The direct thrombin inhibitor bivalirudin — when given to patients with ST-segment elevation myocardial infarction (STEMI) during transport for percutaneous coronary intervention (PCI) — is associated with lower rates of major bleeding after PCI. However, risks for early stent thrombosis are increased sixfold, according to a New England Journal of Medicine study. The drug’s maker participated in the study.
Some 2200 patients with STEMI being transported to facilities for PCI were randomized en route to begin antithrombotic treatment with either bivalirudin or with heparin and optional glycoprotein inhibitors. By 30 days, the composite outcome of death or major bleeding was lower with bivalirudin (5.1% vs. 8.5%). However, the risk for stent thrombosis within 24 hours was higher with bivalirudin (1.1% vs. 0.2%).
An editorialist observes that the “clearest findings” after two bivalirudin trials are that the drug increases stent thrombosis while reducing bleeding complications. He writes that it’s “critical that clinicians weigh the relative importance of these events before selecting an antithrombotic strategy for their patients.”
Two studies, one of leukemia and the other of endometrial tumors, show the usefulness of genomics studies in finding unsuspected classifications, possibly useful for treating these cancers.
One study, published in the New England Journal of Medicine, examined 200 cases of acute myeloid leukemia. Genomic studies allowed the researchers to discern nine distinct categories, revealing “many potentially important biologic relationships.” For instance, certain mutations were associated with distinct patterns of RNA activity. The authors point out that the significance of such findings “is not yet clear.”
Another study, in Nature, of some 375 endometrial cancers found four distinct classes of the disease, as opposed to the two commonly used to stage treatment. In Journal Watch Oncology and Hematology, Virginia Kaklamani observes that breast cancer was the first to use molecular subtypes to guide treatment. The Nature study, she writes, is “a huge step toward applying this technique in other malignancies.”
Moderate-to-severe hypoglycemia is tied to an increased risk for death among patients in the ICU, according to a study in the New England Journal of Medicine.
As part of the NICE-SUGAR trial, roughly 6000 ICU patients were randomized to intensive or conventional glucose control. Nearly half of all patients experienced moderate hypoglycemia (41–70 mg/dL), and 4% had severe hypoglycemia (40 mg/dL or less); the majority of these patients were in the intensive control group. The primary outcome — death within 90 days — was more frequent among those with severe hypoglycemia (35%) or moderate hypoglycemia (29%) than among those with no hypoglycemia (24%).
The authors conclude that “it would seem prudent to ensure that strategies for managing the blood glucose concentration in critically ill patients focus not only on the control of hyperglycemia but also on avoidance of both moderate and severe hypoglycemia.”
Oral immunotherapy with egg-white powder can lead to sustained unresponsiveness to the allergen in nearly a third of children with egg allergy, according to a New England Journal of Medicine study.
Researchers randomized 55 children (aged 5 to 11 years) with egg allergy to oral immunotherapy with egg-white powder or placebo. Immunotherapy lasted 22 months and involved dose-escalation on day one, a build-up phase, and a maintenance phase in which children consumed up to 2 g/day of egg-white powder (roughly equivalent to a third of an egg).
At 22 months, three quarters of immunotherapy recipients passed a 10-g egg-white powder challenge (no placebo recipient did). And 2 months after immunotherapy ended, 28% of treated children successfully ate a whole egg; these children were consuming eggs a year later.
In Journal Watch Pediatrics and Adolescent Medicine, David Amrol writes: “Although oral immunotherapy is our best chance for a food allergy cure, it is not ready for mainstream use until protocols are further refined. Patients who are not enrolled in clinical trials must continue to rely on allergen avoidance, patient education, and self-injectable epinephrine.”