News Briefs

Telephone management of anticoagulation treatment works

Researchers have found that patients being treated with warfarin can be managed by telephone rather than in an anticoagulation clinic with outcomes as good or even better. The study was conducted by Edith Nutescu, MD, at the University of Chicago.

Nutescu says that in the last 10 years, there has been a change in the care of patients receiving anticoagulation drugs. The change took them from traditional physician-based settings to anticoagulation clinics staffed by pharmacists or nurses. Outcomes were found to be better in the clinics, possibly because of more consistent monitoring, early recognition of risk factors, and improved patient education.

Now, some patients are being managed by telephone consultations after other studies have shown that telephone management reduces waiting periods, travel time, and travel costs, and leads to higher patient satisfaction.

In an article in the November 2006 issue of Chest, Nutescu says there had been no studies directly comparing outcomes of telephone management versus clinics. Her research was conducted at two university-affiliated anticoagulant clinics. The trial included 117 patients monitored by office visits and 117 by telephone. Telephone management was chosen for patients who could not be seen in the clinics because of their personal situations. For those patients, blood was drawn and INR (international normalized ratio) measured by local laboratories and results were sent to the clinics.

During 283.4 patient-years of treatment, none of the evaluated measures differed significantly between the groups, including number of INRs in the goal range, frequency of anticoagulation clinic encounters, rates of major hemorrhage, recurrent thromboembolism, and number requiring hospital treatment. "This study suggests the effectiveness of telephone-based anticoagulation management by an anticoagulation clinic for patients who are unable to come to the clinic due to distance, transportation, or disability issues," the researchers said.

The one potential problem they found was that telephone-based care may not be reimbursed by third-party payors, making it unfeasible for providers.

FDA wants to change rules to expand experimental drug availability

FDA has proposed significant regulatory changes to make experimental drugs more widely and easily available for seriously ill patients with no other treatment options and to clarify the circumstances and costs for which manufacturers can charge for experimental drugs.

Under the proposed rule, expanded access for experimental drugs would be available to individual patients, small patient groups, and larger populations under a treatment plan where there is no satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.

Agency officials also said the regulations covering when it is appropriate to charge for an experimental drug need to be revised because they don't account for the full range of circumstances in which charging should be permissible and because they have proven difficult to interpret in practice, resulting in confusion over what costs can be recovered.

Aprotinin injection labeling revised

FDA approved revised labeling for Bayer's aprotinin injection (Trasylol) to strengthen its safety warnings and limit its approved usage to specific situations. Aprotinin injection is given to patients before heart surgery to reduce bleeding and the need for blood transfusions. The new labeling specifies the drug should only be given to patients who are at an increased risk for blood loss and blood transfusion in the setting of coronary bypass graft surgery when patients undergo cardiopulmonary bypass. There also is a labeling warning that aprotinin injection increases the risk for possible kidney damage and suggests ways to manage and reduce patients' hypersensitivity risk.

FDA warns of safety concern with rituximab

FDA has alerted health care professionals and patients being treated with Genentech's rituximab (Rituxan) of reports of an emerging risk of a serious side effect. The agency said it had learned of two patients treated with rituximab for systemic lupus erythematosus who developed progressive multifocal leukoencephalopathy, a fatal viral infection of the central nervous system. The side effect was reported in patients as late as 12 months after their last dose of the drug.

The agency said rituximab is approved only for treating patients with non-Hodgkin's lymphoma and patients with rheumatoid arthritis whose disease no longer responds to other common treatments. It is not indicated for treating systemic lupus erythematosus.

FDA approves novel device for brain damage in infants

FDA has approved a first-of-a-kind medical device for treating babies born with moderate-to-severe hypoxic-ischemic encephalopathy, a potentially fatal injury to the brain caused by low levels of oxygen. Olympic Medical Corp.'s Olympic Cool-Cap system is designed to prevent or reduce damage to the brain of those patients by keeping the head cool while the body is maintained at a slightly below-normal temperature. The device acts by maintaining a steady flow of water at a selected cool temperature through a cap covering the infant's head. The system consists of a cooling unit, a control unit, temperature probes, and a water-filled cap.

It was found safe and effective in a study of 234 infants with moderate to severe hypoxic-ischemic encephalopathy. At 18 months of age, there were fewer deaths and fewer severe cases of neurodevelopmental disability in the cooled group compared with the control group.

Pfizer ends phase 3 torcetrapib/atorvastatin trial

Pfizer suspended a large Phase 3 trial evaluating the investigational cardiovascular therapy torcetrapib/atorvastatin due to an increased rate of mortality in patients receiving the combination drug when compared with those receiving atorvastatin (Lipitor) alone. The company said it made the decision to stop the trial and the drug's development program after learning of the mortality risk from the drug's data safety monitoring board.

FDA said it supported Pfizer's decision and that the system of biomedical research monitoring was effective in this case, assuring that once a signal was seen, the trial was halted.