HCFA delays OASIS collection
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HCFA delays OASIS collection
After weeks of speculation, the Health Care Financing Administration (HCFA) recently announced it was delaying the implementation of all collection and reporting requirements for its Outcome and Assessment Information Set (OASIS). Providers who had not yet met the previously established requirements to encode and transmit OASIS data will not be held out of compliance.
Study shows benefit of extended anticoagulation
A recent study published in the New England Journal of Medicine (1999; 340:901-907) indicates that patients who have a first episode of venous thromboembolism in the absence of known risk factors for thrombosis may benefit from longer anticoagulant treatment than the standard three months.
According to the study, such patients appear to have an increased risk of recurrence after anticoagulant therapy is stopped.
The double-blind study randomly assigned patients who had completed three months of anticoagulant therapy for a first episode of idiopathic venous thromboembolism to continue receiving warfarin or a placebo for another 24 months.
Study terminated for further analysis
The study, terminated due to "a prespecified interim analysis of efficacy," consisted of 162 patients followed for an average of 10 months. Of 83 patients who received the placebo, 17 had a recurrent episode of venous thromboembolism (27.4% per patient-year).
However, only one of the 79 patients who received warfarin had a recurrent episode of venous thromboembolism (1.3% per patient-year.)
Three patients in the warfarin group had nonfatal major bleeding (two gastrointestinal bleeding and one genitourinary bleeding), while none of the patients in the placebo group had nonfatal major bleeding.
In the editorial in the same issue of NEJM, Dr. Andrew Schafer of the Baylor College of Medicine, notes that a past study found that "the incidence of recurrent thromboembolism was 17.5% after two years of follow up, 24.6% after five years, and 30.3% after eight years." t
Fragmin approved for prevention of deep vein thrombosis
Bridgewater, NJ-based Pharmacia & Upjohn recently announced that the Food and Drug Administration (FDA) has approved its low molecular weight heparin, Fragmin (dalteparin sodium injection), for the prevention of deep vein thrombosis following hip replacement surgery.
Administered once daily, Fragmin was shown to significantly lower the risk of deep vein thrombosis that can lead to pulmonary embolism following patients undergoing hip replacement surgery.
Results from the study
In one prospective, randomized multicenter Phase III study that compared Fragmin with warfarin (Coumadin) in 382 patients who had elective total hip replacements, Fragmin lowered the incidence of total deep vein thrombosis to 14.6%, vs. 25.8% for patients receiving warfarin.
In a second study, Fragmin was compared to unfractionated sodium heparin (standard heparin) in 123 patients who had elective total hip replacements. The incidence of total deep vein thrombosis was lower in patients receiving Fragmin (30%), compared with those receiving heparin (42%).
Although statistically insignificant, Framan did prove superior to standard heparin in lowering the incidence of proximal deep vein thrombosis (9.5% vs. 30%). Fragmin was administered once a day; standard heparin was given three times daily.
Fragmin can be given to patients as a subcutaneous once-daily dose; standard heparin is often administered up to three times daily. Fragmin injection is available in packs of 10 single-dose prefilled syringes in two strengths, 2,500 IU and 5,000 IU, as well as a 95,000 IU multidose vial.
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