent Procedure on televangelist Pat Robertson at FirstHeatlh Moore Regional Hospital in August.
Though the Convergent Procedure's results have seemed to produce a significant improvement in quality of life, patients resume a regular blood-thinner regimen after surgery.
Currently, the standard drug prescribed is Coumadin, a blood thinner administered in varying doses based on a patient's blood levels. Doctors require patients on Coumadin to have their blood checked frequently so the proper dosage can be prescribed.
The randomized evaluation of long-term anticoagulant therapy trial compared the efficacy and safety of doses of dabigatran etexilate, the trial blood thinner, to Coumadin for the prevention of stroke and blood clots for patients with atrial fibrillation.
According to Dr. Pat Simpson, a cardiologist at the Pinehurst Medical Clinic, the trial's study has found that 25 percent of patients within the participant pool were out of range for their Coumadin dosage at a given time because of the required variance in dosage.
"Dabigatran appears to be just as good a blood thinner and safer," Simpson said.
Simpson described the trial's results as a "glowing success."
"This will become the anti-coagulant strategy," he said. "It's a much-needed alternative to Coumadin."
Simpson oversaw the trial for three years at the medical clinic. The trial involved two years of treatment and a minimum of one year for follow-ups to check on the drug's results.
"It provides the opportunity to have a lot of investigation on drugs," Simpson said.
The trial ended last fall. After a year of "data crunching", Simpson and his staff have turned their results over to the trial's sponsor for presentation to the Food and Drug Administration in 2010.
The drug is now marketed under the name "Paraxda" or "Paradax" outside the United States.
Simpson highlighted the significant increase in the convenience of taking blood-thinning medication.
"It's quite a big benefit," Simpson said.
Doctors recommend a stable in-take of vitamin K to patients taking Coumadin. Significant changes in the levels can dramatically alter the effects of the medication.
Simpson addressed this concern, but also mentioned that a patient's diet can affect the strengths of many medications.
Besides having to monitor their in-take of vitamin K, patients on Coumadin must have their blood checked regularly in order to determine proper dosage. Adjustment of dosage is based on the patient's diet and current medicine levels.
Frequent trips to the doctor and constantly changing prescriptions can potentially make the medication more of a burden than an improvement in well-being.
Dabigatran offers patients a set dosage without the need of having their blood checked as frequently.
"It's a set-dose regimen. No more checking of the blood."
Simpson said dabigatran offers doctors the assurance that patients are receiving the right amount of medication for their conditions.
"As a physician, you don't have to worry that patients are going to be out of range 25 percent of the time," Simpson said.
After seeing such "glowing" results, Simpson hopes Pinehurst will continue to seek advancements in the treatment for atrial fibrillation, which affects an estimated 2.2 million Americans.
Simpson said he is glad to see that doctors in the area are willing to do research and participate in trials.
"We are encouraged by both Dr. Kiser's results and the pharmacological results of the trial," he said. "The therapy will continue to improve and be safer."
As local physicians continue to make advancements in research, Pinehurst is emerging as a center for treatment of atrial fibrillation.
Hannah Sharpe can be reached at (910) 693-2485.
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