How would you like a new anti-coagulant that does not increase the risk of excessive bleeding? Well, if Pfizer and Bristol-Myers Squibb have it right, you will soon say goodbye to Warfarin and Coumadin for a more effective anti-coagulant that does not increase bleeding. Sound too good to be true? Read on.
Two of the largest pharmaceutical companies in the world, Bristol-Myers Squibb Company and Pfizer, Inc., have collaborated on a new drug, ELIQUIS. The drug has now been approved by the FDA and the US will join the European Union, Canada and Japan in offering this drug for patients suffering non-valvular atrial fibrillation (NVAF). Unlike Coumadin and Warfarin, ELIQUIS does not cause increased bleeding, but has proven to be an excellent anticoagulant.
ELIQUIS (apixaban) has proven successful in the prevention of ischemic stroke and systemic embolism in patients suffering NVAF. The new drug has been in use in Europe for several months and has proven more effective than other anticoagulants while not causing excessive bleeding.
ELIQUIS has shown to reduce the risk of stroke, major bleeding and all-cause death. The drug has proven to be more effective than Warfarin or Coumadin in prevention of systemic embolism and clotting, a risk for wait-list and post heart transplant patients as well as persons with NVAF. 18,201 NVAF patients participated in studies testing ELIQUIS prior to the FDA’s approval.
Atrial Fibrillation is the most common type cardiac arrhythmia. After persons reach 40 years of age, they have a 25 percent possibility of suffering Atrial Fibrillation, or irregular heartbeat. Persons suffering this condition have an increased amount of risk for stroke. Atrial Fibrillation strokes are the most serious type of stroke. 24 percent of patients dies within 30 days. The likelihood of death within 12 months is 50 percent.
Bristol-Myers Squibb and Pfizer began their innovative collaboration in 2007. The goal was to discover an oral anticoagulant. Both manufacturers have a great deal invested in this collaboration.
The FDA requires a 4-phase process.
Phase 1 – The drug is tested on a small number of healthy patients to make sure it is safe and tolerable dosages as well as identify side effects.
Phase 2 – In order to determine the drug’s effectiveness, the drug is administered to a large number of patients with a specific disease.
Phase 3 – The drug is tested upon thousands of patients with the specific disease to monitor effective dosage and observe side effects as well as effectiveness.
Phase 4 – This phase occurs after the drug is approved for use by the FDA and is prescribed. Patients using the drug are observed and evaluated.
According to Pfizer, ELIQUIS (apixaban) is “an oral Factor Xa inhibitor drug that is very effective at reducing the risk of recurrent venous thromboembolism (VT).” VT is the third most common cardiovascular illness. Symptoms of VT include deep vein thromobosis or blood clots in the legs and pulmonary embolism, clotting in the lungs. The drug can be helpful for individuals who have had knee or hip replacements.
In the Phase 3 testing, there were 2,486 participants. 829 of these men and women comprised the placebo group. 84 participants were issued 2.5 mg of apixaban group and 815 participants took 5 mg. per day. All patients had undergone between 6 and 12 months of other anticoagulants prior to their participation in the test.
The placebo group had a recurrence rate or fatality rate of 11.6 percent. The 2.5 mg. group had a 3.8 percent recurrence or mortality rate while the 5.0 mg. group had a 4.2 percent rate. Patients and physicians agreed there was a noticeably less tendency to bleed, a curse for Coumadin and Warfarin patients. Over an extended period of usage, researchers have concluded that ELIQUIS reduced the risk of arterial thrombic events b 80 percent in males.
Most heart transplant patients have difficulty with Warfarin and Coumadin and the possibility of significant blood loss. Until now, they have been the best treatment for clotting. ELIQUIS may well become the drug of choice for cardiologists, pulmonologists and surgeon concerned about clotting.